Rochester,NY 6/27/2009 12:52:13 AM
GILD,European CHMP Adopts Positive Opinion for Aztreonam Lysine
Gilead Sciences Inc
AfterNoon Movers- GILD - European CHMP Adopts Positive Opinion for Aztreonam Lysine- Sourced WhisperFromWallStreet.com
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Gilead Sciences Inc.GILD
After Hours: 47.39 Down 0.49 (1.02%) 1:49PM ET
today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorisation Application for aztreonam lysine 75 mg powder and solvent for nebuliser solution (aztreonam lysine) for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 18 years and older. The opinion is for conditional approval, contingent on the successful completion of an ongoing study.
The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union. Gilead expects the European Commission to issue its decision on the marketing authorization for aztreonam lysine later this year. Aztreonam lysine was previously reviewed by the CHMP in March and received a negative opinion, which Gilead appealed.
About
Gilead Sciences, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of therapeutics for the treatment of life-threatening infectious diseases. Its products include Truvada, Viread, Atripla, and Emtriva for the treatment of human immunodeficiency virus infection in adults; Hepsera, an oral formulation for the treatment of chronic hepatitis B; AmBisome, amphotericin B liposome injection to treat serious invasive fungal infections; Flolan, an injected medication for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension; and Vistide, an antiviral medication for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS). The company also offers Tamiflu, an oral antiviral for the treatment and prevention of influenza A and B; Macugen, an intravitreal injection for the treatment of neovascular age-related macular degeneration; Letairis, an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension in patients with WHO Class II or III symptoms; and Cicletanine, which is being evaluated for the treatment of pulmonary arterial hypertension. Gilead Sciences has operations in North America, Europe, and Australia.
Last Trade: 47.37
Day's Range: 47.07 - 47.72
52wk Range: 35.60 - 57.63
Volume: 3,138,465
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