Gilead Sciences, Inc (
GILD) is awaiting the outcome of the Anti-Infective Drugs Advisory Committee of the US Food and Drug Administration (FDA) scheduled on December 10, 2009. The committee will review Gilead ’s aztreonam for inhalation solution, an investigational product for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF). Earlier, in September 2008, the drug was denied approval by the FDA, which then asked Gilead to resubmit the application with more data.
In September 2009, the drug received conditional marketing approval in Canada and Europe under the trade name Cayston (aztreonam lysine 75 mg powder and solvent for nebuliser solution). Gilead plans to make the product available in Germany and the UK in early 2010. Aztreonam formulated with lysine is a proprietary formulation of aztreonam developed specifically for inhalation, which has orphan drug status in the US and Europe . Applications for marketing approval of Cayston are pending in Australia , Switzerland and Turkey .
CF is a chronic, debilitating genetic disease that affects the respiratory and digestive systems of approximately 70,000 people worldwide, including 35,000 people in the European Union. Cayston was granted conditional marketing authorization to address the unmet medical need of the CF patients. A decision regarding full marketing authorization will be based on the completion of the ongoing phase III study examining the efficacy and safety of Cayston compared to
Novartis’ (
NVS) tobramycin inhalation solution (TOBI) in CF patients with pulmonary P. aeruginosa.
During the third quarter conference call, Gilead stated that it expects to complete enrollment by the year end and make the data available towards the middle of next year. We believe positive data from this study will help it to receive approval from the regulatory authorities in both US and Europe . We have a Neutral recommendation on the stock.
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out-quarter doesn't seem to be impressing investors today, as shares are down 3%.
