Pharmasset

Last updated
Pharmasset Inc.
Industry Pharmaceuticals
Founded1998
Defunct2012
FateAcquired by Gilead Sciences in 2012
Headquarters,
United States
Key people
Raymond Schinazi
Dennis Liotta

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. [1] In November 2011, Pharmasset was acquired by Gilead for $11.2 billion. [2]

Contents

History

Pharmasset was founded in 1998 by Raymond Schinazi and Dennis Liotta, scientists at Emory University. The company was initially incorporated in Barbados (as Pharmasset, Ltd.) and separately in Georgia. However, the company was redomiciled as a Delaware corporation on June 8, 2004. [3]

Pharmasset's initial public offering took place on April 27, 2007, when it was first listed on NASDAQ. [4] The firm's stock return in the first three fiscal quarters (nine months) of 2011 was 278 percent. Among analysts, 17 rated the company's stock as "strong buy" or "buy," while two rated it a "hold." Pharmasset was the best performer in this period among all major U.S. exchanges among stocks trading for at least $1.50 on January 1, 2011. [5]

Market

The company described itself as being a clinical-stage pharmaceutical company and stated that its primary focus is "the development of oral therapeutics for the treatment of hepatitis C virus." [6] The company's secondary focus was the development of Racivir, an investigational antiretroviral drug for the treatment of HIV. The company's research and development concentrated on nucleoside analogs. [7]

Pharmasset's PSI-7977 medication was further developed by Gilead and approved in December 2013 by the FDA as sofosbuvir (Sovaldi) for the treatment of chronic hepatitis C. [8]

Among Pharmasset's competitors were Abbott Laboratories, [9] Merck & Co., and Vertex Pharmaceuticals. [10]

Sovaldi

Pharmasset originally developed Sofosbuvir (brand name Sovaldi). [11] When Gilead Sciences acquired Pharmasset for $11.2 billion in 2012, the "smaller company had forecast a $36,000 price per treatment course of Sovaldi. Gilead's investment bankers, Barclays and Bank of America Merrill Lynch did the "valuation of Pharmasset during merger talks and the related pricing assumptions for Sovaldi." According to The Wall Street Journal in response to the price of Solvadi at $84,000 per treatment course, the United States Senate Finance Committee wrote a letter to CEO John C. Martin questioning how much Pharmasset had spent on research and development on Sovaldi and how much Gilead spent on its "Sovaldi-related research costs since the 2012 buyout. [12]

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Hoffmann-La Roche Swiss multinational healthcare company

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Emtricitabine

Emtricitabine, with trade name Emtriva, is a nucleoside reverse-transcriptase inhibitor (NRTI) for the prevention and treatment of HIV infection in adults and children.

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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 prevention of HIV/AIDS among those at high risk before exposure, and after a needlestick injury or other potential exposure. It is sold both by itself and together as emtricitabine/tenofovir and efavirenz/emtricitabine/tenofovir. It does not cure HIV/AIDS or hepatitis B. It is available by mouth as a tablet or powder.

Vertex Pharmaceuticals

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Hetero Drugs An Indian pharmaceutical company

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Sofosbuvir

Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. It is only recommended with some combination of ribavirin, peginterferon-alfa, simeprevir, ledipasvir, daclatasvir, or velpatasvir. Cure rates are 30 to 97% depending on the type of hepatitis C virus involved. Safety during pregnancy is unclear; some of the medications used in combination may result in harm to the baby. It is taken by mouth.

Simeprevir

Simeprevir, sold under the trade names Olysio among others, is a medication used in combination with other medications for the treatment of hepatitis C. It is specifically used for hepatitis C genotype 1 and 4. Medications it is used with include sofosbuvir or ribavirin and peginterferon-alfa. Cure rates are in 80s to 90s percent. It may be used in those who also have HIV/AIDS. It is taken by mouth once daily for typically 12 weeks.

John C. Martin (businessman)

John Charles Martin was an American billionaire businessman, and the former executive chairman (2016–2018) and CEO (1996–2016) of the American biotechnology company Gilead Sciences. He joined Gilead Sciences in 1990 as vice president for research and development. Gilead is known for developing drugs such as Atripla and commercializing Sovaldi (sofosbuvir) for the treatment of the liver virus hepatitis C. Martin is the recipient of a number of awards, including the Biotechnology Heritage Award (2017).

Ledipasvir Hepatitis C drug

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 tablet for genotype 1 hepatitis C. The ledipasvir/sofosbuvir combination is a direct-acting antiviral agent that interferes with HCV replication and can be used to treat patients with genotypes 1a or 1b without PEG-interferon or ribavirin.

Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals that are classified as high-cost, high complexity and/or high touch. Specialty drugs are often biologics—"drugs derived from living cells" that are injectable or infused. They are used to treat complex or rare chronic conditions such as cancer, rheumatoid arthritis, hemophilia, H.I.V. psoriasis, inflammatory bowel disease and hepatitis C. In 1990 there were 10 specialty drugs on the market, in the mid-1990s there were fewer than 30, by 2008 there were 200, and by 2015 there were 300. Drugs are often defined as specialty because their price is much higher than that of non-specialty drugs. Medicare defines any drug for which the negotiated price is $670 per month or more, as a specialty drug which is placed in a specialty tier that requires a higher patient cost sharing. Drugs are also identified as specialty when there is a special handling requirement or the drug is only available via a limited distributions network. By 2015 "specialty medications accounted for one-third of all spending on drugs in the United States, up from 19 percent in 2004 and heading toward 50 percent in the next 10 years", according to IMS Health, which tracks prescriptions. According to a 2010 article in Forbes, specialty drugs for rare diseases became more expensive "than anyone imagined" and their success came "at a time when the traditional drug business of selling medicines to the masses" was "in decline". In 2015 analysis by The Wall Street Journal suggested the large premium was due to the perceived value of rare disease treatments which usually are very expensive when compared to treatments for more common diseases.

Elbasvir/grazoprevir is a fixed-dose combination for the treatment of hepatitis C, containing elbasvir and grazoprevir. It is used to treat chronic hepatitis C virus (HCV) genotypes 1 or 4 infection in both treatment-naïve and treatment-experienced patients.

Velpatasvir

Velpatasvir is an NS5A inhibitor which is used together with sofosbuvir in the treatment of hepatitis C infection of all six major genotypes.

Michael J. Sofia is a chemist whose main research focus is hepatitis C virus and hepatitis B virus drug discovery. He was a co-recipient of the Lasker-DeBakey Clinical Medical Research Award for his work on hepatitis C in 2016 and of the Gertrude B. Elion Memorial Award from the International Society for Antiviral Research in 2017.

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 genotypes one through six. It also works for hepatitis C in those who also have cirrhosis or HIV/AIDS. It is taken by mouth.

Raymond F. Schinazi is an American organic medicinal chemist with expertise in antiviral agents, pharmacology, and biotechnology. His research focuses on developing treatments for infections caused by human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), herpes, dengue fever, zika, chikungunya, and other emerging viruses. These treatment options include antiviral agents as well as synthetic, biochemical, pharmacological and molecular genetic approaches, including molecular modeling and gene therapy.

References

  1. "Pharmasset Inc (VRUS:US)." Bloomberg.
  2. Tom Murphy (November 21, 2011). "Gilead Sciences to buy Pharmasset for $11 billion". Bloomberg Businessweek .
  3. Pharmasset Inc. Form 10-K Archived 2012-04-25 at the Wayback Machine (annual report filed 12/31/07 for the period ending 09/30/07).
  4. "Pharmasset Announces Second Fiscal Quarter 2007 Financial Results Archived 2012-04-25 at the Wayback Machine " (June 11, 2007) (press release). Pharmasset Inc.
  5. Brian Richards. "With 9 Months Down, These Are the Best Stocks of 2011" (October 3, 2011). The Motley Fool.
  6. "Corporate Overview - Pharmasset, Inc. Archived 2011-11-01 at the Wayback Machine ." - Pharmasset, Inc.
  7. "About Us Archived 2011-10-11 at the Wayback Machine ." Pharmasset Inc.
  8. "FDA approves Sovaldi for chronic hepatitis C". FDA New Release. U.S. Food and Drug Administration. 2013-12-06.
  9. Pat Wechsler, "Pharmasset Falls on Rival Abbott Hepatitis C Therapy Results" (October 21, 2011). Bloomberg.
  10. "Pharmasset expands hepatitis C trial; shares rise" (October 10, 2011). Reuters.
  11. "The lab breakthrough that paved the way for hepatitis C cures". STAT. 2016-09-13. Retrieved 2020-07-28.
  12. Staton, Tracy (14 July 2014). "Riled by $84,000 Sovaldi, Senate panel digs into Gilead's Pharmasset buy". Fierce Pharma. Retrieved 27 October 2015.