Biovest seeks EMA approval for BiovaxID to treat non-Hodgkin's lymphoma

Sep 21 2012

Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today reported milestone achievements advancing BiovaxID™, Biovest's personalized cancer vaccine for the treatment of non-Hodgkin's lymphoma, including a recently conducted regulatory meeting with the European Medicines Agency (EMA) and the appointment of a key contributor to the Human Genome Project to its Scientific Advisory Board.

Biovest reported that it recently conducted a regulatory meeting with the EMA in London, at which the EMA provided Biovest with information to help finalize Biovest's pending Marketing Authorization Application (MAA) seeking EU marketing approval for BiovaxID. The meeting addressed legal, regulatory, and scientific matters for the planned MAA in order to facilitate subsequent validation and assessment of the application. The Company believes that the meeting with the EMA was favorable and will support final preparation and filing of the MAA anticipated for early next year. Based on the meeting, Biovest anticipates that the filing and review of the application will proceed in a timely and customary manner. Next steps in the pre-submission process will include upcoming meetings planned with the Rapporteur and Co-Rapporteur.