Gilead Sciences, Inc., a research-based biopharmaceutical company, discovers, develops and commercializes medicines in areas of unmet medical need. The company’s primary 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. The company has operations in approximately 30 countries worldwide. In the HIV area, the company received approval from the U.S. Food and Drug Administration (FDA) and the European Commission of Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF), a once-daily single tablet regimen for the treatment of HIV-1 infection. Two other TAF-based regimens are under evaluation by FDA and the European Medicines Agency (EMA). In the hematology/oncology area, the company submitted supplemental new drug applications to FDA and the EMA for approval of Zydelig (idelalisib) in combination with ofatumumab in previously-treated patients with chronic lymphocytic leukemia (CLL). Zydelig was originally approved in combination with rituximab for the treatment of certain patients with CLL, small lymphocytic lymphoma and follicular lymphoma, the most common type of indolent non-Hodgkin's lymphoma (iNHL). The company also advanced its research and development pipeline, with 180 active clinical studies in 2015, of which 61 were Phase 3 clinical trials. In addition to advancing treatment options across therapeutic areas, the company enabled access to its medications for people who need them around the world. During 2015, the company expanded its generic licensing agreements with its India-based manufacturing partners to include sofosbuvir (SOF)/velpatasvir (VEL), once approved, for distribution in developing countries. The company also expanded the geographic scope of its licensing agreements with its India-based manufacturing partners to include 101 developing countries. Liver Diseases In the liver diseases area, the company received approval from FDA to expand the use of Harvoni in patients with genotype 4, 5 and 6 chronic HCV infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. The company also submitted marketing applications to FDA and the EMA for the approval of a once-daily fixed-dose combination of SOF, approved as Sovaldi in 2013; and VEL, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 HCV. If approved, SOF/VEL would become the first pan-genotypic, all-oral single tablet regimen for the treatment of HCV and would complement the company’s HCV portfolio of Sovaldi and Harvoni, offering high cure rates and the potential to simplify treatment and eliminate the need for HCV genotype testing. In 2014, the company received FDA and European Commission approval of Harvoni, the first once-daily single tablet regimen for the treatment of HCV genotype 1 infected patients, the most prevalent genotype in the United States. The company received approval of Harvoni in Japan in 2015. In 2015, the company also initiated Phase 3 clinical trials evaluating the once-daily fixed-dose combination of SOF, VEL and GS-9857, an investigational NS3 protease inhibitor, for the treatment of chronic genotype 1-6 HCV. The company is evaluating TAF for the treatment of chronic HBV infection and based on data from two Phase 3 clinical trials, the company filed marketing applications to FDA and the EMA in the first quarter of 2016. The company is also conducting Phase 2 clinical trials of GS-9620, an oral TLR-7 agonist; and GS-4774, a Tarmogen 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 primary sclerosing cholangitis in Phase 2 clinical trials. The company is also evaluating GS-4977, an ASK-1 inhibitor, for NASH in Phase 2 clinical trials. The compan
gilead sciences inc (GILD:NASDAQ GS)
333 Lakeside Drive
Foster City, CA 94404
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