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Alfacell Provides ONCONASE(R) NDA Submission Update
Date:12/5/2008

uld be scheduled no later than mid-December 2008, based on industry guidance published by the FDA. As a result, the end of January 2009 pre-NDA meeting date has affected the company's ability to meet its previous NDA submission target date. The company intends to seek the FDA's permission to complete the submission of the rolling NDA at the pre-NDA meeting. If the FDA grants such permission or accepts the NDA for filing after the submission is completed, no inference can be made concerning the FDA's ultimate decision on whether or not to approve the NDA. It is also possible that the FDA will advise the company at the pre-NDA meeting that the FDA will not allow the company to complete the submission of its NDA.

About ONCONASE(R)

ONCONASE is a first-in-class therapeutic product candidate based on Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action.

Alfacell has licensed the U.S. commercial rights for ONCONASE to Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc. Strategic marketing and distribution agreements for ONCONASE have been secured with Megapharm Ltd. for Israel, BL&H Co. Ltd. for Korea, Taiwan and Hong Kong, USP Pharma Spolka Z.O.O., an affiliate of US Pharmacia, for Eastern Europe, and GENESIS Pharma, S.A. for Southeastern Europe.

ONCONASE has been granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted orphan-drug designation in the European Union and Australia.

About Alfacell Corporation

Alfacell Corporation is the first company to advance a biopharmace
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SOURCE Alfacell Corporation
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Related medicine technology :

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