FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 26, 2009--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that aztreonam for
inhalation solution, an investigational product for the treatment of
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.
In September 2009, the product was granted conditional marketing
approval in Canada and Europe under the trade name Cayston®
(aztreonam lysine 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 activity against Gram-negative bacteria such as P.
aeruginosa. Aztreonam formulated with arginine 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 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, Gilead has operations in North America, Europe and Australia.
Forward-Looking Statement
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act 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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Susan Hubbard, 650-522-5715 (Investors)Amy
Flood, 650-522-5643 (Media)
