Biovest Initiates Formal Regulatory Approval Process for BiovaxID® Cancer Vaccine in Europe

Biovest Initiates Formal Regulatory Approval Process for BiovaxID® Cancer Vaccine in Europe


Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that formal notification was submitted to the European Medicines Agency (EMA) informing of Biovest's intent to file a Marketing Authorization Application (MAA) seeking 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. Upon approval, BiovaxID would be the first cancer vaccine available in Europe for lymphoma patients.

According to Carlos F. Santos, Ph.D., Biovest's Senior Vice President, Product Development and Regulatory Affairs, "This formal notice submitted to the EMA marks a significant milestone in our BiovaxID global regulatory strategy, as this is the initial step required by the EMA in the process leading up to our planned MAA submission."

Biovest based its decision to pursue EU marketing approval for BiovaxID on guidance received at a series of pre-filing clinical advisory meetings conducted with EU-member national regulatory agencies. The Company will soon conduct a meeting with the FDA to define the path for U.S. registration as well.

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. Subsequent to completion of the pre-submission process, 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.

In other news, Biovest has named Prof. J.H. Veelken, M.D., Ph.D., to its Scientific Advisory Board (SAB). The Biovest SAB represents a group of preeminent physicians and doctors from the fields of cancer immunotherapy, immunology, bioinformatics, regulatory affairs and cell culture bio-manufacturing.

Prof. Veelken serves as Professor of Internal Medicine (Hematology) and Head of the Department of Hematology at Leiden University Medical Center, (Leiden, Netherlands). An internationally-recognized authority in cancer immunotherapy, Prof. Veelken's research focuses on the immunopathogenesis of malignant lymphoma, including the role of antigen receptor signaling in the etiology of indolent non-Hodgkin's lymphomas and chronic lymphocytic leukemia. His research also covers natural immunosurveillance and the mechanisms of stroma interaction as survival signals for these tumors, and high-resolution genomic and transcriptomic profiling to identify pathogenetically relevant genetic pathways and novel therapeutic targets. His projects form the basis for translational research and clinical trials for therapeutic anti-tumor vaccination in lymphomas and other malignancies.

According to Prof. Veelken, "BiovaxID will meet an important need in the management of lymphoma in the European clinic as an active immunotherapy that can extend duration of tumor remission and offer patients a non-immunosuppressive post-induction therapy."

About Biovest International, Inc.

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, BiovaxID®, has been evaluated in three clinical trials conducted in collaboration with the U.S. National Cancer Institute (NCI) demonstrating that BiovaxID 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 BiovaxID.

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").

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Forward-Looking Statements:

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about Biovest and its product candidate, BiovaxID® and any other statements relating to products, product candidates, product development programs, the FDA, the EMA, Health Canada or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. In particular (and without limitation), statements regarding the timing of anticipated filing of a Marketing Authorization Application for BiovaxID with the EMA or a New Drug Submission for BiovaxID with Health Canada, pre-filing meetings with the FDA or other jurisdictions and/or commercial plans reflect current expectations but are subject to inherent risks of delay in compilation and finalization of all components of the licensing application. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.


Biovest International, Inc.
Douglas Calder, 813-864-2558
Vice President, Strategic Planning & Capital Markets
[email protected]