1. Company Overview
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercialises innovative
medicines in areas of unmet medical need. With each new
discovery and investigational drug candidate, we seek to improve
the care of patients living with life-threatening diseases around
the world. Gilead’s therapeutic areas of focus include HIV/AIDS,
liver diseases, haematology and oncology, inflammatory and
respiratory diseases, and cardiovascular conditions.
Our portfolio of 19 marketed
products includes a number
of category firsts, including
complete treatment regimens
for HIV and chronic hepatitis
C infection available in once-
daily single pills. Gilead’s
portfolio includes Harvoni®
(ledipasvir 90 mg/sofosbuvir
400 mg) for chronic hepatitis C,
which is a complete antiviral
treatment regimen in a single
tablet that provides high cure
rates and a shortened course
of therapy for many patients.
Nearly 30 Years of Growth
Since its founding in Foster City, California in 1987, Gilead has
become a leading biopharmaceutical company with a rapidly
expanding product portfolio, a growing pipeline of investigational
drugs and 7,500 employees in offices across six continents.
Millions of people around the world are living healthier lives
because of innovative therapies developed by Gilead.
Today, our research and development effort includes more than
400 ongoing and planned clinical studies evaluating compounds
with the potential to become the next generation of effective
medicines.
Gilead’s 2014 annual revenues were $24.9 billion and the company
is #1 in the Barron’s 500 rankings. Recently, Gilead was named
one of Fast Company’s Most Innovative Companies of 2015 and
ranked #36 in Business Insider’s list of the 50 Best Companies To
Work For In America.
Gilead Sciences
Advancing Therapeutics. Improving Lives.
Last updated August 2015 www.gilead.com
Sovaldi®
, Gilead’s first once-daily
pill for treatment of hepatitis C.Harvoni, Gilead’s once-daily single
tablet HCV regimen.
Drug approval dates shown here are EU approval
dates; U.S. approval dates may differ.
Key Moments in Our History
1987
1990
1991
1997
1999
2002
2003
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
Gilead founded
AmBisome®
approved
Nucleotides in-licensed from
IOCB/Rega
Vistide®
approved
NeXstar acquired
Tamiflu®
, Viread®
approved
Triangle Pharmaceuticals acquired;
Emtriva®
, Hepsera®
approved
Truvada®
approved
Corus, Raylo, Myogen acquired;
Macugen®
approved
Atripla®
approved; Cork, Ireland,
manufacturing facility acquired
from Nycomed
Ambrisentan approved as
Volibris®
; Ranexa®
, Viread®
for
hepatitis B approved
CV Therapeutics acquired;
Cayston®
approved
CGI Pharmaceuticals acquired;
Regadenoson approved as
Rapiscan®
Arresto BioSciences,
Calistoga Pharmaceuticals
acquired; Eviplera®
approved
Pharmasset acquired
YM BioSciences acquired; Stribild®
,
Tybost®
, Vitekta®
approved
Sovaldi®
, Zydelig®
, Harvoni®
approved
EpiTherapeutics acquired
2. Atripla (600 mg of efavirenz/200 mg of emtricitabine/245 mg of tenofovir disoproxil (as fumarate))
is indicated for the treatment of HIV-1 infection in patients 18 years of age and older with virologic
suppression to HIV-1 RNA levels of less than 50 copies/mL on their current combination
antiretroviral therapy for more than three months. Atripla combines three medicines in a single
pill: Viread (tenofovir disoproxil (as fumarate)), Emtriva (emtricitabine) and Sustiva®
(efavirenz),
marketed by Bristol-Myers Squibb Company. (EU approval, 2007; first U.S. approval, 2006.
Bristol-Myers Squibb Company commercialises the product in the United States, Western
Europe and Canada; Merck & Co., Inc. commercialises the product in the rest of the world.)
Emtriva (emtricitabine) 200 mg is a once-daily oral nucleoside analog reverse transcriptase
inhibitor (NRTI) used in combination with other antiretroviral agents for the treatment of HIV-1
infection in adults and children aged four months and older. (EU and U.S. approval, 2003. Japan
Tobacco Inc. commercialises the product in Japan.)
Stribild (150 mg of elvitegravir/150 mg of cobicistat/200 mg of emtricitabine/245 mg of tenofo-
vir disoproxil (as fumarate)) is indicated as a complete regimen for the treatment of HIV-1 infec-
tion in adults 18 years of age and older who are antiretroviral treatment-naïve or are infected with
HIV-1 without known mutations associated with resistance to any of Stribild’s three antiretroviral
component agents. Stribild combines four medicines in a single pill: Vitekta (elvitegravir), Tybost
(cobicistat), Emtriva (emtricitabine) and Viread (tenofovir disoproxil (as fumarate)). (EU approval,
2013; U.S. approval, 2012. Japan Tobacco Inc. commercialises the product in Japan.)
Eviplera (200 mg of emtricitabine/25 mg of rilpivirine/245 mg of tenofovir disoproxil (as
fumarate)) is indicated for use as a complete regimen for the treatment of HIV-infected adult
patients without known mutations associated with resistance to the non-nucleoside reverse
transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤100,000
HIV-1 RNA copies/mL. Eviplera combines three medicines in a single pill: Viread (tenofovir
disoproxil (as fumarate)), Emtriva (emtricitabine) and Edurant®
(rilpivirine), manufactured by
Janssen R&D Ireland. (First EU and U.S. approval, 2011; marketed as Complera®
in the United
States. Janssen R&D Ireland commercialises the product in select markets.)
Truvada (200 mg of emtricitabine/245 mg of tenofovir disoproxil (as fumarate)), a combination of
Emtriva (emtricitabine) and Viread (tenofovir disoproxil (as fumarate)), is indicated in combination
with other antiretroviral agents for the treatment of HIV-1 infection in adults 18 years of age and
older. (EU approval, 2005; U.S. approval, 2004. Japan Tobacco Inc. commercialises the product
in Japan.) In the United States, once-daily Truvada is also indicated in combination with safer
sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1
infection in adults at high risk. (U.S. approval, 2012.)
Tybost (cobicistat) 150 mg is a pharmacokinetic enhancer that boosts blood levels of certain
HIV medicines. Tybost is indicated as a boosting agent for the HIV protease inhibitors atazanavir
300 mg once daily and darunavir 800 mg once daily as part of antiretroviral combination therapy
in adults with HIV-1 infection. (EU approval, 2013; U.S. approval, 2014.)
Vitekta (elvitegravir) 85 mg and 150 mg tablets, co-administered with a ritonavir-boosted
protease inhibitor and with other antiretroviral agents, is indicated for the treatment of HIV-1
infection in adult patients without known mutations associated with resistance to elvitegravir.
(EU approval, 2013; U.S. approval, 2014.)
Viread (tenofovir disoproxil (as fumarate)) 245 mg is a once-daily oral nucleotide reverse
transcriptase inhibitor (NtRTI) indicated in combination with other antiretroviral agents for the
treatment of HIV-1 infection in adults 12 years of age and older. Reduced-strength tablets of
Viread in doses of 123 mg, 163 mg and 204 mg, as well as an oral granule formulation, are
available for children ages 2 to 12. (First EU approval, 2002; first U.S. approval, 2001. Japan
Tobacco Inc. commercialises the product in Japan.) Viread is also approved as a treatment for
chronic hepatitis B virus (HBV) infection in patients 12 years of age and older. (First EU and U.S.
approval, 2008.)
2
HIV/AIDS
Marketed Products
Following is a summary of Gilead’s product portfolio. For efficacy and safety information on these products, see full
Prescribing Information on Gilead.com.
3. 3
Letairis (ambrisentan) 5 mg and 10 mg, marketed as Volibris®
outside of the United States, is indicated
for the treatment of adult patients with pulmonary arterial hypertension (PAH) classified as WHO
Functional Class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH
(IPAH) and in PAH associated with connective tissue disease. (EU approval, 2008; U.S. approval,
2007. GlaxoSmithKline Inc. commercialises the product as Volibris outside the United States.)
Lexiscan (regadenoson injection) 0.4 mg, marketed as Rapiscan®
in Europe, is a selective coronary
vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion
imaging (MPI) in adult patients unable to undergo adequate exercise stress. (EU approval,
2010, as Rapiscan; U.S. approval, 2008. Rapidscan Pharma Solutions, Inc. commercialises the
product in Europe and select other markets. Astellas Pharma, Inc. commercialises the product
in the United States and Canada.)
Ranexa (ranolazine) 375 mg is indicated as add-on therapy for the symptomatic treatment of adult
patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal
therapies (such as beta blockers and/or calcium antagonists). (EU approval, 2008; first U.S. approval,
2006. Menarini Group commercialises the product in Europe and select other markets.)
Cardiovascular
Liver Diseases
Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) is indicated for the treatment chronic hepatitis
C (CHC) infection genotype 1 and 4 in adults. Harvoni efficacy has been established in patients
with hepatitis C virus (HCV) genotype 1 and 4, with a treatment duration of eight, 12 or 24
weeks depending on prior treatment history and cirrhosis status. Eight weeks of treatment
with Harvoni can be considered for genotype 1 treatment-naïve patients without cirrhosis. 24
weeks of treatment with Harvoni should be considered for genotype 1 and 4 patients with
decompensated cirrhosis, and genotype 3 patients with cirrhosis and/or prior treatment failure.
Harvoni is also indicated for patients with HCV/HIV-1 co-infection. (EU and U.S. approval, 2014.)
Hepsera (adefovir dipivoxil) 10 mg is indicated for the treatment of chronic HBV infection in adults
with compensated and decompensated liver disease. (EU approval, 2003; U.S. approval, 2002.
GlaxoSmithKline Inc. commercialises the product in China, Japan and Saudi Arabia.)
Sovaldi (sofosbuvir) 400 mg is a HCV nucleotide analog NS5B polymerase inhibitor indicated
for the treatment of CHC as a component of a combination antiviral treatment regimen. Sovaldi
has been studied in HCV genotypes 1-6. Sovaldi efficacy has been established in patients with
genotypes 1-4, in those awaiting liver transplantation and those with HCV/HIV-1 co-infection.
The clinical data supporting the use of Sovaldi in patients with genotypes 5 and 6 is limited. (EU
approval, 2014; U.S. approval, 2013.)
Viread (tenofovir disoproxil (as fumarate)) 245 mg is indicated for the treatment of chronic HBV
infection in patients 12 years of age and older with compensated liver disease and in adults with
decompensated liver disease. (First EU and U.S. approval, 2008; EU indication expanded to
include decompensated liver disease, 2010. Japan Tobacco Inc. commercialises the product
in Japan.) As previously noted, Viread is also approved for the treatment of HIV-1 infection in
patients 2 years of age and older.
Haematology/Oncology
Zydelig (idelalisib) 150 mg is indicated in combination with rituximab for the treatment of adult patients
with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy; or as first-
line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-
immunotherapy. Zydelig is indicated as monotherapy for the treatment of adult patients with follicular
lymphoma (FL) that is refractory to two prior lines of treatment. (EU and U.S. approval, 2014.)
4. 4
Other
AmBisome (amphotericin B) liposome for injection 50 mg/vial is indicated as a treatment for severe systemic
and/or deep mycoses, visceral leishmaniasis in immunocompetent patients, and the empirical treatment of
presumed fungal infections in febrile neutropenic patients, where the fever has failed to respond to broad
spectrum antibiotics and appropriate investigations have failed to define a bacterial or viral cause in adults and
children (above 1 month). (EU approval, 1990; U.S. approval, 1997. Astellas Pharma, Inc. commercialises
the product in the United States and Canada. Dainippon Sumitomo Pharma Co., Ltd. commercialises the
product in Japan.)
Macugen (pegaptanib sodium injection) 0.3 mg is indicated for treatment for neovascular (wet)
age-related macular degeneration. (EU approval, 2006; U.S. approval, 2004. The product is
commercialised in the United States by Valeant Pharmaceuticals International, and outside the
United States by Pfizer Inc.)
Cayston (aztreonam for inhalation solution) 75 mg/vial is indicated for the suppressive therapy of
chronic pulmonary infections due to Pseudomonas aeruginosa infection in patients with cystic
fibrosis (CF) 6 years of age and older. (EU approval, 2009; U.S. approval, 2010.)
Tamiflu (oseltamivir phosphate) 75 mg is an influenza neuraminidase inhibitor indicated for the
treatment and prevention of influenza. Developed by Gilead, Tamiflu is commercialised globally
by F. Hoffmann-La Roche Ltd. (EU approval, 2002; first U.S. approval, 1999.)
Inflammation/Respiratory
5. 5
Research
Gilead’s research and development programme identifies and evaluates investigational compounds that show
potential to advance the treatment of life-threatening diseases in areas of unmet medical need. Safety and efficacy of
the following compounds have not been established.
HIV/AIDS
Liver Diseases
Fixed-dose Combination of E/C/F/TAF
(elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide)
Potential Indication: HIV/AIDS
F/TAF (emtricitabine/tenofovir alafenamide)
Switch Studies
Potential Indication: HIV/AIDS
Fixed-dose Combination of R/F/TAF
(rilpivirine/emtricitabine/tenofovir alafenamide)
Bioequivalence Studies
Potential Indication: HIV/AIDS
Simtuzumab (monoclonal antibody)
Potential Indications: Nonalcoholic Steatohepatitis (NASH);
Primary Sclerosing Cholangitis
Single Tablet Regimen of sofosbuvir and velpatasvir
(pan-genotypic NS5B/NS5A inhibitors)
Potential Indication: Chronic HCV Infection
Tenofovir alafenamide
(nucleotide reverse transcriptase inhibitor)
Potential Indication: Chronic HBV Infection
GS-4774 (Tarmogen T cell immunity stimulator)
Potential Indication: Chronic HBV Infection
GS-9620 (TLR-7 agonist)
Potential Indication: Chronic HBV Infection
Phase 1
Phase 1
Phase 2
Phase 2
Phase 3
Phase 3
EU and U.S. Regulatory Submission
Sofosbuvir, velpatasvir and GS-9857
(pan-genotypic NS3 protease inhibitor)
Potential Indication: Chronic HCV Infection
GS-4997 (ASK-1 inhibitor)
Potential Indication: NASH
EU and U.S. Regulatory Submission
GS-9883 (integrase inhibitor), F/TAF (emtricitabine/
tenofovir alafenamide)
Potential Indication: HIV/AIDS
GS-9620 (TLR-7 agonist)
Potential Indication: HIV/AIDS
U.S. Regulatory Submission
7. Responsibility
As Gilead grows as a company, we strive to play our
part in expanding global access to our medications
and to provide support to the communities in which
we operate.
Global Access Programmes
Gilead recognises the urgent need for access to our
medications worldwide, particularly in developing
countries where the AIDS epidemic and other
health challenges are devastating communities. We
operate access programmes to provide our HIV and
viral hepatitis medications at substantially reduced
prices in 130 low- and middle-income countries.
We also coordinate and support educational
activities for medical and clinical workers to ensure proper use of our medicines. As a result, approximately 7.6 million
patients in the developing world now receive Gilead’s therapies for HIV/AIDS, representing more than 60 percent of all
patients on antiretroviral therapy in resource-limited countries. Gilead is also working with regional partners and generic
manufacturers to scale up distribution of its hepatitis C medicines in low- and middle-income countries, adopting a
systematic country-by-country approach that initially prioritises those with the highest disease burden.
Partnerships with Generic Manufacturers and Medicines Patent Pool
Gilead has signed non-exclusive licences with multiple generic manufacturers, granting them rights to produce high-
quality, low-cost generic versions of certain Gilead medicines for HIV/AIDS and chronic hepatitis B and C. Partners have
also been granted rights to produce generic versions of new Gilead HIV therapies once they receive U.S. regulatory
approval. Gilead was the first pharmaceutical company to sign an agreement with the Medicines Patent Pool, which
is working to increase global access to high-quality, low-cost antiretroviral therapy through the sharing of patents. The
Patent Pool has been granted similar licensing terms for Gilead HIV medicines as our generic manufacturing partners.
Fighting Visceral Leishmaniasis in the Developing World
We work closely with the World Health Organization (WHO) and non-governmental organisations to provide AmBisome
at a preferential price for the treatment of visceral leishmaniasis (VL) in resource-limited settings. VL is the second-largest
parasitic killer in the world after malaria, responsible for approximately 40,000 deaths each year. In December 2011,
Gilead signed a partnership agreement with WHO to donate 445,000 vials of AmBisome over five years. This donation
is being used to treat more than 50,000 patients in resource-limited countries.
Patient Access in the United States
In the United States, Gilead has put in place comprehensive patient access programmes, reflecting feedback from
community groups and patient advocates, to help people who are uninsured or underinsured access our medicines.
This includes providing our medicines to eligible patients at no charge and offering a co-pay coupon programme for
patients with private insurance, regardless of income.
Screening, Diagnosis and Linkages to Care
Gilead is actively involved in several community partnerships at the grassroots level that focus on expanding HIV screening
programmes, encouraging patients to take an active role in their treatment and linking them to prompt, appropriate medical
care. In 2010, Gilead launched the FOCUS programme, which partners with healthcare providers, government agencies
and community organisations across the United States to develop replicable model programmes to routinise HIV screening
and linkage to care. Gilead is now supporting partner organisations to apply the FOCUS model to screening and linkage
to care for hepatitis C, with the goal of identifying replicable programmes that can be applied broadly. At the EMEA level,
Gilead has introduced a new grants programme called Gilead Online Supporting Health Action for Patient Empowerment
(goSHAPE). This programme is similar to the Fellowship Programme, the company’s country-specific grants scheme which
has launched in France, Germany, Italy, Ireland, Portugal, Spain and the UK. The programme awards grants to foster the
research, development and implementation of innovative ideas that promote best practices in patient-centred care, such
as testing and linkages to care. Gilead is also helping strengthen community-level public health efforts to expand screening
programmes for hepatitis B. In the United States, this work focuses on Asian American communities, where hepatitis B hits
the hardest and where significant stigma and misconceptions about the disease persist.
7
Access Operations Emerging Markets Geography
