Vion Pharmaceuticals receives complete response letter related to its NDA for Onrigin injection

Dec 14 2009

VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) today announced that it had received a complete response letter from the U.S. Food and Drug Administration ("FDA") related to its New Drug Application ("NDA") for Onrigin(TM) (laromustine) injection submitted in February 2009. The letter indicates that the FDA cannot approve the Company's NDA in its present form and provides recommendations to address remaining issues.

Alan Kessman, Chief Executive Officer, responded, "Based on the previously disclosed results of the Oncologic Drug Advisory Committee Meeting in September, we expected that the FDA would ask us to conduct an additional randomized study of Onrigin(TM) prior to approval. The complete response letter confirms our expectation."

The complete response letter advised that the Company complete a randomized study or studies to define the efficacy and safety of Onrigin(TM) in the patient population proposed for the indication, and that the study or studies should be designed to demonstrate a survival benefit that is clearly attributable to Onrigin(TM) with an acceptable safety profile in a well-characterized patient population. In addition to clinical and statistical recommendations, the letter also addressed clinical pharmacology and manufacturing issues. The complete response letter also requested that the Company provide an update on Onrigin(TM) safety information when the issues above had been addressed.

In connection with its previously disclosed review of strategic alternatives, the Company also announced that it had terminated its agreement with Merriman Curhan Ford & Co. and that it had retained Roth Capital Partners, LLP as its advisor to assist the Company in its evaluation of strategic alternatives. As previously announced, the Company does not have sufficient capital to fund a new randomized study of Onrigin(TM) and if the Company is not successful in achieving a sale of assets, restructuring, financing or any combination thereof, the Company will have to curtail or cease operations, liquidate its assets or file for bankruptcy. The Company expects to make decisions in the near future.