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Gilead Sciences
Type Public NASDAQGILD
Founded Foster City, California (1987)
Headquarters Foster City, California
Key people John Martin, President and Chief Executive Officer
Industry Healthcare, Biotechnology, Pharmaceutical company
Products AmBisome, Atripla, Emtriva, Flolan, Hepsera, Letairis, Macugen, Tamiflu, Truvada, Viread, Vistide
Revenue US$4.23 billion (2007)[1]
Operating income US$1.62 billion (2007)[1]
Net income US$2.16 billion (2007)
Employees 2,979 (Jan. 31, 2008)
Website http://www.gilead.com

Gilead Sciences NASDAQGILD is a biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs to treat patients infected with HIV, hepatitis B or influenza. In 2006, Gilead acquired two companies that were developing drugs to treat patients with pulmonary diseases. The company has eleven commercially available products. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia. As of Jan. 31, 2008, the company had 2,979 full-time employees.[1]

The company's name and logo refer to the Balm of Gilead. Gilead (a place mentioned in the Bible) was famed for its small trees that produced a resin used in medicine. The leaf in the logo symbolizes healing, life and growth, while the shield represents safety, strength, and honor. Together they signify Gilead's efforts to use the healing power of science to create medicines that treat life-threatening diseases.

Gilead is a member of the NASDAQ Biotechnology Index and the S&P 500.

Contents

History

Gilead Sciences was originally formed under the name of "Oligogen, Inc." in August 1987 by Michael Riordan, a medical doctor who was 29 years old at the time. The name of the company was changed to "Gilead Sciences" in 1988. Riordan looked to Donald Rumsfeld as a mentor in the business world and to navigate the political waters. Under the technical leadership of scientist Mark Matteucci, the company focussed on discovery research, making small strands of DNA (oligomers) to assess the potential of genetic code blockers (gene therapy). Its development of small molecule antiviral therapeutics was ushered in by John Martin in 1992 with the licensing of nucleotide compounds discovered in two European academic labs.

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 IPO raised $86.25 million in proceeds.

In June 1996, Gilead launched its first commercial product, 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 U.S.A.

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 January 1997, Donald Rumsfeld, a Board member since 1988, was appointed Chairman of the company.[2] He stood down from the Board in January 2001 when appointed Secretary of Defense at the start of George W. Bush's first term as President. Federal disclosure forms indicate that Rumsfeld owns between USD$5 million and USD$25 million in Gilead stock. The rise in Gilead's share prices from USD$35 to USD$57 per share will have added between USD$2.5 million to USD$15.5 million to Rumsfeld's net worth.[3]

In November 2005, George W. Bush urged Congress to pass $7.1 billion in emergency funding to prepare for the possible bird flu pandemic, of which one 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 fumarate), a Gilead product.[4][5]

Gilead purchased Raylo Chemicals, Inc. in November 2006 for a price of $133.3 million.[6] 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.

Entry in 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[7], 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.[8][9][10]

Under an agreement with GlaxoSmithKline, Myogen markets Flolan (epoprostenol sodium) in the United States for the treatment of primary pulmonary hypertension. Additionally, Myogen is developing (in Phase 3 studies) darusentan[11], also an endothelin receptor antagonist, for the potential treatment of resistant hypertension.

The other acquisition was Corus Pharma. Corus' 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.[12] Gilead also obtained an inhalation formulation of two antibiotics for treatment of respiratory infections.[13]

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.[14]

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.[15] 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.[16]
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.[17]
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. €107 million This Edmonton, Alberta site will be used for process research and for manufacturing compounds for both clinical studies and commercial products.[18]
2007 Nycomed fr. Altana - Cork €34 million This commercial manufacturing site was purchased by Gilead in place of building out the site in Dublin. This site is formerly Altana in Cork which was purchased by Nycomed.
2009 CV Therapeutics, Inc. $1.4 million 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.

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 C. Martin Chief Executive Officer and Chairman
Norbert W. Bischofberger Executive Vice President, Research and Development and Chief Scientific Officer
John F. Milligan President and Chief Operating Officer
Robin Washington Senior Vice President and Chief Financial Officer
Kevin Young Executive Vice President, Commercial Operations
Gregg H. Alton Senior Vice President and General Counsel
Anthony D. Caracciolo Senior Vice President, Manufacturing and Operations
Paul Carter Senior Vice President, International Commercial Operations
Seigo Izumo Senior Vice President, Head of Cardiovascular Therapeutics
William A. Lee Senior Vice President, Head of Antiviral Therapeutics
James R. Meyers Senior Vice President, Commercial Operations, North America
A. Bruce Montgomery Senior Vice President, Head of Respiratory Therapeutics
John J. Toole Senior Vice President, Corporate Development
Taiyin Yang Senior Vice President, Pharmaceutical Development and Manufacturing
Kristen M. Metza Senior Vice President, Human Resources

Product portfolio

Gilead has 12 products on the market.

Product Portfolio
Brand Name Drug Name(s) Indication Date Approved (USA)[19] Marketing Partner(s) U.S. Patent Expiration[1] European Patent Expiration[1]
AmBisome liposomal amphotericin B fungal infection, cryptococcal meningitis, Aspergillus, Candida, Cryptococcus infections 1997-08-11 Astellas Pharma 2016 2008
Atripla tenofovir, emtricitabine, and efavirenz HIV, AIDS 2006-07-12 Bristol-Myers Squibb 2021 2018
Emtriva emtricitabine HIV, AIDS 2003-07-02   2021 2016
Flolan epoprostenol sodium pulmonary hypertension 1995-09-20 GlaxoSmithKline expired expired
Hepsera adefovir dipivoxil hepatitis B (HBV) 2002-09-20   2014 2011
Letairis ambrisentan pulmonary arterial hypertension 2007-06-15 GlaxoSmithKline 2015 2015
Macugen pegaptanib sodium solution age-related macular degeneration 2004-12-17 OSI and Pfizer 2017 2017
Tamiflu oseltamivir phosphate influenza 1999-10-27 Hoffmann–La Roche 2016 2016
Truvada emtricitabine and tenofovir HIV, AIDS 2004-08-02   2021 2018
Viread tenofovir HIV, AIDS, Hepatitis-B 2001-10-26   2017 2018
Vistide cidofovir CMV retinitis 1996-06-26 Pfizer 2010 2012

References

  1. ^ a b c d e Gilead Sciences (2008-02-27). "2007 Form 10-K Annual Report". SEC. http://www.sec.gov/Archives/edgar/data/882095/000119312508040255/d10k.htm. Retrieved 2008-06-30.  
  2. ^ Gilead Sciences (1997-01-03). "Donald H. Rumsfeld Named Chairman of Gilead Sciences". Press release. http://www.gilead.com/wt/sec/pr_933190157/. Retrieved 2007-06-03.  
  3. ^ Schwartz, Nelson D. (2005-10-31). "Rumsfeld's growing stake in Tamiflu". CNN. http://money.cnn.com/2005/10/31/news/newsmakers/fortune_rumsfeld/?cnn=yes. Retrieved 2007-06-03.  
  4. ^ Pollack, Andrew (2006-07-13). "F.D.A. Backs AIDS Pill to Be Taken Once a Day". New York Times. http://www.nytimes.com/2006/07/13/business/13drug.html. Retrieved 2007-09-20.  
  5. ^ Gilead Sciences and Bristol-Myers Squibb (2006-07-12). "U.S. Food And Drug Administration (FDA) Approves Atripla". Press release. http://www.gilead.com/pr_881419. Retrieved 2007-12-15.  
  6. ^ Gilead Sciences (2006-11-03). "Gilead Sciences Completes Acquisition of Raylo Chemicals Inc.". Press release. http://www.gilead.com/wt/sec/pr_926645. Retrieved 2007-06-07.  
  7. ^ Gilead Sciences (2006-10-02). "Gilead Sciences to Acquire Myogen, Inc. for $2.5 Billion". Press release. http://www.gilead.com/pr_910704. Retrieved 2007-08-15.  
  8. ^ Pollack, Andrew (2007-06-16). "Gilead’s Drug Is Approved to Treat a Rare Disease". New York Times. http://www.nytimes.com/2007/06/16/business/16gilead.html. Retrieved 2007-06-16.  
  9. ^ Gilead Sciences (2007-06-15). "U.S. Food and Drug Administration Approves Gilead's Letairis Treatment of Pulmonary Arterial Hypertension". Press release. http://www.gilead.com/wt/sec/pr_1016053. Retrieved 2007-06-16.  
  10. ^ Food and Drug Administration (2007-06-15). "FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension". Press release. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01653.html. Retrieved 2007-06-22.  
  11. ^ "ClinicalTrials.gov - Information on Clinical Trials and Human Research Studies: Darusentan". http://clinicaltrials.gov/ct/search?term=darusentan&submit=Search. Retrieved 2007-08-18.  
  12. ^ "Clinical Trial: Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection". http://clinicaltrials.gov/ct/show/NCT00499720. Retrieved 2007-08-18.  
  13. ^ Gilead Sciences (2006-04-12). "Gilead Invests $25 Million in Corus Pharma; Establishes Equity Position in Company With Late-Stage Product Candidate for Cystic Fibrosis". Press release. http://www.gilead.com/pr_842319. Retrieved 2007-08-15.  
  14. ^ Gilead Sciences (2007-08-15). "Parion Sciences and Gilead Sciences Sign Agreement to Advance Drug Candidates for Pulmonary Disease". Press release. http://www.gilead.com/pr_1040975. Retrieved 2007-08-15.  
  15. ^ Diatos SA (2006-03-28). "Diatos Announces Acquisition of Specialty Cancer Product DaunoXome from Gilead" (pdf). Press release. http://www.diatos.com/pdf_news/21_diatos_pr_daunoxome_deal_2006_may_11.pdf. Retrieved 2007-08-13.  
  16. ^ Gilead Sciences, Inc (1999-03-01). "Gilead Sciences and NeXstar Pharmaceuticals to Merge". Press release. http://www.gilead.com/pr_933138351. Retrieved 2007-08-13.  
  17. ^ Gilead Sciences (2004-12-04). "Gilead Sciences to Acquire Triangle Pharmaceuticals for $464 Million". Press release. http://www.gilead.com/pr_1038971547. Retrieved 2007-08-15.  
  18. ^ Gilead Sciences (2006-06-06). "Gilead Sciences to Acquire Degussa's Raylo Chemicals Inc.; Purchase to Expand Gilead's Manufacturing Scale-Up Capacity for Investigational Therapies". Press release. http://www.gilead.com/pr_869116. Retrieved 2007-08-15.  
  19. ^ "Drugs@FDA: FDA Approved Drug Products". Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Retrieved 2007-08-13.  

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