For the Love of Life

A CASE STUDY COMPETITION FROM

Case Study Scenario
Priya Mehta is a bright young management graduate, who joined Nuva Pharma and has
successfully completed the two years Graduate Leadership Development Program. The
program provided her with an invaluable learning experience about the industry and the
way Nuva Pharma functions, through structured stints in sales, marketing and a cross-
functional exposure coupled with an international experience for six months. Now, she
has joined the Ophthalmology portfolio which is working on the launch of a new delivery
system for a key brand. She has been able to closely observe what the brand has
brought about to the lives of patients. She is excited to work on the launch that is going
to lead a new wave in the delivery of treatment for retinal disorders and will redefine
outcomes from a physician and patient’s perspective.

Diseases involved:

1. AGE-RELATED MACULAR DEGENERATION (AMD)

There are two types of AMD: dry AMD and neovascular AMD (nAMD).
Generally speaking, dry AMD progresses quite slowly and is usually less severe than
the neovascular type. However, both types damage central vision – that which helps
patients see fine detail directly in front of them.
With impaired central vision patients might not be able to do some of the things they
normally take for granted, such as: Reading, Driving, Shopping, Hobbies
Early detection and intervention are vital to stop or delay vision loss. AMD is a chronic,
degenerative disease of the eye. It affects a specialized area in the center of the retina
called the macula. The macula helps you see fine details directly in front of you, such as
words in a book or images on television. So, while the entire retina lets you see that
there is a book in front of you, the macula lets you see what is written in the book.

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In nAMD, new, abnormal blood vessels grow in the retina and macular region,
affecting vision. This is known as neovascularization.
nAMD develops when the membrane underlying the retina becomes thickened and
breaks, causing disruption to the macular’s oxygen supply. The response to this is the
growth of new, abnormal blood vessels, which grow towards the macular, otherwise
known as choroidal neovascularisation (CNV). These blood vessels can leak fluid or
bleed, causing damage or scarring to the macula. This damage manifests as rapid
central vision loss which is irreversible.
AMD remains a leading cause of severe vision loss and legal blindness in people aged
over 50 years. AMD is expected to affect 196 million people worldwide by 2020.
Today, nAMD can be effectively controlled with treatments.

Risk factors for nAMD:

AGE
Risk increases with advancing age
 Less than 10% - 43 to 54 years
 Nearly 40% - Over 75 years

FAMILY HISTORY
Up to 3 times greater risk within families (parents and siblings)

GENDER
Women are more susceptible

RACE
Caucasians are at higher risk

2. DIABETIC MACULAR EDEMA (DME)

As its name suggests, diabetic macular edema (DME) is a disease linked to diabetes.
Some people with diabetes will get a form of retinopathy – a disorder of the retina in the
eye. Diabetic retinopathy can progress and result in DME (also known as retinal
swelling) that may affect vision, and is one of the most common causes of blindness.
Although DME cannot be cured, there are treatments available, such as anti-vascular
endothelial growth factor (VEGF) treatment, that may help slow down the progression of
vision loss and improve vision. Today DME can be effectively controlled with treatments
like anti-VEGF therapy.
DME occurs when fluid leaks into the center of the retina at the back of the eye (called
the macula), causing it to swell. This swelling blurs vision and affects the ability to read
and see detail clearly. DME occurs in both eyes in more than 50% of people with the
condition, although vision may not always be affected in both. There are a number of
factors both within and outside of patients’ control that can put them at increased risk of

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developing DME, or making it worse if they already have it. All patients with type 1 or
type 2 diabetes are at risk of developing DME.

Risk factors for developing or worsening type 2 diabetes include:

 High cholesterol
 Being overweight or obese
 Not getting enough exercise
 Smoking
The following are additional risk factors associated with DME:
 Diabetic retinopathy severity
 Poor glycemic control
 High blood pressure
 Duration of diabetes
 Age

Manifestation and impact of nAMD and DME:

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Management of nAMD and DME:
NUVA PHARMA revolutionized the way patients see the world
Sitencul

Sitencul: a first of its kind disruptive innovation in the history of retinal disease management

Most commonly, intravitreal anti-VEGF injections are used to treat nAMD and DME.
These work by preventing blood vessels from growing. Repeated injections are
required.
In the past, laser treatments such as photodynamic therapy (PDT) and
photocoagulation therapy were used to treat these disorders, but with the emergence of
anti-VEGF injections they have become much less common. The anti-VEGF era
revolutionized the way nAMD and DME were managed.

Diagnosis:
Traditionally nAMD and DME are diagnosed and monitored using fluorescein
angiography (FA) and optical coherence tomography (OCT). This involves injecting
fluorescein dye into a vein in the arm, and as the dye travels through the retinal blood
vessels, photographs are taken highlighting any abnormal areas.

Treatment options:
Vascular endothelial growth factor A inhibitor (or anti-VEGF) is a treatment that reduces
the growth of blood vessels, which in turn reduces the risk of fluid leakage and vision
loss. It works by inhibiting the VEGF protein produced by cells in the retina. Anti-VEGF
is administered by intravitreal injection i.e. injection into the vitreous chamber of the
eye. The three most commonly used anti-VEGF agents are Nuva Pharma’s Sitencul,
approved in 2006 in the US, and 2007 in the EU; Bonne Pharma’s Vislea approved in
2011 in the US, and 2012 in the EU, and Rouge Pharma’s Nitsava which is not
approved for use in nAMD or DME; it is a less costly treatment option, but its approved
indicated use is in oncology.

Market dynamics in India 2012-13

Off-label competitor, Nitsava, existed at 1/10th the cost of Sitencul. Due to this, Nitsava
captured 90% of the anti-VEGF market while the remaining 10% belonged to Sitencul. .

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Sales of Sitencul began to flatten after a point, owing to the high price. The gap was in
the fact that out-of-pocket expenditure is the primary source of funding healthcare in
India. And less than 10% of the population is covered by medical insurance. Access and
affordability were the 2 key barriers to patients receiving Sitencul.
An innovative brand strategy:
In 2014, Nuva Pharma India launched ‘Made for India’ brand Centrixa, at an India-
specific price point.
Centrixa has brought about a revolution in the number of people who can now access
anti-VEGF treatment, thanks to its lower price point. Together with the price drop and
various patient centric activities, number of patients on Centrixa increased 5-fold, with
an 8-fold increase in number of infusion procedures.
Today, the competitive scenario is different with new entrants in the market and
Centrixa enjoying a 45% share.
The anti-VEGF market today:
Centrixa (45% MS)
 1st approved anti-VEGF for ocular use
 Proven efficacy with wealth of clinical data
 Favourable safety profile

Vislea (3% MS)

 Research molecule
 Efficacy perception is high vs Centrixa
 Curiosity to try latest molecule by Indian Medical Experts
 High price currently is the ONLY deterrent to prescribe this.

Nitsava (47% MS)

 Approved for use in Oncology, not for Ocular use
 Used widely in ocular use, off-label, due to low cost
 Despite safety concerns, Govt. of India accepted the recommendations of
scientific and doctor associations for the off-label use in 2016
 Risk of infection is higher with Nitsava due to the splitting of the vial across many
patients
 New entry of Nitsava biosimilar in a smaller dose vial, may cause less safety
issues

CTX Biosimilar (5% MS)

 This is a biosimilar of Sitencul/Centrixa

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  Experienced batch recalls due to safety concerns and adverse events but
managed to overcome the safety concerns and are on a revival track
 Active participation in National meets and scientific symposium to garner trust
 Aggressive pricing strategy

Indicative cost of anti-VEGFs:

 Centrixa – Rs. 22000
 Nitsava – Rs. 8000
 Vislea – Rs. 55000
 CTX Biosimilar – Rs. 15000

Note that these costs are drug costs and do not include procedure cost charged by the
doctor/institution for administering the injection.

Channel strategy:
 Anti-VEGF drugs are present in both Government and Trade channels.
 Government channels include Government Key Accounts (GKAs) like Army,
Railways, CGHS, ESIC etc. Supply to these institutes is usually direct, and tender-
based.
o This comprises a reimbursed market and these patients are not self-pay
patients.
o Key influencers in these accounts are called Key Decision Makers and are
not necessarily practicing doctors, but part of the administrative and
procurement department.
 Trade channels include private business, where both self-pay and government
empaneled patients avail treatment.
 38% of Centrixa business comes from GKA.
 75% of GKA business is contributed by CGHS/ Army

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Task at hand:
Launch of a new delivery system - Centrixa PREFILLED SYRINGE (PFS)
Nuva Pharma plans to launch Centrixa PFS in the market. Priya is now given the task of
planning for the market launch of Centrixa PFS and needs to think about the target
doctor, patient profile, pricing, positioning, communication and sales strategy to ensure
a positive uptake of PFS, with only minimal cannibalization of Centrixa vial.
Another point to note is that she can only launch Centrixa PFS in the government
channel. This will bring about a differentiation in this channel as:
 Pre-filled syringe is listed as a unique SKU both in terms of delivery system and
strength
 ‘Unique listing’ opportunity to fight off biosimilars

Features of the PFS are:

Simple preparation process:

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Centrixa PFS has the following properties:

EASY TO HANDLE: to potentially minimize ocular risk

EASY TO USE: with fewer preparation steps vs. the vial

SAVES TIME: in daily practice

ACCURATE DOSING: since no aspiration from the vial, and thereby minimized wastage

Key considerations:

1. Safety and ocular risk

Risk of ocular infection is high with anti-VEGF injection and so the same is always
administered in an operation theatre under sterile conditions, in a day-care setting with
local anesthesia.

Risk of infection is higher with Nitsava due to the splitting of the vial across many
patients. The vial is off-label for this indication and thereby not designed for ocular use.

Risk of infection with BioSimilars has been observed too, which is possibly due to the
inconsistency in batches and other quality issues.

However, with Centrixa/Sitencul, infection risk is very low as –

 Quality of the product is consistent and ensured

 Splitting of vial is less common as one vial is designed for one dose

Centrixa/Sitencul vial is therefore considered extremely safe.

2. PFS would be premium priced over the vial.

3. The drug component in PFS including shelf-life, efficacy etc. is exactly the same
as the Centrixa/Sitencul vial

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STAGE 1 – Questions:

1. What should be the key strategic drivers for Nuva Pharma to keep in mind while
preparing to launch Centrixa PFS in key GKAs?
2. How should Nuva Pharma position the value proposition of PFS with minimum
cannibalization of Centrixa vial in these GKAs?
3. At what price point would uptake of Centrixa PFS be successful in this channel
and why?

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