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Contents
Introduction .................................................................................................................................................. 3
Current Market Landscape ........................................................................................................................... 3
Overview of Multiple Sclerosis (MS) Market ................................................................................................ 3
Disease Overview ...................................................................................................................................... 3
Steps in Multiple Sclerosis disease process .............................................................................................. 4
Macro Findings .......................................................................................................................................... 4
Prevalent Cases of Multiple Sclerosis (MS) globally ................................................................................. 5
Commercial Analysis of Competitors ........................................................................................................ 5
Commercial Assessment ........................................................................................................................... 6
Drug Overview: Copaxone and generics ....................................................................................................... 9
Marketed Drug Overview.......................................................................................................................... 9
Pipeline Drug Overview............................................................................................................................. 9
Pipeline Analysis........................................................................................................................................ 9
Partnering Details ................................................................................................................................... 10
Drug Description ......................................................................................................................................... 10
Mechanism of Action .............................................................................................................................. 11
Exclusivity Details ........................................................................................................................................ 11
Regulatory Milestones in the US................................................................................................................. 11
Business Need ............................................................................................................................................. 11
Porter’s 5 Forces’ Industry Attractiveness Analysis .................................................................................... 12
Situation Analysis ........................................................................................................................................ 13
Company ................................................................................................................................................. 13
Competitors ............................................................................................................................................ 13
Customers ............................................................................................................................................... 15
Collaborators........................................................................................................................................... 15
Context .................................................................................................................................................... 16
Lifecycle Management by Teva................................................................................................................... 16
Critical Success Factors and Commercialization Strategy for Biocon ......................................................... 17
Sources ........................................................................................................................................................ 18
Introduction
Biocon is India’s first publicly listed biotech enterprise. Biocon has shaped its business into four key growth
verticals with the aim to deliver sustainable long term value for patients, partners and healthcare systems
across the globe: (i) Biologics (Biosimilars and Novels), (ii) Branded Formulations, (iii) Small Molecules
(APIs & Generic Formulations) and (iv) Research Services.
Biocon Biologics or Biosimilars is a subsidiary of Biocon Ltd. Biocon Biologics is engaged in developing high
quality, affordable biosimilars.
The global multiple sclerosis drugs market size was valued at $23.5Bn in 2018 and is expected to grow to
$39.2Bn by 2026, with a CAGR of 6.7%. Many pharmaceutical companies have drugs approved for
treatment of multiple sclerosis patients, and many are engaged in clinical study for the development of
innovative therapy to enter or further enlarge their market share in the global multiple sclerosis market.
Copaxone is a branded drug from Teva, and its molecule it Glatiramer Acetate. Copaxone lost its patent
in Feb 2017. Mylan and Sandoz, the generic arm of Novartis, have got FDA approval for launching the
generic copies of Glatiramer Acetate. Mylan launched the first generic copy in Oct 2017, and Sandoz
launched the first generic copy in Feb 2018.
Global sales of Copaxone was $3.8Bn in 2017, which constituted 20% of Teva’s overall 2017 revenues.
Branded Copaxone is commercially available in 20mg and 40mg strengths and is available as an injectable
in the form of pre-filled syringe packs. Teva has already felt the impact of Mylan launching its 40mg generic
earlier than expected.
While Mylan launched the generic copy with the generic name of the molecule, Glatiramer Acetate,
Sandoz launched the generic copy with the brand name of Glatopa.
One of the earliest stages in lesion formation in MS is the breakdown of the BBB, followed by the massive
infiltration of immune cells, which proceed to destroy the myelin and damage the oligodendrocytes. MS
is associated with the infiltration of CD4+ cells, CD8 + Tcells, and B-cells within the acute inflammatory
lesions or the area of demyelination. The presence of these immune cells indicates alterations in the BBB
structure, allowing their crossing into the CNS5.
• The four types of MS are RRMS, SPMS, PPMS, and PRMS. PRMS is a less frequent subtype
compared to the others.
• An examination of the MS lesions generally shows the destruction of oligodendrocytes, focal
myelin loss, and reactive astrogliosis, but relative sparing of the axon cylinder.
• Currently, there is no cure for MS. However, treatments can help speed recovery from attacks,
modify the course of the disease, and manage symptoms.
Macro Findings
The MS Pipeline is Strong and • The MS pipeline features 299 drugs across all stages of
Diverse development. A total of
• 65% of these drugs are in preclinical stage of
development.
• Small molecules and mAbs dominate the early-stage
pipeline.
4% of CNS R&D Efforts Focused • In terms of clinical trial investigation, MS ranks 15th in
on MS the CNS therapy area.
• Approximately 40% of MS clinical trials are conducted
in Europe.
MS Clinical Trials Show Moderate • The average number of subjects recruited in Phase III
Enrolment Efficiencies MS trials is approximately 588 subjects.
• All phases showed moderate enrolment efficiencies
except for Phase II/III, which reported higher
enrolment efficiencies.
Approval of Novel STRs Expected • The launch of 10 new therapies will drive growth in the
to Transform MS Market MS space, provide more options for patients, and
stimulate further competition.
• The arrival of novel oral DMTs has fulfilled a significant
unmet need in the treatment of MS. However, MS will
remain a field of high unmet need during the forecast
period.
Commercial Assessment
The leading brands in MS are mostly immunomodulatory agents, which include oral therapies, mAbs, and
nonmAb injectable therapies. The treatment of RRMS remains the primary focus of the currently available
DMTs. Interferons and Copaxone are the most commonly used first-line treatments.
The players can also be mapped in a 2/2 matrix, keeping the strength of their products in Y-axis and
strength of the pipeline in -axis.
Strength
of the
Product
1. Commercial
a. Relevant M&A and licensing activity
b. Pricing changes
c. Patent litigation and/or expiry
d. Product discontinuation
2. Regulatory
a. New drug filings (NDA/BLA)
b. Launch date changes
c. Approval decisions
d. Priority Review designations
e. Reimbursement decisions (if relevant)
3. Clinical
a. Clinical trial milestones/data updates
b. Pivotal initiation/completion dates
Pipeline Analysis
Company Drug Therapy Indication Developm Last Dat Reason for
Name Geograp Area (s) ent Stage Developm e Discontinuat
hy ent Stage ion
Teva Global Central Amyotrop Discontinu Phase II 11- Unspecified
Pharmaceuti Nervous hic Lateral ed Dec
System Sclerosis -
Partnering Details
Agreement Event / Entity Role Entity Geography Status
Date Partnering
Type
04-Dec-2013 Licensing Licensee Takeda Japan Active
Pharmaceutical
Co Ltd.
04-Dec-2013 Licensing Licensor Takeda Japan Active
Pharmaceutical
Co Ltd.
31-Dec-1987 Licensing Licensee Takeda Global Active
Pharmaceutical
Co Ltd.
31-Dec-1987 Licensing Licensor Weizmann Global Active
Institute of
Science
Drug Description
Glatiramer acetate (Copaxone/Copace) is a combination of four amino acids (proteins) with acetate salts
of synthetic polypeptides, acts as immunostimulant agent. It is formulated as injection, solution or powder
for solution for subcutaneous route of administration. Copaxone is indicated for the treatment to reduce
the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (RRMS). Copaxone is
indicated for the treatment of patients who have experienced a first clinical episode and are determined
to be at high risk of developing clinically definite multiple sclerosis (CDMS). Copaxone is indicated for the
reduction in frequency of relapses in ambulatory patients, (i.e. who can walk unaided) with relapsing,
remitting multiple sclerosis (MS) characterized by at least two attacks of neurological dysfunction over
the preceding two-year period. Copaxone was under development for relapse prevention of relapsing-
remitting multiple sclerosis and Rett syndrome, amyotrophic lateral sclerosis (ALS), Crohn's disease and
acute optic neuritis.
Mechanism of Action
Glatiramer acetate (GA) acts by binding to Major Histocompatibility Complex (MHC) class II
molecules. The drug promotes T helper 2 (Th2) cell development and increased IL-10 production
through modulation of dendritic cells which allows modulation of detrimental immune responses to
various antigens and treats the disease.
Exclusivity Details
Exclusivity Expiration Exclusivity Code Number Strength
27-Feb-2012 I - 594 (Indication 020622 20mg/ml
Expanded to Include
Patients Who Have
Experienced A First
Clinical Episode and
Have MRI Features
Consistent with
Multiple Sclerosis)
28-Jan-2017 NP (New Product) 020622 40mg/ml
Business Need
Biocon wants to enter in multiple sclerosis market with the launch of generic Copaxone in the US.
Commercial generic launch in the US is targeted ~12months from now. The objective of the project is to
suggest commercialization launch strategies for the generic launch of Copaxone from Biocon in the US.
Conclusion: With Porter’s 5 Forces’ Analysis, we conclude that entering into the market which comprises
of patients using Glatiramer Acetate (branded as well as generic) as their preferred treatment option for
Multiple Sclerosis is attractive.
Situation Analysis
Next, we do a 5C analysis to analyze the existing situation in the market comprising of patients who using
Copaxone as their preferred treatment option:
Company
Biocon with its generic version of Glatiramer Acetate will be third generic player. Mylan benefited from
6-month exclusivity offered to first generic player as per US Laws. Biocon’s experience in handling generic
versions of drugs will come as handy to compete with Mylan and Sandoz primarily for the share of pie
available for generic players.
Competitors
Teva is the innovator company, and Mylan and Sandoz are the existing generic players. We will analyze
each competitor individually below:
Customers
Distributors and big hospital chains are potential buyers while a Doctor is the influencer here. Revenues
for innovator products are driven through Doctors. Generic players play on volumes, and usually try to
position them as easily replaceable options at drug stores and hospitals. Thus, key customers for Biocon
will be drug stores and hospitals. As per US laws, for patients of generic Copaxone, if their prescriptions
from Doctors are tagged as DAW (Dispensed As Written), drug stores and hospitals must mandatorily
provide branded Copaxone. If a patient’s prescription is not tagged as DAW, only then the drug stores and
hospitals can provide generic copies of Copaxone. As awareness of DAW rights among patients is low,
innovators companies spend a lot in DAW campaigns to educate patients of this rights. Teva, the innovator
company is spending in DAW campaigns which can prove as hindrance to generic players.
Collaborators
Supply chain is crucial for a generic player. As a generic player, the focus will be to flood drug stores and
hospitals with its products and urge the salesperson to easily substitute generic drugs when prescriptions
are not tagged as DAW.
Existing players have long term contracts with collaborators in the industry. Biocon will have to spend
more to make ties with collaborators.
Insurance players, patient support groups and multiple sclerosis support groups are few collaborators.
The existing players, Teva, Mylan and Sandoz, are very actively with these patient support groups and care
givers. Biocon will have to, at least offer POPs with these existing market players to remain competitive
in this market.
The existing players also offer injection device, free of cost, as Copaxone is an injectable drug. Biocon
needs to maintain POP and offer the device free of cost.
Initial administration of drug is done by nurses, and patients are trained to self-administer the drug
themselves. Biocon will have to offer such support services.
Teva and Mylan have developed apps which help a patient track their drug compliance. Sandoz does not
offer one such support currently. Biocon, which is a low price and high-volume player, is suggested to
offer such app support.
Context
1. Psychological Factors:
a. Multiple Relapsing Sclerosis is a lifestyle related disease and the growth trend of the
disease is around 18% YoY
b. This disease is not curable, its only preventable. Once contracted patient needs lifetime
supply of medication
c. The cause of disease has not been discovered yet. Moreover, the trend shows more
occurrences in the colder regions of North America
2. Political Factors:
a. Trade war between US and China may have spill-over effect on the products of Indian
companies such as Biocon and other pharma companies of India
3. Legal Factors:
a. Approval by FDA takes long time – around 12-18 months, which makes entry of new
players difficult
• Teva first launched Copaxone in Israel in Dec 1996 and subsequently in the US in Mar 1997.
• 23rd Apr 2002: Teva declared that Copaxone is available in pre-filled syringe
• 12th Dec 2002: Copaxone approved by FDA for treatment of patients with Multiple Sclerosis
• 11th Oct 2011: Teva announced results based on a 5year study for treatment of newly diagnosed
patients with Relapsing Remitting Multiple Sclerosis on Copaxone. Results showed significant
reduction in brain volume compared to patients treated with other DMTs (disease modifying
therapies)
• 18th Apr 2012: Announcement was made by Teva to present Copaxone new data at American
Academy of Neurology annual meeting 2012
• 23rd Jun 2012: Announcement was made by Teva that the US District Court for Southern District
of New York found in favour Teva’s allegation of patent infringement against Momenta
Pharmaceuticals, Sandoz and Mylan for Copaxone in the treatment of Relapsing Remitting
Multiple Sclerosis
• Since then, Teva has been involved in constant legal battles in which generic manufactures
(Momenta, Sandoz, Mylan and Dr. Reddy’s) challenged Teva for its patent validity on Copaxone.
Intermittent rulings in favour of one party was challenged by the other.
• May 15, 2014: US FDA denied Teva's motion to block FDA from approving generic versions of
Copaxone much to the cheers of the generic manufacturers paving ways for generic version
launches
• Aug 07, 2014: Teva received first paragraph IV notice for its thrice weekly 4mg/ml version of
Copaxone from Dr. Reddy’s
• 23rd May 2013: Sandoz submitted ANDA for thrice weekly Copaxone 40mg/ml version
• 01st Sep 2016: Mylan receives favourable Inter Partes Review (IPR). Third Copaxone patent found
unpatentable
• Jan 31, 2107: Momenta receives favourable judgement in its favour supporting generic Copaxone
launch
• 04th Oct 2017: Teva warned Mylan that any generic Copaxone launch from the latter will be
considered “at-risk” before final outcomes of the legal hearings come. Mylan could be suffer
significant damages financially if it goes ahead with generic launch and a decision comes in favour
of Teva
• 12th Oct 2018: Mylan received favourable court hearing which paved the way for generic
Copaxone launches
• Biocon was initially targeting to launch generic version of Copaxone in second quarter of 2020.
However, in our conversation with Biocon Marketing team, we are informed that there have been
some regulatory delays. The above lifecycle management efforts by Teva were shared to us by
Biocon Marketing team, and this proves that the innovator company Teva has been very
aggressive in protecting its branded sales coming from Copaxone. We are informed that Biocon’s
planned generic Copaxone launch is delayed now. Further details could not be shared to us due
to confidentiality reasons. We have suggested below critical success factors for Biocon’s planned
generic launch with the delayed timeline
1. As Teva has putting significant efforts to demonstrate safety and efficacy of branded Copaxone
through multiple studies, conference presentations, litigations and appeals, Biocon needs to
establish and verify bioequivalence with reference drug, Copaxone
2. Supply Chain Speed: Third biosimilar in the market requires Biocon to ensure ample GA supply at
hospitals and pharmacies
3. Novartis has been an established player in both innovator business and generics business, with its
fully owned generic arm Sandoz. After introduction of Glatopa of Sandoz (from Novartis) in 2015,
it was expected that the patients will have enhanced accessibility of drug Copaxone at reduced
price because of more treatment options. However, that did not happen in the US because Sandoz
came up with price parity as with branded Copaxone. This can be a source of POD for all the new
launches of generic Copaxone including Biocon’s launch. Thus, Biocon should leverage on the
expected price differential and scale advantages to flood the market with generic Copaxone
especially in northern US where market potential is still untapped
4. To leverage this, Biocon needs to leverage its competitive intelligence inputs and file for its generic
launch as soon as possible. Other generic players including Dr Reddy’s is also eyeing to launch a
generic Copaxone and can play on the price and volume differential need that currently exist in
the market
5. Biocon needs to partner with Specialty Pharmacies, Payers, Patients and Caregivers for value
added services provided by existing players. These will serve as POPs w.r.t. existing players
6. In parallel, Biocon needs to invest in data analytics. Biocon should leverage the US Anonymized
Patient Level data (APLD data) by purchasing from vendor data and services companies such as
IQVIA and Symphony Health. Through the US APLD data, Biocon should do the following:
a. Understand the patient journey, patient concentration by geography, age, gender and
family background
b. Identify the hospitals where most patient concentration exists
c. Do a selected targeted marketing campaign on the top 20 hospitals (by patient volume)
identified across the US. The hospital count can be further increased subsequently. This
selective marketing campaign will help Biocon optimize its promotional spend with
increased profitability
d. For prescriptions not tagged as DAW, Biocon should partner with Specialty Pharmacies to
be the preferred first choice for generic substitution. Biocon can do this by offering strong
incentives to Pharmacy Chains (by offering higher margins) and healthcare provider
insurance companies (by demonstrating similar drug profile as innovator’s and cost
savings)
Sources
1. Internal discussions with Biocon’s marketing team
2. GlobalData Industry Reports:
a. GlobalData_GlatopaTakestheFirstSmallStepTowardAffordableTreatmentsforMultipleScle
rosis
b. GlobalData_MultipleSclerosisCompetitiveLandscapeto2026
c. GlobalData_MultipleSclerosisDynamicMarketForecastto2026
d. GlobalData_Drug_Overview