Healthcare Industry News: Accentia Biopharmaceuticals
News Release - July 30, 2012
Biovest Advances Process Seeking European Marketing Approval for BiovaxID(TM) Personalized Lymphoma VaccineTAMPA, Fla. & MINNEAPOLIS--(Healthcare Sales & Marketing Network)--Biovest International, Inc. (BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (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.
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”).
For further information, please visit: http://www.biovest.com
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.
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