Tampa’s Biovest International, a majority-owned subsidiary of Accentia Biopharmaceuticals, has received notification from the European Medicines Agency (EMA) regarding the official designation of the Rapporteur and Co-Rapporteur for BiovaxID, a personalized cancer vaccine for the treatment of follicular non-Hodgkin’s lymphoma.
The EMA has granted Orphan Medicinal Product designation to BiovaxID for the treatment of follicular lymphoma and mantle cell lymphoma, which are B-cell subtypes of non-Hodgkin’s lymphoma. Orphan Drug status gives Biovest a 10-year period of market exclusivity for BiovaxID upon approval for each indication in the EU, thereby offering competitive protection from similar drugs of the same class.
Biovest’s EU regulatory advisor, Adriaan Fruijtier, stated, “This is another key milestone as part of the formal EMA process and a precursor to the upcoming filing of our Marketing Authorization Application (MAA) for BiovaxID. The role of our Rapporteur and Co-Rapporteur is to perform the scientific evaluation for BiovaxID and to prepare an assessment report for the EMA’s Committee for Medicinal Products for Human Use. We look forward to meeting with our selected reviewers, as we will work closely with them, providing the necessary support for a comprehensive submission.” Mr. Fruijtier serves on the Biovest Scientific Advisory Board and as the Managing Director of CATS Consultants GmbH in Germany. He has extensive EU regulatory experience, having held positions with the EMA, Bayer, Glaxo, Micromet and Novartis.