Gilead Sciences, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of therapeutics to advance the care of patients suffering from life-threatening diseases. The company has operations in North America, Europe and Australia.
Products
Truvada
Truvada (tenofovir disoproxil fumarate and emtricitabine) is an oral formulation dosed once a day as part of a combination therapy to treat human immunodeficiency virus (HIV) infection in adults. It is a fixed-dose combination of the company's i-HIV medications, Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine).
The company promotes Truvada in the United States through its U.S. commercial team and sells it in the United States through the wholesale channel. It promotes and sells Truvada in the European Union through its commercial team and distributors, in Australia and New Zealand through its commercial team and in certain Latin American countries through distributors. It promotes and sells Truvada in Japan through its corporate partner, Japan Tobacco, Inc. (Japan Tobacco). It has a worldwide license to patent rights and related technology for the Viread and Emtriva components of Truvada from the Institute of Organic Chemistry and Biochemistry (part of the Academy of Sciences of the Czech Republic) and Rega Stichting v.z.w. (together, IOCB/REGA) and Emory University (Emory).
Viread
Viread is an oral formulation of a nucleotide analogue reverse transcriptase inhibitor, dosed once a day as part of combination therapy to treat HIV infection in adults. The company sells Viread in the United States through its U.S. commercial team and sells it in the United States through the wholesale channel. It promotes and sells Viread in the European Union through commercial team and distributors, in Australia and New Zealand through its commercial team and in certain Latin American countries through distributors. It promotes and sells Viread in Japan through corporate partner, Japan Tobacco. The company has a worldwide license to patent rights and related technology for Viread from IOCB/REGA.
Atripla
Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) is an oral formulation dosed once a day for the treatment of HIV infection in adults. Atripla is once-daily single tablet regimen for HIV intended as a therapy or in combination with other antiretrovirals. It is a fixed-dose combination of the company’s anti-HIV medications, Viread and Emtriva, and Bristol Myers-Squibb Company’s Sustiva (efavirenz). Atripla is approved for commercial sale in the United States. The company promotes Atripla with its joint venture partner, Bristol Myers-Squibb Company (BMS), in the United States through each company’s U.S. commercial teams and sells it through its joint venture with BMS, Bristol Myers-Squibb & Gilead Sciences, LLC, in the United States through the wholesale channel. The company has a worldwide license to patent rights and related technology for the Viread and Emtriva components of Atripla from IOCB/REGA and Emory, respectively. The Sustiva component of Atripla is licensed to the joint venture by BMS.
Emtriva
Emtriva is an oral formulation of a nucleoside analogue reverse transcriptase inhibitor, dosed once a day as part of combination therapy to treat HIV infection in adults. In the United States and Europe, Emtriva is also approved as part of combination therapy to treat HIV infection in children. The company promotes Emtriva in the United States through its U.S. commercial team and sells it in the United States through the wholesale channel. It promotes and sells Emtriva in the European Union through its commercial team and distributors, in Australia and New Zealand through its commercial team and in certain Latin American countries through distributors. The company promotes and sells Emtriva in Japan through its corporate partner, Japan Tobacco. The company has a worldwide license to patent rights and related technology for Emtriva from Emory.
Hepsera
Hepsera (adefovir dipivoxil) is an oral formulation of a nucleotide analogue hepatitis B virus (HBV) DNA polymerase inhibitor, dosed once a day to treat chronic hepatitis B. Hepsera is approved for sale in the United States for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST). The company’s U.S. commercial team promotes Hepsera in the United States, and sells it in the United States through the wholesale channel. It promotes and sells Hepsera in the European Union through its commercial team and distributors and in Australia and New Zealand through its commercial team. The company has licensed the rights to commercialize Hepsera for the treatment of hepatitis B in Asia, Latin America and certain other territories to GlaxoSmithKline, Inc. (GSK), which began selling Hepsera in Japan, The Republic of Korea and Taiwan in 2004 and in China in 2005. The company has a worldwide license to patent rights and related technology for Hepsera from IOCB/REGA.
AmBisome
AmBisome (amphotericin B liposome for injection) is a proprietary liposomal formulation of amphotericin B, an antifungal agent to treat serious invasive fungal infections caused by various fungal species. The company’s corporate partner, Astellas Pharma, Inc. (Astellas), promotes and sells AmBisome in the United States and Canada, and promotes and sells AmBisome in Europe, Australia and New Zealand through its international commercial team. The company also uses various distributors to promote and sell AmBisome in Latin America, South America, Asia (other than Japan, where Dainippon Sumitomo Pharma Co., Ltd. handles promotion and distribution), India, the Mediterranean and the Middle East.
Vistide
Vistide (cidofovir injection) is an antiviral medication for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS). Vistide is approved for sale in the United States. The company promotes Vistide in the United States through its U.S. commercial team and sells it in the United States through the wholesale channel. In 25 countries outside the United States, Vistide is sold by Pfizer, Inc. (Pfizer).
Flolan
Flolan (epoprostenol sodium) is an injected medication for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in New York Heart Association class III and class IV patients who do not respond to conventional therapy.
In November 2006, the company entered into a license agreement and a distribution and supply agreement with GSK under which it has rights to market, promote and distribute Flolan and the sterile diluent for Flolan in the United States until April 2009.
Other Royalty Sources
Tamiflu
Tamiflu (oseltamivir phosphate) is an oral antiviral available in capsule form for the treatment and prevention of influenza A and B. Tamiflu is in a class of prescription drugs called neuraminidase inhibitors. Tamiflu is approved for the treatment of influenza in children and adults in approximately 60 countries, including the United States, Japan and the European Union and is approved for the prevention of influenza in children and adults in the United States, Japan and the European Union. The company has developed Tamiflu with F. Hoffmann-La Roche, Ltd (together with Hoffmann-La Roche, Inc., Roche), and Roche has the right to manufacture, by itself or through third parties, and sell Tamiflu worldwide.
Macugen
Macugen (pegaptanib sodium injection) is an intravitreal injection of an anti-angiogenic oligonucleotide for the treatment of neovascular age-related macular degeneration. Macugen was approved by the U.S. Food and Drug Administration (FDA) in the United States in 2004, and sales commenced in January 2005. In February 2006, the product received marketing approval for sale in the European Union. Macugen was developed by OSI Pharmaceuticals, Inc. (OSI) using technology licensed from the company and is promoted in the United States by OSI and Pfizer. OSI holds the rights to manufacture and sell Macugen worldwide.
DaunoXome
DaunoXome (liposomal daunorubicin injection) is a liposomal formulation of the anticancer agent daunorubicin. It is approved for sale in the United States, Europe and certain other countries for the treatment of AIDS-related Kaposi’s sarcoma. In March 2006, the company licensed worldwide rights to sell DaunoXome to Diatos S.A. (Diatos).
Acquisitions
In August 2006, the company acquired Corus Pharma, Inc. (Corus), a company engaged in drug discovery related to respiratory and infectious diseases. Corus’s primary product candidate, aztreonam lysine for inhalation, is an inhaled antibiotic with activity against Gram-negative bacteria, including Pseudomonas aeruginosa, which can cause lung infections in patients with cystic fibrosis (CF).
In November 2006, the company acquired Myogen, Inc. Myogen engages primarily in drug discovery related to cardiopulmonary disease and other cardiovascular disorders. Myogen’s primary product candidate, ambrisentan, is an endothelin receptor antagonist for the potential treatment of pulmonary arterial hypertension (PAH).
Collaborative Relationships
Commercial Collaborations
Emory University (Emory): The company has worldwide license to all of Emory’s rights to purified forms of emtricitabine for use in the HIV and HBV indications.
Bristol-Myers Squibb Company (BMS): The company has a collaboration with BMS to develop and commercialize the single tablet regimen of its Truvada and BMS’s Sustiva in the United States. This combination was approved for use in the United States in July 2006 and is sold under the name Atripla. The company and BMS structured this collaboration as a joint venture by forming a limited liability company called Bristol-Myers Squibb & Gilead Sciences, LLC. In September 2006, the company and BMS amended the joint venture’s collaboration agreement to allow the joint venture to sell Atripla into Canada.
GlaxoSmithKline Inc. (GSK): In March 2006, Myogen entered into a license and a distribution and supply agreement with GSK under which the company has rights to market, promote and distribute Flolan and the sterile diluent for Flolan in the United States until April 2009. Myogen commenced distribution activities of Flolan in the United States under the distribution and supply agreement in April 2006.
The company has a licensing agreement with GSK providing GSK the right to commercialize Hepsera solely for the treatment of chronic hepatitis B in Asia, Latin America and certain other territories, the most significant of which include China, Japan, The Republic of Korea and Taiwan. Under the agreement, the company retained rights to Hepsera in the United States, Canada, Europe, Australia, New Zealand and Turkey. GSK has full responsibility for development and commercialization of Hepsera for the treatment of hepatitis B in its territories.
University License Equity Holdings, Inc. (ULEHI): The company has an ongoing collaborative arrangement with ULEHI for the University of Colorado at Boulder, relating to the identification of aptamers, oligonucleotides with diagnostic or therapeutic applications, using its SELEX technology. Under this arrangement, ULEHI has granted the company all of its rights to inventions covered by patents and patent applications for SELEX technology, improvements to the SELEX technology it makes or discovers, oligonucleotides or other molecules it makes using SELEX technology and computer software related to its SELEX technology.
Developing World Collaborations
International Partnership for Microbicides (IPM) and CONRAD: In December 2006, the company entered into an agreement under which it granted rights to IPM and CONRAD, a cooperating agency of U.S. Agency for International Development (USAID) committed to improving reproductive health to develop, manufacture for distribution in resource-limited countries of tenofovir as a microbicide to prevent infection with HIV.
Merck: In August 2006, the company entered into an agreement with an affiliate of Merck pursuant to which the company is working with Merck to provide Atripla to HIV-infected patients in developing countries in Africa, the Caribbean, Latin America and Southeast Asia. Under the agreement, the company would manufacture Atripla using efavirenz supplied by Merck, and Merck would handle distribution of the product in the countries covered by the agreement.
Generic Licenses: In 2006, the company entered into license agreements with eleven Indian generic manufacturers, granting them the rights to produce and distribute generic versions of tenofovir to 95 low-income countries around the world, which included India and various countries.
Aspen Pharmacare: In 2005, the company entered into a manufacture and distribution agreement with Aspen Pharmacare, providing for the manufacture and distribution of Viread and Truvada to certain developing world countries included in its Gilead Access Program.
Research Collaborations
Japan Tobacco: In March 2005, the company entered into a licensing agreement with Japan Tobacco, under which Japan Tobacco granted it rights to develop and commercialize a novel HIV integrase inhibitor, GS 9137 (also known as JTK-303), in all countries of the world, excluding Japan, where Japan Tobacco would retain such rights.
Genelabs Technologies, Inc. (Genelabs): The company entered into a license and research collaboration agreement with Genelabs to research, develop and commercialize certain of Genelabs’s novel nucleoside inhibitors of HCV polymerase for the treatment of chronic infection caused by HCV.
Novartis Vaccines and Diagnostics, Inc. (Novartis Vaccines): The company entered into a licensing agreement with Novartis Vaccines for the research, development and commercialization of small molecule therapeutics against selected HCV drug targets. Under the agreement, the company received rights to use Novartis Vaccines’s HCV technology to develop and commercialize products for the treatment of HCV.
GlaxoSmithKline (GSK). In 2006, Myogen entered into a license agreement with GSK under which GSK received a sublicense to its rights to ambrisentan for certain hypertensive conditions in territories outside of the United States.
Novartis Institutes for BioMedical Research, Inc. (Novartis Institutes): Myogen entered into a research collaboration with Novartis Institutes for the discovery and development of novel drugs for the treatment of cardiovascular disease.
Abbott Laboratories, Inc. (Abbott): Myogen entered into a license agreement with Abbott. In December 2006, the company filed an NDA with the FDA for the treatment of PAH with ambrisentan. In March 2006, Myogen licensed rights to commercialize ambrisentan in all territories outside of the United States to GSK.
Myogen entered into a worldwide license agreement with Abbott to develop and commercialize darusentan for all conditions except oncology.
University of Texas System: Myogen entered into a license agreement with the University of Texas System, providing the company rights to certain patents and technology related to cardiac hypertrophy and heart failure.
International Operations
The company has U.S. and international commercial sales operations, with marketing subsidiaries in Australia, Austria, Belgium, Canada, France, Germany, Greece, Ireland, Italy, the Netherlands, New Zealand, Portugal, Spain, Switzerland, Turkey, the United Kingdom and the United States.
Competition
HIV Products: The company’s HIV products primarily competes with the fixed-dose combination products in the nucleotide/nucleoside reverse transcriptase inhibitors (NRTI) class, including Combivir (lamivudine and zidovudine); Epzicom (abacavir and lamivudine) and Trizivir (abacavir/lamivudine/zidovudine), each sold by GSK. Other companies with HIV products competing in the NRTI class include BMS and Roche. The company’s HIV products also compete with Boehringer Ingelheim GmbH, Merck, Abbott Laboratories, Inc. and Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.
AmBisome: The company’s competitors include Pfizer, Merck, Enzon Pharmaceuticals, Inc., Zeneus Pharma, Ltd., Three Rivers Pharmaceuticals, LLC, Genpharma, S.A., BMS, and PROEL Pharmaceuticals.
Hepsera: The company’s competitors include BMS, Novartis Pharmaceuticals Corporation (Novartis), Idenix Pharmaceuticals Limited (Idenix), GSK, Valeant Pharmaceuticals International, Schering Plough Corporation, and Roche.
Vistide: The company’s competitors include Roche, Bausch & Lomb Incorporated, AstraZeneca PLC and CibaVision.
Tamiflu: The company’s competitors include GSK and BioCryst Pharmaceuticals, Inc.
Macugen: The company’s competitors include Novartis and Genentech, Inc.
Flolan: The company’s competitors include the United Therapeutics Corporation in the United States and Actelion, Ltd.
History
Gilead Sciences, Inc. was incorporated in 1987.
