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Executive Summary
This is a 3-year marketing plan for Sofosbuvir. It outlines the current environment in the
Hepatitis C virus (HCV) market, the key issues and opportunities facing the Sofosbuvir brand,
were our brand will be positioned in the HCV market place and the strategies and tactics that will
be employed to execute a successful launch for Sofosbuvir in the United States. We are confident
in the Sofosbuvir brand and confident in the success it will have in the HCV market.
Missionand Brand Goals
The Gilead mission statement is “to discover, develop and commercialize therapeutics that
advance patient care, while challenging employees to make a difference and building a thriving
worldwide enterprise.”41 The plan for Sofosbuvir meets the company mission and also has Brand
Goals listed below.
• Become the preferred drug treatment regimen of choice for HCV 1-4
• Market share leader in all HCV drugs
• Have preferred status on all payers formularies
• Support from advocacy groups, payers, physicians and Key Opinion Leaders
• Become the global drug of choice for HCV 1-4 in combination therapy
Staying true to the Gilead mission and the goals, Sofosbuvir will have a successful launch and
life cycle in the HCV market.
Summary of Situational Analysis
The hepatitis C virus (HCV) is an inflammatory infection that affects the patient’s liver1,
a “vital organ that processes nutrients, filters the blood, and fights infections”19. HCV is chronic,
silent and the long-term effects of the virus are infection, cirrhosis, liver cancer and liver failure2.
Many patients that are infected with HCV are asymptomatic and have no signs of infection until
the disease progresses to the final stages3. The symptoms present as fatigue, nausea, anorexia,
weight loss and or weakness.26 HCV is an epidemic that spreads quickly through the utilization
of needles for blood transfusions, dialysis, and drug usage19,26. In 1992, testing blood for diseases
like HCV aided in decreasing the rapid spread of the hepatitis C virus.19,26
Hepatitis C is a global disease, which has resulted in an estimated 170 million worldwide
infections with 4.7 million new infections yearly4,26. In addition to the high transmission of
infection rates, 350,000 lives are claimed by HCV yearly5. The United States alone houses about
3.2 million people infected with HCV. There are six distinct Hepatitis C genotypes or strains of
the virus found throughout the world. In the US, HCV genotype (GT) 1 is the most common
type of Hepatitis. Additionally, genotypes (GTs) 2 and 3 are found in the United States. In 75-
85% of the persons infected, HCV becomes a chronic illness6. The asymptomatic nature of HCV
skews the number of reported cases causing a variance in the number of reported cases vs the
number of suspected infections in the United States. In 2011, the CDC reported 1,229 cases of
HCV and the estimated number of infections was calculated to be 16,5007. In order to identify
the presence of HCV in a patient, a blood test is administered. The test identifies antibodies
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fighting the infection9. There is a nucleic acid test used to identify if the HCV infection is
chronic8. Once it is determined that HCV is present within the body, only then can steps be taken
to administer the proper treatment as indicated by genotype.
Currently there are limited treatment options available to treat HCV infections. To guide
a patient's treatment, HCV RNA PCR assay can be utilized to detect a viral response10. Genotype
(GT) 1 patients are administered peg interferon, ribavirin and some an additional protease
inhibitor10 like Incivek (Telaprevir) or Boceprevir (Victrelis)20,25. (See Appendix Chart 1:
Telaprevir Algorithm, Appendix Chart 2: Boceprevir Algorithm) The goal is to sustain an
eradication of the virus which is called the sustained virologic response (SVR) and prevention of
cirrhosis, hepatocellular carcinoma (HCC) and or decompensated liver disease requiring a liver
transplant20, 24, 26. (See Appendix Table 3 Current HCV Treatment Options)
The current treatment regimens are not ideal. Victrelis indicated for HCV GT 1,
administered 4 200 mg capsules 3 times daily, ribavirin is twice daily and peg interferon alpha is
one time per week32. The RBV and INF are administered for 36-48 weeks, Victrelis administered
for 31 to 46 weeks32. This treatment regimen has a 38% to 66% reached SVR24.32 Invitek is also
indicated for HCV GT 1 in combination with ribavirin and peg interferon alpha.33 The patient is
administered 3, 375mg Invitek tablets twice daily for 12 weeks in combination with ribavirin and
peg interferon alpha administered from 24 to 36 weeks33. This treatment regimen has a 79% SVR
in treatment naïve patients and 32% SVR in null responders33.
The limitation on current therapy in the HCV market increases the eagerness of
stakeholders for a safe, effective drug. Many patients are unaware of the infection because of
HCV’s asymptomatic nature and patients that are aware are choosing not to be treated because
they are waiting for a safe, effective, tolerable treatment that is interferon free. Caregivers are
awaiting more information about the disease so that they can better protect themselves and the
person under their care14,15. Future treatment options are showing promise to patients in many
different ways. Ribavirin alternatives (taribavirin) are being developed to improve the
effectiveness, safety, and tolerability of therapy for chronic HCV11. There is evidence to suggest
interferon-free, directly acting antiviral agent-only regimens can achieve sustained virologic
response (SVR)12 for patients with GT 128, 29. (See Appendix Table 4: Current HCV Drug
Competition)
Health professionals and payers have high expectations for new drugs like Sofosbuvir in
aiding the patients. Bio-Trends research group indicates, that 84% of physicians polled welcome
an alternative to the current treatment regimens for HCV16. Patients are being warehoused in
anticipation of a promising drug that is interferon free16. The number of warehoused patients is
about 879,000 in 2013 (See Appendix Table 3: Sofosbuvir Revenue Forecast). Payers are
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increasingly anticipating the emergence of a new HCV treatment because the sequale diseases
have a high economic burden17.
Sofosbuvir can meet this unmet need and can reach the market before saturation. Gilead
acquired the Sofosbuvir science after the acquisition of Pharmasset for $11 billion in 2011 It is a
Nucleotide NS5B inhibitor2 with a “direct-acting nucleotide polymerase inhibitor”3 that stops the
RNA duplication when infected by HCV. The drug is incorporated into the RNA chain and that
chain is then terminated3. Sofosbuvir is administered in addition to ribavirin and peg interferon
alpha, sofosbuvir 1 400mg tablet daily, weight based RBV twice daily and peg interferon 1 time
per week for 12 to 16 weeks34. Patients treated had a 90% SVR12
34. We completed marketing
applications for the United States, European Union, Australia, Canada, New Zealand,
Switzerland and Turkey35. The FDA tentatively approved Sofosbuvir for genotypes 1 and 4 with
interferon and ribavirin for GT 2 and 3 with ribavirin35. The associated side effects include
anemia, dizziness, fatigue, headache, insomnia, nausea, puritis38,39. Along with the emergence of
Sofosbuvir, there are many other compounds in development and some that are awaiting final
FDA approval creating the potential for fierce competition. (See Appendix Table 4: Current
HCV Drug Competition)
Key Issues and Opportunities
The key issues Gilead is facing is the need for return on investment, lifecycle
management of the molecule by indication, and the need to clearly differentiate the brand from
current and future competitors. The big challenges Gilead is facing with this brand are how to
maximize patient access for all HCV patients, how to capitalize on warehoused population, and
how to capitalize on product profile (efficacy, safety, duration of therapy) in addressing patient
unmet needs. These challenges are in fact the opportunities that Gilead has with Sofosbuvir.
Their opportunities to capitalize on these challenges (outlined in the SWOT analysis) include
how to obtain first-to-market for an interferon free regimen; how to obtain first-to-market for an
all-oral regimen; and how to enter the global market before competitors.
Brand Objectives and Positioning
Sofosbuvir will be positioned for patients with chronic hepatitis C, genotypes 1-4; it will
be part of every HCV treatment regimen because it provides the second highest SVR, improved
tolerability and shorter duration of therapy compared to current treatment regimens. Based on
this positioning, the brand objectives pre and post launch focus on brand awareness with
clinicians. Specifically, unprompted awareness at 50 percent by end of Q4 2013 and 70 percent
prompted. Post-launch, the expectation is to reach 70 percent unprompted by end of Q1 2014 and
90 percent prompted. Additionally, Gilead’s post-launch brand objectives include becoming the
top HCV drug on the market by prescription sales and fasted growth in 2014. The goal is also to
increase market share to 7 percent of total HCV-positive population. Continued growth will be
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driven by increased disease awareness, expanded indications by 2015, and increased access
through Patient Protection and Affordable Care Act legislation.
Strengths/Weaknesses/Opportunities/Threats
We have some overwhelming opportunities in the marketplace. As a small
pharmaceutical company, there is flexibility to react to market changes and adapt to the current
environment. Gilead is capitalizing on such an opportunity. With a dominate presence in the HIV
market place with drugs Vired, Truvada, Atripla41 and have rising sales from Stribild and
Complera40, strong collaborations with pharmaceutical companies showing commitment to the
patients and the launching of Sofosbuvir in the HCV market place, Gilead has many things to
look forward to in the future.
Figure1: Gilead Sciences SWOT Analysis
Gilead SWOT
Strengths
Leader in the HIV market, driven by: Viread, Truvada, and Atripla
Strong backing by investors due to potential of Sofosbuvir
Marketing Applications for Sofosbuvir have been submitted- US, EU, Australia, Canada,
New Zealand, Switzerland & Turkey
Gilead Sciences Debt to Equity Ratio is low at 0.5274
Strong corporate partnerships/collaborations with GSK, BMS & Janssen
Weaknesses
Lack of diversified product portfolio. Gilead’s portfolio is still heavily reliant on HIV
treatment.
Substantial portion of revenue comes from 6 HIV drugs and Liver antivirals
Acquisition cost of Sofosbuvir - purchase of Pharmasset cost $11.05 Billion
Opportunities
How to capitalize on the approval of Elvitegravir for the treatment of HIV
How to maintain and increase the ROI for Gilead stock
How to capitalize on Sofosbuvir upon FDA approval
How to maintain international growth with worldwide sales
Threats
How to defend Gilead from the extensive generic threat being a 100% small molecular
player
How to defend from competition of new entrants
GSK dolutegravir for the treatment of HIV
Baraclude (entecavir), BMS for treatment of HBV
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How to alleviate impact that the ACA will likely have on pricing & profitability in US
market demanding further discounts for products
How to protect Gilead from law suits - Merck regarding patent infringement in regards to
Sofosbuvir & Vertex for poaching employees and stealing data to make rival drug
Sofosbuvir is a new entrant into the HCV market, expected to launch in 2014 offering
patients an alternative to treating HCV genotypes 1-435. This is a great opportunity for the
patients suffering with HCV and Gilead’s portfolio to introduce Sofosbuvir with its competitive
attributes.
Figure 2: Sofosbuvir SWOT Analysis
Sofosbuvir SWOT
Strengths
Data from clinical trial suggest sustained virologic response (SVR), efficacy
Data from clinical trials suggest tolerable safety profile
Expected to treat several genotypes,1-4 with combination therapies
Genotype 2 & 3 are oral therapy as opposed to injection
Shorter treatment regimen, 12-16 weeks
Weaknesses
HCV is a new therapeutic area for Gilead
Studied in combination with ledipasvir and ribivarin (as opposed to just on its own)
Does not treat all genotypes ofHepatitis C
Long term safety data could indicate a worse profile than expected
Extended SVR has not been studied in clinical trials
Opportunities
How to obtain first-to-market for an interferon free regimen
How to obtain first to market for an all oral regimen
How to enter the global market before competitors using established relationships like
Quadri Pharma, Egypt
How to be first-to-market with Sofosbuvir’s novel MOA
Threats
How to mitigate competition from other new entrants like AbbVie, Q2 2014
How to mitigate potential delays with the FDA, approval issues and governmental delays
How to address possible late-stage failure with drug
How to prepare for potential resistance from payers and patient advocacy groups
regarding premium pricing
How to prepare for potential resistance from payers underthe new legislation PPACA
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Pre-Launch Strategies & Tactics
Since HCV is a highly communicable disease, the brand’s first pre-launch strategy is to
increase awareness of HCV and patient unmet needs. This strategy aligns with key opportunities
of how to maximize patient access for all HCV patients, how to capitalize on warehoused
population and how to capitalize on product profile in addressing patient unmet needs. The
primary tactic for this strategy is to partner with Centers for Disease Control (CDC) across the
US eight months before launch, to do a public awareness campaign targeted to people ages 18-65
via television programming to encourage HCV testing. To ensure ease of access to testing
centers, Gilead will identify a lab testing partner with labs in all 50 states with the goal of
offering low-cost HCV testing to people ages 18-65. The motivator to get tested will be a
message that urges people who believe they do not have the disease to think about possibly being
infected and being asymptomatic. The Key Performance Indicator (KPI) for this strategy will be
the willingness of external partners (CDC, labs) to partner with Gilead.
Another core pre-launch strategy is to prepare the sales team and the broaden Gilead’s
organization for Sofosbuvir’s launch. This strategy aligns with the key issue of achieving return
on investment as well as the need to manage the lifecycle of the molecule by indication. The
plan is to prepare teams for launch by providing extensive clinical training on the current HCV
landscape and the new Sofosbuvir molecule. The goal of this training is to ensure that any teams
that interface with customers will be able to answer customers’ questions appropriately.
Emphasis will be placed on training medical science liaisons (MSLs) and clinical specialist sales
representatives (CSs) on what they can and cannot share with customers to ensure we are in
regulatory alignment with the FDA. The expectation is that all of the MSLs are prepared to
address unsolicited inquiries pertaining to Sofosbuvir by Q2 of 2013 and sales force will have
completed the core training by Q4 of 2013 so that if Sofosbuvir receives FDA approval end of
2013, sales force will be prepared to deploy immediately. To further increase disease awareness,
Gilead will develop an unbranded disease awareness campaign targeted toward people 18-65
years old to encourage HCV testing four months prior to Sofosbuvir launch. Additionally, health
departments in the five states with the highest HCV infection rates will be identified for
partnerships so that Gilead can help provide information to the public on how to get HCV tested;
this initiative to roll out four months prior to launch. The KPI for this strategy will be sales force
and MSL readiness as measured by data based multiple-choice assessments.
The third major pre-launch strategy is to prepare the US market for sofosbuvir by
engaging advocacy groups and practitioners. This strategy supports the key issue of maximizing
return on investment. The plan is to begin about twelve months pre-launch by identifying top
HCV advocacy groups in the US that are willing to partner with Gilead. Potential partners
include the American Liver Foundation, Hepatitis C Foundation, and HCV Advocate. Once
those groups are identified, the goal would be to partner with them to increase disease awareness
in the community. To engage the practitioners there would be advisory board sessions during the
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eight months leading up to launch. This would serve two purposes: to get feedback on potential
marketing ideas as well as to understand what gastroenterologists and other specialists who treat
HCV need. By having the practitioners’ perspectives, the marketing plan could be even more
successful because the unmet need would be even clearer. The KPI for this strategy will be the
advocacy groups’ willingness to partner with Gilead.
Figure 3: Pre-Launch Strategies, Tactics and Key Performance Indicators
Post-Launch Strategies & Tactics
Once FDA approval is granted, a major strategy will be to create awareness of
Sofosbuvir’s high SVR and its potential role in the treatment of the warehoused patient
population. This strategy goes in line with the key brand opportunities of how to capitalize on
the warehouse population and how to capitalize on product profile in addressing patient unmet
needs. A direct-to-consumer advertising campaign will be launched immediately following FDA
approval. The Key Performance Indicator (KPI) for this tactic will be how well patients are able
to recall the sofosbuvir brand and its benefits. Clinical specialists will engage with prescribers as
well as payers to make sure they have all the necessary resources to make appropriate treatment
and formulary placement decisions. The KPI for this tactic will be how well clinicians as well as
payers are able to recall the benefits of the sofosbuvir brand. To build on the partnerships that
were established with advocacy groups in pre-launch, Gilead will continue to work with the
groups with the mission of helping them interface with the community.
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Another key post-launch strategy is to promote the message that sofosbuvir should be
part of every HCV treatment regimen when appropriate. This strategy supports the key issue of
maximizing return on investment of sofosbuvir. Marketing materials will be developed for the
clinician audience. Additionally phase 2 and 3 trial data will be published in Hepatology journals
with the intent of also providing prescribers with valuable journal reprints. A very critical step
will be to work with the VA and AASLD to ensure treatment guidelines are updated to reflect
sofosbuvir’s new role in HCV treatment. Lastly, Gilead will identify Key Opinion Leaders who
can continue to convey key sofosbuvir messaging among specialists through a speaker program.
(See Appendix Table 5: Key Opinion Leaders) The KPI for this overall strategy will be how
receptive are clinicians to adding sofosbuvir to HCV treatment regimens when it is appropriate.
The third major post-launch strategy is to leverage managed markets to become the HCV
market leader. The key tactic to maximize return on investment is to launch at a premium price.
This will ensure maximum gains early on in the product’s lifecycle. Although there will probably
be resistance from government and commercial payers, the plan is to demonstrate sofosbuvir’s
benefits via clinical dossiers which will likely lead to preferred formulary placement. Realizing
the potential implications of premium pricing on patient access, Gilead will also launch a patient
co-pay assistance program. This will ensure that patients, who truly cannot afford the
medication, can still have access to it. Lastly, to ensure best-in-class customer service, Gilead
will contract with a vendor to provide a hotline for distributors, patients, and payers to triage and
resolve all questions. The KPIs for this strategy are product sales volume, market coverage,
market share, and tier placement.
Figure 4: Post- Launch Strategies, Tactics and Key Performance Indicators
Brand Forecast & Assumptions
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In order to forecast sales for Sofosbuvir there were a number of assumptions taken into
account. First was the segmentation of the HCV+ patient population. Since this disease is
asymptomatic, assumptions were made in reference to the total number of infected persons in the
United States, the different genotypes, and the number of newly infected persons per year.
Secondly pricing was estimated at $85,000 per treatment regimen. This price was
established above current market competitors due to Sofosbuvir’s superior efficacy, shorter
duration of treatment, and interferon-free options for some genotypes (and likely all within the
next 12 months). The pricing is based on a skimming strategy, allowing us to charge a premium
price to maximize revenues. The strategy is applicable in markets, such as HCV, that have low
price elasticity while achieving short-term profits quickly; allowing for quick amortization of
research and development expenditures while creating a margin for future price reductions if
necessary.30 To make Sofosbuvir a more appealing treatment option to payors, we are estimating
a 30% discount to the cost of the treatment regimen. The discount will be increased to 35% in
outer years as a way to compete with new treatments that are currently in competitor’s pipelines.
Finally, based on the price of the drug we assume that only patients with insurance will be our
customers.
Revenues are listed in the modified financial forecast, Figure 3. The complete financial
forecast is included in Appendix Table 6.
Figure 3: Sofosbuvir Modified Revenue Forecast
Sofosbuvir Revenue Forecast 2013 2014 2015 2016
HCV Population:
Number of genotype 1 patients in US 659,250 667,838 600,962 468,684
Number of genotypes 2&3 patients in US 219,750 222,613 200,321 156,228
Number of new HCV cases annually 16,500 16,500 16,500 16,500
Average Price per Treatment Regimen - $59,500 $59,500 $55,250
Insurance Coverage HCV Patients 56% 65% 66% 68%
Number of genotype 2&3 patients treated - 35,896 39,664 31,636
Number of genotype 1 patients treated - 21,538 59,495 47,454
Number of newly diagnosed patients treated - 2,661 3,812 3,341
Total number of patients treated - 60,095 102,970 82,432
Forecasted Sales - $3,575,631,675 $6,126,732,612 $4,554,346,551
Life Cycle Management
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LCM plays a critical role in maximizing the revenue of Sofosbuvir and should be part of
the drug development team’s focus from pre-launch through post-patent expiration. The goal is
to look at the entire life of the drug from early development through post-patent expiration to
maximize cumulative, lifetime sales .31
In pre-launch it was determined that Sofosbuvir would target multiple genotypes of HCV
patients some with and some without interferon. Ultimately, Sofosbuvir will seek approval to
treat all HCV genotypes without interferon. Additionally there may be other indications or
markets for the drug. It is important for Gilead to focus on and determine the order of entry for
each other indication. Geographic markets outside of the US and regulatory strategies for
different international markets should also be considered and prioritized in pre-launch stages.
At product launch it is critical to have a rapid uptake of the product to maximize revenues.
At this time it is also important to simultaneously be working to evergreen the brand. This may
include new formulations, indications and/or combination therapies.
As patent expiration approaches Gilead should look for the optimal time to reduce
marketing spend without negatively impacting the brand and sales. Upon expiration of the patent,
opportunities to extend the product life may include price discounting, creative contracting with
payers, the ability to switch to an OTC brand and/or the ability to sell profitably in the generic
market. The result is a product offering long-term profits over a long product life.
Conclusion
HCV medicines that were once revolutionary in their time are next to being obsolete in
world of medicine today. Current HCV treatment therapies have so many limitations as to what
they can do and accomplish. 84% of physicians polled welcome an alternative to the current
treatment regimens for HCV16. Patients that were longing for a new treatment can finally have
what they desire; and for those patients that hid from their current treatment therapies and
warehoused themselves, they can finally come out and battle HCV with what Gilead has to offer,
Sofosbuvir.
Sofosbuvir has a tolerable safety profile than that of its competitors, has a shorter
duration of therapy, treats genotypes 1-4 and patients treated with sofosbuvir had a 90% SVR
rate12
34
. This small criterion alone beats any of the competitors on the current market today.
Sofosbuvir is also the only medicine that will be able to market an interferon free regimen. Out
of the 350,000 lives that are claimed per year, sofosbuvir release can drastically alter the
statistics and reduce the number of deaths that are caused by HCV per year. The future of
treatment lies within sofosbuvir and with it can we cure and reduce the number of deaths caused
by HCV.
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Appendix Table 3: Current HCV Treatment Options
Current Treatment Options HCV GT 123
Drug Generic
Name
Drug Class MOA Preparation Dosing Indication Cost
Rebetol,
Copegus21
Ribavarin antiviral unknown 200 mg
capsule
1000-1200
mg daily
chronic HCV
Victrelis22,
24, 27
Boceprevir NS3/4A
protease
inhibitor
Binds
reversibly
to the
active site
of the HCV
NS3
200 mg
capsule
800 mg
TID
chronic HCV
GT 1
~ 1100
per week
Pegasys23 Pegylated
interferon
alpha, beta,
gamma
Boost
immune
response
180 U/5 ML Weekly
injection
acute/chronic
HCV
Incivek25 Telaprevir NS3/4A
protease
inhibitor
375 mg
capsule
6 capsules/
day
HCV in
combination
therapy w/
RBV and
Interferon
~ 4100
per week
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Appendix Table 4: Current HCV Drug Competition
Drug Company Class Phase Regimen Launch
GS-5816 Gilead N55A Inhibitor
Phase
2
tbd nd
Sovaprevir (ACH-
1625)
Achillion NS3/4A protease inhibitor
Phase
2
once daily n.d.
ACH-2684 Achillion Protease inhibitor
Phase
2
once daily n.d.
Mericitabine RG
7128
Roche/ Pharmasset
NS5B RNA-dependent RNA
polymerase inhibitor
Phase
2
500 mg, 1,000 mg, 1,500
mg Twice-daily
expected
2016
Danoprevir RG7227
Roche/ Pharma Research
and Early Development
NS3/4A protease
Phase
2
100 mg (boosted with
100 mg of ritonavir),
Twice-daily
expected
2016
Setrobuvir RG7790
Roche/ Pharma Research
and Early Development
Phase
2
200 mg, Twice-daily
expected
2016
Simeprevir (TMC-
435)
Janssen Pharmaceutical NS3/4A protease inhibitor
Phase
3
150 mg capsule once
daily
n.d.
Sofosbuvir (GS-7977) Gilead Sciences nucleotide NS5B inhibitor
Phase
3
400 mg capsule once
daily
41621
Faldaprevir (BI-
201335)
Boerhinger Ingelheim NS3/4A protease inhibitor
Phase
3
120 mg capsule once
daily
n.d.
Asunaprevir (BMS-
650032)
Bristol-Myers Squibb NS3 protease inhibitor
Phase
3
200 mg, Twice-daily
expected
2015
Leidipasiv (GS-5885) Gilead N55A Inhibitor
Phase
3
once-daily fixed dose
Expected
June -2014
Vaniprevir (MK-
7009)
Merck Protease Inhibitor
Phase
3
300 mg twice daily or
600-800 mg once daily
41346
Daclatasvir BMS
790052
Bristol-Myers Squibb NS5A replication inhibitor
Phase
3
once daily n.d.
ABT-333, ABT-
450/ritonavir, ABT-
267
AbbVie
non-nucleoside polymerase
inhibitor, protease inhibitor,
NS5A inhibitor
Phase
3
twice daily and once
daily
Expected
2014
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Appendix Table 5: Key Opinion Leaders42
Key Opinion Leaders
United States
Sameh Boktor, MD, Adult Viral Hepatitis Prevention Coordinator, Bureau of Epidemiology, Pennsylvania
Department of Health, Harrisburg, PA, USA
Ramnik J. Xavier, MD, PhD, Director of Hepatology, Medicine Service, Massachusetts General Hospital, MA, US
Dr. Eric J. Lawitz, President and Medical Director at Alamo Medical Research, Texas, US
Paul J. Pockros, MD, Head, Division of Gastroenterology and Hepatology, Scripps Clinic, CA, US
Mitchell Shiffman, MD, Head of the Liver Institute of Virginia, Virginia, US
International Organizations
Department of Hépato-Gastroenterologie, Centre Hospitalier Universitaire de Nancy-Brabois, Vandoeuvre-lès-
Nancy, France
Professor of Medicine at the University of Vienna, Vienna General Hospital, Wien, Austria
Professor at Hôpital Saint Eloi, Montpellier, France
Co-lead of HCV Research UK, MRC Virology Unit, Glasgow, Scotland
Professor of Medicine and Chief of the Department of Medicine, J.W. Goethe University Hospital, Frankfurt,
Germany
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Appendix Table 6: Revenue Forecast
Sofosbuvir Revenue Forecast
Key Assumptions
2013 Baseline 2014 2015 2016
Population:
Number of chronic HCV patients in US 3,300,000 3,316,500 3,222,905 3,086,435
Number of diagnosed US patients 1,229,000 1,290,450 1,261,378 1,187,976
Number who have been treated 350,000 400,000 460,095 563,065
Number of remaining diagnosed patients 879,000 890,450 801,283 624,912
Number of genotype 1 patients in US 659,250 667,838 600,962 468,684
Number of genotypes 2&3 patients in US 219,750 222,613 200,321 156,228
Number of new HCV cases annually 16,500 16,500 16,500 16,500
Pricing:
Sticker Price per regimen NA $85,000 $85,000 $85,000
Average price discount to payers NA 30% 30% 35%
Average price per treatment regimen NA $59,500 $59,500 $55,250
Insurance Coverage (HCV+ patients):
Private insurance, % 35% 38% 40% 43%
Military/state/government insurance,% 10% 9% 8% 7%
Medicare/Medicaid, % 18% 18% 18% 18%
% of HCV+ patients with insurance coverage 63% 65% 66% 68%
Patients:
Genotypes 2&3 warehouse target (interferon-
free) NA 25% 30% 30%
Number of genotype 2&3 patients treated NA 35,896 39,664 31,636
Genotype 1 warehouse target NA 5% 15% 15%
Number of genotype 1 patients treated NA 21,538 59,495 47,454
Number of new cases treated NA 25% 35% 30%
Number of newly diagnosed patients treated NA 2,661 3,812 3,341
Total number of patients treated NA 60,095 102,970 82,432
Forecasted Sales: $3,575,631,675 $6,126,732,612 $4,554,346,551
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Treatment Algorithm for protease inhibitor Boceprevir
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22. MSMII -Final Marketing Plan
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sofosbuvir-for-hepatitis-c
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interferon-free-regimen-181394421.html
Appendix Table 2 References
Daclatasvir BMS 790052
Bennett, S. (2013, April 28). Gilead-bristol hepatitis c drug combo cures all in study. Retrieved
from Bloomberg website: http://www.bloomberg.com/news/2013-04-27/gilead-bristol-hepatitis-
c-drug-combo-cures-100-in-study.html
Franciscus, A. (2013, September 11). Hepatitis c treatments in current clinical development.
Retrieved from HCV Advocate News and Pipeline Blog website:
http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html
Swan, T., & Levin, J. (2013, June). Hepatitis c drug development catapults onward. Retrieved
from Pipeline Report website: http://www.pipelinereport.org/2013/hcv
(2012, March 8). Pipeline asset update for daclatasvir (dcv; bms-790052). Retrieved from Bristol
Myers Squibb website: http://www.bms.com/research/investigational/hepatitis/Pages/DCV-
BMS-790052.aspx
(2012, April 18). Dual oral therapy with ns5a inhibitor daclatasvir (bms-790052) and ns3
protease inhibitor asunaprevir (bms-650032) in hcv genotype 1b-infected null responders or
patients ineligible/intolerant to peginterferon/ribavirin. Retrieved from National Aids Treatment
Advocacy Project website: http://www.natap.org/2012/EASL/EASL_27.htm
Sovaprevir (ACH-1625)
Izlar, M. C., & Langreth, R. (2013, July 2). Achillion hepatitis c drug trial on hold on liver
concern. Retrieved from Bloomberg website: http://www.bloomberg.com/news/2013-07-
01/achillion-hepatitis-c-drug-trial-on-hold-on-liver-concern.html
23. MSMII -Final Marketing Plan
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Manocha, V. (2013, July 1). Update 1-fda places clinical hold on achillion's hep c drug, shares
plunge. Retrieved from Reuters website: http://www.reuters.com/article/2013/07/01/achillion-
fda-hepcdrug-idUSL3N0F73ME20130701
(2012, August 28). Hcv protease inhibitor - sovaprevir (ach-1625). Retrieved from Achillion
website: http://www.achillion.com/ACH_1625
(2012). Sovaprevir. Retrieved from Achillion website:
http://www.achillion.com/PL/pdf/Sum08_1625.pdf
ACH-2684
(2013, August 29). Hcv protease inhibitor ach-2684. Retrieved from Achillion website:
http://www.achillion.com/ACH_2684
Franciscus, A. (2013, September 11). Hepatitis c treatments in current clinical development.
Retrieved from HCV Advocate News and Pipeline Blog website:
http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html
Mericitabine RG 7128
(2013, July 25). Pharmaceuticals pipeline. Retrieved from Roche website:
http://www.roche.com/index.htm
Franciscus, A. (2013, September 11). Hepatitis c treatments in current clinical development.
Retrieved from HCV Advocate News and Pipeline Blog website:
http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html
(2012, July 16). Mericitabine (formerly rg7128). Retrieved from Pipeline Report
website: http://www.pipelinereport.org/browse/hcv-treatment/mericitabine
Danoprevir RG7227
(2013, July 25). Pharmaceuticals pipeline. Retrieved from Roche website:
http://www.roche.com/index.htm
Franciscus, A. (2013, September 11). Hepatitis c treatments in current clinical development.
Retrieved from HCV Advocate News and Pipeline Blog website:
http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html
(2012, July 16). Danoprevir/r (rg7227). Retrieved from Pipeline Report website:
http://www.pipelinereport.org/browse/hcv-treatment/danoprevir
Setrobuvir RG7790
(2013, July 25). Pharmaceuticals pipeline. Retrieved from Roche website:
http://www.roche.com/index.htm
24. MSMII -Final Marketing Plan
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Franciscus, A. (2013, September 11). Hepatitis c treatments in current clinical development.
Retrieved from HCV Advocate News and Pipeline Blog website:
http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html
(2012, July 16). Danoprevir/r (rg7227). Retrieved from Pipeline Report website:
http://www.pipelinereport.org/browse/hcv-treatment/danoprevir
Simeprevir (TMC-435)
(2013, May 21). Primary efficacy and safety findings from phase 3 study of janssen's simeprevir
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genotype 1 chronic hepatitis c adult patients. Retrieved from Johnson & Johnson website:
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(2013, May 21). Simeprevir. Retrieved from Medscape website:
http://www.medscape.com/viewarticle/805259_2
Sofosbuvir (GS-7977)
(2013, June 7). Gilead announces u.s. fda priority review designation for sofosbuvir for the
treatment of hepatitis. Retrieved from Gilead website: http://www.gilead.com/news/press-
releases/2013/6/gilead-announces-us-fda-priority-review-designation-for-sofosbuvir-for-the-
treatment-of-hepatitis-c
Grogan, K. (2013, April 25). Impressive cure rates for gilead hcv drug sofosbuvir. Retrieved
from Pharma Times Online website: http://www.pharmatimes.com/Article/13-04-
25/Impressive_cure_rates_for_Gilead_HCV_drug_sofosbuvir.aspx
(2013, April 10). Gilead files oral hepatitis c drug sofosbuvir in us. Retrieved from PM Live
website:
http://www.pmlive.com/pharma_news/gilead_files_oral_hepatitis_c_drug_sofosbuvir_in_us_470
721
Faldaprevir (BI-201335)
(n.d.). Faldaprevir. Retrieved from Medscape website:
http://www.medscape.com/viewarticle/803815
(2013, April 24). New hcv drugs - easl & beyond. Retrieved from National AIDS treatment
advocacy website: http://www.natap.org/2013/EASL/EASL_87.htm
Asunaprevir (BMS-650032)
(2013, April 29). Daclatasvir and asunaprevir are a promising oral treatment for patients with the
hepatitis c. Retrieved from LGM Pharma Blog website:
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for-patients-with-the-hepatitis-c-virus/
AS Lok, DF Gardiner, C Hezode,et al. Sustained virologicresponse in chronic HCV genotype
(GT) 1-infected null responders with combination of daclatasvir (DCV; NS5A inhibitor and
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asunaprevir (ASV; NS3 inhibitor) with or without peginterferon alfa-2a/ribavirin (PEG/RBV).
63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD
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Leidipasiv (GS-5885)
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newsArticle_Print&ID=1814329&highlight=
sofosbuvir + ledipasvir () UKMi New Drugs Online Database. (n.d.). Welcome to UKMi
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Vaniprevir with pegylated interferon alpha-2a and... [Hepatology. 2012] - PubMed - NCBI.
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Incivek (Telaprevir
INCIVEK® (telaprevir) 375mg Tablets. (n.d.). INCIVEK® (telaprevir) 375mg Tablets.
Retrieved September 28, 2013, from http://www.incivek.com/
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Victrelis (Boceprevir)
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Feuerstein, A. (2011, June 28). Vertex Tops Merck in Early Hep C Drug Launch.National AIDS
Treatment Advocacy Project - NATAP - HIV - AIDS Treatment Information. Retrieved
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Alisporivir
Highleyman, L. (2011, April 3). 6th Annual Meeting of the European Association for the Study
of the Liver.hivandhepatitis. Retrieved September 28, 2013, from
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alisporivir () UKMi New Drugs Online Database. (n.d.). Welcome to UKMi National Medicines
Information. Retrieved September 28, 2013, from
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GS-5816
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Study, Now In Phase 2 | HCV Treatment. hivandhepatitis.com. Retrieved September 28, 2013,
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Appendix Table 3 References
(2013, August 19). Viral hepatitis statistics & surveillance. Retrieved from Centers for Disease
Control and Prevention website: http://www.cdc.gov/hepatitis/Statistics/index.htm
(2013, August 19). Table 4.1 reported cases of acute, hepatitis c, by state ― united states, 2007–
2011. Retrieved from Centers for Disease Control and Prevention website:
http://www.cdc.gov/hepatitis/Statistics/2011Surveillance/Table4.1.htm
Taylor, P. (2013, October 28). Gilead's sofosbuvir aces fda advisory committee. Retrieved from
PM Live website:
http://www.pmlive.com/pharma_news/gileads_sofosbuvir_aces_fda_advisory_committee_51337
6
(2013, January 10). Hepatitis c treatment. Retrieved from US Department of Veterans Affairs
website: http://www.hepatitis.va.gov/provider/reviews/hcv-treatments.asp
Beasley, D. (2013, October 29). Update 2-gilead posts 17 pct profit rise, readies for hcv launch.
Retrieved from Reuters website: http://www.reuters.com/article/2013/10/29/gilead-results-
idUSL1N0IJ26020131029
(2013, November 11). Will gilead sciences be able to continue its growth trajectory? Retrieved
from Seeking Alpha website: http://seekingalpha.com/article/1828292-will-gilead-sciences-be-
able-to-continue-its-growth-trajectory
Pollack, A. (2011, May 13). Merck’s hepatitis c drug wins f.d.a. approval. Retrieved from The
New York Times website: http://www.nytimes.com/2011/05/14/business/14drug.html?_r=0
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Harper, M. (2012, May 10). Inside the secret world of drug company rebates. Retrieved from
Forbes website: http://www.forbes.com/sites/matthewherper/2012/05/10/why-astrazeneca-gives-
insurers-60-discounts-on-nexiums-list-price/
Stepanova, M., Kanwal, F., El-Serag, H. B., & Younossi, Z. M. (2011). Insurance status and
treatment candidacy of hepatitis c patients: Analysis of population-based data from the united
states. Hepatology, 53(3), 737-745. Retrieved from
http://onlinelibrary.wiley.com/doi/10.1002/hep.24131/pdf
