Key Developments For Gilead Sciences, Inc.
Gilead Sciences, Inc. (GILD.O) (Nasdaq)
Gilead Sciences, Inc. and GlaxoSmithKline Announce Agreement To Commercialize Viread For Chronic Hepatitis BinKey Asian Countries
Gilead Sciences, Inc. and GlaxoSmithKline announced a licensing agreement to commercialize Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B (HBV) infection in adults in five countries in Asia. The companies` combined commercialization activities will expand access to Viread for the treatment of HBV, once approved, to patients in Asia where the prevalence in most countries is greater than 8%. Under the agreement announced, Gilead will retain exclusive rights for commercialization of Viread for HBV in Hong Kong, Singapore, South Korea and Taiwan. In China, GSK will have exclusive commercialization rights and registration responsibilities for Viread for HBV. Each company will pay royalties to the other on sales of Viread for HBV in their respective Asian territories. The companies are working to expand this agreement to include Japan and other countries. The Viread agreement modifies the terms of the April 2002 licensing agreement between Gilead and GSK under which GSK received exclusive rights to Hepsera(adefovir dipivoxil), Gilead`s first hepatitis B treatment, in various territories including China, Japan, South Korea and Taiwan, as well as the right to commercialize Viread for the treatment of HBV under certain circumstances.
Graceway Pharmaceuticals Acquires Worldwide Rights To GS 9191 From Gilead Sciences, Inc.
Graceway Pharmaceuticals, LLC announced that the company has acquired from Gilead Sciences, Inc., the worldwide license, including related regulatory filings and intellectual properties, to Gilead`s investigational molecule, GS 9191, for topical use. GS 9191 is an anti-proliferative agent that works by inhibiting cellular DNA synthesis, leading to the induction of apoptosis, or programmed cell death.
Gilead Sciences, Inc. And GlaxoSmithKline plc Announce Plans For Phase IV Clinical Trial Evaluating First-Line Combination Therapy Versus Monotherapy In Pulmonary Arterial Hypertension
Gilead Sciences, Inc. announced that in collaboration with GlaxoSmithKline plc , it plans for an international, event-driven (morbidity and mortality) clinical trial to study combination therapy versus monotherapy in a first-line treatment setting for pulmonary arterial hypertension (PAH). The study, AMBITION (a randomized, double-blind, multicenter study of first-line combination therapy with AMBrIsentan and Tadalafil in subjects with pulmonary arterial hypertensION),will evaluate first-line combination use with ambrisentan, an endothelin receptor antagonist (ERA) and tadalafil, a PDE5 inhibitor, in patients with PAH. Ambrisentan is approved under the tradename Letairis (ambrisentan 5 mg and 10 mg tablets) as a once-daily treatment for PAH (WHO Group 1) in patients with WHO functional class II or III symptoms to improve exercise capacity and delay clinical worsening.
Gilead Sciences, Inc.'s Aztreonam For Inhalation Solution To Be Reviewed By FDA Anti-Infective Drugs Advisory Committee ODecember10,2009
Gilead Sciences, Inc. announced that infections due to Pseudomonas aeruginosa(P. aeruginosa) in patients with cystic fibrosis (CF), is scheduled to be reviewed by the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) on December 10, 2009.
Gilead Sciences, Inc. Raises FY 2009 Net Product Revenue Guidance-Conference Calls
Gilead Sciences, Inc. announced that for fiscal 2009, it expects net product revenues to be approximately $6.35 billion, which is higher than our previous guidance of $6.1 to $6.2 billion. The Company cited that strong financial performance for the first nine months of 2009 as the primary reason for positive guidance.
