Biovest plans to file BiovaxID MAA with EMA for treatment of follicular NHL

May 14 2012

Biovest International, Inc. (OTCQB:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB:ABPI), today announced that Biovest plans to file for marketing approval in the European Union (EU) for BiovaxID®, its personalized cancer vaccine for the treatment of follicular non-Hodgkin's lymphoma, an incurable cancer of the immune system. Biovest plans to file a Marketing Authorization Application (MAA), with the European Medicines Agency (EMA), the Agency responsible for the scientific evaluation of applications for the EU under the centralized procedure. EMA approval would establish BiovaxID as the first cancer vaccine available in Europe for lymphoma patients.

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.

Samuel S. Duffey, Esq., Biovest's President & CEO, stated, "Biovest's EU regulatory strategy focused on conducting pre-filing clinical meetings with national regulatory agencies to obtain scientific advice regarding our BiovaxID clinical data and to facilitate a more predictable marketing approval process in the European Union. Today's announcement confirms that pre-filing meetings have been conducted in Europe, and the Company intends to file a marketing application with the EMA. This is a major regulatory milestone, and it builds on Biovest's recently announced plans to seek marketing approval in Canada following a pre-filing meeting with Health Canada. We next look forward to meetings with the FDA to define the path to U.S. registration as well."

The next step in Biovest's regulatory strategy is to meet with the U.S. FDA. Biovest will conduct meetings with the FDA to review the comprehensive clinical data obtained during the 18-years of clinical development, demonstrating near universal immune responses leading to clinical benefit provided by three separate clinical trials. Further, the meetings will elicit comments from the FDA that will help Biovest determine the most expeditious approach to U.S. registration.

Carlos F. Santos, Ph.D., Senior Vice President, Product Development, Scientific & Regulatory Affairs, discussed Biovest's opportunity to make its personalized cancer vaccine available to patients in the EU, "With our decision to seek marketing approval in both Canada and in the EU, Biovest is pursuing significant market opportunities as we aim to commercialize the world's first cancer vaccine for follicular lymphoma. The EU market has an estimated 23,000 patients diagnosed with follicular lymphoma each year which is roughly equal in size to the U.S. market. We believe that with approval, patients and physicians will embrace BiovaxID as being a safe and effective vaccine therapy that activates the immune system to fight cancer in a manner that complements current treatment regimens."

Biovest's EU regulatory advisor, Adriaan Fruijtier, stated, "We are pleased with the guidance provided in our pre-filing regulatory advisory meetings with the EU-member national medicines regulatory agencies we met with. I believe this feedback will facilitate the approval process. Additionally, there are certain benefits, including procedural, administrative and cost-savings advantages, made available to Biovest based on the EMA designating BiovaxID as an Orphan Medicinal Product and the EMA granting Biovest with SME status (Small and Medium Sized Enterprise)." 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.

The European pre-filing meetings focused on a comprehensive presentation of the clinical evidence provided by Biovest's nearly decade-long collaboration with the U.S. National Cancer Institute (NCI). The data review included long-term outcomes from two Phase II clinical studies and a controlled, randomized, double-blinded, multi-center Phase III clinical trial. In addition to Company representatives, the EU national authorities received presentations from independent lymphoma opinion leaders including: Sattva S. Neelapu, M.D., Associate Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center; Eduardo M. Sotomayor, M.D., Senior Member and Professor and Susan & John Sykes Endowed Chair for Hematological Malignancies, H. Lee Moffitt Cancer Center & Research Institute; and Neil L. Berinstein, M.D., Professor of Medicine, University of Toronto and Director of Translational Research, Ontario Institute for Cancer Research.

Under the EMA centralized procedure, Biovest's application will be assessed by the EMA's Committee for Medicinal Products for Human Use (CHMP). An approval under the centralized procedure is valid in all EU-member countries. The Company will soon initiate the pre-submission process which will include a formal letter of intent to submit followed by the formal marketing authorization application. Biovest could receive a decision regarding EU marketing approval for BiovaxID within 12 months after the MAA submission, assuming its pre-submission, formal marketing application and the rigorous review process advance forward in a timely and positive manner.

Source: Biovest International, Inc.