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Launching A Specialty-Care Blockbuster
Franchise in Hepatitis C:
How Sovaldi & Harvoni Rewrote New Product Launch History

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Table of Contents
 Playbook of a Blockbuster: Key Insights from Sovaldi & Harvoni’s Launch Year
Success
 Birth of A Specialty Medicine Blockbuster -The First Oral Cure for Hepatitis Virus C
(HCV)
 Having The Insight & Expertise To Envision Transforming HCV Treatment Paradigm
 The Seeds of Success: Sovaldi Method of Action Moved Therapy From Treatment to
Cure
 The Seeds of Success: Epidemiology of Hepatitis C Created A Tsunami of Global
Unmet Need
 Market Entry History: The Back Story of The New Blockbuster Model
 Sovaldi Launches Like A Rocket Ship
 Other Noteworthy Market-Entry Tactics and Practices
 Pricing New Therapies Offers Multiple Risk Frontiers
 Public Reaction Ranged From Jubilation To Outrage
 The Global Launch & Pricing Strategy Divided The World Into Key Regions
 Payers Crafted Different Strategies Both To Access The New Therapy & Manage Its
High Price
 Where Blockbusters Grow, Patent Challengers Quickly Spring up
 By Its First “Birthday” Gilead’s HVC Franchise Had Rewritten Biopharma Launch
History – But Still Faced Many Challenges
 Learn More About Best Practices, LLC
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Image Source: The Scripps Research Institute
http://www.scripps.edu/news/press/images/group_images/law_wilson_ward_kong/e2_image.jpg
HEPATITIS C’S E2 PROTEIN
Key Practice Insights & Lessons Learned from Gilead’s Launch
Success With Sovaldi & Harvoni
Target Patient Population: Gilead benefitted
from a “triple dose” of good fortune: (1) a large
patient population, (2) many diagnosed but
untreated patients, and (3) a market eager for
better treatments.
Patient Support: Patient support is instru-
mental at launch for expensive treatments.
Gilead made superior patient support a
cornerstone of launch and market access.
Outcomes: Gilead demonstrated superior
outcomes using a clear marker.
Cannibalization: Embrace “planned
obsolescence” of 1st-generation product to
ensure sustained market leadership.
Price Leadership: Gilead assumed
leadership in discounting to hold volume –
inside and outside the U.S. Market.
Global Epidemic: The market dynamics of
high-volume, global health epidemics are
unique -- and became part of Sovaldi and
Harvoni’s triumphs and tribulations.
Third Generation Treatment: Three decades
of HCV treatments helped educate the market
for Sovaldi – making global patient and payer
constituents both appreciative and more
militant.
Breakthrough Therapy: Sovaldi was a true
breakthrough offering near-perfect cure rates
without difficult side effects.
Launch Tsunami: Sovaldi rewrote pharma
launch history: it doubled the sales of the
previous full-year launch record in its first
quarter – reflecting triple power of its high
price, large target market, and pent up
demand.

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This History of Sofosbuvir’s Development & March Into History
Is An Instructive Lesson for Pharmaceutical Marketers
~2008 Sovaldi
Polymer (PSI-
7977) Discovered
2009-10 Sovaldi
(PSI- 7977)
Developed by
Pharmasset
2010-11 Sovaldi’s
(PSI- 7977)
Method of Action
Refined
2010-11 Sovaldi (PSI-
7977) Shows
Extraordinary Results in
Phase 2b Trials, Granted
Fast Track Designation
by FDA
2011-12 Gilead
Acquires
Pharmasset
2013 FDA Approves
Sovaldi for treatment
of Chronic Hepatitis
C
2014 Sovaldi
Breaks all Launch
Records out of
History Books Four
Months Post
Launch
“Sovaldi selling way beyond our expectations. The initial prescription data are so massively
outperforming even the biggest weeks Incivek ever had, we believe any reasonable comparison
between the two drugs would indicate that U.S. sales in 2014, alone, are going to exceed $5 billion.”
-- Brian Skorney, Analyst, Baird
Source: http://www.gurufocus.com/news/256859/competition-
from-abbvie-will-not-hurt-gilead-sciences-

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“This leaves us optimistic about the opportunity that lies ahead. In fact, with an estimated 1.7 million
diagnosed patients in the U.S. and around 400,000 under treated care, we have to take just a small
fraction of those who can benefit from treatments in the future.”
-- Paul Carter - EVP, Commercial Operations, Gilead Science
Sovaldi’s Initial Target Market In U.S. Consisted Of 1.3 Million
Patients Who Were Diagnosed But Not Under Active Care
Not
Diagnosed,
59%
Diagnosed,
41%
Diagnosed
& Under
Care, 23%
Diagnosed
But Not
Under
Care, 77%
4.1 Million Total Hepatitis C
Patients in the U.S.
In the U.S. Gilead aimed initially to target patients who are already diagnosed but not
under treatment for their disease.
Sovaldi
Target

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HCV Patient Segments Have Multiple Faces Based On Various
Factors
By Genotype By Disease
Progression
By Dosing & Treatment
Regimen

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Sovaldi’s ROI At Launch Was Historic
Gilead Invested Around
$150 Million to Support
Ongoing Sovaldi Launch in
1Q 2014
Gilead’s Sovaldi Sales
Totaled $ 2.3 Billion for 1Q
2014 – its 1st Q In-Market

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“Our U.S. patient assistance program for
Sovaldi, Support Path, has been very active
since launch. This program helps patients
navigate benefits coverage, as well as
provide assistance where allowed with
copays and foundation grants. We anticipate
that 30% to 50% of commercial patients will
utilize our copay assistance program. ”
-- Kevin Young, EVP, Commercial Operations
The Support Path provides Patients with:
• Treatment Information
• Action Planning Tools to help manage
treatment
• Tips to manage stress and cope with
your emotions
• Advice to help you work well with your
healthcare team
Gilead Also Launched Its Online Patient Support Program –
Called “Support Path” – With Entry into the U.S. Marketplace

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Sovaldi Sought A Significant Price Premium to Competitors
Incivek,
$49,200
Vitrellis,
$53,000
Olysio,
$66,000
Sovaldi,
$84,000
$-
$10,000
$20,000
$30,000
$40,000
$50,000
$60,000
$70,000
$80,000
$90,000
$100,000
1st Generation
Treatment
Even though Sovaldi was
not a first in class drug
Gilead Priced Sovaldi much
higher as compared to
competitors. In fact, it is
around 300% higher than
1st generation treatment
and 30% higher than latest
approved Olysio by J&J
“I used to have an easy argument that treating
hepatitis C was cheaper than paying for a liver
transplant or liver cancer,”…
“But it’s getting a little closer.”
-- Jonathan Fenkel, Director of Jefferson University Hospitals’
Hepatitis C Center in Philadelphia

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Gilead Sought To Craft A Global Pricing Strategy That Reflects
Each Country And Its Marketplace…
USA: $84,000
UK: $57,000
France: $76,000
Germany: $66,000
India: $900
‘‘Gilead’s global pricing model is based on a
country’s ability to pay,”
-- Gregg Alton, Executive Vice President of
Corporate and Medical Affairs for Gilead
“The federal government is going to have to step
in and say there’s a concern about the public
welfare, and we can’t allow companies to take
advantage like this,”…. “Is what they’re charging
really appropriate?”
J. Mario Molina, CEO, Molina Healthcare Inc. (MOH)
Source: http://www.bloomberg.com/news/2014-03-05/hepatitis-c-drug-price-limiting-state-medicaid-approvals.html
Egypt: $900
Highest Cost
High-Medium Cost
Lowest Cost
Lowest Cost

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Payers Used Multiple Strategies To Combat High Prices For
Sovaldi and Its Fixed Dose Combination Formulation Harvoni
Public relations
campaigns,
prior
authorization
programs
Influence clinical
guidelines to
support tiering and
stage gates so only
sickest get the
medicines
Shame
Manufacturers
Negotiate with
other competitor
drugs about tiering
Sovaldi if they come
out with less
expensive drugs
Demanding
health
outcomes to
prove efficacy
Organize
coordinated
protests to
pressurize
manufacturer
Wait &
watch
Conduct cost
benefit
analysis
Accept
Sovaldi
http://www.uhcpharmacyinfocus.com/article/hepatitis-c-big-changes-coming-soon-2
Create Deals To
Offer Plan
Exclusivity in
Exchange for
Discounts

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