Healthcare Industry News: sinusitis
News Release - May 10, 2006
Biovest's AutovaxID(TM) Cleared for Commercial SaleFirst and Only Device to Automate Production of Complex Biologics: Applications Include Vaccines and Personalized Medicines, Such as BiovaxID(TM)
TAMPA, Fla. & WORCESTER, Mass.--(HSMN NewsFeed)--May 10, 2006--A majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI ), Biovest International, Inc. (OTCBB:BVTI ), has been informed by the United States Food and Drug Administration (FDA) that its patent-pending AutovaxID(TM) device requires no further review by the FDA, allowing Biovest to commence commercialization of the device. AutovaxID is, to the best of the Company's knowledge, the first and only instrument to enable the cost-effective and scalable production of cells or cell-derived products such as monoclonal antibodies for personalized medicine applications. Potential applications include production of vaccines to treat a variety of diseases, as well as stem-cell amplification for therapeutic uses. AutovaxID is a reusable device that hosts a companion single-use, disposable, closed-system chamber containing a hollow-fiber cell-growth cartridge. This unique instrument has the potential to replace conventional cell-growth chambers that require up to ten times as much laboratory space, as well as additional labor and increased expenses.
"This is an important advancement in the use of cell-culture techniques for production of complex biologics, especially those for personalized medicine applications," said Dr. Steve Arikian, Chairman and Chief Executive Officer of Biovest. "For the first time, with AutovaxID, such production is less susceptible to contamination, more reliable, and truly economical."
Biovest has manufactured and distributed patented hollow-fiber cell-culture technologies for more than 12 years, and AutovaxID is the Company's next-generation computerized host device. By automating the production process and using single-use, closed-system disposable cartridges, AutovaxID minimizes costly and error-prone manual monitoring and adjustments and reduces the need for large production facilities containing costly isolation suites and clean rooms. The new instrument is expected to be a significant enabling technology for the emerging field of personalized medicine by allowing Companies to process personalized therapeutics in far less costly facilities while still maintaining sterility and strict segregation of patient-specific materials.
Dr. Arikian commented: "Our market research suggests a very robust demand from university, biotech, pharmaceutical and diagnostic clients. We believe that this will be a key enabling technology for large segments of the monoclonal antibody production community worldwide. In our case at Biovest, the AutovaxID technology is being used to produce BiovaxID, the personalized anti-cancer vaccine we are developing in coordination with the National Cancer Institute for our pivotal phase 3 trial. AutovaxID will make it economically feasible to produce this personalized medicine as well as scale production in response to growing demand."
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology. Two of these products are SinuNase(TM) and BiovaxID(TM). The Company's SinuNase product, in development to treat chronic sinusitis (rhinosinusitis), is a novel application and formulation of a known anti-fungal licensed from the Mayo Foundation for Medical Education and Research. BiovaxID is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia subsidiary Biovest International, Inc., is currently in a Phase 3 clinical trial. In addition, Accentia's growing specialty pharmaceutical business, TEAMM Pharmaceuticals, has a portfolio of currently marketed products plus a pipeline of additional products under development by third parties. For further information, visit the Company Web site at www.accentia.net.
About Biovest International, Inc.
Biovest International, Inc. is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and clinical trials. In addition, Biovest develops, manufactures and markets patented cell culture systems, including the innovative AutovaxID(TM), which is being developed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest's therapy for follicular non-Hodgkin's lymphoma is currently in a Phase 3 pivotal clinical trial at more than 20 major centers in the U.S., and is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. For further information, visit the Company Web site at www.biovest.com.
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about AutovaxID, BiovaxID and any other statements relating to products, product candidates, and product development programs of Accentia and/or Biovest. Such statement may include, without limitation, statements with respect to either 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. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results of either Accentia or 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 Accentia's and/or Biovest's 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 of Accentia and Biovest with the Securities and Exchange Commission. All forward looking statements are qualified in their entirety by this cautionary statement, and neither Accentia nor Biovest undertakes any obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Source: Accentia Biopharmaceuticals
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