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Gilead Sciences

Gilead Sciences, Inc. (/ˈɡɪliəd/) is an American biopharmaceutical company headquartered in Foster City, California that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19, including ledipasvir/sofosbuvir and sofosbuvir. Gilead is a member of the NASDAQ Biotechnology Index and the S&P 500.

Company type

June 22, 1987 (1987-06-22)

Foster City, California, United States

Worldwide

Decrease US$27.12 billion (2023)

Increase US$7.605 billion (2023)

Increase US$5.613 billion (2023)

Decrease US$62.13 billion (2023)

Increase US$22.83 billion (2023)

c. 18,000 (2023)

Gilead was founded in 1987 under the name Oligogen by Michael L. Riordan. The original name was a reference to oligonucleotides, small strands of DNA used to target genetic sequences. Gilead held its IPO in 1992, and successfully developed drugs like Tamiflu 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. However, it 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.[2][3][4][5][6]

It bought Phenex Pharmaceuticals for $470 million. Its (FXR) program used small-molecule FXR agonists in the treatment of liver diseases such as non-alcoholic steatohepatitis.[46]

Farnesoid X receptor

It bought EpiTherapeutics for $65 million. This acquisition gave Gilead first-in-class small molecule inhibitors of involved in regulating gene transcription in cancer.[47]

histone demethylases

It paid $425 million for a 15% equity stake in Galapagos NV, with additional payments for Gilead to license the experimental anti-inflammatory drug , which may treat rheumatoid arthritis, ulcerative colitis, and Crohn's disease.[48]

filgotinib

Treatments for hepatitis C[edit]

The drug sofosbuvir 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. Forbes 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 for $11 billion as "one of the best pharma acquisitions ever".[78] Deutsche Bank estimated Sovaldi sales in the year's final quarter would be $53 million,[79] and Barron's noted the FDA approval and subsequent strong sales of the "potentially revolutionary" drug as a positive indicator for the stock.[80]


On July 11, 2014, the United States Senate Committee on Finance 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 (D-Oregon) and ranking minority member Chuck Grassley (R-Iowa) wrote to CEO John C. Martin asking Gilead to justify the price for this drug.[81] 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.[82] 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.[83]


Gilead later combined Sovaldi with other antivirals in single-pill combinations. First, Sovaldi was combined with ledipasvir and marketed as Harvoni. This treatment for hepatitis C cures the patient in 94% to 99% of cases (HCV genotype 1).[84] 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.[85] Later single-pill combinations were Epclusa (with velpatasvir) and Vosevi (with velpatasvir and voxilaprevir).

Criticism[edit]

TAF development delays[edit]

Several mass tort lawsuits have been filed against Gilead alleging 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).[94] 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.[95][96]


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.[97][98]

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