Gilead's Aztreonam for Inhalation Solution to be Reviewed by FDA Anti-Infective Drugs Advisory Committee on December 10, 2009.
FOSTER CITY, Calif. -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that aztreonam for inhalation solution, an investigational product for the treatment of infections due to Pseudomonas aeruginosa Pseudomonas aeruginosa A normal soil inhabitant and human saprophyte that may contaminate various solutions in a hospital, causing opportunistic infection in weakened Pts Clinical Infective endocarditis in IVDAs, RTIs, UTIs, bacteremia, meningitis, 'malignant' (P. aeruginosa) in patients with cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. (CF), is scheduled to be reviewed by the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) on December 10, 2009.
In September 2009, the product was granted conditional marketing approval in Canada and Europe under the trade name Cayston([R]) (aztreonam lysine lysine (lī`sēn), organic compound, one of the 20 amino acids commonly found in animal proteins. Only the l-stereoisomer appears in mammalian protein. 75 mg powder and solvent for nebuliser solution). Applications for marketing approval of Cayston are also pending in Australia, Switzerland and Turkey.
About Aztreonam for Inhalation Solution
Aztreonam for inhalation solution is an antibiotic candidate for people with cystic fibrosis who have P. aeruginosa. Aztreonam has potent in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.
In an artificial environment outside a living organism. activity against Gram-negative bacteria such as P. aeruginosa. Aztreonam formulated with arginine arginine (är`jənĭn), organic compound, one of the 20 amino acids commonly found in animal proteins. Only the l-stereoisomer participates in the biosynthesis of proteins. is an FDA-approved agent for intravenous administration for treating various infections. Aztreonam formulated with lysine is a proprietary formulation of aztreonam developed specifically for inhalation. It has been designated with orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status in the United States and Europe.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, that are subject to risks, uncertainties and other factors, including risks related to the Anti-Infective Drugs Advisory Committee's review of aztreonam for inhalation solution. For example, the committee may determine that existing data from our ongoing clinical trials may not support the approval of aztreonam for inhalation solution in the United States, which may cause us considerable expense and may lead to further delays or cause us to abandon further development of the product in the United States. Further, Gilead may not obtain marketing approval of aztreonam lysine in Australia, Switzerland and Turkey, where applications are also pending. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the first and second quarters of 2009, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com.