Epix Achieves Positive Results for Vasovist

Epix Pharmaceuticals is an Israeli biopharmaceutical established in 2000 that discovers and develops novel therapeutics using its proprietary in silico drug delivery platform. According to a press release, the company has “achieved positive results from the blinded, independent re-read of images of its novel blood pool MRA agent, Vasovist.” Previous re-read of images from phase III trials met FDA specifications and the company now plans to resubmit a new application (NDA) to the FDA in mid-2008. Vasovist is approved for marketing in 33 countries.

“There are currently no contrast agents approved in the United States for use with MRA, a non-invasive modality for imaging blood vessels. However, it is estimated that approximately 1.5 million MRAs will be conducted in the United States during 2008 using gadolinium-based products.

Andrew Uprichard, M.D., president and head of R&D at EPIX said the “positive results confirm the efficacy upon which the NDA was based and allow us to move forward with our strategy of achieving U.S. regulatory approval,” and eventually bring Vasovist to the U.S. market.

Michael G. Kauffman, M.D., Ph.D., CEO of EPIX added that the company remains “focused on monetizing our Vasovist asset in the near- to mid-term and these positive results are a significant milestone towards achieving this goal.” “We believe these positive results position us well for FDA approval and that our product, if approved, will serve a large and unmet need in the U.S.”

Check out the details on Vasovist here.

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