Biovest Advances Process Seeking European Marketing Approval for Personalized Lymphoma Vaccine
Biovest International, Inc.Douglas Calder, 813-864-2558Vice President, Strategic Planning & Capital Markets
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 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 throughout all EU-member countries can be obtained simultaneously via a single application. Upon approval, 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 . The role of our Rapporteur and Co-Rapporteur is to perform the scientific evaluation for 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, 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 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 upon approval for each indication in the EU, thereby offering competitive protection from similar drugs of the same class.
Biovest International, Inc. develops active immunotherapies (cancer vaccines) which treat and diminish the aggressiveness of B-cell non-Hodgkin’s lymphoma, a cancer of the immune system. The Company’s lead personalized cancer vaccine product candidate, has been evaluated in three clinical trials conducted in collaboration with the U.S. National Cancer Institute (NCI) demonstrating that increases the duration of cancer remission following chemotherapy and induces immune responses which correlate highly with long-term survival. Biovest is currently in the process of seeking US and international marketing approvals for .
Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the OTCQB™ Market with the stock-ticker symbol “BVTI”, and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: “ABPI”).