Accentia partner BioDelivery gets FDA non-approvable letter for Emezine

By Elaine Rigoli

Tampa, Fla., March 2 - Accentia Biopharmaceuticals, Inc. has received notification that its third-party developer for Emezine (prochlorperazine maleate), BioDelivery Sciences International, Inc., was issued a non-approvable letter from the Food and Drug Administration for BioDelivery's New Drug Application submitted in May 2005.

The letter, delivered Tuesday, recommended that BioDelivery provide additional information to the FDA. In response, BioDelivery requested a meeting with the FDA.

"We continue to be excited about the long-term prospects of our specialty pharmaceutical business' development pipeline. While we are disappointed, Emezine represents only one of 20 products which our specialty pharmaceutical business is either currently marketing or developing through third parties," Accentia chairman and chief executive officer Frank O'Donnell, MD, said in a statement.

Accentia's specialty pharmaceutical business markets and sells 10 pharmaceutical products. The business also has a pipeline of 11 products, including Emezine, under development by third parties.

Accentia has the exclusive U.S. distribution rights to Emezine through its agreement with Arius Pharmaceuticals, Inc., a subsidiary of BioDelivery.

Accentia, located in Tampa, Fla., is a biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology.

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