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Vion Pharmaceuticals Receives a Standard Review from the FDA for Its New Drug Application for Onrigin(TM)
Date:4/23/2009

NEW HAVEN, Conn., April 23 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) today announced that the New Drug Application (NDA) for its lead oncology therapeutic Onrigin(TM) (laromustine) Injection has received a standard review classification by the U.S. Food and Drug Administration (FDA). Therefore, a user fee goal date of December 12, 2009 for a decision by the FDA with respect to the approval of the Company's NDA has been established.

The Company had previously announced the acceptance of the NDA filing for review by the FDA on April 16, 2009. The NDA presents data for Onrigin(TM) as a single agent for remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML). The NDA is based on the results of an international multi-center pivotal Phase II trial of 85 patients sixty years of age or older with de novo poor-risk AML, supplemented by data from 55 patients in a previous Phase II trial in elderly AML. Eighty-six percent of these 140 patients had two or more risk factors that predicted for a poor prognosis.

Alan Kessman, Chief Executive Officer, commented, "Our level of excitement continues to grow as we move forward in the FDA's process of reviewing our NDA. We will continue to work closely with the FDA on the filing with the objective of achieving approval for Onrigin(TM) in its first indication in the United States." He added, "The positive news today is that we can expect to have an FDA decision this year."

About Vion Pharmaceuticals

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative oncology therapeutics. Vion has two agents in clinical trials, Onrigin(TM)(laromustine) Injection and Triapine(R). The FDA is reviewing a New Drug Applicat
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SOURCE Vion Pharmaceuticals, Inc.
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