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Profile: Gilead Sciences Inc (GILD.O)

GILD.O on Nasdaq

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23 Sep 2016
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Gilead Sciences, Inc., incorporated on June 22, 1987, is a research-based biopharmaceutical company. The Company focuses on the discovery, development and commercialization of medicines in areas of unmet medical need. The Company's principal areas of focus include human immunodeficiency virus (HIV), liver diseases, such as chronic hepatitis C virus (HCV) infection and chronic hepatitis B virus (HBV) infection, cardiovascular, hematology/oncology and inflammation/respiratory. Its Nimbus Apollo program includes the candidate NDI-010976, a hepatotropic allosteric Acetyl-CoA Carboxylase (ACC) inhibitor, and other preclinical ACC inhibitors for the treatment of non-alcoholic steatohepatitis (NASH), and for the treatment of hepatocellular carcinoma (HCC) and other diseases. Its Nimbus Apollo program is a Phase II ready clinical program for NDI-010976 and related metabolic and liver diseases.

Human Immunodeficiency Virus

The Company's HIV products include Genvoya, Stribild, Complera/Eviplera, Atripla, Truvada, Viread, Emtriva, Tybost and Vitekta. Genvoya is an oral formulation dosed once a day for the treatment of HIV-1 infection in adults. Genvoya is a fixed-dose combination of its antiretroviral medicines, Vitekta (elvitegravir), Tybost (cobicistat), Emtriva (emtricitabine) and tenofovir alafenamide (TAF). Stribild is an oral formulation dosed once a day for the treatment of HIV-1 infection in treatment-naive adults. Stribild is a fixed-dose combination of its antiretroviral medications, Vitekta, Tybost, Viread and Emtriva. Complera/Eviplera is an oral formulation dosed once a day for the treatment of HIV-1 infection in adults. Complera/Eviplera is a fixed-dose combination of its antiretroviral medications, Viread and Emtriva, and Janssen's non-nucleoside reverse transcriptase inhibitor, Edurant (rilpivirine). Atripla is an oral formulation dosed once a day for the treatment of HIV infection in adults. Atripla is a fixed-dose combination of the Company's antiretroviral medications, Viread and Emtriva, and Bristol-Myers Squibb Company's (BMS's) 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 analog reverse transcriptase inhibitor, dosed once a day as part of combination therapy to treat HIV infection in patients of over two years of age and older. The European Commission approved the use of Viread in combination with other antiretroviral agents for the treatment of HIV-1 infected adolescent patients aged 2 to less than 18 years with nucleoside reverse transcriptase inhibitor resistance or toxicities precluding the use of first-line pediatric agents. Emtriva is an oral formulation of a nucleoside analog 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 available as an oral solution approved as part of combination therapy to treat HIV infection in children. Tybost is a pharmacokinetic enhancer dosed once a day that boosts blood levels of certain HIV medicines. Tybost is indicated as a boosting agent for the HIV protease inhibitors atazanavir and darunavir as part of antiretroviral combination therapy in adults with HIV-1 infection. Vitekta is an oral formulation of an integrase inhibitor, dosed once a day as part of combination therapy to treat HIV infection in adults without known mutations associated with resistance to elvitegravir, the active ingredient of Vitekta. Vitekta is indicated for use as part of HIV treatment regimens that include a ritonavir-boosted protease inhibitor. In addition, the Company is investigating over two additional TAF-based single tablet regimens; TAF, emtricitabine and GS-9883, its integrase inhibitor, which is in Phase III clinical studies, and TAF, emtricitabine, cobicistat and Janssen's darunavir (D/C/F/TAF), which is being developed and commercialized by Janssen.

Liver Diseases

The Company's liver diseases products include Harvoni, Sovaldi, Viread and Hepsera. Harvoni is an oral formulation of the nonstructural 5A (NS5A) inhibitor with a nucleotide analog polymerase inhibitor dosed once a day for the treatment of HCV genotype 1 infection in adults. In Europe, Harvoni is also indicated for certain patients with HCV genotype 4 infection, HCV genotype 3 infection with cirrhosis and/or prior treatment failure and those with HCV/HIV-1 co-infection. Sovaldi is an oral formulation of a nucleotide analog polymerase inhibitor dosed once a day for the treatment of HCV as a component of a combination antiviral treatment regimen. Viread is an oral formulation of a nucleotide analog reverse transcriptase inhibitor, dosed once a day for the treatment of chronic HBV in adults with compensated and decompensated liver disease. The Company licensed to GlaxoSmithKline Inc. (GSK) the rights to commercialize Viread for the treatment of chronic HBV in China, Japan and Saudi Arabia. The European Commission approved the use of Viread for the treatment of chronic HBV infection in adolescent patients aged 12 to less than 18 years with compensated liver disease and evidence of immune active disease. Hepsera (adefovir dipivoxil) is an oral formulation of a nucleotide analog polymerase inhibitor, dosed once a day to treat chronic HBV in patients of over 10 years of age and older. The Company licensed to GlaxoSmithKline Inc. (GSK) the rights to commercialize Hepsera for the treatment of chronic HBV in Asia Pacific, Latin America and certain other territories. The Company initiated Phase III clinical trials evaluating the once-daily fixed-dose combination of sofosbuvir (SOF), velpatasvir (VEL) and GS-9857, an investigational NS3 protease inhibitor, for the treatment of chronic genotype 1-6 HCV. It is evaluating TAF for the treatment of chronic HBV infection and based on data from Phase III clinical trials. It is also conducting Phase II clinical trials of GS-9620, an oral TLR-7 agonist, and GS-4774, a Tarmogen thymus (T) cell immunity stimulator, for the treatment of HBV. The Company is evaluating simtuzumab, a monoclonal antibody, for the treatment of nonalcoholic steatohepatitis (NASH) and sclerosing cholangitis in Phase II clinical trials. It is also evaluating GS-4977, an ASK-1 inhibitor, for NASH in Phase II clinical trials. It is also evaluating GS-9674, a FXR Agonist, for NASH in Phase I clinical trials.

Cardiovascular

The Company's cardiovascular products include Letairis, Ranexa and Lexiscan/Rapiscan. Letairis (ambrisentan) is an oral formulation of an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH) in patients with World Health Organization (WHO) Class II or III symptoms to improve exercise capacity and delay clinical worsening. It 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. The Company 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 (Astellas) 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. Eleclazine, formerly GS-6615, a late sodium channel inhibitor, is being evaluated in Phase III clinical trials for the treatment of Long QT-3 Syndrome. Eleclazine is also being evaluated in Phase II clinical trials for the treatment of hypertrophic cardiomyopathy and ventricular tachycardia/ventricular fibrillation. It is also evaluating GS-4977, an ASK-1 inhibitor, for pulmonary arterial hypertension in Phase II clinical trials.

Hematology/Oncology

The Company oncology product is Zydelig, which is a PI3K delta inhibitor for the treatment of certain blood cancers. The Company initiated Phase III clinical trials evaluating GS-5745, a MMP9 mAb inhibitor, for the treatment of gastric cancer. It is also conducting Phase III clinical trials evaluating momelotinib for the treatment of myleofibrosis and pancreatic cancer.

Respiratory

The Company's respiratory products include Cayston and Tamiflu. Cayston (aztreonam for inhalation solution) is an inhaled antibiotic for the treatment of respiratory systems in cystic fibrosis (CF) patients approximately 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 over 60 countries, including the United States, Japan and the European Union. Its Presatovir, a fusion inhibitor, is in Phase II clinical trials for the treatment of respiratory syncytial virus. The Company is evaluating GS-5745, a MMP9 mAb inhibitor, in Phase II clinical trials for ulcerative colitis and Crohn's disease. It is evaluating Filgotinib, a JAK1 inhibitor, in Phase II clinical trials for rheumatoid arthritis and Crohn's disease.

Other

The Company's other products include AmBisome and Macugen. AmBisome (amphotericin B liposome for injection) is a liposomal formulation of amphotericin B, an antifungal agent to treat serious invasive fungal infections caused by various fungal species in adults. Macugen (pegaptanib sodium injection) is an intravitreal injection of an anti-angiogenic oligonucleotide for the treatment of neovascular age-related macular degeneration.

The Company competes with ViiV Healthcare, AbbVie Inc., Merck & Co. Inc., Bristol-Myers Squibb Company, Janssen Therapeutics, Novartis Pharmaceuticals Corporation, Actelion Pharmaceuticals US, Inc., United Therapeutics Corporation, Pfizer Inc., Pharmacyclics, Inc., Roche Group, Cephalon, Inc., GlaxoSmithKline, Enzon Pharmaceuticals, Inc., Zeneus Pharma Ltd., Three Rivers Pharmaceuticals, LLC and Genpharma, S.A.

Company Address

Gilead Sciences Inc

333 LAKESIDE DR
FOSTER CITY   CA   94404
P: +1650.5743000
F: +1650.5789264

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