In November, Gilead announced that it had entered into a license agreement with Tibotec Pharmaceuticals (Tibotec) for the development and commercialization of a single-tablet regimen combining Tibotec’s darunavir with Gilead’s emtricitabine; the investigational agent GS 7340, a novel prodrug of tenofovir; and cobicistat.
In December, Gilead announced that it will donate 445,000 vials of AmBisome over five years to help the World Health Organization treat more than 50,000 patients with visceral leishmaniasis, a parasitic disease that is prevalent in developing world countries.
Product and Pipeline Update
Antiviral FranchiseIn October, Gilead announced that it submitted a New Drug Application (NDA) to the FDA for marketing approval of the “Quad”, a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults. Subsequently, the FDA accepted the NDA and has set a target review date of August 27, 2012 under the Prescription Drug User Fee Act. Gilead submitted the Marketing Authorisation Application (MAA) for the Quad for the treatment of HIV-1 infection in adults by the European Medicines Agency (EMA) on November 24, 2011. The application was successfully validated by EMEA on December 20, 2011. In November, Gilead announced positive five-year data from the open-label phase of two pivotal Phase 3 clinical trials (Studies 102 and 103) evaluating the efficacy of Viread for the treatment of chronic hepatitis B virus infection among primarily treatment-naïve patients. The findings were presented at the 62nd annual meeting of the American Association for the Study of Liver Diseases in San Francisco. Also in November, the European Commission granted marketing authorization for Eviplera, a complete once-daily single-tablet regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL. The authorization allowed for the commercialization of Eviplera in all 27 countries of the European Union.