Based on the preliminary statistical analysis of the data, Alfacell will continue with the planned submission of the remaining components of the ONCONASE rolling NDA. Pending completion of the analysis of the data and further discussions with the FDA, the company currently estimates that the NDA submission will be completed by the end of calendar year 2008.
John MacPhee, president of Strativa Pharmaceuticals, said, "We remain optimistic about the potential of ONCONASE for patients living with unresectable malignant mesothelioma. We are committed to collaborating with Alfacell as they continue with the planned submission of the NDA."
In January 2008, Strativa entered into an exclusive licensing agreement under which Strativa received commercialization rights in the U.S. to Alfacell's ONCONASE (ranspirnase). In return for the commercialization rights to ONCONASE, Strativa paid Alfacell an initial payment of $5 million, which was incurred as a research and development (R&D) expense in the first quarter 2008. Strativa will also pay Alfacell a development milestone upon FDA approval. In addition to royalties on sales, Alfacell may receive milestone payments on future sales. Alfacell will also retain the right to co-promote ONCONASE in the future.
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.
Strativa Pharmaceuticals is the proprietary products division of Par
Pharmaceutical, Inc. Strativa is committed to developing and marketing
novel prescription drugs. Its initial focus is on supportive care
therapeutics in HIV
|SOURCE Par Pharmaceutical Companies, Inc.|
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