Professional Documents
Culture Documents
Healey, representing the Commonwealth in the above-captioned action. I make this affidavit
under pains and penalty of perjury in support of the Commonwealth’s Memorandum of Law in
Opposition to the Motion of Defendants Craig Landau, John Stewart, and Mark Timney to
2. The Massachusetts Appeals Court reported in Cepeda v. Kass that “[t]he most
typical method of resolving a motion to dismiss for lack of personal jurisdiction” is application
of the prima facie standard. 62 Mass. App. Ct. 732, 737-38 (2004) The court noted:
specific personal jurisdiction over Defendants John Stewart, Mark Timney, and Craig Landau.
3. Consistent with Cepeda, I have attached true and correct copies or excerpts of the
documents listed as exhibits hereto. See id. at 737 (“The most common approach allows a court
to determine a rule 12(b)(2) motion solely on affidavits and other written evidence”).
4. These attached documents are not intended to address the full scope of
jurisdictional facts alleged in the Commonwealth’s Complaint. As explained briefly for each
document, below, these documents are attached to dispute certain assertions made by Defendants
John Stewart, Mark Timney, and Craig Landau in the Declarations submitted with their Motion
to Dismiss.
Purdue Pharma LP in the federal multi-district litigation and subsequently reproduced in this
case (Bates prefixes PPLP and PPLPC; reference to ¶ in FAC); (b) documents produced by
Purdue Pharma LP in the federal multi-district litigation and not subsequently reproduced in this
case (Bates prefixes PPLP and PPLPC; no reference to ¶ in FAC); (c) documents produced by
McKinsey & Company pursuant to a Civil Investigative Demand issued by this office under
M.G.L. Chapter 93A (Bates prefix MCK-MAAG); and (d) documents produced by Publicis
Group pursuant to a Civil Investigative Demand issued by this office under M.G.L. Chapter 93A
John Stewart
6. Stewart states, in his Declaration: “In my role as CEO of Purdue, I was not
Massachusetts or any other state. Nor was I involved in the management or direct oversight of
2
Purdue sales representatives in Massachusetts or any other state.” Stewart Decl. ¶ 10. “As CEO
of Purdue, I did not personally engage in the marketing or promotion of Purdue’s opioid
Massachusetts.” Stewart Decl. ¶ 11. I submit the following documents as written evidence that
Stewart managed the marketing and promotion of opioids in Massachusetts, including directing
• Exhibit 1 is an email chain excerpt dated May 25, 2011 to/from John Stewart “re:
Butrans Weekly Report for the week ending May 13, 2011,” bearing Bates numbers
“Please get your team to pull together the analyses and action plan
referred to in both your memo and my email below, and the action
plan should have elements specifically directed at: sales force call
targeting; sales force prescriptions by representative (range from
high to low, and what ‘performance improvement plans’ are being
put in place for those in the lowest deciles; key questions /
obstacles being identified from the field and medical services, and
how they are being addressed; what other information the sales
force feels will help boost sales; the current situation with each of
the major MCOs, and the plan and targets going forward (with
specific dates); and key marketing activities and their state date
that by themselves may help boost sales….
• Exhibit 2 is an email chain dated March 8, 2012 to/from John Stewart “Re: Copy of
tells Defendant Russell Gasdia that “reduc[ing] the direct contact of Richard [Sackler]
into the organization” is something he works on “virtually every day,” but that when
3
Sackler “does ask for [sales] data – I find it best to just give it to him, but at the same
• Exhibit 3 is an email dated June 11, 2012 from Mike Innaurato to William Mallin and
John Stewart titled “June 18 2012 mid year board Marketing pres v11.pptx” bearing
Slide 5 states: “Purdue Analgesic Franchise Captures 30% of all Brand and
Generic new ERO Patients Monthly.” Slides 10 through 13 discuss the OxyContin
Slide 11 states:
• Exhibit 4 is a memorandum dated July 18, 2013 from McKinsey & Co. to John Stewart
and Russell Gasdia titled “Identifying granular growth opportunities for OxyContin: First
and is referenced in the FAC at ¶ 407 n.463 (bearing different bates). Excerpts from this
At page 2:
4
improve its local market approach to capture these opportunities.”
MCK-MAAG-0024284
At page 3:
At page 6:
At page 11:
At page 15:
At page 17:
5
quickly. These include: higher call productivity, full delivery of
OxyContin P1s, higher reach of decile 6-10 prescribers, greater
adherence to call lists, and field training on how to appropriately
engage medical.” MCK-MAAG-0024299
At page 18:
“We are only partially through our work and many analyses are in
progress. For example, we know that over 40% of OxyContin
decline (in milligrams sold) is due to a reduction in tabs/Rx and
mgs/Rx.” MCK-MAAG-0024300
• Exhibit 5 is a presentation dated August 5, 2013 from McKinsey & Co. to John Stewart
titled “OxyContin growth opportunities: Update with John Stewart” bearing Bates
document.)
Slide 2 states:
Slide 5 states:
• Exhibit 6 is a memorandum dated August 8, 2013 from McKinsey & Co. to John Stewart
and Russell Gasdia titled “Identifying granular growth opportunities for OxyContin:
Addendum to July 18th and August 5th updates,” bearing Bates numbers PPLP004409892
Page 1 states:
6
Page 3 states:
Page 4 states:
While the wholesaler issues are quite visible and real, we believe
the daily decisions being made at local pharmacies, while less
publicly visible, are in fact creating far grater access issues.
7
implemented (e.g., CVS in 2012) or are considering similar
policies. Thus the pharmacy access issue is both urgent and broad.
Page 7 states:
“Our experience makes clear that one fundamental ‘must have’ for
execution success is strong leadership alignment upfront.
• Exhibit 7 is an email from John Stewart dated May 22, 2013 titled “Edits to 2013 Mid-
with handwritten notes, all of which are referenced in the FAC at ¶ 672 n. 808. Slide 9
contains edits to a slide stating: “Causes of the decline in tablets per script are being
Slide 12 titled, “Potential Causes of the decline in scripts – especially the higher
8
• Exhibit 8 is a Rosetta Creative Brief dated September 3, 2013 for “Purdue OxyContin”
Refresh” are to “[e]volve the current OxyContin creative campaign, ‘Individualize the
“MEASURABLE IMPACT: How are we defining success?”, the document states: “Shift
7. In his Declaration, Stewart admits that he came to Massachusetts to meet with the
director of the Massachusetts General Hospital Purdue Pharma Pain Program. He states that he
“was asked to travel” to discuss reinstating Purdue’s payments to the Program, but denies that
the purpose of the trip was in any way to promote Purdue’s opioids or “opioids generally.”
Stewart Decl. ¶ 12a. I submit the following documents as written evidence that Stewart managed
the decision to pay the Massachusetts General Hospital and that a purpose of the payment was
• Exhibit 9 is a memorandum dated July 9, 2009 from J. David Haddox to John Stewart
titled “Re: Massachusetts General Hospital (MGH) Purdue Pharma Pain Program,”
9
“The details of any specific educational program are overseen by
an Educational Program Committee (EPC), comprising the DACC
Chair, three (3) members of the HMS faculty selected by the
DACC Chair in consultation with the Dean of the Faculty of
Medicine HMS [], and one person appointed by PPLP…. The
EPC makes recommendations for funding educational programs to
an Oversight Board…. In making decisions, the Board shall
consult with a person designated by PPLP, provided that such
consultation is purely advisory and all final decisions shall be
made by the Board.
• Exhibit 10 is an email dated December 22, 2009 from Edward Mahony titled “Notes and
Actions Follow Up from November Board Meeting” with the attachment “2010 Budget
Presentation Notes and Actions 12-22-09B send to JHS,” bearing Bates numbers
211. The email states: “At John Stewart’s request, attached is a list of questions raised at
the November Board meeting and answers or actions on each. In certain cases, the action
page 10: “Q: Determine whether or not it would be appropriate to reinitiate funding of
the Mass. General Pain Center. A: John Stewart is working with David Haddox and the
PPLPC012000249337.
Mark Timney
8. In his Declaration, Timney states, “In my role as CEO of Purdue, I was not
Massachusetts or any other state. Nor was I involved in the management or direct oversight of
10
Purdue sales representatives in Massachusetts or any other state.” Timney Decl. ¶ 12. I attach
• Exhibit 11 is an email dated May 14, 2014 from Mark Timney titled “ADF in MA,”
the same email is referenced in the FAC at ¶ 439 n. 520 (different Bates). Timney emails
“MNPConsultinglimited-BoardofDirectors@pharma.com”:
• Exhibit 12 is an email dated November 1, 2016 from Robert Josephson titled “Boston
Globe: Purdue’s Letter to the Editor: Boston Globe” bearing Bates numbers
938.
“Given the gravity of the opioid epidemic, it’s critical your readers
know that not all reductions in opioid prescribing result in reduced
opioid abuse….
11
Opioid manufacturers must promote products responsibly, helping
to ensure that our medicines are prescribed only to the right patient
for the right reason.
9. In his Declaration, Timney states: “to my knowledge, the call center was not used
for affirmative outreach.” I submit the following documents as written evidence that the call
center was used for affirmative outreach and Timney knew this fact.
• Exhibit 13 is an email dated December 18, 2014 from Mark Timney to Russell Gasdia
Product Information Center (PIC)” (Call Center) that defendant Russell Gasdia tells him
12
• Exhibit 14 is an email dated May 23, 2014 from William Mallin “RE: EC Meeting
promoting drugs to “No-see” physicians. Slide 61 states under “Call Center Initiative
Objectives:” “Increase scripts for Butrans and OxyContin with the ‘no see’ HCPs.”
10. In his Declaration, Timney states: “I [] did not personally participate in any sales
or marketing efforts focused on the Partners or Steward hospital systems.” I submit the following
• Exhibit 15 is an excerpted presentation dated April 24, 2014 from McKinsey & Co. titled
Purdue and IDN leadership….” Slide 25 identifies Steward Health Care System, LLC
associated with growing over-performers is: 36K TRx annually ($16M gross revenue).”
Slide 35 identifies Massachusetts as one of four states for “Wave 1” of the IDN strategy,
and lists Steward and Partners HealthCare System as the first two IDNs of four listed for
Massachusetts.
Craig Landau
11. In his Declaration, Landau says that “in the eight months” he served as CEO of
Purdue prior to February 2018, when “Purdue ceased deploying sales personnel to promote its
opioid medications to prescribers,” he was “not involved in the day-to-day marketing activities
13
or promotion of prescription opioids in Massachusetts or any other state.” Landau Decl. ¶¶ 13,
15. I submit the following document as written evidence that this statement is incorrect.
• Exhibit 16 is an email dated October 09, 2017 from Matthew Vance titled “Craig Landau
The document lists six field rides with sales representatives scheduled for Landau from
12. Landau states in his Declaration that he “did not personally negotiate” Purdue’s
contracts with Analgesic Research, that these agreements “were negotiated by other Purdue
departments and presented to me for my signature,” and that “[i]n any event,” these agreements
“related solely to the clinical development of Butrans and Hysingla….” Landau Decl. ¶ 17. I
submit the following documents as written evidence that Landau’s characterizations of the
• Exhibit 17 is an email dated November 25, 2008 from Craig Landau titled “Fw:
14
tomorrow night through the weekend if this helps.”
PPLPC03000335655
• Exhibit 18 is an email dated December 2, 2008 from Craig Landau “First Draft- OTR
Resistant.
Landau states:
“I spoke with Nat this evening. Here are his detailed comments on
the REMS draft and FDA Briefing Document. Given the diverse
nature of his comments, I’ve included what I believe to be the
proper distribution. I’ll look forward to discussing further in a
meeting I’ll look to schedule either late tomorrow or early Wed
morning.” PPLPC018000255234
13. In his Declaration, Landau states: “I have never regularly conducted or solicited
Massachusetts, either as CEO of Purdue or otherwise.” Landau Decl. ¶ 13. He also states: “I
have not personally directed or engaged in the marketing or promotion of Purdue’s opioid
Massachusetts doctors. I have not directed any other Purdue employee to visit particular doctors
any particular promotional activities in Massachusetts.” Landau Decl. ¶ 16. I submit the
• Exhibit 19 is an email dated September 1, 2017 from Craig Landau “Meeting to discuss
Margaret Feltz:
15
“I am concerned about the delay in remediating these sales force
training gaps given the recommended next steps [by] Craig. [sic]
As you and I have discussed a number of times over the last few
weeks, the differences in approach between the detailing of opioids
and Symproic is in my mind a significant source of additional risk
from a compliance perspective. We can always change our
strategy at a later point in time, but it is in my view imperative that
the sales force gets re-certified on the Opioid front against the
existing standard. I also raised these points with Marv once again
last week and encouraged him to align with you so we can put
something in place ideally before the Symproic launch date.”
PPLPC016000315551.
• Exhibit 20 is an email dated November 13, 2017 from Tejash Shah (on behalf of Craig
Landau) titled “Opioid Crisis & Purdue Pharma” together with the attachment “171113
Letter for Pres. Monaco.pdf” signed by Craig Landau, M.D., and bearing Bates numbers
16
In closing, I’d offer that even though our products represent less
than two percent of our nation’s opioid prescriptions, we at Purdue
Pharma believe it as [sic] our responsibility to lead our industry in
helping address our nation’s opioid epidemic. This reflects our
company’s core values, instilled by Drs. Mortimer and Raymond
Sackler, to use science to improve public health. This was their
lifelong goal, reflected in their professional, personal, and
philanthropic endeavors, including their support for Tufts which
began many years before the introduction of Purdue’s first opioid
analgesic product.
Massachusetts as a Target
focus for me as CEO of Purdue, and I did not understand it to be of any particular focus for
focus for me as CEO of Purdue, and I did not understand it to be of particular focus for Purdue.
Timney Decl. ¶ 8. Landau too, in his Declaration, states that “Massachusetts has not been a state
of particular focus for me, and I have not understood it to be of particular focus for Purdue.”
Landau Decl. ¶ 13. Stewart further states in his Declaration that he did not “attempt to influence
legislation in Massachusetts.” Stewart Decl. ¶ 17. Timney further says, in his Declaration:
“sales initiatives in place during my tenure… were not specifically focused on Massachusetts,
which was of no greater importance than any other state from a sales strategy perspective…. I
did not consider Massachusetts to be a ‘high value geography’. Timney Decl. ¶ 16.
I submit the following documents as written evidence that these statements are incorrect.
• Exhibit 21 is a memorandum dated May 7, 2000 from J. David Haddox “re: Site Visit of
Master of Science in Pain Research, Education and Policy, Tufts University School of
17
Medicine, 4/26/00 through 4/27/00,” bearing Bates numbers PPLPC013000048630 –
• Exhibit 22 is a letter dated May 16, 2001 from Dr. Martin Acquadro of Massachusetts
General Hospital to Paul Goldenheim asking for $3 million for a new pain center at
Acquadro writes:
18
“On behalf of the Massachusetts General Hospital, it is with
pleasure that I write to share an exciting opportunity for
collaboration with the MGH Pain Center. We are grateful for
Purdue Pharma’s ongoing support of our world-class program and
invite you to collaborate with us as we expand and improve our
work in the coming months. Specifically, I ask that Purdue
Pharma name the new MGH Pain Center for a gift of $3 million.
On page 2:
• Referring back to Exhibit 9, (a memorandum dated July 9, 2009 from J. David Haddox
to John Stewart titled “Re: Massachusetts General Hospital (MGH) Purdue Pharma Pain
• Exhibit 23 is an email dated August 3, 2014 from Brianne Weingarten “RE: Action
needed by next week for Joe, Mike and Brianne: Purdue Fact Pack - Steward” with
deck states, on slide 12, that Martin McQuadro (Acquadro) was “‘forever in Purdue’s
• Exhibit 24 is an email dated September 13, 2013 from Arnab Ghatak to John Stewart
titled “Final ppt documents” forwarded on January 8, 2014 by Michael Ronning with
geography.” Massachusetts is shaded majority light blue and blue. These colors indicate
Slide 51 lists the territory of Lowell, Massachusetts as “Most attractive,” but with “Below
Average” OxyContin TRx Growth 2011-2012 and notes the territory “Boston South” has
20
“Average” “Market Attractiveness” but “Above Average” OxyContin TRx Growth 2011-
2012.
• Referring back to Exhibit 15 (an excerpted presentation dated April 24, 2014 from
McKinsey & Co. titled “Update on E2E – Evolve to Excellence implementation,” bearing
Bates number MCK-MAAG-0017306), on a map on slide 16, the area around Boston,
Massachusetts is shaded dark orange or red. The map legend indicates that the colors
dark orange or red correspond to less than 20% of OxyContin Core Health Care Providers
over-performing” IDN “by ERO volume. “Total upside associated with growing over-
Slide 26 states that “The Top 50 IDNs by ERO volume are concentrated in 24
states.” The slide lists Massachusetts as one of those states, with Partners HealthCare
System, Inc (“Partners”) and Steward listed as IDNs in Massachusetts. The slide lists an
“estimated incremental TRx generated” of 1,344 for Massachusetts as a result of the IDN
strategy.
21
“External / regional factor” and “Rationale for inclusion,” the slide says “External factors
may make improve (e.g., recent MA legislation) or reduce (E.g., TX is a triplicate state)
Slide 29 states that the OxyContin Market Share at Steward is 31% and 32% at
Partners. OxyContin Managed Care Coverage for both IDNs is designated as “Strong.”
accounts, we propose that the initial phase of this strategy is focused on 14 IDNs.” The
slide lists 4 states with 14 IDNs between them, including Massachusetts with 4: Partners,
October 1, 2014.
• Exhibit 25 is an email dated April 25, 2014 from Brianne Weingarten, with the attached
presentation dated April 23, 2014 titled “Preliminary Corporatized provider profiles,”
Slide 44, one of the Partners slides, states, for Purdue products: “Brigham:
OxyContin used extensively, probably the #1 prescribed long acting. Butrans not used,
although Dr. Ross wrote first 3 Rx.” Under “Purdue connections,” slide 45 lists 8 KOL
22
[Key Opinion Leader] contacts for Partners: Paul Amstein, NP (MGH); Bob Jamison,
Wassan, MD (BW). Under “Other connections” the same slide states “Dr. Sackler
(owner) is major donor to MGH” and under “Next steps” states “Reach out to Dr.
Sackler.”
Signed under the pains and penalties of perjury this 10th day of May 2019.
23
CERTIFICATE OF SERVICE
I, Jenny Wojewoda, Assistant Attorney General, hereby certify that I have this
day, May 10, 2019, served the foregoing document upon all parties by email to:
Counsel for Defendants Purdue Pharma Counsel for Defendants Craig Landau, John
L.P. and Purdue Pharma Inc. Stewart, and Mark Timney
Timothy C. Blank, BBO # 548670 James R. Carroll, BBO # 554426
Jon E. Olsson, BBO # 698783 Maya P. Florence, BBO # 661628
Sarah Magen SKADDEN, ARPS, SLATE MEAGHER &
Debra O’Gorman FLOM LLP
DECHERT LLP 500 Boylston Street
One International Place, 40th Floor Boston, Massachusetts 02116
100 Oliver Street iames.carroll@skadden.com
Boston, MA 02110-2605 maya. florence@skadden. com
timothv.blank@dechert.com
ion.olsson@dechert.com
sarah.magen@dechert.com Counsel for Defendant Russell J. Gasdia
debra.o'gorman@dechert.com Juliet A. Davison, BBO # 562289
DAVISON LAW, LLC
280 Summer St., 5th Floor
Counsel for Defendants Richard Sackler, Boston, MA 02210
Theresa Sackler, Kathe Sackler, Jonathan iuliet@davisonlawllc.com
Sackler, Mortimer D.A. Sackler, Beverly porter@spplawvers.com
Sackler, David Sackler, Ilene Sackler
Lefcourt, Peter Boer, Paulo Costa, Cecil
Pickett; Ralph Snyderman and Judith
Lewent
Robert J. Cordy, BBO # 099720
Matthew L. Knowles, BBO # 678935
Annabel Rodriguez, BBO # 696001
MCDERMOTT WILL & EMERY LLP
28 State Street, Suite 3400
Boston, MA 02109
(617)535-4033
rcordv@mwe.com
mknowles@mwe.com
anrodriguez@mwe.com
COMMONWEALTH OF MASSACHUSETTS
I, Jenny Wojewoda, Assistant Attorney General, hereby certify that I have this day, July 2, 2019,
served the foregoing document with redaction (originally served May 10, 2019 without
redaction) upon all parties by email to:
Counsel for Defendants Purdue Pharma Counsel for Defendants Craig Landau, John
L.P. and Purdue Pharma Inc. Stewart, and Mark Timney
Timothy C. Blank, BBO # 548670 James R. Carroll, BBO # 554426
Jon E. Olsson, BBO # 698783 Maya P. Florence, BBO # 661628
Sarah Magen SKADDEN, ARPS, SLATE MEAGHER &
Debra O'Gorman FLOM LLP
DECHERT LLP 500 Boylston Street
One International Place, 40th Floor Boston, Massachusetts 02116
100 Oliver Street james.carroll@skadden.com
Boston, MA 02110-2605 maya.florence@skadden.com
timothy.blank@dechert.com
jon.olsson@dechert.com
sarah.magen@dechert.com Counsel for Defendant Russell J Gasdia
debra.o'gorman@dechert.com Juliet A. Davison, BBO # 562289
DAVISON LAW, LLC
280 Summer St., 5th Floor
Counsel for Defendants Richard Sackler, Boston, MA 02210
Theresa Sackler, Kathe Sackler, Jonathan juliet@davisonlawllc.com
Sackler, Mortimer D.A. Sackler, Beverly porter@spplawyers.com
Sackler, David Sackler, Ilene Sackler
Le/court, Peter Boer, Paulo Costa, Cecil
Pickett; Ralph Snyderman and Judith
Lewent
Robert J. Cordy, BBO # 099720
Matthew L. Knowles, BBO # 678935
Annabel Rodriguez, BBO # 696001
MCDERMOTT WILL & EMERY LLP
28 State Street, Suite 3400
Boston, MA 02109
(617) 535-4033
rcordy@mwe.com
mknowles@mwe.com
anrodriguez@mwe.com
-
ojewoda
Assistant Attorney General
Exhibit 1
To: Stewart, John H. (US)[/O=PURDUE/OU=Purdue US/cn=Recipients/cn=johns]
From: Gasdia, Russell
Sent: Wed 5/25/2011 2:32:07 PM
Subject: RE: Butrans Weekly Report for the week ending May 13, 2011
CONFIDENTIAL PPLPC012000326096
5 weeks -which was ahead of the rate (430 incremental per week) required to hit this year's budget.
However, it then took 10 weeks to increase from 2,500 to 5,000 scripts per week - and although there
were some weeks of good growth in that period - there were also some with almost no increase.
As Russ noted, the Regional Managers are in this week- and their top priority is to decide the actions
to take to stimulate sales growth. In association with their meeting, a lot of analyses have been
performed - and I'll ask Russ to pull together the salient points along with the feedback and action
plans from the RM Meeting - and set a time to get-together and discuss.
John
Jon Sackler
201 Tresser Boulevard
Stamford, CT. 06901
tel: (203) 588-7200 fax: (203) 588-6500 jsackler@pharma.com
Colleagues
While we experienced a small increase (29) from the previous week, based on total Rxs, we gained
market share and reached 1.07%, the highest level since launch. Also, we are seeing increases in
utilization of the lOmcg/hr and 20mcg/hr strengths.
The regional management team in here this week. A great deal of focus has been on Butrans and
what needs to be done to increase growth at a faster pace. The major areas of focus are:
• Improving physician "targeting" to ensure representatives are calling on the highest potential
physicians
CONFIDENTIAL PPLPC012000326097
*Please note:
• Prescriptions are inclusive of retail, long term care, and mail service channels.
• The store count and patches ordered data reflect all channels of trade.
• The store count reflects the number of outlets that ordered products during the given
CONFIDENTIAL PPLPC012000326098
Exhibit 2
To: Stewart, John H. (US)[/O=PURDUE/OU=Purdue US/cn=Recipients/cn=johns]
From: Gasdia, Russell
Sent: Thur 3/8/2012 6:48:53 AM
Subject: Re: Copy of Butrans Weekly Report 2-24-12-RS.xlsm
Thanks.
CONFIDENTIAL PPLPC012000368569
Share of the Extended Release Opioid Market
(Source: IMS National Sales Perspective; includes branded and
generic opioids)
"Condon, Donna"
conta1r11ngthelatestdata located
the
to
David
CONFIDENTIAL PPLPC012000368570
Exhibit 3
To: Mallin, William[/O=PURDUE/OU=Purdue US/cn=Recipients/cn=MallinW]; Stewart, John H.
(US)[/O=PURDUE/OU=Purdue US/cn=Recipients/cn=johns]
Cc: Gasdia, Russell[/O=PURDUE/OU=Purdue US/cn=Recipients/cn=58B02E32]; Mahony,
Edward[/O=PURDUE/OU=Purdue US/cn=Recipients/cn=MahonyE]; Salwan,
Sharon[/O=PURDUE/OU=Purdue US/cn=Recipients/cn=SalwanS]; Richards,
Tim[/O=PURDUE/OU=Purdue US/cn=Recipients/cn=CBCEAB1 F]
From: lnnaurato, Mike
Sent: Mon 6/11/2012 6:19:56 PM
Subject: June 18 2012 mid year board Marketing pres v11.pptx
All
Attached are the final slides for printing with all changes discussed today.
Thanks
Mike
CONFIDENTIAL PPLPC012000382118
4/29/2019
Mid‐Year Sales and Marketing
Update
June 18, 2012
Mike Innaurato
Confidential 1
PPLPC012000382119 1
4/29/2019
Agenda
• OxyContin® and Butrans® Market Trends
– Prescriptions
– New‐to‐Brand Patients
• Competitive Activity
• Sales/Marketing and R&D Initiatives to drive sales
• Latest Estimates for 2012
Confidential 2
PPLPC012000382119 2
4/29/2019
OxyContin® Tablets
• Identified drivers of the trends:
– 2012 budget assumed an Extended‐Release Opioid market
growth of 3.1% and the YTD growth is actually ‐0.2%
• ERO market Rxs are 820k lower than anticipated in the budget;
OxyContin share = 200k Rxs or $86MM
– Butrans® and Nucynta® ER are affecting New‐to‐Brand Rxs for
other opioids
Confidential 3
PPLPC012000382119 3
4/29/2019
All Extended‐Release Opioid (ERO) Brands Fight for the 105,000
New Patients Who Start on a Branded ERO Each Month
350,000
300,000
250,000
200,000
150,000
100,000
50,000
This is the battleground for branded
Extended‐Release Opioid products
0
PPLPC012000382119 4
4/29/2019
Purdue Analgesic Franchise Captures 30% of all Brand and Generic
new ERO Patients Monthly
35.0% ORF
Butrans® Launch
Launch
30.0%
25.0%
NBRx Share of the ERO Market
Nucynta® ER
Launch
20.0%
15.0%
10.0%
5.0%
0.0%
PPLPC012000382119 5
4/29/2019
The Launches of Butrans® and Nucynta® ER have Impacted
Other Brand NBRx Volume
110,000
Butrans
100,000 Launch
90,000
Nucynta ER
80,000
Launch
70,000
60,000 OxyContin
Butrans
50,000
Nucynta ER
Exalgo
40,000
Opana ER
30,000
20,000
10,000
PPLPC012000382119 6
4/29/2019
OxyContin® Tablets
• Identified drivers of the trends:
– 2012 budget assumed an Extended‐Release Opioid market growth of
3.1% and the YTD growth is actually ‐0.2%
• ERO market Rxs are 820k lower than anticipated in the budget;
OxyContin share = 200k Rxs or $86MM
– Butrans® and Nucynta® ER are affecting New‐to‐Brand Rxs for other
opioids
– Cash and Medicaid Channels decline in sales was not anticipated in
the budget and are, in particular, affecting OxyContin sales
• Impact could be $81MM annualized
Confidential 7
PPLPC012000382119 7
4/29/2019
Cash and Medicaid Experienced Significant Declines in the
2nd Half of 2011. This Amounts to $81MM Annually.
OxyContin® Cash and Medicaid TRxs
Retail Pharmacies, Mail Order, and LTC
40,000
2012 forecast completed
with data thru July 2011
35,000
30,000
Monthly Rxs
Cash
Medicaid
25,000
20,000
15,000
Confidential 8
PPLPC012000382119 8
4/29/2019
OxyContin® Tablets
• Identified drivers of the trends:
– 2012 budget assumed an Extended‐Release Opioid market growth of 3.1% and
the YTD growth is actually ‐0.2%
• ERO market Rxs are 820k lower than anticipated in the budget;
OxyContin share = 200k Rxs or $86MM
– Butrans® and Nucynta® ER are affecting New‐to‐Brand Rxs for other opioids
– Cash and Medicaid Channels decline in sales was not anticipated in the budget
and are, in particular, affecting OxyContin sales
• Impact could be $81MM annualized
– Sales and promotional support behind OxyContin Tablets is in line with budget
and additional promotional activity will be undertaken in Q3 and Q4 in order to
further increase appropriate demand
– We are currently analyzing the impact of OxyContin primary presentations and
will be prepared to present findings at a future BOD Meeting
Confidential 9
PPLPC012000382119 9
4/29/2019
OxyContin® Tablets
• We are executing our 2012 program (budget) to drive
sales including:
– 120,000 primary position calls added – Effective February 2012
– Increased secondary presentations from 77% to 90%
– Leveraging the 2nd tier formulary status (77% of lives)
– Investing in 3 major non‐rep initiatives:
• Expansion of eMarketing Programs from 5,000 to 51,000 prescribers
• Expansion of Professional Television Network from 3,000 to 9,000
prescribers
• Expansion of Patient Co‐Pay Savings Program; participation has doubled
since inception in March 2012
Confidential 10
PPLPC012000382119 10
4/29/2019
Increase New Patient Starts: Patient Savings Card Program
• Introduce new channels to broaden access
to Patient Savings Card program
– Point‐of‐sale automatic savings (RelayHealth)
• Began March 3, 2012
– HCP downloadable savings cards
• Began February 1, 2012
• Continue with the $70 Patient Savings
Card program
– Doctors whose patients redeem the savings card
increase Rx volume by 28%
– ~60% more patients stay on therapy >90 days if a
savings card is redeemed
Confidential 11
PPLPC012000382119 11
4/29/2019
New OxyContin® Patients Remaining on Therapy is
Significantly Higher Among Savings Card Users
100%
Test Control
60% increase Stay on
80% in patients at therapy 41
90 days days longer
% of Patients
60%
40%
20%
0%
*30 * 60 * 90 *120 *150 *180 * 210 * 240 *270 * 300 * 330 360
Time Period (Days)
* Difference between groups is significant at the .05 level
New to OxyContin = New to Therapy + New to Brand
Confidential 12
PPLPC012000382119 12
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
8/6/2011
PPLPC012000382119
8/13/2011
8/20/2011
8/27/2011
9/3/2011
9/10/2011
9/17/2011
9/24/2011
10/1/2011
10/8/2011
10/15/2011
10/22/2011
10/29/2011
11/5/2011
11/12/2011
11/19/2011
11/26/2011
Print Savings Cards
12/3/2011
12/10/2011
12/17/2011
12/24/2011
(Print + eVoucher)
12/31/2011
1/7/2012
1/14/2012
Weekly Savings Card Redemptions
eVoucher
1/21/2012
1/28/2012
2/4/2012
2/11/2012
2/18/2012
OxyContin® Weekly Savings Card Redemptions
2/25/2012
3/3/2012
3/10/2012
3/17/2012
3/24/2012
Confidential
3/31/2012
4/7/2012
4/14/2012
13
13
4/29/2019
4/29/2019
OxyContin® Latest Estimate
• YTD May Factory Sales are below budget by $27MM
– $47MM lower demand and $20MM higher trade inventory
• Full year Factory Sales are projected to be below budget by
$140MM
– This represents a 4% difference against the $2.9B factory forecast
– Demand is forecasted to be $112MM below budget
– Trade inventory is forecasted to be $28 MM below budget
• The Latest Estimate is $2,737MM
• Additional promotional activity will be undertaken in Q3 and Q4 in
order to further increase appropriate demand
Confidential 14
PPLPC012000382119 14
4/29/2019
Butrans®
• Identified drivers of the trends:
– 2012 budget assumed an Extended‐Release Opioid market
growth of 3.1% and the YTD growth is actually ‐0.2%
• ERO market Rxs are 820k lower than anticipated in the budget;
Butrans share = 16k Rxs or $3.7MM
– Average forecast Rx value is $227 versus forecast of $218
• A 4% improvement
– Butrans® 5 mcg/hour discontinuation rates are higher than
starting doses for other ERO products
• We believe it is due to doctors converting existing opioid patients to a
dose lower than appropriate
– Messages and communications are being updated to address
Confidential 15
PPLPC012000382119 15
4/29/2019
Most Butrans® 5 mcg/hr Patients are not Refilling the Rx
This was not anticipated in the 2012 plan
60% 56%
50%
40%
30% 28%
20%
10%
0%
5 mcg/hr 10 mcg/hr 20 mcg/hr
Confidential 16
PPLPC012000382119 16
4/29/2019
Butrans®
• Identified drivers of the trends:
– 2012 budget assumed an Extended‐Release Opioid market
growth of 3.1% and the YTD growth is actually ‐0.2%
• ERO market Rxs are 820k lower than anticipated in the budget;
Butrans share = 16k Rxs or $3.7MM
– Average forecast Rx value is $227 versus forecast of $218
• A 4% improvement
– Butrans® 5 mcg/hour discontinuation rates are higher than
those of the starting doses for other ERO products
• We believe it is due to doctors converting existing opioid patients to a
dose lower than appropriate
– Messages and communications are being updated to address
– Nucynta® ER is affecting New‐to‐Brand Rxs for Butrans
Confidential 17
PPLPC012000382119 17
4/29/2019
Nucynta® ER has Slowed Butrans® Monthly TRxs
Butrans 2012 budget assumed Nucynta ER would launch January 2012. Nucynta ER actual
launch was September 2011.
Monthly Total Prescriptions of Butrans & Nucynta ER
45,000
Butrans Rx trend from Mar to Sept
2011 was projected through Feb 2012 - The difference
40,000
using simple linear regression between the actual
and projected TRx
35,000
trend from Oct
30,000 2011 to Feb 2012
was 18,474 Rxs.
25,000 - Dollarizing this
TRx (Absolute)
PPLPC012000382119 18
4/29/2019
Butrans®
• We are executing our 2012 program (budget) to include:
– 605,000 primary position sales calls
– Focused rep training and messaging on initiation and titration
– Working with R&D to explore 5mcg/hour label changes and
titration trade packaging
– Other initiatives:
• Butrans Experience Program
• 1350 Speaker Programs
• Expansion of Patient Savings Program – offering new patients a
$0 co‐pay
• Expansion of eMarketing Programs from 21,000 to 77,000 targets
• Professional Television Network
Confidential 19
PPLPC012000382119 19
4/29/2019
Butrans® Actual vs. Forecast
Forecast Actual %
Confidential 20
PPLPC012000382119 20
4/29/2019
Butrans® Latest Estimate
• Butrans sales have been reforecasted based on current
script levels and promotion programs – forecast $130 to
$135MM range
• Approved Budget is $136MM (604k Rxs, $218 avg. Rx
price)
• Recommendation: While Butrans Rxs may fall short,
average Rx price will exceed forecast and, along with new
marketing programs and Managed Care Pull Through
programs, should bring actual dollar sales in line with the
original forecast
Confidential 21
PPLPC012000382119 21
4/29/2019
Butrans® Summary
• Drivers
– Macroeconomic factors have depressed ERO market growth
– Average Rx value of $227 is 4% above forecast
– Butrans discontinuation rates of starting doses (73%) are higher
than other ERO starting doses
– Nucynta® ER launch was 4 months sooner than anticipated
• Actions
– Rep training/messaging on appropriate initiation/titration
– Working with R&D on possible label changes and trade
packaging
– Several marketing initiatives underway (i.e., Experience
Program, Speaker Programs, $0 Co‐Pay Program, etc)
Confidential 22
PPLPC012000382119 22
4/29/2019
OxyContin® Summary
• Drivers
– Macroeconomic factors have depressed ERO market growth
– In Medicaid, we are losing volume as commercial payers are
managing business for states and driving patients to generics
– Cash payers are leaving market
– We are investing in budgeted and additional S&P resources
• Actions
– Adding primary presentations and improved reach of
secondaries
– Investment in Patient Savings Program has doubled patients
using the program
– Investment in eMarketing programs has more than doubled
reach and greatly increased frequency
Confidential 23
PPLPC012000382119 23
Exhibit 4
CONFIDENTIAL
Memorandum to
John Stewart
Russ Gasdia
From
McKinsey & Company
In June, Purdue engaged McKinsey to conduct a rapid assessment of the underlying drivers of
current OxyContin performance, identify key opportunities to increase near-term OxyContin
revenue and develop plans to capture priority opportunities.
While our work is only partially complete, we believe there is significant opportunity to improve
OxyContin performance despite strong opioid marketplace trends that may be shaping a 'new
normal'. We are pursuing 20+ distinct opportunities. All require further analysis, some will
require testing, but several can be implemented quickly.
This memo provides an interim update that is not comprehensive of all the work done. The
memo is divided into four sections:
1. Overall analytical approach
2. Early findings from diagnostic
3. Emerging opportunities
4. Next steps
We set out to objectively examine OxyContin performance in seven areas - market landscape,
commercial resourcing levels, messaging, targeting, field execution, market access, and
medical/scientific support. In each area, we are taking an independent, fact-based, and granular
approach. For the analyses, we are leveraging existing data, and where needed, we have
requested that Purdue purchase new data (e.g., IMS prescriber level milligram dosing data). In
l
TRx growth by zip code, Apr 2011-Mar 2012 v. Apr 2012-Mar 2013
Percent
% Growth% Decline
0 0-25 0-25 Number of zipcodes
25-50 25-50 40% 60%
50+
5,481
3,566
Growing Declining
zipcodes zipcodes
Avg
669 538
TRx/zip
; -.
,. ~ ,--"--~
Example
zip codes
Fort Wayne,
IN (+5.1K)
Knoxville,
TN (-1.9K)
\ : AK \
.. Pinehurst, Tampa, FL
.
. ,.'
..
.
.. '
'
NC (+3.2 K) (-1.9K)
.
' Fayetteville, Renton,
\ .--0---.--
" NC (+2.6K) WA(-1 .5K)
OHi \ ,'
'' .. PR
1 Zip codes with fewer than 60 Oxycontin TRx in both 2011 and 2012 were not considered, accounting for approximately 100,000 TRx in 2011 and 20 12
SOU RC E: IMS; Purdue Sales and Marketing; Team analysis McKinsey & Company I 1
B) Growth by Prescriber
Going one step further to a physician level, 47% of all OxyContin writers (between March 2012
and March 2013) increased their prescribing of OxyContin and 60,000 new prescribers began
writing OxyContin. To better understand where this growth is coming from, we examined
growth by specialty.
Nurse practitioners and physician assistants (NP/PAs) stand out as the only group growing in
double digits (11 %, Exhibit 2). They have the greatest sales rep access and are increasingly
important in large group practices. NPs are currently able to prescribe OxyContin in 41 states.
In addition, NP/PAs as a group are expected to grow at ~3.5% over the next 5 years. Today
Purdue calls on NP/PAs when they appear on a target list, however there is not a tailored
approach or strategy for NPs . Purdue also does not systematically capture data affiliating
NP/PA OxyContin writers with the practice in which they work (e.g., in primary care or as part
of a pain practice).
30 ,206 (25%) 26
Called on
39
54
Not called on 79 78
61
46
1 For3-mont h period ending in March 2013; Reac h def ined as any p hysician who received at least one call (P1 or P2) in the time pe ri od specified
SOURCE : IMS ; Purdue Sales and Marketing; team analysis McKinsey & Company I 3
80 81 85
72
62
51
43
33
TRx 24
10
1 2 3 4 5 6 7 8 9 10
OxyContin prescriber decile by TRx
56 59 61
49
36 42
26 31
NBRx 20
13
1 2 3 4 5 6 7 8 9 10
OxyContin prescriber decile by NBRx
SOURC E: IMS; Purdue Sales and Marketing ; Team analysis McKinsey & Company I 4
(No te: each decile contains 10% of the volume ofTRx or NBRx. Each decile has different
numbers of physicians. Decile 10 contains the smallest number ofphysicians but also those of
highest value)
Targeting that only incorporates TRx can create sub-optimal field deployment as reps could
spend too much time with historically high writers. These prescribers may largely be
maintaining patients, with minimal risk of switching stable patients. As a result, these
prescribers may not justify as high a call frequency.
Incorporating NBRx would encourage the field to seek out prescribers who are putting new
patients on OxyContin, both opioid naives and switchers. It is critical for the field to message
physicians experiencing a high rate of brand decision moments, e.g. , someone expanding their
practice. Identifying and supporting high NBRx prescribers is critical to growing your patient
base. We have seen many companies with chronic products initiate sales acceleration strategies
focused on NBRx to boost new sta11s.
Thus there is a tangible opp011unity for Purdue to adjust its targeting to incorporate NBRx.
X
a:
I-
C
Cl)
O>
C
u"'
.c
~
Cl)
4
2
-4
6 7 8 9 10
i:kL
1
u
~ -4
Cl)
-2 1 2 3 4 5 6 7
> >
~ -6 -~ -6
:5 -8 :5
§ -8 § -8
u u
-10 Months of Continuous Vacancy -10 Months of being filled post-vacancy
• After 1o month s of vacancy, O xy TR x fall s an average of 8% v. the overall trend ; the effect is similar
when zips are filled po st- vacancy
• Given that the sale s force call s on N54% of OxyContin volume , thi s is consistent with a 15% N
1 % chang es calculated using a weig hted ave rage of month TRx change for 8373 zip codes with >100 total TRx in a 28 month period (Jan 20 11 to April 20 13)
SOURCE: IMS ; Purdue Sales Operations ; team analysis Mc Kinsey & Company I 6
1,354
1,168
SOURCE: GP/Specialist mix from ZS report "M6 Alignment and Prel iminary Placement Reviewv2.0", slide 74 ; McKinsey
benchmarks; Purdue sales reports; Team analysis
McKinsey & Company I 6
In terms of call attainment for OxyContin, in the first half of 2013 the field delivered 79% of
target PD Es - 67% of the intended first position details (Pls) and 99% of second position details
(P2s).(Exhibit 7) The rebalancing of teITitories in January is a factor but does not explain the
entire difference, as Q2 P 1% had risen to 80%.
• Actual3 37 58 66
SO URCE: Purdue sales reports; Purdue internal interviews ; team analysis McKinsey & Company I 7
Looking more closely at Pls, we examined call adherence to the headquaiters list. The year to
date level of adherence to the HQ list is 56%, meaning that 44% of the calls were made to
prescribers not on the HQ target list. This is well below what we have seen at other companies
which typically reach 85-95% .
10
A
B C
Head- D
quarter Actual P1 On-list P1
Call plan
'
suggested calls calls made
'
# targets
list made
~ 68%/ 38y
~ -
SOURCE: ZS Associates report ; Purdue call data; Team analysis McKinsey & Company I 9
11
F) OxyContin information
Moving to what the field actually says once in the physician's office, it is clear from our early
physician interviews that there is an opportunity to increase awareness and understanding of
both the new formulation and the AD label change.
We detected a consistent difference between pain specialists and PCPs in their understanding of
the new formulation and AD label change. Many pain specialists saw significant value in the
AD properties while PCPs generally had a lower level of understanding and a correspondingly
lower level of perceived value. Pain specialists suggested PCP perception of AD value was
largely driven by their incorrect assessment of the lack of abuse risk in their patients.
In our initial rep rides, we have seen missed opportunities for medical follow up to improve
physician understanding. Yet we also heard from reps and management that medical has not
optimally met physician needs due to a combination of: (a) MSL team being directed to focused
on other stakeholders (but not necessarily prescribers ); (b) no explicit channel for real-time
engagement, and; (c) lack of belief that education will be beneficial for physicians, even when
prescribers ask. In best practice medical organizations, each of these three observations is
reversed: MSLs prioritize building strong relationships with physicians, Medical leverages real
time technology - phone, video and even Google like proprietary tools, and the sales force
routinely coordinates with their Medical colleagues to address physician needs.
The Medical Services information line is underutilized by physicians and the field appears
under-trained on how to appropriately discuss it.
Given the unmet physician need to increase their understanding of the new formulation and AD
label change, MSL resourcing and their ability to strategically engage physicians should be
reconsidered.
12
13
SOURCE: IMS PlanTrak; Purdu e iGallerydata; Purdue interviews ; Team anal ysis McK insey & Co mpany I 10
The second potential opp01iunity we identified was addressing instances of differential field
force pull-through in equal access situations within the same state. This will require further
local inquiry to validate individual opportunities. (Exhibit 10)
14
49
Cherry Hill, Long NJ -60% 38
Branch
22
Goldsboro, NC -55%
33
Burlington
22
Houston Central , TX -45% 14
San Antonio North
16
North Atlanta , GA -45% 24
Savannah
28
West Chester, PA -45% 39
Scranton
More generally, payor pressures like those Purdue has experienced in Part D and MA-PD plans
are likely to intensify. To date, Purdue has not actively prioritized deeply understanding payor
customers and developing value propositions that go beyond rebates. Thus we believe these are
both near-term and mid-term opportunities for Purdue to strengthen its managed care efforts.
Retail pharmacy
The retail channel, both pharmacies and distributors, is under intense scrutiny and direct risk.
We see clear disruption impacting patients and it is spreading. The range of obstacles include
entire pharmacies being shut off by distributors, pharmacies themselves imposing tablet limits,
decreases in channel inventory leading to greater stockouts, and pharmacies choosing to not
stock OxyContin. Yet against this clear and direct threat to patient access, we have not found a
Purdue strategy for response or any significant mitigation steps taken. This requires an urgent
response. Later on, we will describe one early idea to potentially address this issue.
The broader external environment around opioids is being shaped by others and Purdue is being
impacted. In some cases such as state legislation, Purdue has taken action. Yet for other
15
3. Emerging opportunities
Our initial focus has been on the diagnostic. Our work will shift to opportunities over the
coming weeks. To date we have identified and are pursuing 20+ tangible and near term
opportunities to improve Purdue ' s performance. All require further analysis; several will
require real world testing. We are launching a 'test and learn' approach in close coordination
with the sales force.
Initial opportunities fall into three areas: (I) Immediate tactical opportunities for impact within
6 months (II) Near term opportunities requiring testing for impact in 6-12 months, and (III)
Strategic policy decisions to be debated and resolved. (Exhibit 11)
• Make adjustments to select sales force efficiency and effectiveness levers (e.g. , call productivity,
I. reach, targeting , attainment, adherence)
Immediate
tactical • Increase involvement of MSLs in prescriber interactions to ensure effective communication of
opportunities scientific results
• Increase messaging in low-share , high payer access territories on quality of OxyContin coverage
• Promote patient savings cards in areas with high Walgreen 's concentration
• Expand 'starter kit' distribution
• Move to 100% OxyContin P1 sand Butrans P2s in select territories, adjusting incentives accordingly
II.
Opportunities • Selectively reduce peak frequency of OxyContin and use incremental capacity to increase reach ,
requiring targeting high ERO and high NBRx prescribers being missed today
testing
• Increase reach and frequency of calls to NPs and develop tailored messaging
Ill. Create an alternative distribution channel to respond to retail patient access challenges
Strategic
• Increase overall sales force productivity through fundamental re-e xamination of all the sales and
policy
marketing components , ranging from co-positioning to compensation to territory re-definition
decisions
• Develop new strategy to approach or deprioritize corporatized providers
16
I. Immediate tactical opportunities require further validation and adoption by OxyContin brand
leadership. These ideas are primarily about implementing industry best practices in execution.
These best practices can be adapted for Purdue and rolled out quickly. These include: higher
call productivity, full delivery of OxyContin P 1s, higher reach of decile 6-10 prescribers, greater
adherence to call lists, and field training on how to appropriately engage medical.
II. Near term opportunities requiring testing represent a higher degree of change. We suggest
evidence from pilots is needed prior to scale up.
An example would be a transformative shift in OxyContin and Butrans call objectives to l 00%
OxyContin in P 1s and Butrans in P2s. This could be part of a temporary build up or more
permanent in many markets. This could come with corresponding targeting and compensation
changes. We'd suggest this be a 'test and learn' given the value of insight from real world
implementation ( e.g., sizing both the potential OxyContin upside and Butrans downside.)
III. Strategic policy decisions are less about on the ground operations and more about
fundamental change Purdue's go to market model. Many of these decisions could deliver short
perf01mance impact.
Another example is an early idea to create an alternative model for how patients receive
OxyContin. This model would bypass retail , likely through a third party vendor who would
provide adjudication and direct distribution to patients.(Exhibit 12) Physician offices or
patients would send in prescriptions and this alternative channel could replace pharmacy call
backs with patient care value added services. Recordkeeping could be much easier if done
centrally by experts. Pfizer, J&J and AZ have all developed versions of this direct to patient
distribution model to improve patient access.
17
I
I
/
,.
- 3" party
adjudicator
3 3,,; pa,ty acljudicator {call center/ adjudicates
claim with payor {checks benefit. bills
insurance) and transmits order to dist,ibutor
McKinsey ,1 Company I 12
Implementation of ideas in all three areas requires a cultural and mindset change for Purdue.
Successful adoption of new approaches will be challenging for the organization. We are
encouraged by many leaders who are ready and highly supp01tive of driving the types of
changes described here .
4. Next steps
We are only partially through our work and many analyses are in progress. For example, we
know that over 40% of OxyContin decline (in milligrams sold) is due to a reduction in tabs/Rx
and mgs/Rx. We are developing a perspective based on channel inventory data, external
discussions with pharmacists and new IMS data. Other in progress analyses include: deeper
evaluation of the micro-markets, consideration of sales curves by market characteristics and
assessment of pricing by dosage .
Given the focus on near term performance, we will continue to focus disproportionately on
those opp01tunities that can have the biggest impact.
We recognize the urgency, complexity and scale of the issues we have found to date. We will
proceed with our absolute best efforts. We are confident that significant progress will be made
and at a substantially accelerated pace; but the scale and degree of change being considered is
substantial. Capturing these opportunities will be a journey, not an event for Purdue.
18
19
OxyContin growth
opportunities
• When combined with the prior sales and marketing findings, we believe the scale of change needed is significant. As
such, rather than addressing the pieces individually, we believe Purdue should embark on a comprehensive
sales transformation journey, optimizing across a range of levers. For example:
Targeting: we strongly recommend moving from a decile-based system to the industry best practice of a workload-
based system where additional factors such as NB Rx, Gx penetration, and managed care access are used to
more precisely identify high-potential prescribers
Make re-capturing the "biggest losers" among prescribers an ongoing field imperative
Adherence: to capture the value of improved targeting, the reps must adhere to the call list and fundamentally
change their operating model in the field to more closely follow targeting guidance
Frequency: new physician detailing patterns should be im plemented which will likely require higher frequency than
today on the most valuable physicians
Productivity: total field activity (i.e., calls per year) needs to increase to come in line with best practices and to
enable new targeting and frequency goals
Territories: Explore redrawing territories based on maximizing OxyContin
Incentive compensation: change incentive structure to maximize Purdue near term profitability, like ly req ui ring shift
towards OxyContin and away from Butrans
Sizing: Analyze the potential of increasing field size to maximize profitable OxyContin growth
• Based on the experiences of other companies, this journey will require significant further analytics , early recognition of
the organizational changes required (e.g., mindsets, behaviors and culture), strong consensus within senior leadersh ip,
and commitment to and expectations of at least a 6-9 month timeline
From
of OxyContin Is
concentrated in
I
E
prescribers that l
8,600 10,000
1,100 Purdue does not i
3
call
-14 ,900
-900
• The impact of calls is
l
-+
1
~37,700 particu larly strong in
high-deciles; 2/3rds
of 96K decline is in .
'
', deciles 5-10 !
-95 ,700
Analysis also shows
I
.;
t
-127,000
. call sensitivity
throu ghout range of
l
i
;
PDEs
0 0-4 4-8 8-12 12-16 16-24 24+ OVERALL !i"'
# OxyContin PDEs from April 2012-Mar 2013 2 . This suggests that I
increased call activity i
may have a
% decli ne -10% -8% -4% 0% 0% 3% 8% substantial impact on
# slowing th e decli ne of
prescri bers 343K 43K 16K BK 4K 3K 1K 417K OxyConti n
1 TRx change measured in absolute terms between 6 months ending in March 2012 and 6 months ending in March 2013
2 PDE (primary detail equivalent) calculated using 1.0 weight for a P1 and 0.5 for a P2
• We are still working on refining the list of test & learns to focus on those that will
be most impactful
• A good test & learn a) requ ires field testing to verify impact and ease of
implementation , b) can generate results so that a decision can be made in a short
enough timeframe (e.g. 3 months) before rolling out broadly, c) cannot be tested
without field engagement
• In addition, we continue to run retrospective analysis where possible to look for
'natural pilots' that we can learn from without requiring pilots in field
• The most likely set of test & learns that meet our requirements include
In Targeting , we believe the one test & learn should be a shift to 100%
OxyContin in the P1 position, accompanied by a commensurate change in
incentive compensation
In field operations, we fully support the medical training and are continuing
retrospective analysis on the others with the hypotheses that many can simply
be done vs tested
• Given the need for further planning , we anticipate a start date of 9/ 1
• There are a number of Issues at the pharmacy and wholesale level that are significantly impacting patient access:
Pharmacists are increasingly turning away opioid patients, especially at chain pharmacies. Pharmacists are telling patients
that they are low on stock, or giving other reasons for not filling a patient's opioid prescription.
Major pharmacies have implemented stringent guidelines on opioid dispensing, including pill count limits and requirements
that patient must have filled same script at same pharmacy previously
Pharmacists increasingly calling back physicians, creating additional work and hassle for physicians
Walgreen's has eliminated incentives for pharmacists to dispense Class II drugs as part of its DEA settlemen t
Wholesalers are keeping a tight hold on supply of all controlled substances, with pharmacies unable to order more than
historical levels without risking being cut otf
There are reports of wholesalers cutting off pharmacies altogether, with Cardinal reporting having cut off - 300 stores
between 2008- 2012 and McKesson reporting having cut off - 65 stores in the last month.
• We have begun a prelim inary evaluation of the extent of the access issue
Patient calls to the Medical Service line on access issues have been increasing - though this represents only a fraction of the
potential impact
Walgreen 's purchasing has been declining at a rate far faster than other pharmacies, with an acceleration in the March-
June 2013 time period after the Good Faith Dispensing policy was rolled out in full
0 Walgreen's estimated monthly retail purchasing of OxyContin declined -1 8% (in units) from Mar 2013 to June 20 13
0 This compares to a 1% decrease over the same period for all other pharmacies
0 Walgreen's accounted fo r - 50-70% of the OxyContin decline over this period
0 There has been a high decline in overall OxyContin tablets sold in certain zip codes where Walgreen 's has stopped dispensing
0 In addition, fewer Walgreens stores are purchasing high-dosage (60mg , 80mg) OxyContin
• There are several recommendations for near-term steps that can be taken to address these issues
Ensure that adequate senior level discussions are taking place with Walgreens
Increase efforts with patient advocacy groups to ensure appropriate access for patients
Accelerate conversations with potential partners on setting up an alternative distribution channe l
Purchase more data that allows store-level insight into all major chains purchasing and inventory, and build an internal capability
to track this in real-time
significantly
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Caller is a parapelegic who has been taking OxyContin for 8 years for chronic pain , caller takes very high doses/high quantities and is
not able to fill Rx? Pharmacists are telling caller that they are unable to get In the quantities caller needs. Caller also takes IR
oxycodone.
- Milwaukee, WI (4/8/2013)
Caller unable to fill prescription for OxyContin 60 mg twice daily in Sorrento, FL 32776. Caller has been taking OxyContin laking for 15
years and has recently run into the issue of not being able to fill prescription. Caller explains that over the last few days has not been
taking OxyContin q12h because caller needs to make it last until caller is able to get prescription filled . Caller has tried Walgreens and
CVS in zip code 32757. Also tried Lake Marie Pharmacy in the next county, but was told it was on back order due to the
reformulation. Looked into using insurance's mail order pharmacy, but doctor is not allowed to write for mail order in FL. Caller is
working with doctor and considering an alternative product.
- Sorrento, FL(4/19/2013)
Caller is a 59 year old with RA who has been without pain medications for the last 8 weeks. Caller is regularly on fentanyl , MSER 100
mg , oxycodone and methadone. Caller is unable to find a pharmacy to fill prescription in the entire state of Pennslyvania and has
driven approximately 1,000 miles in last 3 weeks and even went into Ohio , West Virginia. Pharmacies are saying that they cannot
get the medication from the supplier and caller's insurance will not fill prescriptions under mail order due to the high dosages.
- Lilly, PA (5/6/2013)
"It used to be that prescriber decided what drugs "Patients went to many
pati ents get, now pharmacists are now questioning the pharmacies [in Manhattan] and
decision ... for example, we had a case today where the most pharmacies don 't
patient was on IR, and we called the doctor back to dispense OxyContin"
suggest he change the prescription to 80/20 ER/IR" - Physician specializing in pain
- Former senior pharmacy director at CVS (FL) control
"We are now asking doctors to modify prescriptions ... 'The patient population is annoying, the
for example , if we think the patient isn't opioid tolerant documentation is annoying. A lot of my colleagues
already, we will call the doctor." decide to stop doing opioid prescription later in their
- Former Walgreens Pharmacy Manager (KY) career (because they are tired of the hassle)"
- Anesthesiologist and Pain Management Physician
at major hospital
"Pharmacist should look for different flags : In a certain
market area? IR and ER? Days supplied? Proximity of
the patient to the pharmacy and prescriber? Does the
"PCPS are increasing referrals to specialists , part
prescription look altered? Is this a valid DEA number? Is
because of the big hassle around drug testing, pain
this a valid prescriber? ... Then he calls the prescriber to
contracts, and patient monitoring"
validate for every TRx (requirement in the last year or
-Anesthesiologist and Head/Neck surgeon
two)"
- Former senior pharmacy director at CVS (FL)
SOURCE: Pharmacist expert interviews during week of 7/1512013; Prescriber interviews during June and July 2013 McKinsey & Company I 12
Pharmacy chains are implementing guidelines for ... moreover, pharmacists report increased work
which patients can fill opioid prescriptions, increasing and hassle associated with filling opioid
pharmacists' risk of filling opioid prescriptions ... prescriptions
166
319 experienced sim ilar i
declines, with i;
Walgreens store ~
on 181h St going
from 83 bottles to
57
• Independents in
th e area did not
Total Independents Walgreens increase to pick up
th e excess
#stores 7 2 5 demand
-20 .9 • Th is may be i
driving part of the
i
10mg 20mg 30mg 40mg 60mg 80mg Any
strength overall decline in
hiah-strenaths
OxyContin dosage
04 2012 02 2013
SOURCE: Walg reens inventory data from Purdue McKinsey & Company I 17
Wholesalers cutting 2008-2012 Nationwide , with Cardinal Cardinal stops shipping controlled
off specific concentration in FL medicines to more than 350
pharmacies pharmacies it determined posed an
unreasonable risk of diversion and
reported them to DEA (160 in FLA)
Distribution May 2012 Lakeland , FL Cardinal Cardinal settles the action brought by
facilities closed by the DEA by agreeing to suspend
DEA shipments of controlled drugs from its
Lakeland, FL facility for two years
Other April 2011 Nationwide Harvard After paying $8mn fine to DEA, Harvard
Drug Drug stops selling oxycodone in the US
SOURCE: NYTimes , Cardinal press release, Cardinal website, BusinessWeek, Keyl local news website, Purdue McKinsey & Company I 18
~ - - - - - - - - - - • - Analyzed managed care access and impact • - Size access issue - - - - - - - - ;.1- - 1
r A & (e.g. plan-level performance) • Build recommendations to r
1 cc.~s~.llt • Conducted pharmacists interviews address pharmacy access issue 1
: avar a I Y • Identify key drivers of pharmacy and • Assess planned management of :
'- - - - - - - - - - - -......:.~?.£;,.~~.:.~.;~;,(;,.~,;l,:; ....,,................,........ ..r.•.-r..n-..,-, •.e.~~
. .~.!.f.~...,...... .-,........................ . .......,-,....... .......-,,........ .!
• Assessed current data/gaps •
Scientific support
Commercial spend
levels
• Over the next month, we will develop specific recommendations and , if you
agree, a and detailed workplan for your team for the transformation journey
This addendum highlights two additional findings since our July 18th and August 5th updates and
specific actions we believe Purdue should take to begin to increase sales.
1. Prescriber Targeting
Our refined analyses confirm significant opportunity to improve sales through better targeting.
We believe the upside is >$100 million in annual sales.
Today Purdue spends as much effort detailing the lesser value prescribers (decile 0-4) as it does
on the higher value prescribers (decile 5-10). To put this in perspective, the average prescriber
in decile 5-10 writes 25 times as many OxyContin scripts as a prescriber in decile 0-4. In QI
2013 the majority (52%) of OxyContin primary calls were made to decile 0-4 prescribers.
Including the secondary calls, 57% of the primary detail equivalents (PDEs) were made to decile
0-4 prescribers. Best practice in the industry is over 80% of effort on higher value prescribers.
(Exhibit 1)
U.S. -3
HIGHLY CONFIDENTIAL -ATTORNEYS' EYES ONLY PPLP004409892
Furthermore, 75% of the decline in OxyContin sales comes from prescribers that Purdue is not
calling upon. Two thirds of this decline is from prescribers in deciles 5-10. (Exhibit 2) In
addition, the field sales force primary OxyContin calls are running at 65% of goal.
U.S. -4
HIGHLY CONFIDENTIAL -ATTORNEYS' EYES ONLY PPLP004409893
________ ! ; I
I
~~::1:::;::~~ f
i
.S:00 ! ~
10
[_____J
-127,000 • Analysis also shows •
!
Collectively these findings show significant opportunity to improve targeting and also
emphasize the upside from improvement as OxyContin' s responsiveness to calls appears
significant.
2. Retail access
Access to OxyContin for some patients has become quite challenging in specific local markets.
This is due to a combination of factors including: regulations, DEA initiatives, PROP,
wholesaler initiatives and local pharmacist perceptions_
There is direct evidence of this reduced access through patient calls to Purdue's Medical
Information line which have recorded a 300% increase in instances of patients reporting
difficulty filling opioid prescriptions, often needing to travel to multiple pharmacies in an
attempt to fill their prescription.
There are reports of wholesalers stopping shipments entirely to an increasing number of
pharmacies, causing temporary supply disruptions. Although, it appears that pharmacies are
able to secure alternative distributors.
U.S. -5
HIGHLY CONFIDENTIAL -ATTORNEYS' EYES ONLY PPLP004409894
Pharmacy chains are Implementing guidelines for ... moreover, pharmacists report increased work
which patients can fill opioid prescriptions, increasing and hassle associated with filling opioid
pharmacists' risk of filling opioid prescriptions ••• prescriptions
Separately, as part of their agreement with the DEA, Walgreens eliminated controlled
substances from their bonus calculations for pharmacists. Thus individual pharmacists
effectively lose money every time they accept the work of fulfilling an opiod prescription. Thus
there is a strong dis-incentive for pharmacists to dedicate the extra time needed to maintain
patient access to opiods, even independent of the chain's national guidelines on opioid
dispensing.
U.S. -6
HIGHLY CONFIDENTIAL -ATTORNEYS' EYES ONLY PPLP004409895
% change from
Monthly OxyContin purchasing by pharmacy chain
Millions oftablels
Mar 2013-
June 2013
~----~1i:
~
12 - ~
• 50-70% of the ;
,,,__ _ _ _ Independents -1% decline in ~
OxyContin tablets (
over the Mar-June
9
2013 time period is
attributable to
f
l
Walgreens
8 -
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•
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is accelerating post
roll out of the Good
Fait Dispensing
~•
(GFD) policy--
5 • • • • • - , • • / "::-•'-. • • • • • • • • CVS -4% monthly average
4 / •• ' /-..... changewas-1.8%
, / , Walgreens from Sept 2012 to
3 Rite Aid -3% Jan 2013, and
2 : .. - ...... • - • .. ~ ........ "' - • .. • .. Otherchains 3% accelerated to -
-2% 2.5% between Mar
- - - - - - - - - - - - - Walmart
2013 and May 2013
1
0 "------------<----------->------------·-------------~-------
Sep-12 Nov-12 Jan-13 Mar-13 May-13
We have examined multiple zip codes where Walgreens is a major supplier, and the other local
pharmacies have not seen offsetting increases in purchases - thus it appears that many of these
patients are either going untreated or being forced to find alternatives.
Further, the Walgreens data also shows a significant impact on higher OxyContin dosages.
Among Walgreen stores that stock OxyContin 20mg, in the last three months there has been a
21 % reduction in the number of stores also purchasing the 80mg. It is also important to note
that Walgreen's reduction in the 80mg far exceeds the national trend. Their share of national
purchases of the 80mg has fallen by nearly 20%. Thus Walgreens is not simply reflecting lower
demand, but apparently taking independent action to further reduce 80mg purchasing.
While Walgreens is currently having the most dramatic impact, there is reason to believe that
many of the chains either have implemented (e.g., CVS in 2012) or are considering similar
policies. Thus the pharmacy access issue is both urgent and broad.
The magnitude of today's patient access issues underscores the need to: (1) take immediate
actions to address issues at pharmacies (e.g., ensure appropriate senior level dialogue with
Walgreens, increase patient advocacy efforts); and (2) accelerate exploration of potential
U.S. -7
HIGHLY CONFIDENTIAL -ATTORNEYS' EYES ONLY PPLP004409896
Our experience with other pharmaceutical companies suggests that such a comprehensive Sales
transformation program takes nine months, although positive impact will be seen within 2-3
months. It is critical that Purdue commits to addressing sales as an organizational journey, not
an event. Success requires not only the analytic answer, but even more importantly winning the
hearts and minds of the sales force and permanently changing how the company operates, from
1 Recommended actions to address "retail access" will be included in our final report
U.S. -8
HIGHLY CONFIDENTIAL -ATTORNEYS' EYES ONLY PPLP004409897
U.S. -9
HIGHLY CONFIDENTIAL -ATTORNEYS' EYES ONLY PPLP004409898
Attached are my edits to the mid-year update slides. However, as you are making the edits, please also
look to ensure that the terminology is consistent throughout, that heading are consistent and that the
slides all have the same basic "look" - as opposed to being a random collection from several different
presentations. Some that I feel could be improved from this perspective are #10, #19 (compare it to the
look of #s 20 and 21 ).
Thanks - JS
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lower scripts; strength mix.
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• Jmpact of generic Opana ~R
• ~ Y How lack of patient access to pain medications impacts
healthcare costs. For example, reports of an increase in ER visits.
• Undertake research to determine impact of PROP, Walgreens
· pharmacy aetio11s and DEA actions.
• Undertake physician le·,el analysis of the impact of local PRGP
activity.
-u
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;o o Reiterate patient savings programs/managed care formulary messaging
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PPLPC012000424621
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Trade Inventor y_contract ion in 2013 is now estimate d at
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end of 2013 (inventory at the end of April was $246 million).
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end of April 2013 was $192 million. Reductions are due to:
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o c_v_s and Walgreen~ have mad~ public announcements targeting inventory reductions.Att$,1
o Walgreens switch to ABC to improve store service levels.
As a resul- Walgreens closed their Perrysburg distribution center. ABC is moving
Walgreens pharmacies from a 3 times to a 6 times a week delivery schedule.
o Like Walgreens other chains are increasing their reliance on wholesaler just in time
deliveries to reduce carrying cos.OiJ~
· rtleJF1D.t:ut
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28,817, 24,744 and 22,823 stores, respectively, purchased OxyContin.
o ~e<£_onsu ltants have reported other clients having similar levels of inventory
contraction.
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PPLPC012000424622
Exhibit 8
ePMR Submission Page 1 of 1
Job#
Lit. Code
Brand OxyContin
Description OxyContin Campaign Refresh for 2014
PMR Date 9/12/2013 FDA Code POT Print Due Date 2/1/2014
Requestor R. Cadet Budget Code 1 208-611210-86000RF Act Plan Qtr
{non taxable) (non taxable)
Budget Range 73,500.00 Quantity
Budget Year 2013
TOTAL: $ _ _ _ _ _ _ _ _ __
IRouUnq
Reques tor
SPECIAL APPROVAL
Date
Group VP Date
http://ep1m.us01.apmn.org/PMRReport.asp 9/12/2013
CONFIDENTIAL PUBLICIS-0000094
Creative Brief
Date: 9/3/13
Rosetta Job#: PUROXC13SIRXXXXX SOW Line item: start 2014 projects in 2013
PO: 4500069913
Background
The mean patient dose of OxyContin has fallen significantly over the past several years. This is happening
across all EROs. We have established this is not a managed care-driven phenomenon.
The consensus opinion is that many prescribers- despite deciding to treat with an ERO- are ever more cautious
and conservative with the starting dose, and reluctant to increase it when additional analgesia is clinically
indicated. As a result, it stands to reason that today many patients' pain is being treated sub-optimally.
It is also important to note that the current conversion/dosing recommendations currently listed in the FPI are
extremely conservative in comparison to the previous conversion ratios. Thus making it difficult to provide
HCPs with guidance on how to convert patients to OxyContin from other opioids.
Objectives
Evolve the current OxyContin creative campaign, "Individualize the Dose" to address an emerging market dynamic
Assignment
Agency to present 5-7 concepts in "adcepts" format. Of the presented concepts the client will choose 3-4 to take
into testing. This estimate includes time for minor revisions to be made prior to testing. This estimate also
includes time for revisions to final concept to reflect research findings. It does not include time (or OOPs) required
for a photoshoot. It also does not include time for attendance (or watching) market research. Message refresh
work will also be covered under a separate SOW.
Executional Mandatories
As the creative campaign, this evolution will live across all promotional materials (online and offline). Agency to
leverage people/pill imagery look and feel as much as possible.
Timing
Detailed timeline to come.
CONFIDENTIAL PUBLICIS-0000095
-2-
Estimate
CONFIDENTIAL PUBLICIS-0000096
Cover Sheet
UID LEAD NA
Alvaro Luna
1
, l, I 11
,,
CONFIDENTIAL PUBLICIS-0000097
Conceptual Creative Brief
BACl<GRO UND
ASSIGNMENT: What have we been tasked with? MEASURABLE IMPACT: How are we defining success?
Evolve the current OxyContin creative campaign, "Individualize Shift in trend of declining mean dose of OxyContin
the Dose" to address an emerging market dynamic
The situation, problem or behavior we The idea, belief or behavior that The focused truth about your audience
are addressing, changing, chal lenging or anchors t he brand, that we are to t hat we are to leverage? The belief,
solving: leverage to solve the chal lenge: motivation, need, behavior, or fee ling
t hat can be exp loited.
The mean patient dose of OxyContin has With the flexibility of 7 dose strengths,
fallen significantly over the past several OxyContin can be finely individualized Prescribers want to effectively treat
years. This is happening across all EROs. to the analgesic need of a patient their patient's pain. And they believe
We have establ ished this is not a throughout his or her treatment. they sti ll do. But they are clearly
managed care-driven phenomenon . responding to pressure to be cautious
The consensus opinion is that many and conservative with opioid treatment.
prescribers- despite deciding to treat This is appropriate and responsible. But
with an ERO- are ever more cautiou s prescribers need to be reminded that
and conservative with the starting dose, pa tients in pain deserve effective
and reluctant to increase it when analgesia, and that requires fine tuning
additional analgesia is clinically dosage throughout treatment.
indicated. As a result, it stands to reason To effectively manage patient pain, a
that today many patients' pain is being HCP needs to ask the patient how they
treated sub-optimally. feel. We hypothesize they are not
It is also important to note that the asking because it wou ld require them to
current conversion/dosing respond by titrating when they wou ld
recommendations currently listed in the rather not and often times are pressed
FPI are extremely conservative in for time and therefore don't ask.
comparison to the previous conversion
ratios . Thus making it difficult to provide
HCPs with guidance on how to convert
patients to OxyContin from other
opioids.
TRANSFORMATIVE IDEA
THE STRATEGY: The plan, met hod, or series of mane uvers for THE IDEA: The form the strategy will take
obtaining specified goal
The right dose, at the right time, for the right patient.
Remind prescribers that effectively treating pain means
ongoing patient assessment to inform ongoing dose
adjustments (first).
Reinforce the ability to Individualize ana lgesia with the
flexibility of 7 available doses of OxyContin
2
) IA I ' 11,. I I ' I II I , 11
CONFIDENTIAL PUBLICIS-0000098
EXECUTIONAL CONS IDERATIONS
Channel/Program Requirements: Where wi ll this idea live and Client/Brand/Audience Considerations: Client mandatories
any thought starters? copy/image ry needs and assets and audience watch outs
As the creative campaign, this evolution will live across most e Leverage people/pill imagery look and feel
promotional materials, from th e print ad to HCP eMarketing o This is intended for prescribers only- not patients
initiatives to trade co mmunications • Develop in landscape "adcepts" format
S T A R >T
1R81f:ijiJ&MtJM!l11M:\itl&III
S upplement with an immediate-release analgesic, such as:
• IR oxycodone for patients being converted to OxyContin from other oplolds to manage
Inadequate analgesia
• IR opioid or non-opioid medication for patients who experience breakthrough pain that may
require rescue medication
T itrate every 1-2 days as needed
• Steady-state plasma concentrations are approximated in 1 day
A djust the dose by 25%- 50%
• Total daily dose usually can be increased by 25% to 50",i, of current dose as clinical need
dictates while maintaining q12h dosing
R eassess the patient's analgesia and tolerability throughout treatment
• If the level of pain Increases, attempt to Identify the source of increased pain, while adjusting the
OxyContin dose
T ailor the dose based on the reassessment, titrating up or down
• If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced
• Adjust the dose to obtain an appropriate balance between management of pain and opioid-related
adverse reactions
3
A I, I • 11
CONFIDENTIAL PUBLICIS-0000099
Individualize the dose
4
r< J1 I I ,) ! l I l 1
CONFIDENTIAL PUBLICIS-0000100
Exhibit 9
Health Policy Memorandum
This memo was prepared at the request of Dr. Raymond, who asked me to review the situation as it
developed with the MGH and to provide a basis for dealing with the remainder of this grant commitment.
Background:
An Agreement between Purdue Pharma LP. (PPLP), MGH and Harvard Medical School (HMS) became
effective on 24 September 2003. The Agreement had several provisions, which are summarized in
Appendix 1. In brief, the situation is that a Purdue Pharma Fund for Pain Education and Research was
established and Purdue has made payments totaling $1.5 million of the total funding commitment of $3.0
million - with funding being suspended in 2003 due to the company's financial situation. Now that the
financial situation has improved, the question arises as to whether or not we should restart the funding -
presumably at the level of $500,000 for each of 2009, 2010 and 2011 - which would complete our
obligation.
Although the funding by Purdue has not been restarted, several of the contract-defined interactions
between the Program and PPLP have occurred, including visits by the then-Chair of the Department of
Anesthesia and Critical Care (DACC), Dr. Warren Zapol, and the then-Director of the MGH Purdue
Pharma Pain Program (hereinafter, "the Program"}, Dr. Jane Ballantyne to Purdue, and a few visits by
Purdue staff to MGH. In addition, I have personally met with various physicians involved in the Program
and attended some of the required committee meetings.
The leadership of the DACC and the Program has changed since the Agreement was executed. The
new DACC Chair, who I have yet to meet, is Jeanine Wiener-Kronish, MD, who is board-certified in
Internal Medicine, Pulmonary Medicine, Critical Care Medicine and Anesthesiology. Her clinical interests
include Critical Care Medicine and preoperative assessment. Her research interests include
Pseudomonas aeruginosa pulmonary infections (a significant complication following lung surgery) and
the molecular identification of bacteria.
The new Director of the Program is James P. Rathmell, MD, Chief, Division of Pain Medicine and
Associate Professor, HMS. I have known Jim for well over a decade. He is very active in the
anesthesiology-pain community, including being an examiner for the American Board of Anesthesiology,
a member of the Anesthesiology Residency Review Committee of the Accreditation Council on Graduate
Medical Education, an Associate Editor of Anesthesiology (the premier publication in the field, and the
CONFIDENTIAL PPLPC023000228147
official organ of the American Society of Anesthesiologists) and the Associate Editor-in-Chief of Regional
Anesthesiology and Pain Medicine (the official organ of the American Society of Regional Anesthesia). I
have met with Jim in his capacity as the new Director of the Program and he is eager to have John
Stewart and me meet with him and Dr. Wiener-Kronish - to update us on the Program's progress and
potential future activities. Dr. Rathmell also raised with me the issue of Purdue's resumption of
payments toward the fund/project.
The official designation of the MGH Purdue Pharma Pain Program, including a plaque displayed in the
MGH Center for Pain Medicine.
MGH publishes a series colloquially referred to as "the Handbooks." These are quite popular with
medical students and residents - and provide an in-depth, outlined-based approach to a particular
discipline, such as Psychiatry or Surgery. The following is an exact quote of the Acknowledgement page
of the third edition of the Massachusetts General Hospital Handbook of Pain Management (© 2006):
"We are greatly indebted to Purdue Pharma for their generous and unrestricted grant toward
establishing the MGH Purdue Pharma Pain Program. Purdue's support strengthens our
academic mission and is a mark of their recognition that discovery and knowledge form the
foundations of good clinical care. Purdue has been committed to promoting appropriate pain
management for more than two decades, working closely with MGH and a number of other
organizations to increase awareness of the problem of persistent pain and its cost to individuals
and to society."
As of the last written report, dated 22 May 2005, the MGH Purdue Pain Program had offered
approximately 200 lectures to various MGH groups, including palliative care, internal medicine,
neurology, neurosurgery, psychiatry and pharmacy, as well as anesthesia. Other medical institutions,
such as the Tufts University Schools of Medicine and Dentistry, and the Boston Pain Forum (an informal
collaborative of persons in the Boston health care community with interests in pain care and research),
have often attended these lectures.
There has also been an effort to create an active educational collaboration between the Program and
Beth Israel Harvard Review Course in Pain Medicine (in which I have lectured on several occasions), to
increase the visibility of the Program.
The Program has been studying ways of predicting risk in patients receiving opioid analgesics, has been
tracking outcomes of non-cancer patients receiving opioid analgesics, and has conducted a survey of
physician attitudes towards opioid prescribing (the results of which I do not have). The Program also has
put out a newsletter (Pain Management Frontline) that is typically devoted to a pain topic and includes
brief summaries of articles of interest, as well as notices of upcoming meetings. In each of these
newsletters, PPLP's support is acknowledged, per the Agreement.
Perhaps the most significant achievement of the Program to date is the award of a multi-year NIH grant
to fund translational research on the effects of opioid analgesics correlating basic science research with
clinical use, based on pilot studies made possible by the monies from PPLP.
Observations:
MGH has been very understanding of our commercial situation, but is interested in our reactivating the
schedule.
-2-
CONFIDENTIAL PPLPC023000228148
The Boston media created a frustrating series of stories when they learned of the grant, insinuating that
Purdue was going to be controlling the educational content offered by the Program, which, of course, is
neither allowed nor is it in any way Purdue's intent. The New England Journal of Medicine joined the
fray, suggesting that it might not publish any research that came out of the program, implying that
Purdue's funding created too great a conflict of interest for the research conclusions to be unbiased.
At the time of the press assault on our funding of this project, the individuals at MGH and Harvard who
had responsibility for the Program were essentially silent in defending the agreement and in pointing out
both its propriety and the enormous public health interest it supported. Those individuals (who
disappointed us at that time) are no longer involved with the Center, and I believe their successors see
the project's great value, are committed to it, and will continue its progress in the manner we
contemplated at the outset.
There has been a great deal of legislative activity/debate in Massachusetts around the issues of whether
or not OxyContin® (oxycodone HCI controlled-release) Tablets should remain available to persons in the
Commonwealth. Some legislators have suggested that the product should be classified as a banned
substance under the Commonwealth's controlled substances regulation - in the same class as heroin and
LSD - by introducing a total of five bills to this end. Alan Must and I testified at the Massachusetts
OxyContin and Other Drug Abuse Commission (that became known in the media as the OxyContin
Commission) several years ago. In the most recent legislative session a newly-formed OxyContin and
Heroin Commission has been active; evidence that the legislative focus on Purdue and OxyContin
continues (see Appendix 2). I believe that these activities are relevant, since our actions regarding the
continued support of this project may have an impact on those in the legislature. I fear that a termination
of support might fuel the efforts of those already hostile to us, or reduce the willingness of those who
have supported our positions to continue to do so.
Dr. Rathmell has indicated a willingness to meet with representatives of PPLP to discuss the way
forward. I think it would be worthwhile for you and I to make a trip to Boston to meet with Dr. Rathmell
and Dr. Wiener-Kronish, along with Dr. Jianren Mao, the lead basic researcher in the Program, to chart
the future of this grant. I think there is the potential for excellent, relevant science to derive from our
funding of the Program. However, I believe that we should only meet with MGH representatives if we
are prepared to restart the funding to the Pain Program - unless our visit raises issues of concern.
-3-
CONFIDENTIAL PPLPC023000228149
Appendix 1
The Agreement established the Harvard Medical School Purdue Pharma Fund for Pain Education and
Research (hereinafter, "the Fund").
The Fund was to be created from $3,000,000 cash from PPLP, payable according to the
following schedule:
The purpose of the Fund is to support pain-related projects through the Program, which is
currently housed in the MGH Department of Anesthesia and Critical Care (DACC). Specifically,
the Fund is to be used for recruitment and salaries, equipment and capital needs, and on-going
educational or research programs or projects within the Program. An amount of the Fund, not to
exceed 15% ($450,000), can be used as defray overhead expenses.
The details of any specific educational program are overseen by an Educational Program
Committee (EPC), comprising the DACC Chair, three (3) members of the HMS faculty selected
by the DACC Chair in consultation with the Dean of the Faculty of Medicine HMS (hereinafter,
"the Dean"), and one person appointed by PPLP. Historically, I have been the PPLP appointee.
The EPC makes recommendations for funding educational programs to an Oversight Board
(hereinafter, "the Board"), of no more than five (5) members, which is responsible for overall
administration of the Fund. This Board is constituted as follows: The Chair is the DACC Chair;
one member shall be the President of MGH or his/her designee; with the remainder being HMS
faculty chosen by the DACC Chair in consultation with the Dean. Members of the Program, the
MGH Pain Center and, with the exception of the Chair, the EPC are not eligible to sit on the
Board. In making decisions, the Board shall consult with a person designated by PPLP, provided
that such consultation is purely advisory and all final decisions shall be made by the Board.
Historically, I have also been that PPLP designee. The Board was envisioned to meet quarterly
and to provide PPLP with a comprehensive annual update that provides a detailed outline of how
monies from the Fund were expended.
It also established, in perpetuity, the MGH Purdue Pharma Pain Program (hereinafter, "the Program").
The Program's obligations under the Agreement include:
The area to be utilized by the program is to be marked with a plaque, to remain in perpetuity,
that bears the name of the Program.
Any publications, programs or public events resulting from the Program shall publicly and
conspicuously identify its relationship to the Fund or the Program.
-4-
CONFIDENTIAL PPLPC023000228150
Neither party may publicly disclose the terms of the Agreement or contributions thereto without
consent of the other.
If, in the judgment of HMS or MGH, it becomes impossible or impractical to expend the Fund in
the manner envisioned in the Agreement, the principal and any interest can be used for similar
purposes, as determined by the Dean with the advice of MGH Trustees.
The Agreement supersedes any other letters, Agreements, etc. between PPLP and HMS or
MGH.
The Agreement cannot be modified, except with the written, signed Agreement of party that is
bound by the modification.
-5-
CONFIDENTIAL PPLPC023000228151
Appendix 2
By David Pepose
Posted: 06/01/2009 01:01:15 AM EDT on:
"It is an enormous problem in the Commonwealth, and one that often doesn't receive the attention that it
should," said State Sen. Benjamin B. Downing, D-Pittsfield. "This is not so much a public safety issue,
but rather a public health issue, and we need to address that in that way."
According to Downing, there were more than 3,300 opioid-related overdoses in Massachusetts between
2002 and 2007. The National Drug Intelligence Center stated in May that overdoses cost medical
insurers an estimated $72.5 billion per year.
"The key is bringing light to the issue that is out there, an issue that is statewide," Downing said. "It's
about access to a drug that is taken without supervision that can not only become addictive, but kill
individuals."
"I would say that the abuse of prescription medications is the fastest growing form of substance abuse
that we're seeing," Berkshire County District Attorney David Capeless said.
"Despite the fact that we in the commission are focusing on drugs which are extremely dangerous, there
is a perception that because of their initial use as medication that they are considered 'safe,'" he added.
"In fact, they are still as dangerous as heroin or cocaine."
Dr. Alex Sabo, chairman and program director of the Department of Psychiatry and Behavioral Sciences
at Berkshire Medical Center, agreed. "The No. 1 initiate drug is prescription pain relievers -- this is past
even marijuana," he said.
To fight this war at home, the Berkshire County District Attorney's Office, as well as law enforcement
officials and Berkshire Health Systems, has put together what Sabo calls the Community Pain
Management lnitative.(sic)
"We've put together nonaddictive options for pain treatment," he said, including the Brien Center's
bupenorphine (sic) clinic, an alternative to methadone that helps addicts wean themselves from opioids
without getting an addictive euphoric high.
Among the systems being prescribed is an electronic prescription system, "to make sure that people
don't 'doctor shop,' don't go to four different doctors, four different pharmacies."
Sabo hopes that this hearing will both bring in additional funds for fighting opioid abuse, as well as
showcase the more innovative methods Berkshire County has employed.
"The drugs have a very narrow margin of safety -- that's what its (sic) so important," Sabo said. "It's
going to cost money, but we think solving this problem will reduce the overall price to society
dramatically."
-6-
CONFIDENTIAL PPLPC023000228152
Heroin, OxyContin commission in city Friday
By Will Richmond
Posted May 14, 2009@ 09:19 PM on:
Fall River - A legislative commission analyzing the state's growing rate of heroin and OxyContin
addiction will be in the city today.
Sen. Joan Menard's office announced the Massachusetts OxyContin and Heroin Commission will hold
the third in a series of hearings at the University of Massachusetts Dartmouth's Advanced Technology
and Manufacturing Center at 11 a.m.
The Massachusetts OxyContin and Heroin Commission was created during the 2007-2008 legislative
session and will hold regular public hearings across the commonwealth through August. The group is
chaired by state Sen. Steven A. Tolman, D-Boston.
Public attendance and participation is vital, according to Menard's office, as the commission needs to
hear the public stories and experiences to develop relevant policy recommendations. The commission
will release a final report of its findings in the fall.
"Substance abuse is a vital public health concern in the commonwealth," Menard said. "The work of this
commission will focus on the various elements of prevention, treatment and intervention. I am pleased
that the commission is visiting the SouthCoast so that our region may also have an opportunity to
participate in these important policy discussions."
Tolman said the Fall River hearing will provide an opportunity to a wide range of commenters from
experts in the field to the general public.
-7-
CONFIDENTIAL PPLPC023000228153
Exhibit 10
To: Sackler, Beverly[Beverly.Sackler@pharma.com]; Sackler,
Jonathan[Jonathan.Sackler@pharma.com]; Sackler, Dr Kathe[Dr.K.A.Sackler@pharma.com]; Sackler,
Dr Mortimer[mdsackler@chsquare.co.uk]; Sackler, Mortimer JR[msackler@pharma.com]; Sackler, Dr
Raymond R[DrRaymondR.Sackler@pharma.com]; Sackler, Dr
Richard[DrRichard.Sackler@pharma.com]; Sackler, Theresa[Theresa.Sackler@mdsackler.co. uk];
Sackler Lefcourt, llene[llene. SacklerLefcourt@pharma.com]; Boer, Peter[Peter. Boer@pharma.com];
Lewent, Judy[Judy.Lewent@pharma.com]
Cc: Stewart, John H. (US)[John.H.Stewart@pharma.com]; Gasdia,
Russell[Russell.Gasdia@pharma.com]; Kyle, Don[Don.Kyle@pharma.com]; Landau, Dr.
Craig[Dr.Craig.Landau@pharma.com]; Dolan, James[James.Dolan@pharma.com]; Kaiko, Dr
Robert[Dr.Robert.Kaiko@pharma.com]; Long, David[David.Long@pharma.com]; Rosen,
Burt[Burt.Rosen@pharma.com]; Lundie, David[David.Lundie@pharma.com]; Mallin,
William[William.Mallin@pharma.com]; Haddox, Dr. J. David[Dr.J.David.Haddox@pharma.com];
Strassburger, Philip[Philip.Strassburger@pharma.com]
Bee: Stewart, John H. (US)[John.H.Stewart@pharma.com]
From: Mahony, Edward
Sent: Tue 12/22/2009 5:01 :35 PM
Subject: Notes and Actions Follow Up from November Board Meeting
2010 Budget Presentation Notes and Actions 12-22-099 sent to JHS (2).docx
In certain cases, the action is for a presentation to the Board. Bill Mallin is
scheduling those presentations into the 2010 Board calendar.
Regards,
Ed
CONFIDENTIAL PPLPC012000249327
Purdue Pharma L.P.
Budget Presentation 2010 - November 2nd and 3rd, 2009
1.0 OxyContin
A:
i. Response to questions i-v were provided to Dr. Kathe and Dr. Richard by e-mail from
Mike lnnaurato 12/3/09 13:45h - copy attached.
MI FW 2010 Budget 2010 Budget vlO O LASEO OER and Oxy Market Forecast Nucynta Forecast vl
vlO O revised order_i revised order (2). ppt: Historical Data (2).xls 100709 (2).xlsx O surrmary (2).xlsx
ii. The 2010 gross sales target has been increased by $56 million due to expected delays
in marketing of Covidien's Exalgo and Endo's significant reduction in S&P in support
of Opana ER.
iii. The McKinsey report referred to in question v. will be available in Q2 2010.
Action: Russ Gasdia
b. Q: OxyContin Pediatric - provide the Board with a detailed update on the program, timing,
impact on exclusivity and value created.
A: The R&D group is currently developing the OxyContin pediatric clinical program with
input from the FDA to ensure that the trials can be executed on a timely basis and that
the additional exclusivity is earned. Enrollment in the studies will likely begin in lQ 2011
Once the studies are complete, submitted and accepted by the FDA, Purdue will apply
the additional 6 month exclusivity to one of the patents then listed in the Orange Book -
preferably the "042" patent.
Page 1 of 10
CONFIDENTIAL PPLPC012000249328
c. Q: Report back on the status of the development of a next generation formulation OTR
(e.g. polycapalactone), including IP.
A: The Purdue research team is evaluating two new TR platforms - polycapalactone and
eudrogit NE. The important next steps are to secure manufacturing cabability, prepare
small sample batches, and test prototype formulations. This project is budgeted in
2010, has adequate resources and detailed progress will be included in our R&D report
to the Board in mid 2010.
Action: Don Kyle
d. Q: What are OxyContin's clinical advantages vs. Opana ER, MS Cantin, Kadian, Exalgo,
Avinza, Nucynta and Duragesic? How are these differences communicated?
A: OxyContin has the following advantages vs. the other above products:
i. OxyContin has been studied in more pain syndromes (e.g., LBP, OA, neuropathic pain)
with demonstrated efficacy and published results
ii. Prompt onset of analgesia
iii. Less variability in blood levels
Methods of communication
i. Most of the differences above are published in the Full Prescribing Information or in
the medical literature and, as such, can be provided to clinicians in various formats to
provide clinicians with the information.
Page 2 of 10
CONFIDENTIAL PPLPC012000249329
e. Q: Reconsider the 3% OxyContin price increase planned for 2010 - i.e. consider a higher
price increase in recognition of the increased COGS and cost of royalties with OTR.
A: Over the last 3 years OxyContin list price has been increased a total of 23%. A further
increase of at least 3% is anticipated in 2010. The logic for the proposed price increase will
be discussed at that time, but management believes it is important not to have any price
increase timed directly with the switch from the current to new OxyContin formulatin. A
history of recent OxyContin list price increases is attached.
Microsoft Office
Word 97 - 2003 Docu
2.0 BuTrans
a. Q: Compare proposed USA price (gross and net) with international prices by strength.
A: This analysis is underway as part of the overall Bu Trans launch planning and will be
reported in 2010 as part of the Bu Trans review presentation.
Action: Russ Gasdia
b. Q: Provide the Board with copies of the market research that supports the proposed
pricing.
A: This analysis is underway as part of the overall Bu Trans launch planning and will be
reported in 2010 as part of the Bu Trans review presentation.
Action: Russ Gasdia
c. Q: Regarding the BuTrans pediatric program - provide the Board with a detailed update on
the program, timing, impact on exclusivity and value created.
A: Successful completion of the pediatric studies will extend the patent life for the Bu Trans
product. For instance, it will extend the life of the 7-day patch patent from September
29, 2017 until March 29, 2018.
The Proposed Pediatric Study Request (PPSR), submitted as part of Purdue's complete
response package sent to the FDA on September 30, 2009, describes 3 studies to be
conducted in children between birth and 16 years of age. The 3 proposed studies are as
follows:
i. Study 1: A Multicenter, Inpatient, Open-label Study to Characterize the
Pharmacokinetics, Safety, and Efficacy of a Continuous Intravenous Infusion of
Buprenorphine in Children from Birth to up to 6 Years of Age Who Require Opioid
Analgesia for Acute Moderate to Severe Pain
ii.Study 2: A Multicenter, Randomized, Double-blind, Active Comparator-controlled,
Multiple-dose, Titration Study with an Open-label Extension to Evaluate the Efficacy,
Safety, and Pharmacokinetics of Buprenorphine Transdermal System (BTDS) in Opioid-
Page 3 of 10
CONFIDENTIAL PPLPC012000249330
tolerant Children from 6 to 16 Years of Age Who Require Continuous Opioid Analgesia
for Moderate to Severe Persistent Pain
111. Study 3: An Open-label, Multicenter Study of the Safety, Pharmacokinetics, and
Efficacy of Buprenorphine Transdermal System (BTDS) in Opioid-na'ive Children from 6
to 16 Years of Age Who Require Continuous Opioid Analgesia for Moderate to Severe
Prolonged or Persistent Pain Anticipate up to 4 year enrollment periods, particularly
for double-blind and open-label studies.
The third BuTrans™ patent U.S. 6,344,212, et. al. covers 7-day use of patches and
expires Feb. 24, 2017 w/ possible pediatric exclusivity until Aug. 24, 2017. The final
study reports for pediatric clinical trials conducted must be sent to FDA by no later
than November 2015 to allow the FDA sufficient time to review the reports in support
of exclusivity. As double-blind and open-label pediatric pain trials may take up to 4
years to enroll, the plan is to initiate work on the program immediately in order to
have the potential to gain pediatric exclusivity.
Protocol development and the contracting process with PRA are targeted for
completion by the PDUFA date (March 30, 2009). All tasks up to dosing of first subject
are planned to be completed by September 30, 2009, consistent with an extended
PDUFA date. $4.5 M is currently budgeted for BuTrans™ pediatrics in 2010, sufficient
to cover planned activities. The regulatory environment for pediatric study conduct
and progress towards approval of BuTrans™ will be monitored closely as at-risk work
proceeds.
d. Q: In preparation for the launch, be sure the US Sales and Marketing group is fully aware of
international marketing strategies and sales force activity.
A: Gary Lewandowski will meet with colleagues in markets where BuTrans/Norspan has
been launched. The trip schedule is now being developed.
Action: J. Stewart/R. Gasdia
e. Q: Report US sales projections vs. international sales history in both dollars and numbers of
patches by strength.
A: This analysis is underway as part of the overall Bu Trans launch planning and will be
reported in 2010 as part of the Bu Trans review presentation.
Action: Russ Gasdia
f. Q: Explain the nature of the spend and output expected from the proposed $6.9 mm
BuTrans 2010 marketing spend.
A: The Bu Trans 2010 budget of $6.9 mm is for pre-DDMAC approval related expenses and is
comprised of the following:.
• $2.6 mm - Agency fees (Abelson Taylor)
• $1.4 mm - Promotional items (sell sheets, brochures, presentations)
• $1.4 mm - Market research
• $1.2 mm -Advisory board and website development
Page 4 of 10
CONFIDENTIAL PPLPC012000249331
• $0.3 mm - REMS
3.0 Ryzolt
a. Q: Ryzolt sales are far below expectations - the Board asked for an analysis of how/why
this occurred.
A: Once December sales are available a final report/presentation will be developed for
review with the Board - most likely in February 2010.
Action: Russ Gasdia
b. Q: Evaluate converting Ryzolt primary position calls to secondary position calls starting lQ
2010.
4.0 POA
A: In process.
Action: BDC
A: Infinity's draft FAAH IND is under review at Purdue. An update on the FAAH project will
be included in the next R&D update to the Board.
Action: Jim Dolan
Page 5 of 10
CONFIDENTIAL PPLPC012000249332
Erroeda Warning
Letter 2009-10-08. pc
d. Q: Provide the Board with names and biographies of External Advisory Board members and
plans for the Advisory board in 2010.
The first face-to-face meeting of the board is scheduled for January 29th.
Microsoft Office
Word Document
Page 6 of 10
CONFIDENTIAL PPLPC012000249333
Action: C. Landau/R. Kaiko
e. Q: R & D should develop metrics on industry wide FDA review performance (e.g. first
cycle approval, etc.) and measure Purdue performance against those metrics.
A: In process
Action: C. Landau, D. Long, E. Mahony
A: John Stewart is working to arrange the meeting, with input from Craig Landau, Karen
Reimer and Ake Wikstrom.
Action: J. Stewart/C. Landau
a. Q: What specific messages does Purdue want picked-up? How are those messages
developed, what are those messages and how will they be presented to the target
communities?
A: Burt Rosen will present this information as part of the upcoming CEAC presentation to
the Board.
Action: Burt Rosen
a. Q: The Noramco oxycodone API contract provides back-up to Rhodes, but at a cost to
Purdue. How can Purdue ensure the same back-up protection, but at a lower cost?
A: This analysis will be coordinated with Rhodes and will be completed in late 2010, in
time for contract renewal negotiations with Noramco. No new oxycodone API orders
will be placed with Noramco until that negotiation is complete.
Action: E. Mahony/D. Lundie
b. Q: Negotiate with LTS now to incorporate Rhodes Technologies API in the BuTrans patch
once that API becomes available.
A: LTS just signed a new 5-year exclusive supply agreement with Tasmanian
Alkaloids/Noramco. If Rhodes can manufacture buprenorphine, validate the
process, generate drug substance/drug product stability in 3-4 years the timing may
be good to negotiate the API switch at that time. The only other possibility is if DEA
closes the borders to the importation of buprenorphine and Rhodes has API available
and qualified sooner than Noramco.
Action: B. Mallin/E. Mahony
c. Q: Can the Wilson plant serve as a Targin backup for Napp Laboratories?
Page 7 of 10
CONFIDENTIAL PPLPC012000249334
A: There are no technical reasons why Wilson could not serve as backup to Cambridge for
supply of Targin. There may be regulatory and/or fiscal considerations that should be
more fully explored.
A: To become a back-up supplier for polyethylene oxide, Rhodes would have to invest up
to $10mm in capital. Purdue supply chain is evaluating less expensive, but still very
reliable third party alternatives. In the meantime, Purdue is keeping approximately 2
years safety stock.
Action: David Lundie
8.0 Finance
a. Q: Explain the nature of the $19.3 mm Discovery budget, particularly as it relates to the
increase over the prior year.
A: The budget for Discovery Research in 2010 of $19.3 mm comprises the following key
components:
• Complete the IND-enabling studies & GMP manufacturing ofV116957 (ORL-1 agonist)
and complete substantial authoring of the IND in preparation for filing early Ql 2011.
• Discover new chemotype, establish IP, and create an advanced SAR to support a backup
program for the ORL-1 program.
• Nominate a developmental candidate from either the sodium channel blocker program
or the novel opiates exploratory research activities.
CONFIDENTIAL PPLPC012000249335
Health Policy - includes Medical Liaisons, non branded medical education, $19.4
medical services, library and health policy
Risk Management - includes $8.3 mm in support of marketed products 8.3
including a placeholder budget of $5.0 mm for REMS and expert consulting
Regulatory support of marketed products 2.1
Drug Safety processing of adverse events 12.0
Support of due diligence 1.6
All Other (largely represents a portion of costs not allocated to projects such 7.7
as cost of facilities, depreciation, non-project consulting etc)
Total $51.1
c. Q: Explain the reasons for the decline in the operating margin ratios from 2009 LE to 2010
Budget.
d. Q: What will it cost the group in 2010 to use Noramco API vs. the variable supply cost at
Rhodes Technologies?
e. Q: Adjust the Gruenenthal royalty expense in the budget to assume the patents issue later
in the year.
A: Done - We assume the patent will issue 9/1/2010 and the 2010 budget has been
reduced by $38.7 million to $33.3 million.
f. Q: Consider recasting OTR Medicaid budget (sales and rebate) to include the lower rebate
rate that the NOA is entitled to.
A: Current thinking is that we will hold two "welcome home" events. The first will be in
the second quarter celebrating the first returning group, and the second one
celebrating the return of the last group of the SS residents. The "welcome home"
events will likely be a BBQ on the Plaza level.
A:
Arrerican Acadamy
of Pain Medicine
A: John Stewart is working with David Haddox and the CEAC on this issue.
Action: J. Stewart/D. Haddox
Page 10 of 10
CONFIDENTIAL PPLPC012000249337
Exhibit 11
To: MNP Consulting Limited - Board of Directors[MNPConsultingLimited-
BoardofDirectors@pharma.com]; Baker, Stuart[sbaker@chadbourne.com]
Cc: Must, Alan[Alan.Must@pharma.com]; Haddox, Dr. J.
David[Dr.J .David.Haddox@pharma.com]; Erensen, Jennifer[Jennifer. Erensen@pharma.com]; Petro,
Melissia[Melissia.Petro@pharma.com]; Damas, Raul[Raul.Damas@pharma.com]
From: Timney, Mark
Sent: Wed 5/14/2014 2:39:28 PM
Subject: ADF in MA.
Dear all,
I applaud the Health Policy and State Government Affairs teams for proactively crafting
this model legislation and advocating it through the state legislative process,
respectively. This initiative, so closely aligned with our commercial strategy and being
replicated in several other states, helps ensure that patients continue to have access to
our medicines and that broader public health goals are served.
Below I've linked to a new story about the legislation, highlighting mention of our policy
provision.
Mark
CONFIDENTIAL PPLPC020000793243
CONFIDENTIAL PPLPC020000793244
Exhibit 12
To: Motahari, Saeed[Saeed.Motahari@pharma.com]; Strassburger,
Phi Ii p[Ph iIi p. Strassburger@pharma.com]; Robinson, Susie[Susie. Robi nson@pharma.com]; Charhon,
JJ[JJ.Charhon@pharma.com]; Butcher, Alan[Alan.Butcher@pharma.com]; Cawkwell,
Gail[Gail.Cawkwell@pharma.com]; Mahony, Edward[Edward.Mahony@pharma.com]; Dunton,
Alan[Alan.Dunton@pharma.com]; Lundie, David (US)[David.Lundie@pharma.com]; Feltz,
Margaret[Margaret. Feltz@pharma.com]; Perl man, Zach[Zach. Perl man@pharma.com]; Baker,
Stuart[sbaker@chadbourne.com]
Cc: Damas, Raul[Raul.Damas@pharma.com]
Bee: David.Lundie@mundipharma-cbd.com[David.Lundie@mundipharma-cbd.com]
From: Josephson, Robert
Sent: Tue 11/1/2016 8:48: 19 AM
Subject: Boston Globe: Purdue's Letter to the Editor: Boston Globe
Good Morning-
I want to ensure you have seen Mark's response to the Boston Globe's article on rebating in West
Virginia. The letter to the editor published today.
Thanks,
Bob
11/1/2016
RE "DRUG maker foiled antiopioid effort" (Page A 1, Oct. 26): I write to provide necessary context to
<https://www.statnews.com/2016/10/26/oxycontin-maker-thwarted-limits/> your article regarding Purdue
Pharma's 2001 contracting practices. Given the gravity of the opioid epidemic, it's critical your readers
know that not all reductions in opioid prescribing result in reduced opioid abuse.
Opioid prescribing in the United States has been declining since 2013. Yet the problem persists because
it requires a comprehensive approach, not just the blunt instrument of prior authorizations, which often
impede prescribing to appropriate patients in pain. Opioid manufacturers must promote products
responsibly, helping to ensure that our medicines are prescribed only to the right patient for the right
reason.
CONFIDENTIAL PPLPC011000126443
In the past, Purdue failed to meet this standard, but we accepted full accountability for those missteps,
and for the past 14 years we've worked tirelessly to help reduce opioid abuse and diversion of opioids to
those for whom they were not prescribed. We led the industry in developing medications with abuse-
deterrent properties and advocated for the establishment of prescription drug monitoring programs.
Today, thanks in part to Purdue's contribution, Massachusetts' prescription drug monitoring program
shares prescribing data with neighboring states to help reduce misprescribing of opioids.
To best serve public health, the Globe should recognize the impactful efforts companies like Purdue
have taken to address the opioid epidemic.
Mark Timney
Purdue Pharma
Stamford, Conn.
CONFIDENTIAL PPLPC011000126444
Exhibit 13
To: Gasdia, Russell[Russell.Gasdia@pharma.com]
Cc: Motahari, Saeed[Saeed.Motahari@pharma.com]
From: Timney, Mark
Sent: Thur 12/18/2014 10:58:50 AM
Subject: RE: Call Center Up and Running
Thanks Russ.
Regards, Mark.
Mark
As I mentioned, in addition to the significant work on the IDN Initiative, I've been as focused on the
Purdue Product Information Center (PIC).
We established a goal of launching the PIC by end of 2014, which I can now report has been
accomplished! We had targeted October, but as we got deeper into the process, it became evident that
we needed to do this right, not fast...
The 8 Customer Service Representatives (CSRs) began making outbound calls the week of December rt.
The 9 Professional Representatives (PSRs) are receiving their training (same as our new field-based
representatives) and will initiate outbound calls next week.
We have identified -22,000 high decile prescribers for OxyContin/Butrans, who our field-based
representatives have indicated as "no see". Based on the analogues that MediMediaHealth (Call Center
CSO) and our previous experiences with an outbound call center 10 year ago, we have assumed -$4mm
upside for OxyContin and -$1mm for Butrans over the 6 month pilot. If we hit those assumptions, this
should be more than self-funding and you'll be able to continue with Phase 11, which can expand the way
this is deployed. This will also support vacant territory management, so we will track results with those
HCPs as well.
A full eMarketing campaign is in place to support this, as are updated websites that promote the PIC,
and journal ads will now call out the PIC. This should promote inbound calls.
Some photos below were taken by me earlier in the week, while I attended a day of the PSR training.
Nice to see it in action!
Russ Gasdia
CONFIDENTIAL PPLPC012000510219
Head of Strategic Initiatives
Purdue Pharma LP.
203-588-7399
As I transition out of Purdue, Tony is taking on more leadership of the Call Center, as Lisa wants this to
be a sales function, which makes sense.
Thank you for your hard work and efforts on this pilot/initiative. I am very confident that this will be
successful...1'11 be checking in to watch the progress!
Russ Gasdia
Head of Strategic Initiatives
Purdue Pharma LP.
203-588-7399
CONFIDENTIAL PPLPC012000510220
Exhibit 14
To: Damas, Raul[Raul.Damas@pharma.com];
Alessandro_Radici@mckinsey.com[Alessandro_Radici@mckinsey.com]
From: Mallin, William
Sent: Fri 5/23/2014 9:35:27 AM
Subject: RE: EC Meeting Content
20140519 Prcsnmation deck. pptx
Raul:
Bill
I'm building the board memo and would like to use some of the information, especially regarding E2E
results.
Raul Damas
Vice President, Corporate Affairs
Purdue Pharma L.P.
203-588-7600
646-915-4062 - m
CONFIDENTIAL PPLPC035000220405
2014-05-20
CONFIDENTIAL
PPLPC035000220406
2014-05-20
Contents
▪ Update on Communication
42
PPLPC035000220406
2014-05-20
Develop acquisition ▪ Evaluate standalone market value for ▪ Analyses under way for
strategies for each target products for purchase Kadian, Avinza, Vicodin
molecule ▪ Evaluate value for Purdue of NDA
ownership through:
– Increased probability of market
conversion to AD
– Share of market affected by
conversion
▪ Develop optimal acquisition strategy ▪ N/A
43
PPLPC035000220406
2014-05-20
Status
Molecule overview Status description
PPLPC035000220406
2014-05-20
Potential implications
▪ Still control MS Contin NDA
Acquire ▪ Can trigger FDA proceedings on MS Contin only; convert 90% of market
neither ▪ Potential for managed care to require step edits through generics of
other 2 MS products; however, unlikely due to current pricing differential
45
PPLPC035000220406
2014-05-20
68 63
59 54
50 45 52
40 40 40 40 40 39
2014-2024 34 34 30 30 30 30 30 30 30
Gross
Revenue
2014-2024
Cash
Flow2 11 10 9 8 8 7 8
6 6 6 6 6 6 5 5 5 5 5 5 5 5 5
1 NPV calculated using a 40% cut from gross to net sales, a 40% operating margin, and a 35% tax rate, and a 9% discount rate
2 Cash flow is defined as operating margin minus taxes
PPLPC035000220406
2014-05-20
PPLPC035000220406
2014-05-20
Contents
▪ Update on Communication
48
PPLPC035000220406
2014-05-20
Supporting team ▪ David Rosen, Brianne Weingarten, Garry Hughes, Tim Richards, Others
members
Tasks Supported/ 3.2 Restructure and Upgrade R&D for Future Operating Model
co-owned 3.2.2.3.4 Define R&D/BD/ Commercial interface
49
PPLPC035000220406
2014-05-20
▪ Update on Communication
PPLPC035000220406
2014-05-20
We refined the critical objectives of the core E2E workstreams post NSM
51
PPLPC035000220406
2014-05-20
In high institutional In territories with difficult access, reps have to select large
Access areas, maybe numbers of prescribers (e.g. up to 180+) to reach the required
consider- carve those docs calls/year, leading to dilution of reps’ efforts – especially
Opportunities
PPLPC035000220406
2014-05-20
▪ Update on Communication
PPLPC035000220406
2014-05-20
1 Source: iGallery
2 Product % Mix based on Split between OxyContin and Butrans.
PPLPC035000220406
2014-05-20
OxyContin value decile 7-103 OxyContin value decile 5-64 OxyContin value decile 3-4
93% 93% 89%
76% 74%
48%
▪ E2E has increased the emphasis on reps selecting the highest value targets
▪ The impact is clear from the increasing trend of mid to high value OxyContin targets being selected;
much of this increase comes from re-allocating targets from low value prescribers
▪ This measures targets selected for either brand – so not simply a result of shifting mix to OxyContin
1 As OxyContin or Butrans primary targets
2 No-sees as identified by the field
3 Comparable numbers for Butrans: 100% in Q3 to 94% in Q2 (not excluding no-sees)
4 Comparable numbers for Butrans: 96% in Q3 to 90% in Q2 (not excluding no-sees)
55
PPLPC035000220406
2014-05-20
We are drilling down on the OxyContin Core targets that were not
reached in Q1
▪ 8,389 Selected Core HCPs were not reached with a P1 (7,870 with a P1 or
P2)
– 2,249 (27%) HCPs were in value deciles 5-10
– 6,140 (78%) were in value deciles 0 – 4
▪ There are multiple explanations for why the sales force did not reach these
prescribers
– Vacant territories and disability/illness: 1,304 (15%) of these unreached
Cores were impacted by partial or full territory vacancies or disability/illness
status of rep
– Days on Territory: 1,040 (12%) of these unreached Cores can be attributed
to lower than expected days on territory1
– Calls per day: 1,986 (23%) of these unreached Cores can be attributed to
lower than expected calls/day2
▪ Other: 4,158 (49%) of HCPs were not seen are not attributed to territory
vacancy, rep disability, lower than expected days on territory, or lower than
expected calls per day
56
PPLPC035000220406
2014-05-20
-3.2
-16.8
Deciles 7-10
▪ Sales force calls have
N = 1,140 N = 5,470 a strong impact on
TRx performance
▪ Ensuring the sales
force calls on as
-2.5
-9.7 many high value
Deciles 5-6 prescribers as
N = 3,279 N = 8,357 possible is a core
component of E2E
-0.1
-8.2
Deciles 3-4
N = 14,219 N = 13,250
PPLPC035000220406
2014-05-20
▪ Update on Communication
PPLPC035000220406
2014-05-20
Multi-channel approach
Self-directed
interactions
59
PPLPC035000220406
2014-05-20
Month 01 Month 02 Month 03 Month 04 Month 05 Month 06 Month 07 Month 08 Month 09 Month 10 Month 11 Month 12
Coupon on Demand
Secure, convenient access
QuickSpot™
Brief interstitial program
between calls to action
eDetail / mDetail
Online and mobile
programs for deeper
engagement and drive rep
follow up visits
MedAlert Pro™
3 clinical
communications via
mobile and e-mail
Physician Feedback™:
Voice of the Customer
OMNIO™:
Omnio clinical decision support
brand pages
Expected to generate additional
revenues of $91.1M
60
PPLPC035000220406
2014-05-20
3. Increase scripts for Butrans and OxyContin with the “no see”
HCPs
PPLPC035000220406
2014-05-20
Day to Day Operations: Who are the reps and what do they do?
62
PPLPC035000220406
2014-05-20
▪ Timeline assumes
– SOW to Purdue May 16
– SOW signed by June 6
– First Outbound Call - July 21
63
PPLPC035000220406
2014-05-20
▪ Update on Communication
PPLPC035000220406
2014-05-20
Over the course of the next 2 years, Purdue will build its IDN PRELIMINARY
1 May consider adding high value multi-specialty medical groups (currently not captured in HCOS) such as Hill Physicans and Brown and Toland in CA
in future waves
2 Atrius Physicians in greater Boston should also be added (although not-captured through HCOS) because of the high level of centralized control 65
PPLPC035000220406
2014-05-20
1 Excludes multi-specialty medical groups and IPA, as well as large hospital systems like Tenet, HCA, etc
2 Assumes all IDNs reach OxyContin market share of 23%
3,4 Full List of Top 50 IDNs (both over-performing and over-performing) provided in appendix
PPLPC035000220406
2014-05-20
Value
▪ Develop detailed profiles for target IDNs
Proposition
▪ Develop and test preliminary value propositions
for these IDNs
▪ Develop criteria/ reporting structure for
Role AM role and benchmark job description/salary
definition, ▪ Evaluate existing talent pool to identify
reporting internal candidates
structure, ▪ Define key measurements/ signposts to track
and KAM success
resource ▪ Identify source of resource allocation
allocation for new FTEs (e.g., low workload territories)
▪ Post positions and hire for new roles
▪ Build physician affiliation process/tool
Physician for use during Q3 call list “clean up” process
Affiliations ▪ Train field on affiliation process in Phoenix
▪ Complete field affiliations
▪ Develop and roll out rep training
Training program for targeted markets
▪ Roll out training in field
Meeting ▪ Begin to schedule top-to-top leadership
Scheduling discussions with key IDN leadership
PPLPC035000220406
2014-05-20
▪ Update on Communication
PPLPC035000220406
2014-05-20
Purdue has employed multiple tactics to address these issues, but could
consider additional activities to more fully address stakeholders
Primary stakeholder Secondary Stakeholder impacted
impacted stakeholder impacted Large
Small chains/
Retail
independent
Chain
Purdue activity Wholesalers pharmacies HCP Patient
Pharmacy
1 Collaborate with NABP to develop industry standards for dispensing
guidelines
2 Encourage wholesaler/retailers to establish thresholds by NDC (vs. API),
segregate problematic products, or give protective benefit to ADFs
3 Work with retailers to modify dispensing guidelines to recognize value
of ADF products
Current activity
PPLPC035000220406
Exhibit 15
Doc ID
Update on E2E – Evolve to Excellence
implementation
April 24, 2014
CONFIDENTIAL MCK-MAAG-0017306
Doc ID
Agenda
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
In today’s meeting we will cover six main topics:
▪ Re‐cap of core E2E initiatives
▪ Metrics
▪ IDN Strategy
▪ Multi‐channel approach to No‐sees
Printed 4/17/2014 12:56 PM Eastern Standard Time
▪ Patient Access
▪ Next steps
E2E – Evolve to Excellence 1
CONFIDENTIAL MCK-MAAG-0017306
Doc ID
The sales force is selecting an increasing percentage of high‐value
OxyContin prescribers as targets
% HCPs selected as targets, excluding no‐sees1,2 TARGET SELECTION
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
93% 93% 89%
76% 74%
48%
Printed 4/17/2014 12:56 PM Eastern Standard Time
Q3 ’13 Q2 ’14 Q3 ’13 Q2 ’14 Q3 ’13 Q2 ’14
▪ E2E has increased the emphasis on reps selecting the highest value targets
▪ The impact is clear from the increasing trend of mid to high value OxyContin targets being
selected; much of this increase comes from re‐allocating targets from low value prescribers
▪ This measures targets selected for either brand – so not simply a result of shifting mix to
OxyContin
1 As OxyContin or Butrans primary targets
2 No‐sees as identified by the field
3 Comparable numbers for Butrans: 100% in Q3 to 94% in Q2 (not excluding no‐sees)
4 Comparable numbers for Butrans: 96% in Q3 to 90% in Q2 (not excluding no‐sees) E2E – Evolve to Excellence 13
13
CONFIDENTIAL MCK-MAAG-0017306
Doc ID
While reach and frequency are trending upward, there is still room for
improvement ‐ particularly in reach
ACTUAL REACH/FREQUENCY
% OxyContin HCPs
reached with P1 or P2 Frequency1
94% 96% 5.1 5.2 Target=6
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
SuperCores
▪
OxyContin target3
Reach on targets has
improved slightly from Q3
2.7 2.8 Target=3 ‘13 to Q1 ’14
72% 72%
Cores ▪ A process is in place to
increase the Core reach of
72% currently
Q3 ’13 Q1 ’14 Q3 ’13 Q1 ’14
– In Q2, there will be
83% 85% Phoenix tools and
7‐102 management focus to
OxyContin value decile
Printed 4/17/2014 12:56 PM Eastern Standard Time
help improve reach
Q3 ’13 Q1 ’14
1 P1 frequency only
2 Excluding no‐sees as identified by field
3 Comparable numbers for Butrans in Appendix p. 4. Reach has changed from 95% to 96% for SuperCores and 79% to 78% for
Butrans. Frequency has changed from 4.9 to 4.7 for SuperCores and 2.8 to 2.8 for Cores E2E – Evolve to Excellence 14
14
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We are drilling down on the OxyContin Core targets that were not
reached in Q1
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
– 2,249 (27%) HCPs were in value deciles 5‐10
– 6,140 (78%) were in value deciles 0 – 4
▪ There are multiple explanations for why the sales force did not reach these prescribers
– Vacant territories and disability/illness: 1,304 (15%) of these unreached Cores were
impacted by partial or full territory vacancies or disability/illness status of rep
– Days on Territory: 1,040 (12%) of these unreached Cores can be attributed to lower
than expected days on territory1
Printed 4/17/2014 12:56 PM Eastern Standard Time
– Calls per day: 1,986 (23%) of these unreached Cores can be attributed to lower than
expected calls/day2
▪ Other: 4,158 (49%) of HCPs were not seen are not attributed to territory vacancy, rep
disability, lower than expected days on territory, or lower than expected calls per day
1 Assumes expected days on territory is the median, or 50 days
2. Assumes expected 7.5 calls per day
E2E – Evolve to Excellence 15
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We are evaluating territory level data to better understand and address
territory‐specific variability in reach
Thematic Map Legend ‐ % Called On
Vacant 0%+ to 10% 20%+ to 30% 40%+ to 50% 60%+ to 70% 80%+ to 90%
10%+ to 20% 30%+ to 40% 50%+ to 60% 70%+ to 80% 90%+ to 100%
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
Printed 4/17/2014 12:56 PM Eastern Standard Time
E2E – Evolve to Excellence 16
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TRx performance among called‐on prescribers is better than those not
called on
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
Not called on Called on
‐3.2
‐16.8
Deciles 7‐10 ▪ Sales force calls have
N = 1,140 N = 5,470 a strong impact on
TRx performance
▪ Ensuring the sales
‐2.5 force calls on as many
‐9.7
high value prescribers
Deciles 5‐6 as possible is a core
N = 3,279 N = 8,357
Printed 4/17/2014 12:56 PM Eastern Standard Time
component of E2E
‐0.1
‐8.2
Deciles 3‐4
N = 14,219 N = 13,250
1 Selected either as Butrans or OxyContin target in Q1 2014
2 No see HCPs do not include limited access HCPs
3 Comparison of week ending 1/3/14 – 3/28/14 to 10/4/13 – 12/27/13
NOTE: excludes physicians not deciled by ZS and reg 0. Source IMS Earlyview
E2E – Evolve to Excellence 17
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OxyContin HCPs with increased calls consistently outperform HCPs with
decreasing or no change in call frequency
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
Q3 2013 to Q4 2013 HCP Count TRx % change ▪ Better target selection and
increased frequency have a
Increase 14,594 3.40%
positive impact:
Decrease 13,240 ‐2.90% – In Q1, there were more
No change 4,283 0.40% prescribers with
increasing calls and
No Call in Q3 or Q4 120,931 1.50% fewer prescribers with
Grand Total 153,048 0.90% decreasing calls
– Approximately 50% of
HCPs increasing from Q4
Printed 4/17/2014 12:56 PM Eastern Standard Time
Q4 2013 to Q1 2014 HCP Count TRx % change
to Q1 were new to the
Increase 20,267 1.40% call list
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Contents
▪ Re‐cap of core E2E initiatives
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
▪ Metrics
▪ IDN Strategy
– Overview of proposed approach
– Assessment of the IDN opportunity
– Developing a meaningful value proposition
– Proposed timeline
Printed 4/17/2014 12:56 PM Eastern Standard Time
▪ Multi‐channel approach to no‐sees
▪ Improved Patient Access
▪ Next Steps
E2E – Evolve to Excellence 20
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Executive summary: IDN strategy
▪ The provider landscape is undergoing considerable change
– Physicians are increasingly professionalizing and consolidating into larger provider systems
– Decision making is becoming more ‘corporatized’
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
– A targeted approach to these corporatized accounts is increasingly becoming “table stakes” for
Pharmaceutical companies across a broad spectrum of Therapeutic areas
▪ The top 50 IDN’s by OxyContin ER TRx volume represent ~30% of Purdue’s IDN business
▪ Evolution of healthcare environment is impacting patient access to our offerings
– ~30% of OxyContin volume flows through limited and no see physicians within these the top 50 IDNs
– We have not yet responded to address most complex accounts and/or markets
– A concerted approach to these IDNs could result in 107k incremental OxyContin TRx annually, with an annual
incremental gross revenue value of ~$47M
▪
Printed 4/17/2014 12:56 PM Eastern Standard Time
We have evaluated these IDNs and propose a phased approach to addressing this business
– Focus near term efforts on ~14 IDNs in 4 high value geographies
– Incorporate additional ~10‐15 IDNs every 4‐6 months beginning in Q2 2015
▪ Detail around Purdue’s value proposition for addressing unmet needs
– Purdue has many commercial and non‐commercial tools/ resources that can be built out or better leveraged
to address the needs of these various stakeholders
▪ A targeted IDN strategy will require “top‐to‐top” interactions between Purdue and IDN leadership, but will also
require a supporting infrastructure to manage the implementation and refinement of ongoing collaboration
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Scope of Purdue’s initial IDN strategy: “Corporatized Providers” with
centralized control over ambulatory prescribing
Examples
High
Hospital systems/ single
▪ HCA
▪ TENET
▪
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
hospitals
▪ Catholic Health Groups in this
category have some
IDN/ PHO1 (including
▪ Providence degree of centralized
ACOs)2
▪ Sutter decision‐making that
▪ Intermountain impacts the
▪ HealthCare Partners prescriber writing
Multi‐specialty Medical
▪ Facey ▪ Initial assessment for
Groups
‘In‐patient/ ▪ Brown & Toland Purdue based on
aggregation HCOS3 affiliation
level’ ▪ Hill Physicians data, but more
Independent Physician ▪ Primecare rigorous opportunity
Association (IPA) ▪
Printed 4/17/2014 12:56 PM Eastern Standard Time
Greater Newport IPA analysis will require
▪ Inland Rheum & Osteo field‐driven physician
Single‐specialty Group ▪ San Diego Cardiology affiliations in target
Practices Clinic markets
▪ Ctrl Coast GI Group
Solo physicians
▪ Dr. Jim Kim
Low ▪ Dr. Gary R Feldman
1 PHO – Physician Hospital Organization
2 Focus on retail volume for initial round of analysis
3 IMS Healthcare Organization Services Data
SOURCE: Team analysis E2E – Evolve to Excellence 22
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Initial interviews with select corporatized provider administrators
highlight opportunities for Purdue to more effectively meet their needs
Group Role Relevant quote
▪ Director of Pharmacy [Pharma] really needs to have a champion or
▪ Previously Director of Pharmacy and sponsor at medical or pharmacy management
Chronic Disease Management level. The executive level is too in the weeds to be
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
the only one to engage
Printed 4/17/2014 12:56 PM Eastern Standard Time
▪ Former CEO of regional hospital
We have a tough time identifying the 5% of
within Fairview
patients who are responsible for 50% of costs
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Contents
▪ Re‐cap of core E2E initiatives
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
▪ Metrics
▪ IDN Strategy
– Overview of proposed approach
– Assessment of the IDN opportunity
– Developing a meaningful value proposition
– Proposed timeline
Printed 4/17/2014 12:56 PM Eastern Standard Time
▪ Multi‐channel approach to no‐sees
▪ Improved Patient Access
▪ Next Steps
E2E – Evolve to Excellence 24
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A focus on the Top IDNs by ERO volume could generate $47M in
incremental annual gross revenue annually
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
Sutter Health 102,317 22 1461 volume in IDNs
PeaceHealth 72,726 20 2488
▪ 25 of the Top 50 IDNs2
UPMC 56,453 23 187
by ERO volume are
Top 10 BayCare Health System 52,388 15 4063
under‐ underperforming
Intermountain Healthcare 49,635 18 2430 compared to the
performing
McLaren Health Care Corporation 47,721 15 3701 national OxyContin
Adventist Health 45,414 18 2269 market share of 23%,
IASIS Healthcare Corporation 43,175 19 1627 and 25 are over‐
Baptist Memorial Health Care Corporation 43,131 19 1846 performing
▪ Total upside
associated with “right‐
Printed 4/17/2014 12:56 PM Eastern Standard Time
Catholic Healthcare Partners 68,834 27 1377 sizing”
Carolinas HealthCare System 58,604 24 1172 underperformers is:
SSM Health Care 52,729 27 1055 71K TRx annually
Mercy Health 52,035 26 1041 ($31M gross revenue)
Top 10 over‐ The Cleveland Clinic Health System 39,231 29 785
performing Baptist Healthcare System, Inc 36,645 24 733
▪ Total upside
Steward Health Care System, LLC 36,428 associated with
31 729
growing over‐
Novant Health, Inc 36,354 25 727
performers is: 36K TRx
Banner Health 35,977 28 720
annually ($16M gross
UC Health 35,053 27 701
revenue)
1 Excludes multi‐specialty medical groups and IPA, as well as large hospital systems like Tenet, HCA, etc
2 Assumes all IDNs reach OxyContin market share of 23%
3,4 Full List of Top 50 IDNs (both over‐performing and over‐performing) provided in appendix
SOURCE: HCOS data (note, HCOS data is ~60% accurate), IMS E2E – Evolve to Excellence 25
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Last Modified 4/23/2014 11:02 PM Eastern Standard Time
Network System, LLC
▪ UPMC
Washington (4,591 TRx) Michigan (8,471 TRx)
▪ Legacy Health ▪ Beaumont Health System
▪ Peace Health ▪ Franciscan Alliance, Inc
▪ Providence Health and ▪ McLaren Health Care
Services Corporation
▪ Spectrum Health
California (5,380 TRx)
▪ Adventist Health Ohio (3,555 TRx)
▪ Saint Joseph Health ▪ Catholic Healthcare Partners
▪ OhioHealth
System
▪ The Cleveland Clinic Health
▪ Sutter Health System
▪ University of California ▪ UC Health
Office of the President
Health Sciences and Indiana (992 TRx)
▪ Indiana University Health
Printed 4/17/2014 12:56 PM Eastern Standard Time
Services
Utah (2,429 TRx) Kentucky (1,032 TRx)
▪ Intermountain ▪ Baptist Healthcare System, Inc
Healthcare ▪ Norton Healthcare, Inc
Wisconsin (1,201TRx)
Arizona (719 TRx) ▪ Aurora Health Care, Inc
▪ Banner Health ▪ Wheaton Franciscan Healthcare
North Carolina (2,7480TRx)
Texas (2,569 TRx) ▪ Carolinas HealthCare System
▪ Baylor Health Care ▪ Duke University Medical Center
System and Health System
▪ Texas Health Resources Missouri (2,685 TRx) Arkansas (1,846 TRx) Alabama (507 Louisiana (1,221 TRx) Florida (4,062 ▪ Novant Health, Inc
▪ United Surgical Partners ▪ BJC HealthCare ▪ Baptist Memorial TRx) ▪ Franciscan TRx) ▪ Sentara Healthcare
International, Inc ▪ Mercy Health Health Care ▪ UAB Missionaries of ▪ BayCare
▪ SSM Health Care Corporation Health Our Lady Health Health Tennessee (1,627 TRx)
System System, Inc System ▪ IASIS Healthcare Corporation
1 Assumes 2% lift for all IDNs currently performing above national average of 23%, and assumes that all IDNs under‐performing compared to national average
are brought up to national average E2E – Evolve to Excellence 26
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We considered a number of quantitative and qualitative criteria when
evaluating Purdue’s opportunity to drive impact within these IDNs
Detail included on following pages
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
opportunity size ▪ OxyContin market share compared to National ▪ Estimate the potential upside associated with
Average each of these IDNs
▪ ▪
Quantitative
Geographic
▪ High value IDNs located within moderate ▪ Difficult for organization to implement IDN
geographic proximity (e.g., metro areas, state) strategy effectively without geographic
concentration
concentration
▪ ▪
Printed 4/17/2014 12:56 PM Eastern Standard Time
Physician employment More “controlling” groups are better
Group control over
HCP prescribing
▪ Existence of out‐patient PDL equipped to affect broad‐scale change among
▪ Degree of risk sharing their HCPs
ships/contacts initiate initial executive‐level conversations
▪ Key legislation impacting opioids (e.g., ADF ▪ External factors may make improve (e.g.,
External/ regional
support, “triplicate” states) recent MA legislation) or reduce (e.g., TX is a
factors
▪ Regional advocacy efforts (e.g., PROP) triplicate state) likelihood of success
E2E – Evolve to Excellence 27
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Limited
Moderate
Quantitative analysis of Top 50 IDNs (1/2) Red text = IDN performing below market share average Strong
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
Beaumont Health System 22,601 19% 919 7,129 4,286
Franciscan Alliance, Inc 28,169 22% 337 1,372 5,274
Adventist Health 45,414 18% 2,269 8,644 7,208
Sutter Health 102,317 22% 1,461 24,506 18,730
California Saint Joseph Health System 37,399 20% 1,074 5,755 5,403
University of California Office of the President Health
Sciences and Services 28,794 26% 576 10,315 1,397
PeaceHealth 72,726 20% 2,488 32,628 13,293
Pacific
Providence Health and Services 134,190 22% 1,585 49,246 21,403
NW
Legacy Health 25,914 23% 518 11,966 2,395
Florida BayCare Health System 52,388 15% 4,062 708 3,514
Catholic Healthcare Partners 68,834 27% 1,377 7,202 15,073
The Cleveland Clinic Health System 39,231 29% 785 6,580 7,687
Ohio
UC Health 35,053 1,260 5,241
Printed 4/17/2014 12:56 PM Eastern Standard Time
27% 701
OhioHealth 34,635 23% 693 3,180 4,968
Carolinas HealthCare System 58,604 24% 1,172 3,866 11,172
North
Novant Health, Inc 36,354 25% 727 1,016 4,292
Carolina
Duke University Medical Center and Health System 24,815 29% 496 879 4,576
Sentara Healthcare 26,045 22% 352 1,628 5,539
SSM Health Care 52,729 27% 1,055 8,185 8,980
Missouri
Mercy Health 52,035 26% 1,041 4,904 8,113
BJC HealthCare 29,510 29% 590 3,654 8,652
Baylor Health Care System 24,267 18% 1,143 1,511 1,990
Texas Texas Health Resources 27,843 19% 1,022 1,535 2,748
United Surgical Partners International, Inc 24,829 21% 404 2,436 2,949
1 No‐see/ limited see HCPs identified through field‐level targeting 2 Tier Coverage for Top 2‐3 plans associated with each IDN
SOURCE: IMS, HCOS data, Managed Care Team E2E – Evolve to Excellence 28
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Limited
Moderate
Quantitative analysis of Top 50 IDNs (2/2) Red text = IDN performing below market share average Strong
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
Presence Health 26,048 20% 910 2,070 3,295
Arkansas Baptist Memorial Health Care Corporation 43,131 19% 1,846 2,309 7,515
Tennessee IASIS Healthcare Corporation 43,175 19% 1,627 1,981 5,052
Sanford Health Network 23,041 21% 499 1,078 6,100
Minnesota Allina Health System 24,857 42% 497 9,031 4,091
Mayo Clinic 22,431 32% 449 4,291 2,895
Mass‐ Steward Health Care System, LLC 36,428 31% 729 4,204 10,106
achusetts Partners HealthCare System, Inc 30,787 32% 616 11,428 3,103
Allegheny Health Network 28,466 26% 569 3,373 5,052
Penn‐
Geisinger Health System 27,016 26% 540 5,329 5,357
sylvania
UPMC 56,453 23% 187 9,993 9,378
Louisiana Franciscan Missionaries of Our Lady Health System, Inc 22,209 18% 1,221 598 6,321
Printed 4/17/2014 12:56 PM Eastern Standard Time
Aurora Health Care, Inc 34,779 31% 696 2,309 6,608
Wisconsin
Wheaton Franciscan Healthcare 25,302 30% 506 1,609 3,056
Baptist Healthcare System, Inc 36,645 24% 733 3,586 8,153
Kentucky
Norton Healthcare, Inc 32,683 22% 300 4,052 8,925
Indiana Indiana University Health 36,616 20% 992 3,655 10,028
Arizona Banner Health 35,977 28% 720 4,681 7,203
New York North Shore Long Island Jewish Health System 26,637 33% 533 3,852 5,119
Alabama UAB Health System 25,349 28% 507 1,059 948
New Dartmouth‐Hitchcock 24,274 32% 485 3,836 6,842
Hampshire UnityPoint Health 34,479 22% 192 4,293 11,284
1 No‐see/ limited see HCPs identified through field‐level targeting 2 Tier Coverage for Top 2‐3 plans associated with each IDN
SOURCE: IMS, HCOS data, Managed Care Team E2E – Evolve to Excellence 29
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Based on the quantitative and qualitative assessments of these accounts,
we propose that the initial phase of this strategy is focused on 14 IDNs
Red text = IDN performing below market share average
Quantitative Rationale for
Market IDN inclusion Qualitative Rationale for inclusion
▪ Sutter ▪ ~160K ERO TRx flowing through ▪ Moderate system‐level control over out‐patient Rx
▪ Adventist No‐Sees/ Limited Sees annually ▪ Increasing amount risk‐bearing
▪ ▪
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
1 California University of Moderate to good Managed ▪ Key geography targeted with IDN‐specific strategy
California? Care Coverage by other mid/ large cap PharmaCos
▪ St. Josephs ▪ ~$4.4M potential upside
▪ Legacy Health ▪ ~260K ERO TRx flowing through ▪ Several Key relationships already in place (e.g.,
▪ Peace Health No‐Sees/ Limited Sees annually Providence Health)
▪ Providence Health ▪ Moderate Managed Care ▪ Potential to counter PROP influence with relevant
Pacific
2 and Services Coverage value propositions
Northwest
▪ ~$4.3M potential upside ▪ Moderate risk‐sharing
▪ Key geography targeted with IDN‐specific strategy
by other mid/ large cap PharmaCos
▪ Partners Health‐ ▪ ~52K ERO TRx flowing through ▪ Moderate to high system‐level control over
Printed 4/17/2014 12:56 PM Eastern Standard Time
Care System No‐Sees/ Limited Sees annually outpatient Rx
▪ Steward Health ▪ Good Managed Care Coverage ▪ Increasing amount of risk sharing
3 Massachusetts
Care System ▪ ~$1.2M potential upside3 ▪ Key geography targeted with IDN‐specific strategy
▪ UMass1 by other mid/ large cap PharmaCos
▪ Atrius Physicians2
▪ Allegheny Health ▪ ~74K ERO TRx flowing through ▪ Several Key relationships already in place (e.g.,
Network No‐Sees/ Limited Sees annually Geisinger)
4 Pennsylvania ▪ Geisinger Health ▪ Moderate Managed Care ▪ Moderate‐high system level control over
System Coverage outpatient Rx
▪ UPMC ▪ ~$1.2M potential upside ▪ Increasing amount of risk sharing
1 Should consider adding UMass to this KAM region. It is within the Top 100 IDNs by ERO volume – and adding an additional account in this market may ensure that the Account Manager has sufficient worklo
2 Atrius Physicians in greater Boston should also be added (although not‐captured through HCOS) because of the high level of centralized control
3 Upside excludes potential lift from Atrius, which has not yet been calculated because of HCOS data limitations
SOURCE: Team Analysis E2E – Evolve to Excellence 30
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Contents
▪ Re‐cap of core E2E initiatives
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
▪ Metrics
▪ IDN Strategy
– Overview of proposed approach
– Assessment of the IDN opportunity
– Developing a meaningful value proposition
– Proposed timeline
Printed 4/17/2014 12:56 PM Eastern Standard Time
▪ Multi‐channel approach to no‐sees
▪ Improved Patient Access
▪ Next Steps
E2E – Evolve to Excellence 31
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IDN administrators identify several unmet needs and potential Pharma
value propositions based on the evolving healthcare landscape
Green text = initial focus of value prop development NOT EXHAUSTIVE
Unmet Needs Potential Value Props
▪ Coordinating health of patient through continuum of care (e.g. transitions, home care,
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
etc.)
Care quality ▪ Reducing adverse events (e.g. hospital acquired conditions)
and clinical ▪ Improving patient satisfaction (e.g. pain in HCAHPS surveys)
outcomes ▪ Monitoring opioid use in ambulatory setting (variation in prescribing patterns/protocols,
identify red flags)
▪ Reducing redundancy among providers by increasing communication
▪ Disseminating best practices for pain (prescribing, preventing abuse, appropriate urine
Provider screening tests)
education ▪ Analyzing data to flag high‐risk behavior
▪ Reducing overall cost of care (reduce ER visits, readmission, LOS; increase pre‐noon
Printed 4/17/2014 12:56 PM Eastern Standard Time
Improved discharges, preventing back surgery due to back pain)
practice ▪ Value based purchasing (eliminating wholesaler, buying meds in bulk and distributing to
economics hospitals)
▪ Providing tools to access state Rx monitoring in EMR, so not an additional step
Patient ▪ Helping patients buy into lifestyle changes, exercise
adherence ▪ Tracking medication adherence
and support ▪ Creating a pain discharge plan
Administrators often identified pain management as
a specific IDN pain point, which suggests a unique
opportunity for Purdue to generate near term value
to form long term relationships with IDNs
SOURCE: Expert interviews E2E – Evolve to Excellence 32
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We are currently taking inventory of current Purdue resources that are
well‐positioned to address these unmet needs
ILLUSTRATIVE
Analyzing Data to Flag High‐Risk Behavior Disseminating Best Practices for Pain
Palliative Care: Improving Quality of Care Across the Healthcare Continuum Overview of Federation of State Medical Boards Model Policy on Use of Opioids… *
Tele Assessment of Pain Flyer (Print and PDF) Opioid Analgesics Utilization Data Review Flyer (Print and PDF)
Introduction to Clinical Pharmacology Palliative Care: Improving Quality of Care Across the Healthcare Continuum
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
FACETS Flyer (Print and PDF) Introduction to Clinical Pharmacology
Complexities of Caring for People in Pain Medication Routes and Delivery Systems: Administration & Safety Considerations
Pain Pathophysiology: An Illustrated Resource Complexities of Caring for People in Pain
3rd Party Resources via Consultation How to Protect Your Medicines at Home (English)
Handbook for People with Pain
A Hands‐On Approach for Pain Management Communication Guide Reducing Redundancy Among Providers by Increasing Communication
Medication Therapy Management: Opportunities for Improving Pain Care FACETS (Print and PDF)
PDMP Consultation Tips for Overcoming the Challenges of Communicating About Pain with Your Patients
Current epidemiology data on abuse, misuse, diversion and addiction
Prescription Opioid Abuse: Strategies to Minimize Risks Monitoring Opioid Use in an Ambulatory Setting
Pearls and Pitfalls of Urine Drug Testing During Opioid Therapy Flyer Community Action Toolkit
Providing Relief, Preventing Abuse Brochure Community Anti‐Drug Coalitions of America (CADCA)
How to Protect Your Practice National Council on Patinet Information and Education (NCPIE)
How to Protect Your Pharmacy National Education Association (NEA)
How to Protect Your Institution Brochure Partnership@Drugfree.org
Printed 4/17/2014 12:56 PM Eastern Standard Time
How to Protect Your Medicines at Home (English) AMA Community grants
Diversion Prevention in Pharmacies and Healthcare Institutions Diversion Prevention in Pharmacies and Healthcare Institutions (PPT‐CD ROM)
Internal Pharmacy Theft: Tips and Practices to Protect Your Pharmacy From Diversion Internal Pharmacy Theft: Tips and Practices to Protect Your Pharmacy From Diversion
State Rx Drug Monitoring Program and prescribing guidelines RxSafetyMatters Community Action Kit (1 kit = 5 c
Patient Satisfaction Reducing Adverse Events
Overview of Federation of State Medical Boards Model Policy on Use of Opioids… * Pain PACT Information Flyer / Order Form (Print and PDF)
Palliative Care: Improving Quality of Care Across the Healthcare Continuum Introduction to Clinical Pharmacology
Home Care of the Hospice Patient (English) (BOOKLET) Opioid‐Related Adverse Effects: Mechanisms, Etiology, and Considerations for Care
Opioid‐Related Adverse Effects: Mechanisms, Etiology, and Considerations for Care FACETS Flyer (Print and PDF)
Patient Comfort Assessment Guide (pad of tear‐off) Senokot Laxatives Protocol Pad
Coordinating Health of Patient Through the Care Continuum
Overview of Federation of State Medical Boards Model Policy on Use of Opioids… *
Opioid Analgesics Utilization Data Review Flyer (Print and PDF)
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Contents
▪ Re‐cap of core E2E initiatives
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
▪ Metrics
▪ IDN Strategy
– Overview of proposed approach
– Assessment of the IDN opportunity
– Developing a meaningful value proposition
– Proposed timeline
Printed 4/17/2014 12:56 PM Eastern Standard Time
▪ Multi‐channel approach to no‐sees
▪ Improved Patient Access
▪ Next Steps
E2E – Evolve to Excellence 34
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Over the course of the next 2 years, Purdue will continue to build its IDN
strategy by incorporating more groups into this new commercial model
PRELIMINARY
Proposed “go
live” timing “Wave 1” – October 1, 2014 “Wave 2” – Q2 2015 “Wave 3” – Q1 2016
Proposed ▪ California1 ▪ Michigan ▪ Select remaining groups based
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
Regions/ – Sutter – Beaumont Health System on pre‐defined criteria (e.g.,
Accounts
– Adventist – Franciscan Alliance, Inc market share, potential upside,
– University of California – McLaren Health Care managed care coverage, etc.)
– St. Josephs Corporation
▪ Pacific Northwest – Spectrum Health
– Legacy Health ▪ Missouri
– Peace Health – BJC HealthCare
– Providence Health and – Mercy Health
Services – SSM Health Care
▪ Massachusetts ▪ North Carolina
– Partners HealthCare System – Carolinas HealthCare Wave 2 and Wave 3 IDNs must
– Steward Health Care System System be defined using refreshed
Printed 4/17/2014 12:56 PM Eastern Standard Time
– UMass (within Top 100 IDNs – Duke University Medical data (both qualitative and
by ERO volume) Center and Health System quantitative) at the time of
– Atrius Physicians2 – Novant Health, Inc decision‐making – this current
▪ Pennsylvania – Sentara Healthcare list is very preliminary
– Allegheny Health Network ▪ Minnesota
– Geisinger Health System – Allina Health System
– UPMC – Mayo Clinic
– Sanford Health Network
Incremental ▪ 4 Account Managers ▪ 4 Account Managers
FTEs ▪ 2 MSL ▪ 2 MSL
1 May consider adding high value multi‐specialty medical groups (currently not captured in HCOS) such as Hill Physicans and Brown and Toland in CA in future waves
2 Atrius Physicians in greater Boston should also be added (although not‐captured through HCOS) because of the high level of centralized control
E2E – Evolve to Excellence 35
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Proposed timing for key upcoming activities to develop the infrastructure
to support Purdue’s IDN strategy Most resource intensive timeframe
NOT EXHAUSTIVE
Value
▪ Develop detailed profiles for target IDNs
Proposition
▪ Develop and test preliminary value propositions
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
for these IDNs
▪ Develop criteria/ reporting structure for
AM role and benchmark job description/salary
Role
▪ Evaluate existing talent pool to identify
definition,
internal candidates
reporting
▪ Define key measurements/ signposts to track
structure, and
KAM success
resource
▪ Identify source of resource allocation
allocation
for new FTEs (e.g., low workload territories)
▪ Post positions and hire for new roles
▪ Build physician affiliation process/tool
Physician for use during Q3 call list “clean up” process
▪ Train field on affiliation process in Phoenix
Printed 4/17/2014 12:56 PM Eastern Standard Time
Affiliations
▪ Complete field affiliations
▪ Develop and roll out rep training
Training program for targeted markets
▪ Roll out training in field
Meeting ▪ Begin to schedule top‐to‐top leadership
Scheduling discussions with key IDN leadership
Confidential MCK-MAAG-0017306
Doc ID
Contents
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
▪ Re‐cap of core E2E initiatives
▪ Metrics
▪ IDN Strategy
▪ Multi‐channel approach to no‐sees
▪ Improved Patient Access
Printed 4/17/2014 12:56 PM Eastern Standard Time
▪ Next Steps
E2E – Evolve to Excellence 37
Confidential MCK-MAAG-0017306
Doc ID
We will utilize a 3‐pronged multi‐channel strategy to increase Purdue
interactions with “No‐see” physicians
Multi‐channel approach
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
Purdue Brand
delegate visits Live interaction and
Remote
the Interactions materials are
interactions
prescriber’s presented over
office and the phone/
presents brand internet
materials
Self‐directed
Printed 4/17/2014 12:56 PM Eastern Standard Time
interactions
Brand interaction or
content is viewed by the
prescriber at time and
channel of their choosing
E2E – Evolve to Excellence 38
Confidential MCK-MAAG-0017306
Doc ID
The multi‐channel strategy utilizes numerous modalities to maximize
Budgeted
reach, both broadly and specifically for no/ limited see HCPs Proposed
<1 1‐2 >2
Timing for roll‐out Prospective no‐see/ limited see impact
Total # of No‐ Total # of
Sees Limited‐Sees
Budgeted/ # Prescribers targeted4 targeted4
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
Modality Proposed Status Targeted (N = 10,896) (N= 14, 470) ROI5
1. Company reps deliver brand folders Q3 2014 5,2501 5,2501 N/A
Live
Inter‐ 2. Contract sales organization N/A N/A N/A N/A
actions 3. Concierge reps TBD TBD TBD TBD N/A
Remote 4. Outbound call center Q3 2014 54,000 8,695 387
Inter‐ 5. Online Webinar Current 3,079 343 494
actions 1962 312
6. Virtual lunch in learn Q4 2014 N/A
7. Content on third party sites (e.g., Medscape) Q3 2014 N/A N/A N/A N/A
8. eMR savings cards Current TBD TBD TBD
9. E‐mail broadcast Current 63,000 6,045 7,905
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10. e‐details Q3 2014 3,5732 1962 3122
11. Virtual case studies/vignettes Q3 2014 230 2 11
Self‐
directed 12. Savings cards Current TBD TBD TBD
Inter‐ 13. Third party collaborations (e.g., Peer Review) Q3 2014 3,5742 1962 3122
actions
14. Direct mail Current 3,5742 1962 3122
15. Third party e‐mails TBD N/A N/A N/A
3
16. Patient management program Q3 2014 TBD TBD TBD
17. Mobile apps/website 2015 N/A N/A N/A N/A
18. Physicians interactive Q3 2014 47,500 8,211 10,596 N/A
1 10 prescribers/territory 3 In place for Butrans 5 ROI is “N/A” for in those instances where we are unable
2 Decile 8‐10 prescribers 4 Deciles 2‐10 to calculate ROI (e.g., data/measurement limitations)
SOURCE: Purdue proposed multi‐channel marketing plan; Physicians Interactive; Team analysis E2E – Evolve to Excellence 39
Confidential MCK-MAAG-0017306
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A collaboration with Physicians Interactive could increase coverage
against no‐see and limited‐see prescribers
Current1 # of digital touches per # of touches per no/limited see pre‐ ▪ If Physicians
no/limited see prescriber scriber with Physicians Interactive Interactive
Prescribers, n=25,3662 Prescribers, n=25,3662 agreement is
approved, # of
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~18K no‐ ~10K no‐
no/ limited see
0 8,092 see/ 0 2,628 see/
HCPs with <2
limited see limited see
touches would
prescribers prescribers
1 8,526 1 7,730 decrease from
have <2 have <2
~18,000 to
interactions interactions
~10,000
2 6,365 2 7,556
▪ Other ideas
3 5,407 currently be
3 2,171
explored to
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increase reach:
4 169 4 1,860 – Nurse
Educators
5 146
– Education on
5 43 reimburse‐
ment
6 39 – Additional call
center duties
1. Prescribers either targeted in last 12 months or plan to target with budgeted campaign
2 Deciles 2‐10
SOURCE: Purdue proposed multi‐channel marketing plan; Physicians Interactive; Team analysis E2E – Evolve to Excellence 40
Confidential MCK-MAAG-0017306
Doc ID
Contents
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
▪ Re‐cap of core E2E initiatives
▪ Metrics
▪ IDN Strategy
▪ Multi‐channel approach to no‐sees
▪ Improved Patient Access
Printed 4/17/2014 12:56 PM Eastern Standard Time
▪ Next Steps
E2E – Evolve to Excellence 41
Confidential MCK-MAAG-0017306
Doc ID
CVS and Walgreens implemented more stringent programs to restrict
opioid dispensing between 2011 and 2013
Rolling 3‐mo purchasing levels % change,
$M July 11‐ Dec 13
All
80 Pharmacies ‐8.0
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75 Indepen‐
‐4.0
dents
35
30
CVS ‐23.0
25 Walgreens ‐24.0
Printed 4/17/2014 12:56 PM Eastern Standard Time
15 Jan – Jun 2012 purchasing declines 28%–
▪ CVS monthly purchasing declines 19%– corresponding with the
purchasing increases 8%–
10 corresponding with implementation of corresponding with new
national implementation of NDC quotas.
stricter opioid dispensing policies at CVS GFD
5
CVS declines 2%
Independents decline 1%
0
MAR 2012
MAR 2013
MAR 2014
NOV 2011
NOV 2012
NOV 2013
AUG 2011
MAY 2012
AUG 2012
MAY 2013
AUG 2013
OCT 2011
OCT 2012
OCT 2013
APR 2012
APR 2013
DEC 2011
DEC 2012
DEC 2013
JUN 2012
JUN 2013
JAN 2012
JAN 2013
JAN 2014
FEB 2012
FEB 2013
FEB 2014
SEP 2011
SEP 2012
SEP 2013
JUL 2011
JUL 2012
JUL 2013
Confidential MCK-MAAG-0017306
Doc ID
Purdue has employed multiple tactics to address these issues, but could
consider additional activities to more fully address stakeholders
Primary stakeholder Secondary stakeholder Stakeholder impacted
impacted impacted
Large Retail Small chains/
Chain independent
Purdue activity Wholesalers Pharmacy pharmacies HCP Patient
1 Collaborate with NABP to develop industry standards for dispensing
Last Modified 4/23/2014 11:02 PM Eastern Standard Time
guidelines
2 Encourage wholesaler/retailers to establish thresholds by NDC (vs. API),
segregate problematic products, or give protective benefit to ADFs
3 Work with retailers to modify dispensing guidelines to recognize
value of ADF products
Current activity
4 Encourage patients to raise concerns with wholesalers / retailers to
create broader awareness of patient access issues
5 Develop medical services playbook to address patient concerns
6 Organize event with the former DEA agent and discuss potential
solutions and partnerships to address the patient access issue.
7 Engage former/ current wholesalers in collaborative discussions to
Printed 4/17/2014 12:56 PM Eastern Standard Time
identify what it would take to address independent retailer
challenges
8 Work with NCPA to support independent pharmacy OMS programs
9 Create national “playbook “ for reps to standardize key messages and
Additional activities for
tactics used to address patient access at the field level
10 Refine Medical Services playbook to be more proactive in generating
consideration
solutions (e.g., form letters sent to legislators)
11 Facilitate a patient or provider verification system to streamline
pharmacist identification of “trusted” HCPs and ERO patients
12 Create alternate distribution model (e.g, direct to patient) ,
independently or through partnerships through which Purdue
assumes some risk (e.g., indemnifies other stakeholders )
SOURCE: Patient Access team analysis E2E – Evolve to Excellence 43
Confidential MCK-MAAG-0017306
Exhibit 16
To: Maldonado, Martha[Martha.Maldonado@pharma.com]
Cc: Kelly, Marv[Marv.Kelly@pharma.com]; Cramer, Phil[Phil.Cramer@pharma.com]
From: Vance, Matthew
Sent: Mon 10/9/2017 8:09:21 AM
Subject: Craig Landau Field Rides
2018 Sales Calendar.pptx
Martha,
Below are the updated dates and TBM/ATBMs that Craig will be working with. A couple notes:
• I deleted the dinner on 10/31 in Hartford as this is Halloween and will be a hard night to get
people out to dinner
• Red Team is Symproic Leads and Blue Team is Opioid Leads
Region City Date Activity Date Activity TBM/ATBM Team DBM RBD
Midwest Chicago 11/7 Dinner 11/8 Field Carol Devries- Red Dan Neyl
(6-9) Ride (8- WituckiTBM McAvoy Williams
2) II
Southeast Atlanta 11/20 Dinner 11/21 Field Sarah Red Mike Ron
(6-9) Ride (8- Leatherwood Moulton Cadet
2) TBM II
Southcentral Dallas 11/21 Dinner 11/22 Field Robert Blue Uames David
(6-9) Ride (8- LefflerTBM Gallucci McIntyre
2) II p
Mid-Atlantic Baltimore 12/4 Dinner 12/5 Field Tim Blue Mike Tony
(6-9) Ride (8- Oakjones K:iaffi Morello
2) TBM I
West San 1/10 Dinner 1/11 Field Eric Horowitz Red Patrick Rich
Francisco (6-9) Ride (8- ATBM Nave Gilardon
2) (acting i
DBM)
Thanks!
CONFIDENTIAL PPLPC014000361559
Matthew Vance
Associate Director, Field Force Effectiveness
Purdue Pharma LP.
C. 203.914.6388
0. 203.588.7019
CONFIDENTIAL PPLPC014000361560
Exhibit 17
To: maria_gordian@mckinsey.com[maria_gordian@mckinsey.com]
From: Landau, Dr. Craig
Sent: Tue 11/25/2008 3:19:06 PM
Subject: Fw: Deliverable Summary for Call
Opioid Training Program PurduePharma.Deliverable Summary.doc
Hi Craig:
Best,
Kevin
I believe we're on the same paragraph, if not the same sentence. I suggest a more detailed discussion
with a subset of the most appropriate folks (yours and mine) to determine how to move forward
contractually. This is not be area of responsibility, but of course will do everything I can to move the
ball forward. I can speak late tonight from Toronto if you wish, or any time from tomorrow night
through the weekend if this helps.
-Craig
CONFIDENTIAL PPLPC039000335655
Subject: opioid training registry
Hi Craig, Just got your voicemail, glad to hear we are moving forward.
We are certainly willing to help with the briefing package as we begin
this project, and are comfortable moving forward in parallel with the
contracting process. However it would be important for us to define in
general terms the scope of the entire contract in general terms before
proceeding, even if the minutiae take awhile to work out. We are
assuming that Purdue will contract with AR, and our technology
partners, to carry out the activities outlined in the Powerpoint
presentation, including developing a web-based training program for
prescribers, pharmacists, patients/caregivers, and a registration process
for pharmacies/health care systems, as well as develop a few different
methods for potential registrants to get into the system without direct
web access. The issue of how to get the data into pharmacies real-time
at point of care will be determined outside the scope of this specific
project. Are we on the same page? My Tufts meeting will end early
tomorrow afternoon, so if you are available we could talk then. Nat
CONFIDENTIAL PPLPC039000335656
Analgesic Research
Your #1 Cure for Pain Research
The OTR will be priced on a fixed-fee basis plus annual subscription. Annual subscription
will be waived for a certain number of years for a company or companies that fund a
substantial portion of the OTR development costs.
Website Features
Portals
• Pharmacies (for certification)
• Prescribers (for training, certification, and patient enrollment)
• Patients (for education)
• Pharmacists (for education)
The FDA letter does not require pharmacist certification (just pharmacies), and it does not
make patients responsible for their own training and enrollment into the registry (these
tasks are placed on the prescriber). However, we believe that:
• educational opportunities should also be provided to these audiences
Supplementary education for patients (and their caregivers) will enhance public
health, and having an educational program for pharmacists may enhance pharmacy
buy-in
• patients should have the option of self-registering and self-educating
• pharmacists should have the option of enrolling patients in the registry at the point
of dispensing-multiple paths to registration should be included to prevent barriers
to access
CONFIDENTIAL PPLPC039000335657
Analgesic Research
Your #1 Cure for Pain Research
Database Components/Features
CONFIDENTIAL PPLPC039000335658
Exhibit 18
From: Landau, Dr. Craig
To: maria_gordian@mckinsey.com; Tony_Tramontin@mckinsey.com;
Laura_Nelson_Carney@mckinsey.com; Sarraf, Pasha; Kenneth_Yoon@mckinsey.com
CC: lnnaurato, Mike; Egan, Larry; Steiner, LaDonna; Haddox, Dr. J. David; Natarajan, Sayee; Pickett,
Larry; Weingarten, Brianne; Harris, Stephen; Karen Becker; Udell, Howard; Stewart, John H. (US);
Steven Weisman
BCC: Pasha_Sarraf@mckinsey.com; Mike. Innaurato@pharma.com; Larry. Egan@pharma.com;
LaDonna.Steiner@pharma.com; Dr.J.David.Haddox@pharma.com; Sayee.Natarajan@pharma.com;
LAP1957@pharma.com; Brianne.Weingarten@pharma.com; Stephen.Harris@pharma.com;
Howard.Udell@pharma.com; John.H.Stewart@pharma.com; Stewart, John H. (US)
Sent: 12/2/2008 1:44:02 AM
Subject: First Draft- OTR Briefing Document for FDA
Attachments: 20081204 FDA Briefing Document EARLY DRAFT v10 nk. doc; APPENDIX TO 90 - REMS
description DRAFT V2 nk.doc
Colleagues,
I spoke with Nat this evening. Here are his detailed comments on the REMS draft and FDA Briefing Document. Given
the diverse nature of his comments, I've included what I believe to be the proper distribution. I'll look forward to
discussing further in a meeting I'll look to schedule either late tomorrow or early Wed morning.
-Craig
Craig Landau, MD
Chief Medical Officer
VP Clinical, Medical and Regulatory Affairs
Purdue Pharma LLP
Stamford, CT 06901-3431
Cell (203) 912-5576
Office (203) 588-7252
Email: dr.craig.landau@pharma.com
Craig,
Attached are marked up documents.
A few overarching comments:
1. The strategy of meeting the FDA's expectations for OxyContin and/or OTR by
responding with a "class-wide" REMS could backfire.
a. They might get the idea that Purdue only intends to meet its product-specific
obligations if these are implemented for the class (however one might define the class)
b. Not all elements of REMS should be, or can be, class-wide. For example the
Med Guide must be product-specific. Only certain elements make more sense for the
class than specific products, such as education/training, registration when required, pt
treatment agreements, core pt education, surveillance, etc.
CONFIDENTIAL PPLPC018000255234
2. I made a number of comments in the place they first came up, but did not repeat them
in other portions of the document when they would also have applied.
4. The major comment I had on the REMS Appendix was that it would be better to
cleave the PROMISE program into discrete parts. (1) the training program and registry,
for prescribers, pharmacists, and patients. Analgesic Research would develop and
maintain this. That way you have a respected independent third party doing the
training and tracking the outcomes, and nobody is in a Purdue or FDA database. This
makes it more convincing and feasible to crank it up to industry standard. We would
also take patient-enrollments into the database by a variety of means (fax, phone, web,
etc). (2) the inputs into the database (sales reps, phone training, letters, phone calls, etc).
Purdue could take responsibility for this. Main goal is to push people to the website. (3)
integration with dispensing systems. This will take some thought, planning, and
negotiation, as pointed out.
I think the major flaw of the current proposal is that it looks like a Purdue-only
program, down to the P in PROMISE, which undermines your strategy of creating a
class-wide program ultimately.
I will take a more detailed look and mark up the appendix in more detail tomorrow.
Regards,
Nat
CONFIDENTIAL PPLPC018000255235