Profile: Gilead Sciences Inc (GILD.O)
18 Dec 2013
Gilead Sciences, Inc. (Gilead), incorporated on June 22, 1987, is a research-based biopharmaceutical company that discovers, develops and commercializes medicines. Gilead’s primary areas of focus include human immunodeficiency virus (HIV)/AIDS, liver diseases, such as hepatitis B and C and cardiovascular/metabolic and respiratory conditions. The Company has operations in North America, Europe and Asia Pacific. The Company’s products include Atripla, Truvada, Viread, Complera/Eviplera, Emtriva, Hepsera, Letairis, Ranexa, Lexiscan/Rapiscan, AmBisome, Vistide, Macugen, Cayston and Tamiflu. In January 2012, the Company acquired Pharmasset, Inc. On February 8, 2013, its subsidiary, acquired YM BioSciences Inc.
On February 17, 2012, the Company announced that the majority of HCV genotype 1 patients with a prior null response to an interferon-containing regimen enrolled in an arm of its ongoing ELECTRON study experienced viral relapse within four weeks of completing 12 weeks of treatment with GS-7977 plus ribavirin. Ten patients were randomized to this arm of the ELECTRON study and data were available for eight of the ten patients at the time of the announcement. Among these eight patients, six experienced viral relapse. Two patients had not relapsed; however, they had only reached the two week post-treatment time point. These data indicate that treatment of genotype 1 patients classified as null responders with GS-7977 plus ribavirin for 12 weeks will not be sufficient to cure their disease.
Atripla (efavirenz 600 milligrams/ emtricitabine 200 milligrams/tenofovir disoproxil fumarate 300 milligrams) is an oral formulation dosed once a day for the treatment of human immunodeficiency virus (HIV) infection in adults. It is a fixed-dose combination of its antiretroviral medications, Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine), and Bristol Myers-Squibb Company’s (BMS) non-nucleoside reverse transcriptase inhibitor, Sustiva (efavirenz). Truvada (emtricitabine and tenofovir disoproxil fumarate) is an oral formulation dosed once a day as part of combination therapy to treat HIV infection in adults. It is a fixed-dose combination of its antiretroviral medications, Viread and Emtriva. 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 patients 2 years of age and older. Viread is also approved for the treatment of chronic hepatitis B in adults.
Complera/Eviplera is an oral formulation dosed once a day for the treatment of HIV-1 infection in treatment-naive adults. The product, marketed in the United States as Complera and in Europe as Eviplera, is a single-tablet regimen for the treatment of HIV and is a fixed-dose combination of its antiretroviral medications, Viread and Emtriva, and Tibotec Pharmaceuticals’ non-nucleoside reverse transcriptase inhibitor, Edurant (rilpivirine). 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. Viread is an oral formulation of a nucleotide analog reverse transcriptase inhibitor, dosed once a day for the treatment of chronic hepatitis B in adults with compensated and decompensated liver disease.
Hepsera (adefovir dipivoxil) is an oral formulation of a nucleotide analogue polymerase inhibitor, dosed once a day to treat chronic hepatitis B in patients 12 years of age and older. It has licensed to GSK the rights to commercialize Hepsera for the treatment of chronic hepatitis B in Asia, Latin America and certain other territories. Letairis (ambrisentan) is an oral formulation of an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO Class II or III symptoms to improve exercise capacity and delay clinical worsening. The Company has sublicensed to GSK the rights to ambrisentan, marketed by GSK as Volibris (ambrisentan), for PAH in territories outside of the United States. Ranexa (ranolazine) is an extended-release tablet for the treatment of chronic angina. It has licensed to Menarini International Operations Luxembourg SA the rights to Ranexa in territories outside of the United States.
Lexiscan/Rapiscan (regadenoson) injection is indicated for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI), a test that detects and characterizes coronary artery disease, in patients unable to undergo adequate exercise stress. Astellas US LLC has rights to manufacture and sell regadenoson under the name Lexiscan in the United States. Rapidscan Pharma Solutions, Inc. (RPS) holds the right to manufacture and sell regadenoson under the name Rapiscan in Europe and certain territories outside the United States. The Company receives royalties from Astellas and RPS for sales in these territories. Cayston (aztreonam for inhalation solution) is an inhaled antibiotic as a treatment to improve respiratory systems in cystic fibrosis (CF) patients seven years of age and older with Pseudomonas aeruginosa (P. aeruginosa).
Tamiflu (oseltamivir phosphate) is an oral antiviral available in capsule form for the treatment and prevention of influenza A and B. Tamiflu is approved for the treatment of influenza in children and adults in more than 60 countries, including the United States, Japan and the European Union. Tamiflu is also approved for the prevention of influenza in children and adults in the United States, Japan and the European Union. The Company developed Tamiflu with F. Hoffmann-La Roche Ltd (together with Hoffmann-La Roche Inc., Roche). Roche has the right to manufacture and sell Tamiflu worldwide. AmBisome (amphotericin B liposome for injection) is a liposomal formulation of amphotericin B, an antifungal agent to treat invasive fungal infections caused by various fungal species in adults. Its partner, Astellas Pharma US, Inc., promotes and sells AmBisome in the United States and Canada, and the Company promotes and sells AmBisome in Europe, Australia and New Zealand. Vistide (cidofovir injection) is an antiviral injection for the treatment of cytomegalovirus retinitis in adult patients with AIDS. Macugen (pegaptanib sodium injection) is an intravitreal injection of an anti-angiogenic oligonucleotide for the treatment of neovascular age-related macular degeneration. Eyetech holds the rights to manufacture and sell Macugen in the United States, and Pfizer Inc. (Pfizer) holds the right to manufacture and sell Macugen in the rest of the world.
The Company competes with Abbott Laboratories, Inc., Boehringer Ingelheim GmbH, Merck & Co., Inc., Roche, Tibotec Pharmaceuticals, Bristol Myers-Squibb Company, Novartis Pharmaceuticals Corporation, GlaxoSmithKline Inc., Actelion Pharmaceuticals US, Inc., United Therapeutics Corporation, Pfizer Inc., Enzon Pharmaceuticals, Inc, Zeneus Pharma Ltd, Three Rivers Pharmaceuticals, LLC, Genpharma, S.A., Bausch & Lomb Incorporated, AstraZeneca PLC, Genentech, Inc. and CibaVision.
Gilead Sciences Inc
333 Lakeside Drive
FOSTER CITY CA 94404
Company Web Links
- Stellar hepatitis C data puts Gilead farther ahead of pack
- UPDATE 3-Stellar hepatitis C data puts Gilead farther ahead of pack
- Stellar hepatitis C data puts Gilead farther ahead of pack
- Gilead to seek okay for combo hepatitis C pill in Q1
- BRIEF-Gilead to submit new drug application for Sofosbuvir and Ledipasvir in Q1 2014