European CHMP Adopts Positive Opinion for Aztreonam Lysine
June 26 2009 - 8:30AM
Business Wire
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 Gilead appealed.
�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.
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 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 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.
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