Gilead Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for CF

Sept. 16, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) announced that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for aztreonam lysine for inhalation, an investigational therapy in development for people with cystic fibrosis who have Pseudomonas aeruginosa (P. aeruginosa).

In this letter, the FDA informed Gilead that the review of the company's NDA has been completed. The agency stated that they cannot approve the application in its current form and an additional clinical study will be required. Gilead will continue its dialogue with the FDA to determine whether further analyses of existing data could lead to approval, or whether the company will need to conduct the additional study as stated in the letter... Gilead Sciences' Press Release -

Gilead : Interim 12-Month Phase III Study Results for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis

Jun 13, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) announced results from an interim analysis of 12-month data from its open-label, Phase III AIR-CF3 (006) study of aztreonam lysine for inhalation, an investigational therapy in development for the treatment of people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa). AIR-CF3 is an ongoing, multi-center study designed to evaluate the safety of repeated exposure to aztreonam lysine in cystic fibrosis patients who originally participated in the pivotal Phase III AIR-CF1 (007) or AIR-CF2 (005) studies... Gilead's Press Release -

Gilead : Letairis (ambrisentan) Phase IV Program

May 1, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) announced the initiation of ATHENA-1, a Phase IV, randomized, double-blind, placebo-controlled study evaluating Letairis(R) (ambrisentan 5 mg and 10 mg tablets) in patients with pulmonary arterial hypertension (PAH) demonstrating a sub-optimal response to sildenafil monotherapy. ATHENA-1 is the first of several Phase IV Letairis studies Gilead plans to initiate in 2008 and 2009. Letairis is currently approved 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' Press Release -

Gilead, Aztreonam Lysine 75 mg Powder for Nebuliser Solution, a Potential New Treatment for Cystic Fibrosis

Mar 07, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) announced the submission of a Marketing Authorisation Application (MAA) for marketing approval of aztreonam lysine 75 mg powder for nebuliser solution (aztreonam lysine) in the European Union. The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), subject to validation by the European Medicines Agency (EMEA). Review of the MAA will be conducted by the EMEA under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all member states of the European Union. Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. Aztreonam lysine 75 mg powder for nebuliser solution is administered using an eFlow(R) Nebuliser (PARI GmbH)... Gilead Sciences' Press Release -

Gilead and LG Life Sciences, Global License Agreement to Advance Novel Drug Candidates for Treatment of Fibrotic Diseases

Nov. 6, 2007- ...Caspases are cellular proteases involved in processes such as apoptosis (cell death) and inflammation. By inhibiting various caspases, it may be possible to slow or stop the progression of fibrosis in the liver for patients with chronic viral hepatitis and non-alcoholic steatohepatitis (NASH), as well as potentially in other fibrotic diseases such as idiopathic pulmonary fibrosis (IPF)... Gilead's Press Release - LG Life Sciences' Press Release -

Gilead, Phase III Study of Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis

Oct. 4, 2007--Gilead Sciences, Inc. (Nasdaq:GILD) announced detailed results of its Phase III AIR-CF1 (CP-AI-007) study of aztreonam lysine for inhalation, an investigational therapy in development for the treatment of people with cystic fibrosis* (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa). In this study, a 28-day treatment course of aztreonam lysine improved respiratory symptoms as assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a patient-reported outcome (PRO) tool. Aztreonam lysine also improved pulmonary function in this study, as measured by relative improvement of forced expiratory volume in one second (FEV1), a standard measure of lung function... Gilead's Press Release -