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Source: Alfacell Corporation, December 21, 2006
Alfacell Corporation Files for U.S. Orphan Drug Designation for Onconase
BLOOMFIELD, N.J. -- Alfacell Corporation, a biopharmaceutical company focused on the discovery, development and commercialization of novel ribonuclease therapeutics for cancer, today announced it has filed an application with the U.S. Food and Drug Administration (FDA) to obtain orphan designation for its lead drug candidate ONCONASE® (ranpirnase) for the treatment of patients with unresectable malignant mesothelioma (UMM). ONCONASE is currently being evaluated in a confirmatory Phase IIIb clinical trial in UMM.
The FDA orphan drug designation provides incentives to pharmaceutical and biotechnology companies to develop drugs for the treatment of diseases affecting fewer than 200,000 people in the United States. Unresectable malignant mesothelioma qualifies under this requirement, as about 4,000 new cases are reported in the U.S. each year.
If granted, orphan drug status will entitle ONCONASE to seven years of marketing exclusivity for the UMM indication after FDA approval. Other key benefits which Alfacell would be eligible for upon approval of the orphan drug application include protocol assistance by FDA in the preparation of a dossier that will meet regulatory requirements, tax credits, grant funding for research and development, and reduced filing fees for the marketing application.
Kuslima Shogen, Chief Executive Officer of Alfacell, said, "Orphan drug designation is an important tool for companies like Alfacell that are developing drugs for rare and emerging diseases. This is why we pursued and were granted orphan designation for ONCONASE for the mesothelioma indication in Europe and Australia. As such, we believe we are well-positioned with FDA for review of our application."
Shogen added, "With the U.S. orphan drug application filed and over 385 patients enrolled in the pivotal UMM study, we are continuing to make progress on the critical path leading to the anticipated completion of the NDA submission for ONCONASE, pending positive data, in mid-2007."