Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that the European Medicines Agency (EMA) has notified Biovest 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 Rapporteur and Co-Rapporteur are members of the EMA's Committee for Medicinal Products for Human Use (CHMP). They are supported by a team of assessors from their National Authority. The Rapporteur and Co-Rapporteur have been assigned with the primary responsibility of preparing and delivering an approvability evaluation report under the EMA's Centralized Procedure. Under this procedure, a registration of BiovaxID throughout all EU-member countries can be obtained simultaneously via a single application. Upon approval, BiovaxID would be the first cancer vaccine available in Europe for lymphoma patients.
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 CHMP. 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.
According to Carlos F. Santos, Ph.D., Biovest's Senior Vice President, Product Development and Regulatory Affairs, "We are targeting an urgent unmet need, as approximately 25,000 patients are newly diagnosed with follicular lymphoma in Europe every year, and for these patients that achieve a complete remission following induction therapy, BiovaxID represents the only non-immunosuppressive, highly-safe consolidation (maintenance) therapy capable of significantly extending a patient's remission. For these patients in first remission, our primary goal is deliver a treatment option that offers a likelihood of clinical benefit with quality of life not being adversely affected."
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.
Source Biovest International, Inc.