Gilead's New Drug Application for Ambrisentan Receives Priority Review Status
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S.
Food and Drug Administration (FDA) has accepted for filing and granted
a Priority Review for the company's New Drug Application (NDA) for
marketing approval of ambrisentan (5 mg and 10 mg) for the once-daily
treatment of pulmonary arterial hypertension (PAH).
Priority Review status is assigned to drug products that, if
approved, would be a significant improvement compared to marketed
products in the treatment, diagnosis or prevention of a disease. A
Priority Review means that the time it takes FDA to review a new drug
application is reduced. The FDA goal for reviewing a drug with
Priority Review is six months. Gilead submitted its NDA for
ambrisentan on December 18, 2006. The FDA has established a target
review date, under the Prescription Drug User Fee Act (PDUFA), of June
18, 2007.
About Ambrisentan
Ambrisentan is a non-sulfonamide, propanoic acid-class, endothelin
receptor antagonist that is selective for the endothelin type-A (ETA)
receptor. Activation of the ETA receptor by endothelin, a small
peptide hormone, leads to vasoconstriction and cell proliferation. PAH
is associated with elevated endothelin blood levels. Ambrisentan has
been granted orphan drug designation for the treatment of PAH in both
the United States and European Union.
As an investigational compound, ambrisentan has not yet been
determined safe or efficacious in humans.
GlaxoSmithKline holds rights to commercialize ambrisentan in
territories outside of the United States.
About Pulmonary Arterial Hypertension
PAH is a debilitating disease characterized by constriction of the
blood vessels in the lungs leading to high pulmonary arterial
pressures. These high pressures make it difficult for the heart to
pump blood through the lungs to be oxygenated. Patients with PAH
suffer from shortness of breath as the heart struggles to pump against
these high pressures causing such patients to ultimately die of heart
failure. PAH can occur with no known underlying cause, or it can occur
secondary to diseases such as connective tissue disease, congenital
heart defects, cirrhosis of the liver and HIV infection. PAH afflicts
approximately 200,000 patients worldwide.
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. For more information on Gilead Sciences, please
visit the company's website at www.gilead.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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 Gilead's ability to successfully commercialize this
product. For example, the FDA may not approve ambrisentan for the
treatment of PAH in the United States, and marketing approval, if
granted, may have significant limitations on its use. In addition,
future discussions with the FDA may impact the amount of data needed
and timelines for review, which may differ materially from Gilead's
current projections. 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, 2005 and Reports on Form 10-Q for the first
three quarters of 2006, 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.