Gilead Sciences

Gilead Sciences
Public
Traded as
Industry Pharmaceutics
Biotechnology
Founded 1987 (1987)
Headquarters Foster City, California, U.S.
Key people
 John C. Martin,
(Executive Chairman)
Products AmBisome, Atripla, Cayston, Emtriva, Flolan, Harvoni, Hepsera, Letairis, Lexiscan, Macugen, Ranexa, Sovaldi, Tamiflu, Truvada, Viread, Vistide
Revenue Increase US$32.639 billion (2015)[1]
Increase US $22.193 billion (2015)[1]
Increase US $18.108 billion (2015)[1]
Total assets Increase US $51.839 billion (2015)[1]
Total equity Increase US $19.113 billion (2015)[2]
Number of employees
 7,900 (2015) [3]
Website www.gilead.com

Gilead Sciences is an American biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza. In 2006, Gilead acquired two companies which were developing drugs to treat patients with pulmonary diseases.

The company's current commercially available products include Atripla, Complera, Emtriva, Viread, Tybost, Vitekta, Truvada, Stribild, Harvoni, Hepsera, Sovaldi, Zydelig, Letairis, Lexiscan, Ranexa, Cayston, Tamiflu, AmBisome, and Macugen.[4]

Headquartered and founded in Foster City, California, Gilead has operations in North America, Europe and Australia. As of the end of 2015, the company had approximately 7,900 full-time employees.[5] Gilead is a member of the NASDAQ Biotechnology Index and the S&P 500.

The company's name and logo refer to the Balm of Gilead, inspired by a 1965 play by Lanford Wilson featuring the underworld adventures of the patrons of the namesake cafe.

History

External video
Gregg Alton of Gilead Sciences & others, "The Evolution of HIV/AIDS Therapies: A Conversation", 2012, Chemical Heritage Foundation

Gilead Sciences was founded in June 1987 by Michael L. Riordan, a medical doctor who was 29 years old at the time.[6][7][8] Riordan graduated from Washington University, the Johns Hopkins School of Medicine and the Harvard Business School.[9][10][11] Three core scientific advisers worked with Riordan to create the company and establish its scientific vision. These were Peter Dervan of Caltech, Doug Melton of Harvard, and Harold Weintraub of the Fred Hutchinson Cancer Research Center. Riordan served as CEO from inception until 1996.[12] Menlo Ventures, a venture capital firm where Riordan worked for a year, made the first investment in Gilead, of $2 million, and Menlo's partner DuBose Montgomery served as Chairman of the Board until 1993, when Riordan became Chairman.[8] Riordan also recruited as scientific advisers Harold Varmus, a Nobel laureate who later became Director of the National Institutes of Health, and Jack Szostak, recipient of the Nobel Prize for Physiology or Medicine in 2009.[13]

The company's primary therapeutic focus was, and continues to be, in antiviral medicines, a field that interested Riordan because he contracted dengue fever, an untreatable viral disease, while working in malnutrition clinics as a Henry Luce Scholar in the Philippines.[14][15] Riordan recruited Donald Rumsfeld to join the board of directors in 1988, followed by Benno C. Schmidt, Sr., Gordon Moore, and George P. Shultz. Riordan tried to recruit Warren Buffett as an investor and board member, but was unsuccessful.[16] Under the technical leadership of scientist Dr. Mark Matteucci, the company focused its early discovery research on making small strands of DNA (oligomers) to assess the potential of genetic code blockers (gene therapy). Its development of small molecule antiviral therapeutics began in 1991 when CEO Riordan and R&D head John C. Martin in-licensed a group of nucleotide compounds discovered in two European academic labs; one of the compounds was tenofovir, a pro-drug of which, trade named Viread, became one of the most widely used anti-AIDS drugs.[17]

In 1990, Gilead entered into a collaborative research agreement with Glaxo for the research and development of genetic code blockers, also known as antisense. This collaboration was terminated in 1998, and Gilead's antisense intellectual property portfolio was sold to Isis Pharmaceuticals.

Gilead debuted on the NASDAQ in January 1992. Its initial public offering raised $86.25 million in proceeds.

In June 1996, Gilead launched Vistide (cidofovir injection) for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. The company cooperated with Pharmacia & Upjohn to market the product outside the United States.

In January 1997, Donald Rumsfeld, a Board member since 1988, was appointed Chairman of the company.[18] He stood down from the Board in January 2001 when appointed United States Secretary of Defense at the start of George W. Bush's first term as President. Federal disclosure forms indicate that Rumsfeld owned between US$5 million and US$25 million in Gilead stock. The rise in Gilead's share prices from US$35 to US$57 per share will have added between US$2.5 million to US$15.5 million to Rumsfeld's net worth.[19]

In March 1999, Gilead acquired NeXstar Pharmaceuticals of Boulder, Colorado following two years of negotiations with the company. At the time, NeXstar's annual sales of $130 million was three times Gilead's sales. NeXstar's two revenue-generating drugs were AmBisome, an injectable fungal treatment, and DaunoXome, an oncology drug taken by HIV patients. Also in 1999, Roche announced first approval of Tamiflu (oseltamivir) for the treatment of influenza. Tamiflu was originally discovered by Gilead and licensed to Roche for late-phase development and marketing. Viread (tenofovir) achieved first approval in 2001 for the treatment of HIV.

In January 2003, Gilead completed its acquisition of Triangle Pharmaceuticals. The company also announced its first full year of profitability. Later that year Hepsera (adefovir) was approved for the treatment of chronic hepatitis B, and Emtriva (emtricitabine) for the treatment of HIV.

In 2004, Gilead launched Truvada, a fixed-dose combination of tenofovir and emtricitabine.

In November 2005, President George W. Bush urged the United States Congress to pass $7.1 billion in emergency funding to prepare for the possible bird flu pandemic, of which $1 billion is solely dedicated to the purchase, and distribution of Tamiflu.

In July 2006, the U.S. Food and Drug Administration (FDA) approved Atripla, a once a day single tablet regimen for HIV, combining Sustiva (efavirenz), a Bristol-Myers Squibb product, and Truvada (emtricitabine and tenofovir disoproxil), a Gilead product.[20][21]

Gilead purchased Raylo Chemicals, Inc. in November 2006 for a price of $133.3 million.[22] Raylo Chemical, based in Edmonton, Alberta, 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.

In 2009 the company received the award for one of the Fastest Growing Companies by Fortune. In the same year they were also named as one America's Top Companies to work for by Forbes.

On July 16, 2012, the U.S. FDA approved the first drug shown to reduce the risk of HIV infection manufactured by Gilead Sciences. The pill Truvada as a preventive measure (PrEP) for people who are at high risk of getting HIV through sexual activity.[23]

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”, Gilead Sciences was reported as the number 4 ranked drug company of 2013 by Forbes Magazine.[24] The strong performance of Gilead in 2013 has also been linked to the FDA approval, and strong sales performance, of their “potentially revolutionary” Hepatitis-C drug Sovaldi.[25] with US 4Q’13 sales estimated by Deutsche Bank at $53M.[26]

On July 11, 2014, the Committee of Finance of the United States Senate launched an investigation into the pricing of the hepatitis C drug Sovaldi (sofosbuvir). This was in reaction to the high cost per pill ($1,000), which raised serious questions about the extent to which the market was operating “efficiently and rationally” for this drug. In a letter to CEO John C. Martin, Senators Ron Wyden (Chairman) and Charles E. Grassley (Member) asked Gilead to provide a series of documents to the Committee, and to answer a list of questions, in order for the Committee to get a better understanding of how the company had arrived at the price for this drug.[27]

Entry into the cardiovascular and respiratory therapeutic areas

In 2006, Gilead completed two acquisitions that allowed the company to branch out from its historical antiviral franchise into the cardiovascular and respiratory therapeutic arenas.

Myogen,[28] based in Boulder, Colorado, was completing Phase 3 studies of ambrisentan—now marketed as "Letairis"—an orally available endothelin receptor antagonist. The U.S. FDA subsequently approved ambrisentan for the treatment of pulmonary arterial hypertension in June 2007.[29][30][31]

Under an agreement with GlaxoSmithKline, Myogen marketed Flolan (epoprostenol sodium) in the United States for the treatment of primary pulmonary hypertension. Additionally, Myogen was developing (in Phase 3 studies) darusentan,[32] also an endothelin receptor antagonist, for the potential treatment of resistant hypertension.

The other acquisition was Corus Pharma. Corus's lead product candidate, aztreonam lysine for inhalation, is an antibiotic with activity against gram-negative bacteria including Pseudomonas aeruginosa, which can cause lung infections in patients with cystic fibrosis. The product is in Phase 3 studies.[33] Gilead also obtained an inhalation formulation of two antibiotics for treatment of respiratory infections.[34]

Gilead expanded its move into respiratory therapeutics in 2007 by entering into a licensing agreement with Parion for an epithelial sodium channel inhibitor for the treatment of pulmonary diseases, including cystic fibrosis, chronic obstructive pulmonary disease and bronchiectasis.[35]

In 2009, Gilead acquired CV Therapeutics for about $1.4B. This acquisition brought Ranexa and Lexiscan as commercial products.[36]

Current Gilead Sciences CEO is John F. Milligan.

Timetable of mergers and acquisitions

Timetable of Mergers and Acquisitions
Year Company Price Notes
1999 NeXstar Pharmaceuticals $550 million NeXstar had two drugs (AmBisome and DaunoXome) of which only AmBisome is still in Gilead's portfolio, although it is not a major source of income for the company. DaunoXome was sold to Diatos in 2006.[37] As important as the products, NeXstar also provided Gilead with a much-needed sales force and commercialization team in Europe and Australia, and a manufacturing plant in San Dimas, California.[38]
2003 Triangle Pharmaceuticals $464 million Triangle owned the development and commercialization rights to emtricitabine, which although marketed as a stand-alone product (Emtriva), is also a component of the more profitable combination products Atripla and Truvada.[39]
2006 Corus Pharma, Inc. $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 who are infected with Pseudomonas aeruginosa
2006 Myogen, Inc. $2.5 billion 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.
2006 Raylo Chemicals, Inc. $148 million This Edmonton, Alberta site will be used for process research and for manufacturing compounds for both clinical studies and commercial products.[40]
2007 Nycomed fr. Altana - Cork $47 million This commercial manufacturing site was purchased by Gilead in place of building out the site in Dublin. This site used to be Altana in Cork which was purchased by Nycomed.
2009 CV Therapeutics, Inc. $1.4 billion This acquisition brings Ranexa and Lexiscan as commercial products. Ranexa is a cardiovascular drug used to treat chest pain related to coronary artery disease. These products and pipeline build out Gilead's cardiovascular franchise.
2010 CGI Pharmaceuticals $120 million This acquisition helps to broaden Gilead's research expertise into kinase biology and chemistry.
2010 Arresto Biosciences, Inc. $225 million This acquisition brings Gilead developmental-stage research for treating fibrotic diseases and cancer.[41]
2011 Calistoga Pharmaceuticals $375 million ($225 million additional w/ milestones) Acquisition of Calistoga bolsters areas of oncology and inflammation.[42]
2011 Pharmasset, Inc $10.4 billion This acquisition helps Gilead take the lead in HCV with 7977 (Sofosbuvir).
2013 YM Biosciences, Inc $510 million This acquisition brings drug candidate CYT387, an orally-administered, once-daily, selective inhibitor of the Janus kinase (JAK) family, specifically JAK1 and JAK2. The JAK enzymes have been implicated in a number of disorders including myeloproliferative diseases, inflammatory disorders and certain cancers.
2015 Phenex Pharmaceuticals up-to $470 million This acquisition will revolve around the Phenexs Farnesoid X Receptor (FXR) program, which consists of utilising small molecule FXR agonists in the treatment of liver diseases such as nonalcoholic steatohepatitis[43]
2015 EpiTherapeutics $65 million This acquisition will give Gilead first-in-class small molecule inhibitors of histone demethylases involved in regulating gene transcription in cancer.[44]
2015 Galapagos NV $725 million This acquisition will give Gilead access to experimental anti-inflammatory drug filgotinib which is planned to treat rheumatoid arthritis, ulcerative colitis, and Crohn's disease.[45][46]
2016 Nimbus Apollo, Inc. $400 million This acquisition will give Gilead 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[47][48]

Board of directors

Senior management

Gilead's Executive Committee is responsible for making the critical decisions that determine the company's future. Its members include:

Name Title
John F. Milligan, PhD President and Chief Executive Officer
Norbert W. Bischofberger, PhD Executive Vice President, Research and Development and Chief Scientific Officer
Robin L. Washington, MBA Executive Vice President and Chief Financial Officer
John McHutchison, MD Executive Vice President, Clinical Research
Gregg H. Alton, JD Executive Vice President, Corporate and Medical Affairs
Paul Carter Executive Vice President, Commercial Operations
William A. Lee, PhD Executive Vice President, Head of Antiviral Therapeutics
James R. Meyers Senior Vice President, Commercial Operations, North America
Taiyin Yang, PhD Executive Vice President, Pharmaceutical Development and Manufacturing
Andrew Cheng, MD, PhD Executive Vice President, Clinical Research and Development Operations
Katie L. Watson Executive Vice President, Human Resources

Product portfolio

Gilead has 21 products on the market.

Product Portfolio
Brand Name Drug Name(s) Indication Date Approved (USA)[49] Marketing Partner(s) U.S. Patent Expiration[50] European Patent Expiration[50]
AmBisome liposomal amphotericin B fungal infection, cryptococcal meningitis, Aspergillus, Candida, Cryptococcus infections 1997-08-11 Astellas Pharma(USA)Rapiscan(EU) 2016 expired
Atripla tenofovir, emtricitabine, and efavirenz HIV, AIDS 2006-07-12 Bristol-Myers Squibb 2021 2018
Cayston Aztreonam Cystic Fibrosis 2010-02-22 2021 2021
Complera/Eviplera tenofovir, emtricitabine, and rilpivirine HIV, AIDS 2011-08-10 Johnson and Johnson  
Emtriva emtricitabine HIV, AIDS 2003-07-02   2021 2016
Flolan epoprostenol sodium pulmonary hypertension 1995-09-20 GlaxoSmithKline expired expired
Harvoni sofosbuvir, ledipasvir Hepatitis C 2014-10-10
Hepsera adefovir dipivoxil hepatitis B (HBV) 2002-09-20   2014 2011
Letairis ambrisentan Pulmonary arterial hypertension 2007-06-15 GlaxoSmithKline 2015 2015
Lexiscan regadenoson myocardial perfusion imaging 2008-04-10 Astellas 2019 2020
Macugen pegaptanib sodium solution age-related macular degeneration 2004-12-17 OSI and Pfizer 2017 2017
Ranexa ranolazine angina 2006-01-27 Hoffmann–La Roche 2019 2019
Sovaldi sofosbuvir Hepatitis C 2013-12-06
Stribild elvitegravir, cobicistat, emtricitabine, tenofovir HIV, AIDS 2012-08-27
Tamiflu oseltamivir phosphate influenza 1999-10-27 Hoffmann–La Roche 2016 2016
Truvada emtricitabine and tenofovir HIV, AIDS 2004-08-02   2021 2018
Tybost cobicistat HIV, AIDS 2013-09-25 (EU), 2014-09-24 (US)
Viread tenofovir HIV, AIDS, hepatitis B 2001-10-26   2017 2018
Vistide cidofovir CMV retinitis 1996-06-26 Pfizer expired expired
Vitekta elvitegravir HIV, AIDS 2013-09-25 (EU), 2014-09-24 (US)
Zydelig idelalisib oncology, lymphoma 2014-07-23

See also

References

  1. 1 2 3 4 "Gilead Sciences Announces Fourth Quarter and Full Year 2014 Financial Results" (PDF).
  2. ↑ "Gilead Sciences Inc (GILD:NASDAQ GS)".
  3. ↑ "Media FAQs". Gilead Sciences. Retrieved 2015-03-16.
  4. ↑ http://gilead.com. Gilead Sciences http://www.gilead.com/medicines. Retrieved 25 October 2015. Missing or empty |title= (help); External link in |website= (help)
  5. ↑ Krantz, Matt (March 20, 2015). "Workers at 11 companies haul in $3.5M each!". Gannet. USA Today. Retrieved 11 November 2015.
  6. ↑ Gilead IPO prospectus 1992 page 39
  7. ↑ Forbes Admin Gilead Sciences Board Resolution
  8. 1 2 "History of Gilead Sciences, Inc. – FundingUniverse". fundinguniverse.com.
  9. ↑ "Balms From Gilead" Washington University Magazine, Spring 1997.
  10. ↑ Gilead SEC IPO prospectus January 1992
  11. ↑ Engineering Awards 1996
  12. ↑ 1996 SEC offering prospectus
  13. ↑ page 37
  14. ↑ Washington University Magazine "Balms From Gilead", Spring 1997
  15. ↑ Forbes Magazine,"The Golden Age of Antivirals", October 27, 2003 http://www.forbes.com/global/2003/1027/090_print.html
  16. ↑ Buffett-Riordan Correspondence 1998
  17. ↑ [IPO prospectushttp://www.scribd.com/doc/176254938/Gilead-Sciences-Initial-Public-Offering-Prospectus-January-1992] January, 1992, page 7
  18. ↑ "Donald H. Rumsfeld Named Chairman of Gilead Sciences" (Press release). Gilead Sciences. 1997-01-03. Retrieved 2007-06-03.
  19. ↑ Schwartz, Nelson D. (2005-10-31). "Rumsfeld's growing stake in Tamiflu". CNN. Retrieved 2007-06-03.
  20. ↑ Pollack, Andrew (2006-07-13). "F.D.A. Backs AIDS Pill to Be Taken Once a Day". New York Times. Retrieved 2007-09-20.
  21. ↑ "U.S. Food And Drug Administration (FDA) Approves Atripla" (Press release). Gilead Sciences and Bristol-Myers Squibb. 2006-07-12. Retrieved 2007-12-15.
  22. ↑ "Gilead Sciences Completes Acquisition of Raylo Chemicals Inc." (Press release). Gilead Sciences. 2006-11-03. Retrieved 2007-06-07.
  23. ↑ Perrone, Matthew. "FDA approves first pill to help prevent HIV". Today Health. NBC News. Retrieved 16 July 2012.
  24. ↑ "Grading Pharma in 2013". Forbes. December 31, 2013.
  25. ↑ "Stocks to Watch". Barrons. January 2, 2014.
  26. ↑ "Q4 Sovaldi Sales Tracking at $53 Million". Street Insider. January 3, 2014.
  27. ↑ Sanger-katz, Margot (2014-08-02). "Critics Raise Concerns About Sovaldi". The New York Times. ISSN 0362-4331. Retrieved 2015-10-04.
  28. ↑ "Gilead Sciences to Acquire Myogen, Inc. for $2.5 Billion" (Press release). Gilead Sciences. 2006-10-02. Retrieved 2007-08-15.
  29. ↑ Pollack, Andrew (2007-06-16). "Gilead's Drug Is Approved to Treat a Rare Disease". New York Times. Retrieved 2007-06-16.
  30. ↑ "U.S. Food and Drug Administration Approves Gilead's Letairis Treatment of Pulmonary Arterial Hypertension" (Press release). Gilead Sciences. 2007-06-15. Retrieved 2007-06-16.
  31. ↑ "FDA Approves New Orphan Drug for Treatment of Pulmonary arterial hypertension" (Press release). Food and Drug Administration. 2007-06-15. Retrieved 2007-06-22.
  32. ↑ "ClinicalTrials.gov - Information on Clinical Trials and Human Research Studies: Darusentan". Retrieved 2007-08-18.
  33. ↑ "Clinical Trial: Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection". Retrieved 2007-08-18.
  34. ↑ "Gilead Invests $25 Million in Corus Pharma; Establishes Equity Position in Company With Late-Stage Product Candidate for Cystic Fibrosis" (Press release). Gilead Sciences. 2006-04-12. Retrieved 2007-08-15.
  35. ↑ "Parion Sciences and Gilead Sciences Sign Agreement to Advance Drug Candidates for Pulmonary Disease" (Press release). Gilead Sciences. 2007-08-15. Retrieved 2007-08-15.
  36. ↑ Reuters, via the New York Times. 12 March 2009. Gilead, a White Knight, to Buy CV Therapeutics
  37. ↑ "Diatos Announces Acquisition of Specialty Cancer Product DaunoXome from Gilead" (pdf) (Press release). Diatos SA. 2006-03-28. Retrieved 2007-08-13.
  38. ↑ "Gilead Sciences and NeXstar Pharmaceuticals to Merge" (Press release). Gilead Sciences, Inc. 1999-03-01. Retrieved 2007-08-13.
  39. ↑ "Gilead Sciences to Acquire Triangle Pharmaceuticals for $464 Million" (Press release). Gilead Sciences. 2004-12-04. Retrieved 2007-08-15.
  40. ↑ "Gilead Sciences to Acquire Degussa's Raylo Chemicals Inc.; Purchase to Expand Gilead's Manufacturing Scale-Up Capacity for Investigational Therapies" (Press release). Gilead Sciences. 2006-06-06. Retrieved 2007-08-15.
  41. ↑ "Gilead Sciences to Acquire Arresto Biosciences for $225 Million; Deal Adds Pipeline Candidates for Fibrotic Diseases" (Press release). Gilead Sciences. 2010-12-20. Retrieved 2011-01-15.
  42. ↑ "Gilead Sciences to Acquire Calistoga Pharmaceuticals for $375 Million; Deal Adds Pipeline Candidates in Oncology and Inflammation --" (Press release). Gilead Sciences. 2011-02-22. Retrieved 2011-02-22.
  43. ↑ "Gilead to Acquire Phenex's FXR Program for Up-to-$470M". GEN.
  44. ↑ "Gilead Boosts Cancer Pipeline With $65M EpiTherapeutics Buy". GEN.
  45. ↑ Taqi, Hadia. "How Gilead Sciences M&A Can Pan Out Next Year". www.bidnessetc.com. Bidnessetc. Retrieved 31 December 2015.
  46. ↑ N/A, Zack's Market Research. "Gilead (GILD) Collaborates with Galapagos for Filgotinib". Yahoo Finance. Yahoo/Zack's. Retrieved 31 December 2015.
  47. ↑ "Gilead - Investors - News Release".
  48. ↑ "Gilead Sciences: Nimbus Drug Acquired, Offering Cure For Fatty Liver". Parent Herald.
  49. ↑ "Drugs@FDA: FDA Approved Drug Products". Food and Drug Administration. Retrieved 2011-01-15.
  50. 1 2 Gilead Sciences (2010-03-01). "2009 Form 10-K Annual Report". SEC. Retrieved 2011-01-15.
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