March 19, 2009
European CHMP Adopts Negative Opinion on Aztreonam Lysine
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 19, 2009--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee
for Medicinal Products for Human Use (CHMP), the scientific committee of
the European Medicines Agency, has adopted a negative opinion on the
company’s Marketing Authorisation Application (MAA) for aztreonam lysine
75 mg powder and solvent for nebuliser solution (aztreonam lysine) in
the European Union. Aztreonam lysine is an investigational therapy in
development for people with cystic fibrosis who have pulmonary Pseudomonas
aeruginosa (P. aeruginosa) infection.
“We are disappointed by the Committee’s opinion, but remain committed to
advancing therapies for patients with cystic fibrosis,” said Norbert
Bischofberger, PhD, Executive Vice President, Research and Development
and Chief Scientific Officer, Gilead Sciences. “Chronic pseudomonal
airway infection is the leading cause of morbidity and mortality among
people living with cystic fibrosis, and with a limited number of
treatment choices, there remains a significant unmet medical need.”
Gilead will confer with European regulatory bodies to determine
appropriate options to address the issues outlined in the CHMP opinion.
In the United States, the U.S. Food and Drug Administration (FDA) has
informed Gilead of the need to conduct an additional clinical study
before the company can resubmit its New Drug Application. Gilead has two
ongoing clinical studies evaluating aztreonam for inhalation solution.
About Aztreonam Lysine
Aztreonam lysine 75 mg powder and solvent for nebuliser solution is an
inhaled 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 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 our ability to obtain marketing approval of aztreonam lysine
in the European Union and the United States. For example, there is the
risk that existing data from any ongoing or from any further clinical
trials that we may commence to satisfy regulatory authorities’ concerns
will not support approval of aztreonam lysine and that this may cause
Gilead to incur considerable expense, would lead to further delays or
cause the company to abandon further development of the product. There
are also risks that health authorities in other countries where
marketing authorization applications are pending will undertake similar
additional reviews which would compound the risks described above. 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, 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)
