Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Encysive Pharmaceuticals (ENCY) -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (163)	12/19/2006 12:57:35 PM
From: tuck	Respond to of 205

>>Gilead Submits New Drug Application To U.S. FDA for Ambrisentan for the Treatment of Pulmonary Arterial Hypertension Monday December 18, 4:15 pm ET FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD - News) 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.<< snip As I've said, I don't expect GILD's regulatory road to be entirely smooth. This may give me another chance to pick some ENCY cheap, if it reacts anything like CBST aparently did to the THRX NDA. Edit: I see they're going for both doses, which is a good selling point. Shouldn't be surprised, as liver tox at the 10mg dose never seemed to reach the tipping point. Cheers, Tuck