June 26, 2009
European CHMP Adopts Positive Opinion for Aztreonam Lysine
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 26, 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 positive opinion on the
company’s Marketing Authorisation Application for aztreonam lysine 75 mg
powder and solvent for nebuliser solution (aztreonam lysine) for the
suppressive therapy of chronic pulmonary infections due to Pseudomonas
aeruginosa in patients with cystic fibrosis (CF) aged 18 years and
older. The opinion is for conditional approval, contingent on the
successful completion of an ongoing study.
The CHMP's positive recommendation will be reviewed by the European
Commission, which has the authority to approve medicinal products for
use in the 27 countries of the European Union. Gilead expects the
European Commission to issue its decision on the marketing authorization
for aztreonam lysine later this year. Aztreonam lysine was previously
reviewed by the CHMP in March and received a negative opinion, which
“We are pleased that the CHMP has recognized the potential therapeutic
benefit of aztreonam lysine in addressing chronic pseudomonal airway
infection – the single greatest cause of morbidity and mortality for
people with cystic fibrosis,” said Norbert Bischofberger, PhD, Executive
Vice President, Research and Development and Chief Scientific Officer,
Gilead Sciences. “We look forward to delivering this new therapeutic
option to patients in the European Union as quickly as possible.”
Gilead has also submitted applications for marketing approval of
aztreonam lysine in Australia, Canada, Switzerland and Turkey. 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 the product among patients with CF.
About Cystic Fibrosis
Today, more than 70,000 people worldwide have cystic fibrosis. Cystic
fibrosis is a chronic, debilitating genetic disease. A major
characteristic of cystic fibrosis is production of abnormally thick,
sticky mucus in the lungs that traps bacteria and predisposes people
with cystic fibrosis to lung infections. Currently, there is no known
cure for cystic fibrosis, and the goal of cystic fibrosis therapy is to
control symptoms and prevent further lung damage.
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 formulated with arginine (Azactam®) is an
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.
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
uncertainty of when the European Commission will issue its decision on
the marketing approval of aztreonam lysine. In addition, the CHMP’s
positive opinion is contingent on the successful completion of an
ongoing study, and there is the risk that safety issues may arise or the
results from the clinical study may be otherwise inadequate to support
regulatory approval of the product. Further, existing data from any
ongoing clinical trials or any additional clinical trial that we may
commence to satisfy FDA concerns may not support the approval of
aztreonam lysine 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. 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 quarter ended March 31, 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
For more information on Gilead, please call the Gilead Public Affairs
1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Flood, 650-522-5643 (Media)