Message #120 From:
NewsBot Date: December 18, 2006 01:15:00 PM
GILD News Gilead Submits New Drug Application To U.S. FDA for Ambrisentan for the Treatment of Pulmonary Arterial Hypertension
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD) today announced the submission of a
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for marketing approval of ambrisentan (5 mg and 10 mg) for the
once-daily treatment of pulmonary arterial hypertension (PAH). The
application is supported by data from two Phase III clinical studies
(ARIES-1 and ARIES-2) and three Phase II studies in patients with PAH.
“Current therapeutic options are limited, and
there remains an urgent need for safe and effective treatments for
patients with PAH,” said John C. Martin, PhD,
President and CEO, Gilead Sciences. “The
achievement of today’s milestone reflects the
tremendous dedication of numerous clinical investigators and other
research collaborators, all of whom share our goal of advancing new
treatment options for patients suffering from PAH. This is also a
testament to our Colorado-based team, who designed and managed the
clinical development program for ambrisentan and whose efforts led to
the completion of this new drug application.”
About ARIES Pivotal Trials
In the two ARIES clinical trials, patients were randomized in a blinded
fashion to receive placebo or one of two doses of ambrisentan. The
trials were of identical design except for the doses of ambrisentan
studied and the geographic locations of the investigative sites. Both
trials were designed to enroll 186 patients (62 patients per dose
group). ARIES-1 evaluated once-daily doses of 5 mg and 10 mg of
ambrisentan. ARIES-2 evaluated once-daily doses of 2.5 mg and 5 mg of
ambrisentan. ARIES-1 enrolled 202 patients primarily in the United
States while ARIES-2 enrolled 192 patients primarily in Europe.
Approximately 400 patients from these and other studies are continuing
ambrisentan treatment in long-term clinical trials.
About Ambrisentan
Ambrisentan is a non-sulfonamide, propanoic acid-class, endothelin
receptor antagonist that is selective for the endothelin type-A (ETa)
receptor. Endothelin is a small peptide hormone that plays a critical
role in the control of blood flow and cell growth. Elevated endothelin
blood levels are associated with PAH. Ambrisentan has been granted
orphan drug designation for the treatment of PAH in both the United
States and European Union.
Ambrisentan is an investigational compound and has not yet been
determined safe or efficacious in humans.
Gilead acquired the U.S. rights to ambrisentan when it completed its
acquisition of Myogen, Inc. on November 17, 2006. GlaxoSmithKline holds
rights to commercialize ambrisentan 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 develop and commercialize this product.
For example, ambrisentan may not be approved for the doses Gilead is
seeking, the safety and efficacy data from additional clinical studies
may not warrant further development of this compound and initiating and
completing clinical trials may take longer or cost more than expected.
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 the Gilead
Annual Report on Form 10-K for the year ended December 31, 2005, 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.
