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Max Planck Institute Presents Study Positioning Biovest Bioreactor Systems as Potential Novel Viral Vaccine Manufacturing Platform

Thu, 07/19/2012 - 8:15am
The Associated Press

TAMPA, Fla. & MINNEAPOLIS--(BUSINESS WIRE)--Jul 19, 2012--Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that the Max Planck Society recently hosted a research seminar in Berlin, Germany at which the Max Planck Institute for Dynamics of Complex Technical Systems (Magdeburg, Germany) presented highly encouraging viral growth data from studies using a Biovest proprietary hollow fiber bioreactor system to produce human influenza virus. The results reported by the Max Planck Institute were consistent with earlier studies conducted by the U.S. Naval Health Research Center (NHRC) finding that Biovest’s instruments offer a flexible and modular manufacturing platform for the rapid, robust and cost-effective production of virus for vaccine production.

Biovest's AutovaxID™ bioreactor represents a novel manufacturing platform for the production of viral vaccines and personalized medicines. (Photo: Business Wire) According to Dr. Yvonne Genzel (Max Planck Institute), a recognized expert in the field of bioprocess engineering, influenza virus production and bioreactor systems, “Our preliminary results suggest that Biovest’s hollow fiber technology may provide a novel solution for urgently needed improvements in the cell culture manufacture of viral vaccines. The Biovest instrument we used in our preliminary studies supported the growth of both adherent and suspension MDCK cells with high titers of H1N1 virus. Our next studies will implement further optimization and scale-up techniques in Biovest’s AutovaxID® bioreactor which we expect may further improve the already encouraging results.” These initial study results are expected to be published in a peer-reviewed journal.

In addition to the Max Planck Institute, Biovest is collaborating with the NHRC and U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) on additional studies utilizing Biovest’s hollow fiber technology for production of vaccines, virus-like particles (VLPs) and antibodies for treatment and prevention of influenza and filovirus diseases including those caused by Ebola and Marburg viruses.

According to Biovest’s consulting medical advisor, J. David Gangemi, Ph.D., Professor Emeritus, Microbiology and Molecular Medicine, Clemson University, “In a series of world-class collaborative studies, we’re establishing the utility, versatility and flexibility of Biovest’s hollow fiber perfusion systems as an optimal cell culture biomanufacturing platform. Additionally, based on our success to date, there is considerable interest being expressed from other companies, government agencies and research institutes which I believe will result in new contracts and collaborations to be established this year.” To review the viral growth study results previously reported by the NHRC and published in Genetic Engineering & Biotechnology News (GEN), please visit: http://www.genengnews.com/gen-articles/novel-uses-for-hollow-fiber-bioreactors/3700/ Biovest’s patented hollow fiber bioreactor systems are compact, scalable and economical for large-scale virus and antibody production. In contrast to other systems, Biovest’s technology provides multiple benefits including: 1) controlled culture conditions with high cell density attained; 2) space efficiency and high-yield production; and 3) selective dilution/removal of inhibitory byproducts.

AutovaxID® is an automated, self-contained, scalable system that employs a single-use, hollow-fiber bioreactor for cell expansion. Since it is functionally closed, computer-controlled and fully-automated, operation of the AutovaxID requires limited supervision and minimal manpower compared to other systems. The AutovaxID is a flexible system, uniquely designed to address a variety of biotechnology and pharmaceutical applications.

About the Max Planck Institute The Max Planck Institute for Dynamics of Complex Technical Systems is part of the Max Planck Society, Germany’s most successful research organization with more than 17 Nobel laureates having emerged from the rank of its scientists.

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: 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. Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50346297&lang=en

CONTACT: Biovest International, Inc.

Corporate Contact: Douglas Calder, 813-864-2558 Vice President, Strategic Planning & Capital Markets dwcalder@biovest.com KEYWORD: UNITED STATES EUROPE NORTH AMERICA FLORIDA MINNESOTA GERMANY INDUSTRY KEYWORD: HEALTH GENERAL HEALTH SOURCE: Biovest International, Inc. Copyright Business Wire 2012 PUB: 07/19/2012 08:15 AM/DISC: 07/19/2012 08:15 AM http://www.businesswire.com/news/home/20120719005171/

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