Pharmabiz
 

Genta seeks market exclusivity for oblimersen generic in EU

Berkeley Heights, New JerseyTuesday, February 6, 2007, 08:00 Hrs  [IST]

Genta Incorporated has completed its response to the 180 - day List of Outstanding Issues from the European Medicines Agency (EMEA) regarding its Marketing Authorization Application (MAA) for Genasense (oblimersen sodium), its lead anticancer product, for treatment of patients with advanced melanoma. The company currently anticipates that EMEA's Committee on Human Medicinal Products (CHMP) will complete its review and issue its opinion regarding approval within the next 90 days. Genasense, Genta's lead anticancer drug, is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of resistance to cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma.

 
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