FDA Reiterates Position of Complete Response LetterFOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 18, 2009--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has
received a response from the U.S. Food and Drug Administration (FDA) to
its appeal, submitted under the formal Dispute Resolution process,
regarding the Agency’s Complete Response Letter for its New Drug
Application (NDA) for aztreonam for inhalation solution. Gilead
initiated the formal Dispute Resolution process in November 2008,
following receipt of the Complete Response Letter in September 2008. In
its review under the Dispute Resolution process, the FDA reiterated its
position outlined in the Complete Response Letter, including the need
for Gilead to conduct an additional clinical study of aztreonam for
inhalation solution before the company can resubmit its NDA.
Gilead has two ongoing clinical studies evaluating aztreonam for
inhalation solution. The company has not yet discussed with the FDA
whether or not either of these studies would be sufficient to address
the FDA’s requirements or whether Gilead will need to design and conduct
a new study. The company will provide further updates once it has more
clarity regarding timelines.
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 a 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 the
risk that ongoing clinical studies will not be sufficient to address the
FDA’s requirements and the risk that the FDA may ultimately decline to
approve aztreonam for inhalation solution, even after additional data
are submitted. 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 Annual Report on Form 10-K for the year ended
December 31, 2007 and its Quarterly Report on Form 10-Q for the first,
second and third quarters of 2008, 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)
