Biovest to file for EU approval of BiovaxID, a personalized cancer vaccine

USA-based Biovest International (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals (OTCQB: ABPI), says that it plans to file for marketing approval in the European Union for BiovaxID, its personalized cancer vaccine for the treatment of follicular non-Hodgkin’s lymphoma, an incurable cancer of the immune system.

European Medicines Agency will review the vaccine under the centralized procedure and EMA approval would establish BiovaxID as the first cancer vaccine available in Europe for lymphoma patients. The potential of the cancer vaccine market is forecast to approach $3 billion in 2015, according to USA-based pharma consultancy Technology Catalysts International (TCI).

Biovest based its decision to pursue EU marketing approval on pre-filing clinical advisory meetings with EU-member national regulatory agencies. Under the EMA centralized procedure, Biovest will simultaneously seek approval for BiovaxID for all EU-member countries.