Enzon annouces termination of agreements with Inex
Enzon Pharmaceuticals, Inc. announced that it has entered into an agreement with INEX Pharmaceuticals Corporation to terminate the companies' partnership for the development and commercialization of INEX's proprietary oncology product, MARQIBO® (vincristine sulfate liposomes injection).
After a careful evaluation, ENZON determined it will not support further development of MARQIBO. In January 2005, the United States Food and Drug Administration (FDA) provided an action letter detailing MARQIBO is "not approvable" under the FDA's accelerated approval regulations for relapsed aggressive non-Hodgkin's lymphoma. The FDA's response also stated additional randomized controlled studies would need to be conducted prior to re-applying for approval. After a strategic analysis of the FDA's recommendation, required investment, development timeframe, and associated development risks, the Company concluded it would be in its best interest to redirect this investment to pursue other opportunities.
ENZON expects to pay INEX $5 million for certain contractual obligations, including development expenses and milestone payments.
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