Epix Pharmaceuticals (MM) (NASDAQ:EPIXD)
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EPIX Pharmaceuticals, Inc. (NASDAQ: EPIXD) today
announced that it has received a letter from the U.S. Food and Drug
Administration (FDA) denying EPIX's formal appeal to approve its novel
blood-pool imaging agent Vasovist(TM) (gadofosveset trisodium) and
turning down EPIX's request for an Advisory Committee to review
Vasovist. In its response letter, the Office of New Drugs (OND) of the
FDA also suggested that if EPIX decides to conduct additional clinical
research to support approval, then rather than relying on a blinded
re-read of previously submitted data and data from a new clinical
trial, a safer course of action would be to conduct two new clinical
trials to support the application for approval. EPIX submitted the
appeal to the OND on June 30, 2006 in response to two prior approvable
letters for Vasovist.
"We are disappointed by the Agency's action. We are evaluating
several options available to us as next steps with Vasovist in the
United States, including the option to appeal this decision to the
next level at the FDA, and will update the market accordingly," said
Andrew Uprichard, M.D., president of EPIX Pharmaceuticals.
Dr. Uprichard added, "We remain committed to bringing Vasovist to
market in the United States. Vasovist was approved throughout the
European Union late last year and is already being marketed in several
countries within Europe. Vasovist was also recently recommended for
approval in Australia."
About Vasovist(TM)
Vasovist is an injectable intravascular contrast agent designed to
provide visual imaging of the vascular system through magnetic
resonance angiography. EPIX's initial target indication for Vasovist
is for use in magnetic resonance angiography imaging of non-coronary
vascular disease. In October 2005, the European Medicines Agency
granted marketing approval of Vasovist for all 25 member states of the
European Union. Vasovist has also been approved in Switzerland and
recommended for approval in Australia.
Vasovist has been studied in 18 clinical trials totaling more than
1,400 patients. The clinical trials were conducted to determine
comparability of Vasovist MRA to conventional catheter-based X-ray
angiography for the identification and characterization of vascular
stenosis. The studies included evaluation of a single bolus injection
of Vasovist for diagnosis of non-coronary vascular disease in the
aortoiliac, renal and pedal arteries.
About EPIX
EPIX Pharmaceuticals is a biopharmaceutical company focused on
discovering, developing and commercializing novel pharmaceutical
products through the use of proprietary technology to better diagnose,
treat and manage patients. The company has a blood-pool imaging agent
approved and marketed in Europe (Vasovist(TM)), and five
internally-discovered drug candidates currently in clinical trials
targeting conditions such as anxiety, depression, Alzheimer's disease,
cardiovascular disease and obesity. These drug candidates include
PRX-00023 in Phase 3 clinical development for generalized anxiety
disorder, PRX-08066 in Phase 2 clinical development for pulmonary
hypertension associated with chronic obstructive pulmonary disease,
and PRX-03140, which has completed a Phase 1b clinical trial in
Alzheimer's patients. EPIX also has collaborations with leading
organizations, including Amgen, Cystic Fibrosis Foundation
Therapeutics, and Schering AG (Germany). For more information about
EPIX, please visit the company's website at www.epixpharma.com.