Gilead Sciences

Template:Infobox Company

## Contents

* 1 Overview
* 2 History
* 2.1 Entry in the pulmonology therapeutic area
* 2.2 Timetable of mergers and acquisitions
* 3 Board of Directors
* 4 Senior Management
* 5 Product portfolio
* 6 References
* 7 External links

## Overview

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Gilead Sciences Template:Nasdaq is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases. 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, 2007, the company had 2,515 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.

## History

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Gilead Sciences was originally formed under the name of "Oligogen" in June 1987 by Michael Riordan, a medical doctor who was 29 years old at the time. But the name of the company was changed to "Gilead Sciences" for the incorporation 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 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.[2][3]

Gilead purchased Raylo Chemicals, Inc. in November 2006 for a price of $133.3 million.[4] 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 pulmonology therapeutic area

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In 2006, Gilead completed two acquisitions that allowed the company to branch out from its historical antiviral franchise into the pulmonology therapeutic arena.

Myogen[5], based in Boulder, Colorado, was completing Phase 3 studies of ambrisentan, an orally available endothelin receptor antagonist. The U.S. FDA subsequently approved ambrisentan for the treatment of pulmonary arterial hypertension in June 2007.[6][7][8]

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[9], also an endothelin receptor antagonist, for the potential treatment of resistant hypertension.

The second 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.[10] Gilead also obtained an inhalation formulation of two antibiotics for treatment of respiratory infections.[11]

Gilead expanded its move into pulmonology 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.[12]

### Timetable of mergers and acquisitions

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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.[13] 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.[14]
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.[15]
2006  | Corus Pharma, Inc.  | $365 million  | The acquisition of Corus and Myogen signaled Gilead's entry into the pulmonary 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.[16]

## Board of Directors

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* James M. Denny (Chairman)
* Paul Berg
* John F. Cogan
* Etienne F. Davignon
* Carla A. Hills
* John W. Madigan
* John C. Martin (CEO)
* Gordon E. Moore
* Nicholas G. Moore
* George P. Shultz (emeritus)
* Gayle Edlund Wilson

## Senior Management

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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  | President and Chief Executive Officer
Norbert W. Bischofberger  | Executive Vice President, Research and Development and Chief Scientific Officer
John F. Milligan  | Chief Operating Officer 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
Michael J. Gerber  | Senior Vice President, Clinical Research
William A. Lee  | Senior Vice President, Research
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, Clinical Research
Taiyin Yang  | Senior Vice President, Pharmaceutical Development and Manufacturing
Kristen M. Metza  | Senior Vice President, Human Resources

## Product portfolio

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Gilead has 11 products on the market.

Product Portfolio  Brand Name  | Drug Name(s)  | Indication  | Date Approved (USA)[17] | 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 |  |
Macugen® | pegaptanib sodium solution | age-related macular degeneration | 2004-12-17 | OSI and Pfizer | 2017  | 2017
Tamiflu® | oseltamivir phosphate | influenza | 1999-10-27 | Roche | 2016  | 2016
Truvada® | emtricitabine and tenofovir | HIV, AIDS | 2004-08-02 |  | 2021  | 2018
Viread® | tenofovir | HIV, AIDS | 2001-10-26 |  | 2017  | 2018
Vistide® | cidofovir | CMV retinitis | 1996-06-26 | Pfizer | 2010  | 2012

## References

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1. ↑ 1.0 1.1 1.2 Invalid `<ref>` tag; no text was provided for refs named `GILD_2006_10K`
2. ↑ Pollack, Andrew (2006-07-13). "F.D.A. Backs AIDS Pill to Be Taken Once a Day". New York Times. Retrieved 2007-09-20. Check date values in: `|date=` (help)
3. ↑ "U.S. Food And Drug Administration (FDA) Approves Atripla" (Press release). Gilead Sciences and Bristol-Myers Squibb. 2006-07-12. Retrieved 2007-06-03. Check date values in: `|date=` (help)
4. ↑ "Gilead Sciences Completes Acquisition of Raylo Chemicals Inc" (Press release). Gilead Sciences. 2006-11-03. Retrieved 2007-06-07. Check date values in: `|date=` (help)
5. ↑ "Gilead Sciences to Acquire Myogen, Inc. for $2.5 Billion" (Press release). Gilead Sciences. 2006-10-02. Retrieved 2007-08-15. Check date values in: `|date=` (help)
6. ↑ Pollack, Andrew (2007-06-16). "Gilead's Drug Is Approved to Treat a Rare Disease". New York Times. Retrieved 2007-06-16. Check date values in: `|date=` (help)
7. ↑ "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. Check date values in: `|date=` (help)
8. ↑ "FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension" (Press release). Food and Drug Administration. 2007-06-15. Retrieved 2007-06-22. Check date values in: `|date=` (help)
9. ↑ "ClinicalTrials.gov - Information on Clinical Trials and Human Research Studies: Darusentan". Retrieved 2007-08-18.
10. ↑ "Clinical Trial: Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection". Retrieved 2007-08-18.
11. ↑ "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. Check date values in: `|date=` (help)
12. ↑ "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. Check date values in: `|date=` (help)
13. ↑ "Diatos Announces Acquisition of Specialty Cancer Product DaunoXome® from Gilead" (pdf) (Press release). Diatos SA. 2006-03-28. Retrieved 2007-08-13. Check date values in: `|date=` (help)
14. ↑ "Gilead Sciences and NeXstar Pharmaceuticals to Merge" (Press release). Gilead Sciences, Inc. 1999-03-01. Retrieved 2007-08-13. Check date values in: `|date=` (help)
15. ↑ "Gilead Sciences to Acquire Triangle Pharmaceuticals for $464 Million" (Press release). Gilead Sciences. 2004-12-04. Retrieved 2007-08-15. Check date values in: `|date=` (help)
16. ↑ "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. Check date values in: `|date=` (help)
17. ↑ "Drugs@FDA: FDA Approved Drug Products". Food and Drug Administration. Retrieved 2007-08-13.

## External links

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* Gilead corporate web site
* Answers.com page on Gilead, including entry from Encyclopedia of Company Histories
* Gilead Sciences company profile from Yahoo!
* Gilead Sciences stock performance chart from GStock
* Press Release on 2005 Financial Results

de:Gilead Sciences

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