Profile: Gilead Sciences Inc (GILD.O)
26 May 2017
Gilead Sciences, Inc., incorporated on June 22, 1987, is a research-based biopharmaceutical company that discovers, develops and commercializes medicines in areas of unmet medical need. The Company's portfolio of products and pipeline of investigational drugs includes treatments for Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS), liver diseases, cancer, inflammatory and respiratory diseases and cardiovascular conditions. Its products include AmBisome, Atripla, Cayston, Complera/Eviplera, Descovy, Emtriva, Epclusa, Genvoya, Harvoni, Hepsera, Letairis, Odefsey, Ranexa, Sovaldi, Stribild, Truvada, Tybost, Vemlidy, Viread, Vitekta and Zydelig. The Company's areas of focus include HIV; liver diseases, such as chronic hepatitis C virus (HCV) infection and chronic hepatitis B virus (HBV) infection; hematology/oncology; cardiovascular, and inflammation/respiratory diseases. The Company had operations in more than 30 countries, as of December 31, 2016.
Human Immunodeficiency Virus
The Company focuses on HIV patients to choose a single-tablet regimen that allows them to adhere to a fully suppressive course for the management of the disease. Its tenofovir alafenamide (TAF) is a targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than 0.1% that of the Company's Viread (tenofovir disoproxil fumarate (TDF)), as well as improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Its TAF-based single-tablet regimens include Genvoya (elvitegravir 150 milligrams (mg)/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg) and Odefsey for the treatment of HIV. The Company's products for HIV/AIDS patients include Descovy, Odefsey, Genvoya, Stribild, Complera/Eviplera, Atripla, Truvada, Emtriva, Tybost and Vitekta.
Descovy is an oral formulation indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age or older. Odefsey is an oral formulation dosed once a day for the treatment of HIV-1 infection in certain patients. Genvoya is an oral formulation dosed once a day for the treatment of HIV-1 infection in adults. Genvoya is a single-tablet regimen for the treatment of HIV and is a fixed-dose combination of its antiretroviral medicines, Vitekta (elvitegravir), Tybost (cobicistat), Emtriva and TAF. Stribild (elvitegravir/cobicistat/emtricitabine/TDF) is an oral formulation dosed once a day for the treatment of HIV-1 infection in treatment-naive adults. Stribild is a single-tablet regimen for the treatment of HIV and is a fixed-dose combination of its antiretroviral medications, Vitekta, Tybost, Viread and Emtriva. Complera/Eviplera (emtricitabine/rilpivirine/TDF) is an oral formulation dosed once a day for the treatment of HIV-1 infection in adults. Atripla (efavirenz/emtricitabine/TDF) is an oral formulation dosed once a day for the treatment of HIV infection in adults. Atripla is a single-tablet regimen for HIV intended as a stand-alone therapy or in combination with other antiretrovirals.
Truvada (emtricitabine/TDF) 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 two years of age and older. 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.
The Company's products for patients with liver diseases include Vemlidy, Epclusa, Harvoni, Sovaldi, Viread and Hepsera. Vemlidy is an oral formulation of a once-daily treatment of TAF for adults with HBV infection with compensated liver disease. Epclusa is an oral formulation of sofosbuvir and velpatasvir and the first pan-genotypic, single-tablet regimen for the treatment of adults with genotype 1-6 chronic infection. Epclusa is also the first single-tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. Harvoni is an oral formulation of ledipasvir and sofosbuvir dosed once a day for the treatment of genotypes 1, 4, 5 and 6, HCV/HIV-1 co-infection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis. 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 sofosbuvir 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 HBV in adults with compensated and decompensated liver disease. Hepsera (adefovir dipivoxil) is an oral formulation of a nucleotide analog polymerase inhibitor, dosed once a day to treat HBV in patients 12 years of age and older.
The Company offers Zydelig to patients with hematology/oncology diseases. Zydelig (idelalisib) is a Phosphoinositide 3-Kinase (PI3K) delta inhibitor for the treatment of certain blood cancers.
The Company's products for patients with various cardiovascular diseases include Letairis, Ranexa and Lexiscan. Letairis (ambrisentan) is an oral formulation of an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization (WHO) Group 1) in patients with WHO Class II or III symptoms. Ranexa (ranolazine) is an extended-release tablet for the treatment of chronic angina. Lexiscan (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.
The Company's products include Cayston and Tamiflu. Cayston (aztreonam for inhalation solution) is an inhaled antibiotic for the treatment of respiratory systems in cystic fibrosis 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.
The Company also offers products, including AmBisome and Macugen. 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. 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., AbbVie, Merck & Co. Inc., Bristol-Myers Squibb Company, Janssen Therapeutics, Novartis Pharmaceuticals Corporation (Novartis), Actelion Pharmaceuticals US, Inc., United Therapeutics Corporation, Pfizer, Pharmacyclics, Inc., Roche Group, Cephalon, Inc., GSK, Enzon Pharmaceuticals, Inc., Zeneus Pharma Ltd., Three Rivers Pharmaceuticals, LLC and Genpharma, S.A.
Gilead Sciences Inc
333 LAKESIDE DR
FOSTER CITY CA 94404
Company Web Links
- BRIEF-Gilead says stockholders did not approve proposal requesting board take steps to adopt policy that chairman of board be independent director
- Gilead profit falls as hepatitis C sales drop, shares down
- UPDATE 2-Gilead profit falls as hepatitis C sales drop, shares down
- Gilead net profit falls 25 percent on lower hepatitis C sales
- BRIEF-Galapagos announces new phase 2 proof-of-concept study with filgotinib