Gilead Sciences
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Gilead Sciences, Inc. () is an American
biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...
company headquartered in Foster City, California, that focuses on researching and developing
antiviral drug Antiviral drugs are a class of medication used for treating viral infections. Most antivirals target specific viruses, while a broad-spectrum antiviral is effective against a wide range of viruses. Unlike most antibiotics, antiviral drugs do n ...
s used in the treatment of
HIV/AIDS Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual ...
,
hepatitis B Hepatitis B is an infectious disease caused by the '' Hepatitis B virus'' (HBV) that affects the liver; it is a type of viral hepatitis. It can cause both acute and chronic infection. Many people have no symptoms during an initial infection. ...
,
hepatitis C Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver; it is a type of viral hepatitis. During the initial infection people often have mild or no symptoms. Occasionally a fever, dark urine, ...
,
influenza Influenza, commonly known as "the flu", is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptom ...
, and
COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease quick ...
, including ledipasvir/sofosbuvir and
sofosbuvir Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. It is taken by mouth. Common side effects include fatigue, headache, nausea, and trouble sleeping. Side effects are generally more common i ...
. Gilead is a member of the NASDAQ Biotechnology Index and the
S&P 500 The Standard and Poor's 500, or simply the S&P 500, is a stock market index tracking the stock performance of 500 large companies listed on stock exchanges in the United States. It is one of the most commonly followed equity indices. As of ...
. Gilead was founded in 1987 under the name Oligogen by Michael L. Riordan. The original name was a reference to oligomers, small strands of DNA used to target genetic sequences. Gilead held its IPO in 1992, and successfully developed drugs like
Tamiflu Oseltamivir, sold under the brand name Tamiflu, is an antiviral medication used to treat and prevent influenza A and influenza B, viruses that cause the flu. Many medical organizations recommend it in people who have complications or are at hi ...
and Vistide that decade. In the 2000s, Gilead received approval for drugs including Viread and Hepsera, among others. It began evolving from a biotechnology company into a pharmaceutical company, acquiring several subsidiaries, though it still relied heavily on contracting to manufacture its drugs. The company continued its growth in the 2010s, but came under heavy scrutiny over its business practices, including extremely high pricing of drugs such as Sovaldi and Truvada in the United States relative to production cost and cost in the developing world.


History


Foundation

In June 1987, Gilead Sciences was originally founded under the name Oligogen by Michael L. Riordan, a medical doctor. Riordan graduated from Washington University in St. Louis, the
Johns Hopkins School of Medicine The Johns Hopkins University School of Medicine (JHUSOM) is the medical school of Johns Hopkins University, a private research university in Baltimore, Maryland. Founded in 1893, the School of Medicine shares a campus with the Johns Hopkins Hospi ...
, and the
Harvard Business School Harvard Business School (HBS) is the graduate business school of Harvard University, a private research university in Boston, Massachusetts. It is consistently ranked among the top business schools in the world and offers a large full-time MBA ...
. Three scientific advisers worked with Riordan to create the company: Peter Dervan of
Caltech The California Institute of Technology (branded as Caltech or CIT)The university itself only spells its short form as "Caltech"; the institution considers other spellings such a"Cal Tech" and "CalTech" incorrect. The institute is also occasional ...
, Doug Melton of
Harvard Harvard University is a private Ivy League research university in Cambridge, Massachusetts. Founded in 1636 as Harvard College and named for its first benefactor, the Puritan clergyman John Harvard, it is the oldest institution of higher le ...
, and Harold M. Weintraub of the
Fred Hutchinson Cancer Research Center The Fred Hutchinson Cancer Center, formerly known as the Fred Hutchinson Cancer Research Center and also known as Fred Hutch or The Hutch, is a cancer research institute established in 1975 in Seattle, Washington. History The center grew out o ...
. Riordan served as CEO from the company's founding until 1996. Menlo Ventures, a venture capital firm where Riordan had previously worked, made the first investment in Gilead of $2 million. Riordan also recruited scientific advisers including Harold Varmus, a Nobel laureate who later became Director of the
National Institutes of Health The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the lat ...
, and Jack Szostak, recipient of the Nobel Prize for Physiology or Medicine in 2009. The company's primary therapeutic focus was in antiviral medicines, a field that piqued Riordan's interest after he contracted
dengue fever Dengue fever is a mosquito-borne tropical disease caused by the dengue virus. Symptoms typically begin three to fourteen days after infection. These may include a high fever, headache, vomiting, muscle and joint pains, and a characteristic ...
. Riordan recruited
Donald Rumsfeld Donald Henry Rumsfeld (July 9, 1932 – June 29, 2021) was an American politician, government official and businessman who served as Secretary of Defense from 1975 to 1977 under president Gerald Ford, and again from 2001 to 2006 under Preside ...
to join the board of directors in 1988, Available through
NewsBank NewsBank is a news database resource that provides archives of media publications as reference materials to libraries. History John Naisbitt, the author of the book ''Megatrends'', founded NewsBank.Andrews 1998, p. 17. The company was launched ...
.
followed by Benno C. Schmidt, Sr., Gordon Moore, and George P. Shultz. Riordan tried to recruit
Warren Buffett Warren Edward Buffett ( ; born August 30, 1930) is an American business magnate, investor, and philanthropist. He is currently the chairman and CEO of Berkshire Hathaway. He is one of the most successful investors in the world and has a net ...
as an investor and board member, but was unsuccessful. The company focused its early research on making small strands of DNA (
oligomer In chemistry and biochemistry, an oligomer () is a molecule that consists of a few repeating units which could be derived, actually or conceptually, from smaller molecules, monomers.Quote: ''Oligomer molecule: A molecule of intermediate relati ...
s, or more particularly,
oligonucleotide Oligonucleotides are short DNA or RNA molecules, oligomers, that have a wide range of applications in genetic testing, research, and forensics. Commonly made in the laboratory by solid-phase chemical synthesis, these small bits of nucleic acids ...
s) to target specific genetic code sequences – that is, antisense therapy, a form of
gene therapy Gene therapy is a Medicine, medical field which focuses on the genetic modification of cells to produce a therapeutic effect or the treatment of disease by repairing or reconstructing defective genetic material. The first attempt at modifying ...
. According to Riordan, he had always wanted to use the name Gilead Sciences all along, but used Oligogen as a temporary name because he needed to deal with a trademark clearance issue with a California nonprofit organization that was already using the word Gilead in its name. He had first heard of the Balm of Gilead when he read Lanford Wilson's play '' Balm in Gilead'' while in medical school, then learned that naturally occurring acetylsalicylic acid (
aspirin Aspirin, also known as acetylsalicylic acid (ASA), is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and/or inflammation, and as an antithrombotic. Specific inflammatory conditions which aspirin is used to treat inc ...
) had been found in modern times in a
willow Willows, also called sallows and osiers, from the genus ''Salix'', comprise around 400 speciesMabberley, D.J. 1997. The Plant Book, Cambridge University Press #2: Cambridge. of typically deciduous trees and shrubs, found primarily on moist so ...
tree species from that part of that world, and was therefore inspired to name his company Gilead. After founding Oligogen, he contacted the nonprofit about the naming issue and secured the right to use the Gilead Sciences name in exchange for a $1,000 donation. By 1988, the company had moved its headquarters to Foster City's Vintage Park neighborhood, where it has been based ever since. The company began to develop small molecule antiviral therapeutics in 1991, when the company in-licensed a group of nucleotide compounds including
tenofovir Tenofovir disoproxil, sold under the trade name Viread among others, is a medication used to treat chronic hepatitis B and to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used for preven ...
. Riordan later recalled that Gilead's first decade as a startup was an extremely stressful experience for him, as a young venture capitalist serving for the first time as the founder, chairman, and chief executive officer of his own biotech company. The new company had no products and very little income, and narrowly escaped going out of business on several occasions: "It was touch and go for a long time". Finding a way for Gilead to make money was Riordan's top priority "every second of the day for eight years".


1990–1999: IPO

Gilead's antisense intellectual property portfolio was sold to Ionis Pharmaceuticals. Gilead debuted on the
NASDAQ The Nasdaq Stock Market () (National Association of Securities Dealers Automated Quotations Stock Market) is an American stock exchange based in New York City. It is the most active stock trading venue in the US by volume, and ranked second ...
in January 1992. Its
initial public offering An initial public offering (IPO) or stock launch is a public offering in which shares of a company are sold to institutional investors and usually also to retail (individual) investors. An IPO is typically underwritten by one or more investme ...
raised $86.25 million in proceeds. In June 1996, Gilead launched Vistide (
cidofovir Cidofovir, brand name Vistide, is a topical or injectable antiviral medication primarily used as a treatment for cytomegalovirus (CMV) retinitis (an infection of the retina of the eye) in people with AIDS. Cidofovir was approved for medical u ...
injection) for the treatment of
cytomegalovirus ''Cytomegalovirus'' (''CMV'') (from ''cyto-'' 'cell' via Greek - 'container' + 'big, megalo-' + -''virus'' via Latin 'poison') is a genus of viruses in the order '' Herpesvirales'', in the family '' Herpesviridae'', in the subfamily '' Betah ...
(CMV) retinitis in patients with
AIDS Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual ma ...
. In January 1997,
Donald Rumsfeld Donald Henry Rumsfeld (July 9, 1932 – June 29, 2021) was an American politician, government official and businessman who served as Secretary of Defense from 1975 to 1977 under president Gerald Ford, and again from 2001 to 2006 under Preside ...
was appointed chairman, but left the board in January 2001 when he was appointed
United States Secretary of Defense The United States secretary of defense (SecDef) is the head of the United States Department of Defense, the executive department of the U.S. Armed Forces, and is a high ranking member of the federal cabinet. DoDD 5100.1: Enclosure 2: a The se ...
during George W. Bush's first term as president. In March 1999, Gilead acquired NeXstar Pharmaceuticals of
Boulder, Colorado Boulder is a home rule city that is the county seat and most populous municipality of Boulder County, Colorado, United States. The city population was 108,250 at the 2020 United States census, making it the 12th most populous city in Colora ...
. At the time, NeXstar's annual sales of $130 million was three times Gilead's sales; it sold AmBisome, an injectable fungal treatment, and DaunoXome, an
oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''ó ...
drug taken by HIV patients. That same year,
Roche F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX ...
announced FDA approval of
Tamiflu Oseltamivir, sold under the brand name Tamiflu, is an antiviral medication used to treat and prevent influenza A and influenza B, viruses that cause the flu. Many medical organizations recommend it in people who have complications or are at hi ...
( oseltamivir) for the treatment of
influenza Influenza, commonly known as "the flu", is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptom ...
. Tamiflu was originally discovered by Gilead and licensed to Roche for late-phase development and marketing. One reason for entering into the Tamiflu licensing agreement was that with only 350 employees, Gilead still did not yet have the capability to sell its drugs directly to overseas buyers. Available through
NewsBank NewsBank is a news database resource that provides archives of media publications as reference materials to libraries. History John Naisbitt, the author of the book ''Megatrends'', founded NewsBank.Andrews 1998, p. 17. The company was launched ...
.
To avoid having to license future drugs in order to access international markets, Gilead simply acquired the 480-employee NeXstar, which had already built its own sales force in Europe to market AmBisome there.


2000 to 2009

Viread (
tenofovir Tenofovir disoproxil, sold under the trade name Viread among others, is a medication used to treat chronic hepatitis B and to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used for preven ...
) achieved first approval in 2001 for the treatment of HIV. In 2002, Gilead changed its corporate strategy to focus exclusively on antivirals, and sold its cancer assets to OSI Pharmaceuticals for $200 million. In December 2002, Gilead and Triangle Pharmaceuticals announced that Gilead would acquire Triangle for around $464 million; Triangle's lead drug was
emtricitabine Emtricitabine (commonly called FTC, systematic name 2',3'-dideoxy-5-fluoro-3'-thiacytidine), with trade name Emtriva (formerly Coviracil), is a nucleoside reverse-transcriptase inhibitor (NRTI) for the prevention and treatment of HIV infection i ...
that was near FDA approval, and it had two other antivirals in its pipeline. The company also announced its first full year of profitability. Later that year, Hepsera (
adefovir Adefovir is a prescription medicine used to treat (chronic) infections with hepatitis B virus. A prodrug form of adefovir was previously called bis-POM PMEA, with trade names Preveon and Hepsera. It is an orally administered nucleotide analog reve ...
) was approved for the treatment of chronic
hepatitis B Hepatitis B is an infectious disease caused by the '' Hepatitis B virus'' (HBV) that affects the liver; it is a type of viral hepatitis. It can cause both acute and chronic infection. Many people have no symptoms during an initial infection. ...
, and Emtriva (
emtricitabine Emtricitabine (commonly called FTC, systematic name 2',3'-dideoxy-5-fluoro-3'-thiacytidine), with trade name Emtriva (formerly Coviracil), is a nucleoside reverse-transcriptase inhibitor (NRTI) for the prevention and treatment of HIV infection i ...
) for the treatment of HIV. During this era, Gilead completed its gradual evolution from a biotech startup into a pharmaceutical company. The ''San Francisco Chronicle'' noted that by 2003, the Gilead corporate campus in Foster City had expanded to "seven low-slung sand-colored buildings around a tiny lake on which ducks happily paddle." Like many startups, Gilead originally leased its space, but in 2004, the company paid $123 million to buy all its headquarters buildings from its landlords. However, even as Gilead developed its ability to distribute and sell its own drugs, it remained distinct from most pharmaceutical companies in terms of its strong reliance on subcontracting most of its manufacturing to contract manufacturing organizations. In 2004, during the Avian flu pandemic scare, Gilead Sciences' revenue from Tamiflu almost quadrupled to $44.6m as more than 60 national governments stockpiled the antiviral drug, though the firm had made a loss in 2003 before concern about the flu started. As stocks soared, US Defense Secretary and Pentagon chief
Donald Rumsfeld Donald Henry Rumsfeld (July 9, 1932 – June 29, 2021) was an American politician, government official and businessman who served as Secretary of Defense from 1975 to 1977 under president Gerald Ford, and again from 2001 to 2006 under Preside ...
sold shares of the company, receiving more than $5 million in capital gains, while still maintaining up to $25m-worth of shares by the end of the year. Sales of Tamiflu almost quadrupled again in 2005, to $161.6m, during which time the share price tripled. A 2005 report showed that, in all, Rumsfeld owned shares worth up to $95.9m, from which he got an income of up to $13m. In 2006, Gilead completed two acquisitions that allowed the company to branch out from its historical antiviral franchise into the
cardiovascular The blood circulatory system is a system of organs that includes the heart, blood vessels, and blood which is circulated throughout the entire body of a human or other vertebrate. It includes the cardiovascular system, or vascular system, tha ...
and respiratory therapeutic arenas. Under an agreement with
GlaxoSmithKline GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the tent ...
, Myogen marketed
Flolan Prostacyclin (also called prostaglandin I2 or PGI2) is a prostaglandin member of the eicosanoid family of lipid molecules. It inhibits platelet activation and is also an effective vasodilator. When used as a drug, it is also known as epoprosteno ...
( epoprostenol sodium) in the United States for the treatment of primary pulmonary hypertension. Additionally, Myogen was developing (in Phase 3 studies) darusentan, also an endothelin receptor antagonist, for the potential treatment of resistant
hypertension Hypertension (HTN or HT), also known as high blood pressure (HBP), is a long-term medical condition in which the blood pressure in the arteries is persistently elevated. High blood pressure usually does not cause symptoms. Long-term high b ...
. In 2006, the company acquired Corus Pharma, Inc. for $365 million. The acquisition of Corus signaled Gilead's entry into the respiratory arena. Corus was developing aztreonam lysine for the treatment of patients with
cystic fibrosis Cystic fibrosis (CF) is a rare genetic disorder that affects mostly the lungs, but also the pancreas, liver, kidneys, and intestine. Long-term issues include difficulty breathing and coughing up mucus as a result of frequent lung infections. Ot ...
who are infected with ''
Pseudomonas aeruginosa ''Pseudomonas aeruginosa'' is a common encapsulated, gram-negative, aerobic– facultatively anaerobic, rod-shaped bacterium that can cause disease in plants and animals, including humans. A species of considerable medical importance, ''P. a ...
''. In July 2006, the U.S.
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) approved
Atripla Efavirenz/emtricitabine/tenofovir, sold under the brand name Atripla among others, is a fixed-dose combination antiretroviral medication used to treat HIV/AIDS. It contains efavirenz, emtricitabine, and tenofovir disoproxil. It can be used by ...
, a once a day single tablet regimen for HIV, combining Sustiva (
efavirenz Efavirenz (EFV), sold under the brand names Sustiva among others, is an antiretroviral medication used to treat and prevent HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used for prevention after a needle ...
), a
Bristol-Myers Squibb The Bristol Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the ''Fortune'' 500 list of the lar ...
product, and Truvada (
emtricitabine Emtricitabine (commonly called FTC, systematic name 2',3'-dideoxy-5-fluoro-3'-thiacytidine), with trade name Emtriva (formerly Coviracil), is a nucleoside reverse-transcriptase inhibitor (NRTI) for the prevention and treatment of HIV infection i ...
and tenofovir disoproxil), a Gilead product. Gilead purchased Raylo Chemicals, Inc. in November 2006, for a price of . Raylo Chemical, based in
Edmonton, Alberta Edmonton ( ) is the capital city of the Canadian province of Alberta. Edmonton is situated on the North Saskatchewan River and is the centre of the Edmonton Metropolitan Region, which is surrounded by Alberta's central region. The city anch ...
, was a wholly owned subsidiary of Degussa AG, a German company. Raylo Chemical was a custom manufacturer of active pharmaceutical ingredients and advanced intermediates for the pharmaceutical and biopharmaceutical industries. Later in the same year, Gilead acquired Myogen, Inc. for $2.5 billion (then its largest acquisition). With two drugs in development (ambrisentan and darusentan), and one marketed product (Flolan) for pulmonary diseases, the acquisition of Myogen has solidified Gilead's position in this therapeutic arena. Gilead expanded its move into respiratory therapeutics in 2007 by entering into a licensing agreement with Parion for an
epithelial sodium channel The epithelial sodium channel (ENaC), (also known as amiloride-sensitive sodium channel) is a membrane-bound ion channel that is selectively permeable to sodium ions (). It is assembled as a heterotrimer composed of three homologous subunits α ...
inhibitor for the treatment of pulmonary diseases, including cystic fibrosis,
chronic obstructive pulmonary disease Chronic obstructive pulmonary disease (COPD) is a type of progressive lung disease characterized by long-term respiratory symptoms and airflow limitation. The main symptoms include shortness of breath and a cough, which may or may not produce ...
and
bronchiectasis Bronchiectasis is a disease in which there is permanent enlargement of parts of the airways of the lung. Symptoms typically include a chronic cough with mucus production. Other symptoms include shortness of breath, coughing up blood, and chest ...
. In 2009, the company acquired CV Therapeutics, Inc. for $1.4 billion, bringing Ranexa and Lexiscan into Gilead. Ranexa is a cardiovascular drug used to treat chest pain related to coronary artery disease, with both of these products and pipeline building out Gilead's cardiovascular franchise. Later that year, the company was named one of the Fastest Growing Companies by ''
Fortune Fortune may refer to: General * Fortuna or Fortune, the Roman goddess of luck * Luck * Wealth * Fortune, a prediction made in fortune-telling * Fortune, in a fortune cookie Arts and entertainment Film and television * ''The Fortune'' (1931 film) ...
''.


2010 to 2019

In 2010, the company acquired CGI Pharmaceuticals for $120 million, expanding Gilead's research expertise into kinase biology and chemistry. Later that year, the company acquired Arresto Biosciences, Inc. for $225 million, obtaining developmental-stage research for treating fibrotic diseases and cancer. In February 2011, the company acquired Calistoga Pharmaceuticals for ($225 million plus milestone payments). The acquisition boosted Gilead's oncology and inflammation areas. Later that year, Gilead made its most important acquisition – and by then most expensive – with the purchase of
Pharmasset Pharmasset Inc. was a pharmaceutical company based in Princeton, New Jersey in the United States. The company develops antiviral drugs for HIV (including racivir), hepatitis B (including clevudine, marketed as Levovir), and hepatitis C. In Nove ...
, Inc. This transaction helped cement Gilead as the leader in treatment of the
hepatitis C virus The hepatitis C virus (HCV) is a small (55–65 nm in size), enveloped, positive-sense single-stranded RNA virus of the family '' Flaviviridae''. The hepatitis C virus is the cause of hepatitis C and some cancers such as liver cancer (hepatoc ...
by giving it control of
sofosbuvir Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. It is taken by mouth. Common side effects include fatigue, headache, nausea, and trouble sleeping. Side effects are generally more common i ...
(see below). In October 2011, Gilead broke ground on a massive multi-year expansion of its 17-building headquarters campus in Foster City. By replacing eight one or two-story buildings with seven new structures ranging as tall as 10 stories, Gilead nearly doubled its headquarters real estate footprint from about 620,000 square feet to about 1.2 million square feet. On July 16, 2012, the FDA approved Gilead's Truvada for prevention of HIV infection (it was already approved for treating HIV). The pill was a preventive measure ( PrEP) for people at high risk of getting HIV through sexual activity. In 2013, the company acquired YM Biosciences, Inc. for $510 million. The acquisition brings drug candidate
CYT387 Momelotinib (INN, formerly GS-0387, CYT-387) is an inhibitor of Janus kinases JAK1 and JAK2, acting as an ATP competitor with IC50 values of 11 and 18 nM, respectively. The inhibitor is significantly less active towards other kinases, including ...
, an orally-administered, once-daily, selective inhibitor of the Janus kinase (JAK) family, specifically JAK1 and JAK2, into Gilead's oncology pipeline. The JAK enzymes have been implicated in myeloproliferative diseases, inflammatory disorders, and certain cancers. In 2015, the company made a trio of acquisitions: * It bought Phenex Pharmaceuticals for $470 million. Its Farnesoid X Receptor (FXR) program used small-molecule FXR agonists in the treatment of liver diseases such as non-alcoholic steatohepatitis. * It bought EpiTherapeutics for $65 million. This acquisition gave Gilead first-in-class small molecule inhibitors of histone demethylases involved in regulating gene transcription in cancer. * It paid $425 million for a 15% equity stake in Galapagos NV, with additional payments for Gilead to license the experimental anti-inflammatory drug filgotinib, which may treat rheumatoid arthritis,
ulcerative colitis Ulcerative colitis (UC) is a long-term condition that results in inflammation and ulcers of the colon and rectum. The primary symptoms of active disease are abdominal pain and diarrhea mixed with blood (hematochezia). Weight loss, fever, and ...
, and
Crohn's disease Crohn's disease is a type of inflammatory bowel disease (IBD) that may affect any segment of the gastrointestinal tract. Symptoms often include abdominal pain, diarrhea (which may be bloody if inflammation is severe), fever, abdominal distensi ...
. In 2016, the company acquired Nimbus Apollo, Inc. for $400 million, giving Gilead control of the compound NDI-010976 (an ACC inhibitor) and other preclinical ACC inhibitors for the treatment of non-alcoholic steatohepatitis and for the potential treatment of
hepatocellular carcinoma Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer in adults and is currently the most common cause of death in people with cirrhosis. HCC is the third leading cause of cancer-related deaths worldwide. It occurs in t ...
. Also in 2016, the company was named the most generous company on the 2016 ''Fortune'' list of The Most Generous Companies of the ''Fortune'' 500. Charitable donations to HIV/AIDS and liver disease organizations totaled over 440 million in 2015. In August 2017, the company announced it would acquire Kite Pharma for $11.9 billion, equating to $180 cash per share, a 29% premium over the closing price of the shares. The deal was Gilead's entry into the
cell therapy Cell therapy (also called cellular therapy, cell transplantation, or cytotherapy) is a therapy in which viable cells are injected, grafted or implanted into a patient in order to effectuate a medicinal effect, for example, by transplanting T-c ...
market and added a
CAR-T In biology, chimeric antigen receptors (CARs)—also known as chimeric immunoreceptors, chimeric T cell receptors or artificial T cell receptors—are receptor proteins that have been engineered to give T cells the new ability to target a specifi ...
candidate to the company's portfolio. By 2022 this acquisition had led to two marketed products for lymphoma: Yescarta and Tecartus. In November, the company announced it will acquire Cell Design Labs for up to $567 million, after it indirectly acquired a stake of 12.2% via the Kite Pharma deal. On May 9, 2019, the U.S. Department of Health and Human Services announced that Gilead Sciences will donate Truvada, the only drug approved to prevent infection with H.I.V., for free to 200,000 patients annually for 11 years. On December 3, 2019, HHS explained how the government would distribute the donated drugs. HHS Secretary Alex Azar explained that the U.S. government will pay Gilead $200 per bottle for 30 pills for costs associated with getting the drug from factories into the eventual hands of patients.


2020 onwards

In March 2020, the company announced it would acquire Forty Seven Inc. for $95.50 a share ($4.9 billion in total). On April 7, 2020, Gilead completed acquisition of Forty Seven, Inc. for "$95.50 per share, net to the seller in cash, without interest, or approximately $4.9 billion in the aggregate." In June 2020, ''Bloomberg'' reported that AstraZeneca Plc had made a preliminary approach to Gilead for a potential merger, worth almost $240 billion. In the same month, the company announced it would acquire a 49.9% stake in privately held Pionyr Immunotherapeutics Inc for $275 million. In September 2020, Gilead announced it had reached a deal to acquire
Immunomedics Immunomedics was a biotechnology company focused on the development of antibody-drug conjugates for the treatment of cancer. In 2020, the company was acquired by Gilead Sciences. History Immunomedics was founded in July 1982 by David M. Goldenb ...
for $21 billion ($88 per share), gaining control of the cancer treatment Trodelvy (
Sacituzumab govitecan Sacituzumab govitecan, sold under the brand name Trodelvy, is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate used for the treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer. The most c ...
-hziy) – a first-in-class
Trop-2 Tumor-associated calcium signal transducer 2, also known as Trop-2 and as epithelial glycoprotein-1 antigen (EGP-1),Immunomedics Awarded Fast Track Designation by FDA for Sacituzumab Govitecan (IMMU-132) for Triple-Negative Breast Cancer Therap/re ...
antibody-drug conjugate. In December, the business announced it would acquire German biotech, MYR GmbH, for €1.15 billion plus up to a further €300 million. MYR focuses on the treatment of chronic
hepatitis delta virus Hepatitis D is a type of viral hepatitis caused by the hepatitis delta virus (HDV). HDV is one of five known hepatitis viruses: A, B, C, D, and E. HDV is considered to be a satellite (a type of subviral agent) because it can propagate only in ...
. On August 11, 2021, U.S. Senator
Rand Paul Randal Howard Paul (born January 7, 1963) is an American physician and politician serving as the Seniority in the United States Senate, junior United States Senate, U.S. senator from Kentucky since 2011. A member of the Republican Party (Un ...
disclosed that his wife Kelley Paul had purchased a stake in Gilead Sciences on February 26, 2020. In January 2022, Gilead pulled its cancer drug Zydelig (idelalisib) from its accelerated approval in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL). In September, the company completed its acquisition of MiroBio for $405 million.


Acquisition history

* Gilead Sciences ** NeXstar Pharmaceuticals (Acq 1999) ** Triangle Pharmaceuticals (Acq 2003) ** Myogen, Inc. (Acq 2006) ** Corus Pharma, Inc (Acq 2006) ** Raylo Chemicals (Acq 2006) ** CV Therapeutics, Inc. (Acq 2009) ** CGI Pharmaceuticals (Acq 2010) ** Calistoga Pharmaceuticals (Acq 2011) **
Pharmasset Pharmasset Inc. was a pharmaceutical company based in Princeton, New Jersey in the United States. The company develops antiviral drugs for HIV (including racivir), hepatitis B (including clevudine, marketed as Levovir), and hepatitis C. In Nove ...
Inc (Acq 2011) ** Phenex Pharmaceuticals (Acq 2015) ** EpiTherapeutics (Acq 2015) ** Galapagos NV (Acq 2015) ** Nimbus Apollo, Inc. (Acq 2016) ** Kite Pharma (Acq 2017) *** Cell Design Labs (Acq 2017) ** Forty Seven (Acq 2020) **
Immunomedics Immunomedics was a biotechnology company focused on the development of antibody-drug conjugates for the treatment of cancer. In 2020, the company was acquired by Gilead Sciences. History Immunomedics was founded in July 1982 by David M. Goldenb ...
(Acq 2020) ** MYR GmbH (Acq 2020) ** MiroBio (Acq 2022)


Sovaldi and Harvoni

The drug
sofosbuvir Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. It is taken by mouth. Common side effects include fatigue, headache, nausea, and trouble sleeping. Side effects are generally more common i ...
had been part of the 2011 acquisition of Pharmasset. In 2013, the FDA approved this drug, under the trade name Sovaldi, as a treatment for the
hepatitis C virus The hepatitis C virus (HCV) is a small (55–65 nm in size), enveloped, positive-sense single-stranded RNA virus of the family '' Flaviviridae''. The hepatitis C virus is the cause of hepatitis C and some cancers such as liver cancer (hepatoc ...
. ''
Forbes ''Forbes'' () is an American business magazine owned by Integrated Whale Media Investments and the Forbes family. Published eight times a year, it features articles on finance, industry, investing, and marketing topics. ''Forbes'' also r ...
'' magazine ranked Gilead its number 4 drug company, citing a market capitalization of US$113 billion and stock appreciation of 100%, and describing their 2011 purchase of
Pharmasset Pharmasset Inc. was a pharmaceutical company based in Princeton, New Jersey in the United States. The company develops antiviral drugs for HIV (including racivir), hepatitis B (including clevudine, marketed as Levovir), and hepatitis C. In Nove ...
for $11 billion as "one of the best pharma acquisitions ever".
Deutsche Bank Deutsche Bank AG (), sometimes referred to simply as Deutsche, is a German multinational investment bank and financial services company headquartered in Frankfurt, Germany, and dual-listed on the Frankfurt Stock Exchange and the New York St ...
estimated Sovaldi sales in the year's final quarter would be $53 million, and '' Barron's'' noted the FDA approval and subsequent strong sales of the "potentially revolutionary" drug as a positive indicator for the stock. On July 11, 2014, the
United States Senate Committee on Finance The United States Senate Committee on Finance (or, less formally, Senate Finance Committee) is a standing committee of the United States Senate. The Committee concerns itself with matters relating to taxation and other revenue measures general ...
investigated Sovaldi's high price ($1,000 per pill; $84,000 for the full 12-week regimen). Senators questioned the extent to which the market was operating "efficiently and rationally", and committee chairman
Ron Wyden Ronald Lee Wyden (; born May 3, 1949) is an American politician and retired educator serving as the senior United States senator from Oregon, a seat he has held since 1996. A member of the Democratic Party, he served in the United States Hou ...
( D-
Oregon Oregon () is a U.S. state, state in the Pacific Northwest region of the Western United States. The Columbia River delineates much of Oregon's northern boundary with Washington (state), Washington, while the Snake River delineates much of it ...
) and ranking minority member
Chuck Grassley Charles Ernest Grassley (born September 17, 1933) is an American politician serving as the president pro tempore emeritus of the United States Senate, and the senior United States senator from Iowa, having held the seat since 1981. In 2022, h ...
( R-
Iowa Iowa () is a U.S. state, state in the Midwestern United States, Midwestern region of the United States, bordered by the Mississippi River to the east and the Missouri River and Big Sioux River to the west. It is bordered by six states: Wiscon ...
) wrote to CEO John C. Martin asking Gilead to justify the price for this drug. The committee hearings did not result in new law, but in 2014 and 2015, due to negotiated and mandated discounts, Sovaldi was sold well below the list price. For poorer countries, Gilead licensed multiple companies to produce generic versions of Sovaldi; in India, a pill's price was as low as $4.29. Gilead later combined Sovaldi with other antivirals in single-pill combinations. First, Sovaldi was combined with
ledipasvir Ledipasvir is a drug for the treatment of hepatitis C that was developed by Gilead Sciences. After completing Phase III clinical trials, on February 10, 2014, Gilead filed for U.S. approval of a ledipasvir/sofosbuvir fixed-dose combination ta ...
and marketed as
Harvoni Ledipasvir/sofosbuvir, sold under the trade name Harvoni among others, is a medication used to treat hepatitis C. It is a fixed-dose combination of ledipasvir and sofosbuvir. Cure rates are 94% to 99% in people infected with hepatitis C virus ...
. This treatment for hepatitis C cures the patient in 94% to 99% of cases (HCV genotype 1). By 2017, Gilead was reporting drastic drops in Sovaldi revenue from year to year, not only because of pricing pressure but because the number of suitable patients decreased. Later single-pill combinations were Epclusa (with velpatasvir) and Vosevi (with velpatasvir and voxilaprevir).


Finances

For the fiscal year 2017, Gilead Sciences reported earnings of US$4.628 billion and annual revenue of US$26.107 billion, a decline of 14.1% over the previous fiscal cycle. Gilead Sciences's shares traded at over $70 per share, and its market capitalization was valued at US$93.4 billion in October 2018.


Prospects for the future

As of 2017, Gilead's challenge is to develop or acquire new blockbuster drugs before its current revenue-producers wane or their patent protection expires. Gilead benefited from the expansion of
Medicaid Medicaid in the United States is a federal and state program that helps with healthcare costs for some people with limited income and resources. Medicaid also offers benefits not normally covered by Medicare, including nursing home care and per ...
in the ACA; Leerink analyst Geoffrey Porges wrote that Gilead's HIV drugs could face funding pressure under reform proposals. Gilead has $32 billion in cash, but $27.4 billion is outside the U.S. and is unavailable for acquisitions unless Gilead pays U.S. tax on it, though it could borrow against it. Gilead would benefit from proposals to let companies repatriate offshore capital with minimal further taxation. Gilead's
Entospletinib Entospletinib is an experimental drug for the treatment of various types of cancer under development by Gilead Sciences. It is an inhibitor of spleen tyrosine kinase (Syk). It has entered clinical trials for acute myeloid leukaemia (AML), chro ...
has shown a 90% complete response rate for MLL type
acute myeloid leukaemia Acute myeloid leukemia (AML) is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal cells that build up in the bone marrow and blood and interfere with normal blood cell production. Symptoms may inclu ...
(AML).


Criticism


TAF development delays

Several class-action lawsuits have been filed against Gilead over allegations that the company deliberately delayed development of antiretroviral drugs based on tenofovir alafenamide fumarate (TAF) in order to maximize profits from previous-generation medications containing tenofovir disoproxil fumarate (TDF). Plaintiffs allege that Gilead suspended TAF in 2004 despite clear evidence indicating that TAF-based medications were safer than TDF, a compound whose long-term use was associated with adverse side effects such as nephrotoxicity and bone density loss. Gilead's first TAF medication, marketed under the trade name Genvoya, came out in 2015. Lawsuits allege that in the interim period, many HIV patients who continuously took Gilead's older TDF-based drugs suffered severe side effects, including nephrotoxicity.


Pricing


Sovaldi

Gilead came under intense criticism for its high pricing of its patented drug
sofosbuvir Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. It is taken by mouth. Common side effects include fatigue, headache, nausea, and trouble sleeping. Side effects are generally more common i ...
(sold under the brand name Sovaldi), used to treat
hepatitis C Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver; it is a type of viral hepatitis. During the initial infection people often have mild or no symptoms. Occasionally a fever, dark urine, ...
. In the US, for instance, it was launched at $1,000 per pill or $84,000 for the standard 84-day course, but it was drastically cheaper in the developing world; in India, it dropped as low as $4.29 per pill. While Sovaldi represented a significant improvement over contemporary treatments, the controversy surrounding its price ignited a national debate in the US, according to Reuters. The
United States Senate Committee on Finance The United States Senate Committee on Finance (or, less formally, Senate Finance Committee) is a standing committee of the United States Senate. The Committee concerns itself with matters relating to taxation and other revenue measures general ...
launched an 18-month investigation of Gilead's Sovaldi pricing, and argued in its 2015 report that Gilead set prices high in disregard of the human cost and in order to set the stage for a higher eventual price for Sovaldi's successor, Harvoni. The committee's investigation, based in part on internal documents obtained from Gilead, revealed that the company had considered prices ranging from $50,000 to $115,000 per year, trying to strike a balance between revenue and predicted activist and public relations blowback, with little regard to research and development costs. The high prices forced state
Medicaid Medicaid in the United States is a federal and state program that helps with healthcare costs for some people with limited income and resources. Medicaid also offers benefits not normally covered by Medicare, including nursing home care and per ...
programs to ration treatment to patients, delaying treatment of less advanced hepatitis C cases. In Oregon, for example, 10,000 Medicaid patients were deemed good candidates for Sovaldi therapy, but the Oregon Health Authority estimated that treating half of these patients would more than double the state's total drug expenditures. The state thus opted to limit treatment to 500 patients per year.


Truvada and Descovy

When Truvada was introduced, it cost approximately $1,200 per month in the United States. By 2018, this price had increased to up to $2,000, despite generally costing less than $100 outside the U.S. Gilead made over $3 billion in sales of Truvada in 2018. The high price drew the ire of activist groups such as
ACT UP AIDS Coalition to Unleash Power (ACT UP) is an international, grassroots political group working to end the AIDS pandemic. The group works to improve the lives of people with AIDS through direct action, medical research, treatment and advocacy ...
and was the subject of a Congressional hearing in May 2019. Gilead's CEO defended its pricing in the hearing by noting the large sums the company spends on HIV/AIDS research. The research behind Truvada was primarily funded by the United States government, which filed the original patent. In May 2019, Gilead announced it would donate enough Truvada to treat up to 200,000 patients annually for up to 11 years, the result of discussions with the Department of Health and Human Services under Trump. Dr. Rochelle Walensky noted that the donations still covered less than one-fifth of the people who need the drug, and argued it was possibly a move to help the company market Descovy, a more advanced successor drug. Walensky led a 2020 study that concluded the high costs of Descovy would on the whole negate any comparative advantage of prescribing it over a generic Truvada alternative. In July 2021, Gilead announced it would decrease 340B Drug Pricing Program reimbursements to clinics serving primarily low-income communities; clinics argued this severely hinders their ability to provide HIV/AIDS prevention and treatment services among vulnerable populations.


Anticompetitive behavior

Gilead has also been accused of stifling competition. A lawsuit filed in the United States in 2019 alleged that the company entered "pay for delay" agreements with other manufacturers, wherein the manufacturers agreed to delay releasing generic versions of Truvada. In 2021,
CVS Pharmacy CVS Pharmacy, Inc. is an American retail corporation. A subsidiary of CVS Health, it is headquartered in Woonsocket, Rhode Island. It was also known as, and originally named, the Consumer Value Store and was founded in Lowell, Massachusetts, in ...
and
RiteAid Rite Aid Corporation is an American drugstore chain based in Philadelphia, Pennsylvania. It was founded in 1962 in Scranton, Pennsylvania, by Alex Grass under the name Thrift D Discount Center. The company ranked No. 148 in the Fortune 500 l ...
filed a lawsuit on similar grounds against Gilead,
Bristol-Myers Squibb The Bristol Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the ''Fortune'' 500 list of the lar ...
, and Teva Pharmaceuticals in 2021. In response to criticisms over the price of Sovaldi, Gilead began licensing the rights to produce generic versions of the drug to select producers in India in 2015. Included in the licensing agreements were 'anti-diversion' provisions, designed to prevent the drug from being exported back to developed countries where the cheaper, generic alternatives were still unavailable. (In India, a one-month treatment cost approximately US$300, versus $1,000 per pill in the United States.) Gilead required the Indian producers to screen patients to determine who could buy Sovaldi, which was criticized by
Médecins Sans Frontières (MSF; pronounced ), also known as Doctors Without Borders, is a humanitarian medical non-governmental organisation (NGO) or charity of French origin known for its projects in conflict zones and in countries affected by endemic diseases. ...
since it could lead to the exclusion of vulnerable groups like refugees and migrants from accessing the medicines. In response to the criticism, Gilead eventually relaxed these requirements.


Tax structures and tax avoidance

Gilead has been criticized for
tax avoidance Tax avoidance is the legal usage of the tax regime in a single territory to one's own advantage to reduce the amount of tax that is payable by means that are within the law. A tax shelter is one type of tax avoidance, and tax havens are jurisdi ...
. Tax avoidance, as opposed to
tax evasion Tax evasion is an illegal attempt to defeat the imposition of taxes by individuals, corporations, trusts, and others. Tax evasion often entails the deliberate misrepresentation of the taxpayer's affairs to the tax authorities to reduce the tax ...
, is the use of legal means to shift tax burdens from the one jurisdiction to overseas affiliates that pay a lower tax rate, even if revenue is primarily generated outside the overseas jurisdiction. A 2016 report by the liberal think tank Americans for Tax Fairness argued that Gilead was able to avoid up to $10 billion in taxes on U.S. sales through mechanisms such as
transfer pricing In taxation and accounting, transfer pricing refers to the rules and methods for pricing transactions within and between enterprises under common ownership or control. Because of the potential for cross-border controlled transactions to distort ...
, the sale of assets between affiliated entities. In particular, Gilead sells intellectual property to an Irish subsidiary, which then sells the finished products, such as Sovaldi, in the United States and elsewhere, paying the low Irish tax rate on profits. The practice is common among multinational pharmaceutical companies like Gilead. On December 26, 2018, ''
The Times ''The Times'' is a British daily national newspaper based in London. It began in 1785 under the title ''The Daily Universal Register'', adopting its current name on 1 January 1788. ''The Times'' and its sister paper '' The Sunday Times'' ( ...
'' reported that Gilead had used the
Double Irish arrangement The Double Irish arrangement was a base erosion and profit shifting (BEPS) corporate tax avoidance tool used mostly by United States multinationals since the late 1980s to avoid corporate taxation on non-U.S. profits. It was the largest ta ...
to avoid U.S. corporate taxes on global profits, stating that the firm "used a controversial tax loophole arrangement to shift almost in profits through an Irish entity in just two years" without paying Irish taxes. The company repatriated a portion of the Irish subsidiary's holdings, $28 billion, to the United States in 2018 following reductions of the corporate tax rate. For this it paid an estimated $5.5 billion in tax.


Remdesivir

Gilead sought and obtained
orphan drug An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of ...
designation for remdesivir from the US
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) on March 23, 2020. This designation is intended to encourage the development of drugs affecting fewer than 200,000 Americans by granting strengthened and extended legal monopoly rights to the manufacturer, along with waivers on taxes and government fees. Remdesivir became a candidate for treating COVID-19; at the time the status was granted, fewer than 200,000 Americans had COVID-19, but numbers were climbing rapidly as the
COVID-19 pandemic The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identi ...
reached the US, and crossing the threshold soon was considered inevitable. Gilead retains 20-year remdesivir patents in more than 70 countries. In 2021, remdesivir (tradename ''Veklury'') generated more than $4.5 billion in annual revenues, and was Gilead's highest selling product.


COVID-19

Emergency use authorization for remdesivir was granted in the U.S. on May 1, 2020, for people hospitalized with severe COVID-19. In September 2020 following a review of the evidence, the WHO issued guidance not to use remdesivir for people with COVID-19, as there was no good evidence of benefit. However, over 2020–22 with further
clinical research Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treat ...
, remdesivir had been approved for treatment of hospitalized people with COVID-19 in the United States, European Union, and multiple other countries. In 2022, the Canadian component of the WHO international Solidarity Trial reported that in-hospital people with COVID-19 treated with remdesivir had lower death rates (by about 4%) and reduced need for oxygen and mechanical ventilation compared to people receiving standard-of-care treatments.


Regulatory approval

''Veklury'' received approval from the US
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) in October 2020 use in hospitalized adults and children 12 years and older for treatment of severe COVID-19 infections. In January 2022, the FDA gave regulatory approval to ''Veklury'' for use in adults and children (12 years of age and older who weigh at least and are positive for COVID-19, not hospitalized, and are ill having high risk for developing severe COVID-19, including hospitalization or death. The FDA also provided
Emergency Use Authorization An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, includ ...
for ''Veklury'' treatment of children under age 12 who are COVID-positive and not hospitalized, but have mild-to-moderate COVID-19 with high risk of developing severe COVID-19, including hospitalization or death.


References


External links

* {{Authority control American companies established in 1987 1987 establishments in California 1992 initial public offerings Biopharmaceutical companies Biotechnology companies established in 1987 Biotechnology companies of the United States Companies based in Foster City, California Life sciences industry Companies associated with the COVID-19 pandemic Pharmaceutical companies established in 1987 Specialty drugs