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
Foster City is a city located in San Mateo County, California. The 2020 census put the population at 33,805, an increase of more than 10% over the 2010 census figure of 30,567. Foster City is sometimes considered to be part of Silicon Valley ...
, 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. Fo ...
,
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, a ...
,
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 symptoms ...
, 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 COVID-19 pandemic in Hubei, identified in Wuhan, China, in December ...
, including
ledipasvir/sofosbuvir
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 (H ...
and
sofosbuvir
Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. It is taken Oral administration, by mouth.
Common side effects include fatigue, headache, nausea, and trouble sleeping. Side effects are gen ...
. Gilead is a member of the
NASDAQ Biotechnology Index The NASDAQ Biotechnology Index is a stock market index made up of securities of NASDAQ-listed companies classified according to the Industry Classification Benchmark as either the Biotechnology or the Pharmaceutical industry. A list of the 213 compo ...
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 D ...
.
Gilead was founded in 1987 under the name Oligogen by Michael L. Riordan. The original name was a reference to
oligomers
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 relative ...
, small strands of DNA used to target genetic sequences. Gilead held its
IPO
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 investment ...
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 hig ...
and
Vistide that decade.
In the 2000s, Gilead received approval for drugs including
Viread
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 ...
and
Hepsera
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 ...
, 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
Washington University in St. Louis (WashU or WUSTL) is a private research university with its main campus in St. Louis County, and Clayton, Missouri. Founded in 1853, the university is named after George Washington. Washington University is r ...
, 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 p ...
. 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
Harold M. "Hal" Weintraub was an American scientist who lived from 1945 until his death in 1995 from an aggressive brain tumor. Only 49 years old, Weintraub left behind a legacy of research.
Early life and education
Born on June 2, 1945, in ...
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
Menlo Ventures is a venture capital firm based in Menlo Park, California with an additional office in San Francisco, California. The firm was founded as one of the earliest venture capital firms in Silicon Valley in 1976 and provides technology ...
, 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
Harold Eliot Varmus (born December 18, 1939) is an American Nobel Prize-winning scientist. He is currently the Lewis Thomas University Professor of Medicine at Weill Cornell Medicine and a senior associate at the New York Genome Center.
He was a ...
, 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 late ...
, and Jack Szostak
Jack William Szostak (born November 9, 1952) is a Canadian American biologist of Polish British descent, Nobel Prize laureate, university professor at the University of Chicago, former Professor of Genetics at Harvard Medical School, and Alexand ...
, 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 characterist ...
. 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 Presi ...
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 i ...
. followed by Benno C. Schmidt, Sr.
Benno Charles Schmidt Sr. (January 10, 1913 – October 21, 1999) was an American lawyer and venture capitalist who was active in New York City civic affairs and played an important role in the initiation of the War on Cancer. , Gordon Moore
Gordon Earle Moore (born January 3, 1929) is an American businessman, engineer, and the co-founder and chairman emeritus of Intel Corporation. He is also the original proponent of Moore's law.
As of March 2021, Moore's net worth is rep ...
, and George P. Shultz
George Pratt Shultz (; December 13, 1920February 6, 2021) was an American economist, businessman, diplomat and statesman. He served in various positions under two different Republican presidents and is one of the only two persons to have held fou ...
. 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 w ...
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 relativ ...
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 c ...
s) to target specific genetic code sequences – that is, antisense therapy
Antisense therapy is a form of treatment that uses antisense oligonucleotides (ASOs) to target messenger RNA (mRNA). ASOs are capable of altering mRNA expression through a variety of mechanisms, including ribonuclease H mediated decay of the pre-m ...
, a form of gene therapy
Gene therapy is a 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 human DN ...
. 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
Balm of Gilead was a rare perfume used medicinally, that was mentioned in the Hebrew Bible, and named for the region of Gilead, where it was produced. The expression stems from William Tyndale's language in the King James Bible of 1611, and has c ...
when he read Lanford Wilson
Lanford Wilson (April 13, 1937March 24, 2011) was an American playwright. His work, as described by ''The New York Times'', was "earthy, realist, greatly admired ndwidely performed."Margalit Fox, Fox, Margalit"Lanford Wilson, Pulitzer Prize-Wi ...
's play ''Balm in Gilead
''Balm in Gilead'' is a 1965 play written by American playwright Lanford Wilson. Dramatic structure
Wilson's first full-length play, ''Balm in Gilead'' centers on a café frequented by heroin addicts, prostitutes, and thieves. It features many unc ...
'' 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 s ...
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
Ionis Pharmaceuticals, Inc. is a biotechnology company based in Carlsbad, California, that specializes in discovering and developing RNA-targeted therapeutics. The company has 3 commercially approved medicines: Spinraza (Nusinersen), Tegsedi ( I ...
. 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 investment ...
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 us ...
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 ''Betaherpe ...
(CMV) retinitis
Retinitis is inflammation of the retina in the eye, which can permanently damage the retina and lead to blindness. The retina is the eye's "sensing" tissue. Retinitis may be caused by a number of different infectious agents. Its most common form, ...
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 m ...
.
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 Presi ...
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 s ...
during George W. Bush
George Walker Bush (born July 6, 1946) is an American politician who served as the 43rd president of the United States from 2001 to 2009. A member of the Republican Party, Bush family, and son of the 41st president George H. W. Bush, he ...
'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 Color ...
. 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
The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...
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 S ...
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 hig ...
(oseltamivir
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 hig ...
) 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 symptoms ...
. 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 i ...
. 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
OSI Pharmaceuticals, Inc. was an American pharmaceutical company formerly based on Long Island, New York with facilities in Colorado, New Jersey and the United Kingdom. On Sunday, May 16, 2010 OSI agreed to be acquired by Japan-based, TSE-listed ...
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 in ...
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. Fo ...
, 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 in ...
) 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 organization
A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organ ...
s.
In 2004, during the Avian flu
Avian influenza, known informally as avian flu or bird flu, is a variety of influenza caused by viruses adapted to birds.[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 Presi ...](_blank)
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
The respiratory system (also respiratory apparatus, ventilatory system) is a biological system consisting of specific organs and structures used for gas exchange in animals and plants. The anatomy and physiology that make this happen varies grea ...
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 ten ...
, 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 epoprosten ...
( 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 bl ...
.
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. O ...
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. aerugi ...
''.
In July 2006, the U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(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 needlest ...
), 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 in ...
and tenofovir disoproxil
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 ...
), 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 anchor ...
, was a wholly owned subsidiary of Degussa AG
Evonik Industries AG is a stock-listed German specialty chemicals company headquartered in Essen, North Rhine-Westphalia, Germany. It is the second largest chemicals company in Germany, and one of the largest specialty chemicals companies in the ...
, 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 bronchi, airways of the lung. Symptoms typically include a chronic cough with sputum, mucus production. Other symptoms include shortness of breath, hemoptysis, co ...
.
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 N ...
, 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 ( hepato ...
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 Oral administration, by mouth.
Common side effects include fatigue, headache, nausea, and trouble sleeping. Side effects are gen ...
(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
Emtricitabine/tenofovir, sold under the brand name Truvada among others, is a fixed-dose combination antiretroviral medication used to treat and prevent HIV/AIDS. It contains the antiretroviral medications emtricitabine and tenofovir disopro ...
for prevention of HIV infection (it was already approved for treating HIV). The pill was a preventive measure (PrEP
PowerPC Reference Platform (PReP) was a standard system architecture for PowerPC-based computer systems (as well as a reference implementation) developed at the same time as the PowerPC processor architecture. Published by IBM in 1994, it allo ...
) 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, an orally-administered, once-daily, selective inhibitor of the Janus kinase
Janus kinase (JAK) is a family of intracellular, non-receptor tyrosine kinases that transduce cytokine-mediated signals via the JAK-STAT pathway. They were initially named "just another kinase" 1 and 2 (since they were just two of many discoveries ...
(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
Non-alcoholic fatty liver disease (NAFLD), also known as metabolic (dysfunction) associated fatty liver disease (MAFLD), is excessive fat build-up in the liver without another clear cause such as alcohol use. There are two types; non-alcoholic ...
.
* 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
Filgotinib, sold under the brand name Jyseleca, is a medication used for the treatment of rheumatoid arthritis (RA). It was developed by the Belgium, Belgian-Netherlands, Dutch biotech company Galapagos NV.
The most common side effects include na ...
, 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 a ...
, 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 distension ...
.
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
Non-alcoholic fatty liver disease (NAFLD), also known as metabolic (dysfunction) associated fatty liver disease (MAFLD), is excessive fat build-up in the liver without another clear cause such as alcohol use. There are two types; non-alcoholic ...
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
Kite Pharma is an American biotechnology company that develops cancer immunotherapy products, with a primary focus on genetically engineered autologous CAR T cell therapy, a cell-based therapy which relies on chimeric antigen receptors and T ce ...
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 specific ...
candidate to the company's portfolio. By 2022 this acquisition had led to two marketed products for lymphoma: Yescarta
Axicabtagene ciloleucel, sold under the brand name Yescarta, is a medication used for the treatment for large B-cell lymphoma that has failed conventional treatment. T cells are removed from a person with lymphoma and genetically engineered to p ...
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
Alex Michael Azar II (; born June 17, 1967) is an American attorney, businessman, lobbyist, and former pharmaceutical executive who served as the United States secretary of health and human services from 2018 to 2021. Azar was nominated to his p ...
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. Goldenbe ...
for $21 billion ($88 per share), gaining control of the cancer treatment Trodelvy
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 com ...
(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 co ...
-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 junior U.S. senator from Kentucky since 2011. A member of the Republican Party, he is a son of former three-time presidential candidate and 12 ...
disclosed that his wife Kelley Paul
Kelley Ashby Paul (born September 3, 1963) is an American political consultant and freelance writer. She has worked as a consultant for The Strategy Group for Media, and she published a book titled ''True and Constant Friends'' in April 2015. Her ...
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 N ...
Inc (Acq 2011)
** Phenex Pharmaceuticals (Acq 2015)
** EpiTherapeutics (Acq 2015)
** Galapagos NV (Acq 2015)
** Nimbus Apollo, Inc. (Acq 2016)
** Kite Pharma
Kite Pharma is an American biotechnology company that develops cancer immunotherapy products, with a primary focus on genetically engineered autologous CAR T cell therapy, a cell-based therapy which relies on chimeric antigen receptors and T ce ...
(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. Goldenbe ...
(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 Oral administration, by mouth.
Common side effects include fatigue, headache, nausea, and trouble sleeping. Side effects are gen ...
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 ( hepato ...
. ''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 re ...
'' 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 N ...
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 Sto ...
estimated Sovaldi sales in the year's final quarter would be $53 million, and ''Barron's Barron's or Barrons may refer to:
*Barron's Educational Series, a publisher of books, as well as college entrance exam preparation classes and materials, now an imprint of Kaplan Test Prep
** B.E.S. Publishing, the former owner of Barron's
* ''Barr ...
'' 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 generall ...
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 Seniority in the United States Senate, senior United States Senate, United States senator from Oregon, a seat he has held since 1996 United Stat ...
( 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 Seniority in the United States Senate, senior United States Senate, United States sen ...
( R-Iowa
Iowa () is a state in the 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: Wisconsin to the northeast, Illinois to the ...
) 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 table ...
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 (H ...
. 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
Sofosbuvir/velpatasvir, sold under the brand name Epclusa among others, is a fixed-dose combination medication for the treatment of hepatitis C in adults. It combines sofosbuvir and velpatasvir. It is more than 90% effective for hepatitis C geno ...
(with velpatasvir
Velpatasvir is an NS5A inhibitor (by Gilead) which is used together with sofosbuvir in the treatment of hepatitis C infection of all six major genotypes.
Side effects
Side effects in studies occurred with similar frequencies as in people treat ...
) and Vosevi
Sofosbuvir/velpatasvir/voxilaprevir, sold under the brand name Vosevi, is a fixed-dose combination medication for the treatment of hepatitis C. It combines three drugs that each act by a different mechanism of action against the hepatitis C viru ...
(with velpatasvir
Velpatasvir is an NS5A inhibitor (by Gilead) which is used together with sofosbuvir in the treatment of hepatitis C infection of all six major genotypes.
Side effects
Side effects in studies occurred with similar frequencies as in people treat ...
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 pers ...
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), chronic ...
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 include ...
(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 Nephrotoxicity is toxicity in the kidneys. It is a poisonous effect of some substances, both toxic chemicals and medications, on kidney function. There are various forms, and some drugs may affect kidney function in more than one way. Nephrotoxin ...
and bone density
Bone density, or bone mineral density, is the amount of bone mineral in bone tissue. The concept is of mass of mineral per volume of bone (relating to density in the physics sense), although clinically it is measured by proxy according to optica ...
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 Nephrotoxicity is toxicity in the kidneys. It is a poisonous effect of some substances, both toxic chemicals and medications, on kidney function. There are various forms, and some drugs may affect kidney function in more than one way. Nephrotoxin ...
.
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 Oral administration, by mouth.
Common side effects include fatigue, headache, nausea, and trouble sleeping. Side effects are gen ...
(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, a ...
. 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 generall ...
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 pers ...
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
The Oregon Health Authority (OHA) is a government agency in the U.S. state of Oregon. It was established by the passage of Oregon House Bill 2009 by the 75th Oregon Legislative Assembly, and split off from Oregon Department of Human Services, O ...
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
Rochelle Paula Walensky (née Bersoff; born April 5, 1969) is an American physician-scientist who is the director of the Centers for Disease Control and Prevention and the administrator of the Agency for Toxic Substances and Disease Registry. P ...
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
The 340B Drug Pricing Program is a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. The intent of ...
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 li ...
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
Teva Pharmaceutical Industries Ltd. (also known as Teva Pharmaceuticals) is an Israeli multinational pharmaceutical company with headquarters in Tel Aviv, Israel. It specializes primarily in generic drugs, but other business interests include ...
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. M ...
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 jurisdict ...
. 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 taxp ...
, 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'' (fou ...
'' 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 tax ...
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
Remdesivir, sold under the brand name Veklury, Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged. is a broad-spectrum antiviral medication developed by the ...
from the US Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(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 identif ...
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, treatm ...
, 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
The Solidarity trial for treatments is a multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness. The tria ...
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 List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(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 Act of Congress, Acts of ...
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