Accentia Biopharmaceuticals Majority-Owned Subsidiary Receives Rare Disease Designation from European Drug Agency for Follicular non-Hodgkin's Lymphoma.Designation Will Provide Significant Advantages to Company TAMPA, Fla. -- A majority-owned subsidiary majority-owned subsidiary A firm in which more than 50% of outstanding voting stock is owned by the parent company. of Accentia Biopharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ABPI ABPI Association of the British Pharmaceutical Industry ABPI Associação Brasileira da Propriedade Intelectual (Brazilian Intellectual Property Association; Brazil) ABPI Ankle Brachial Pressure Index ), Biovest International, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :BVTI), has received notification from the Commission of the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community on its acceptance of Biovest's BiovaxID[TM] therapy for Follicular Lymphoma follicular lymphoma n. See nodular lymphoma. follicular lymphoma Follicle center lymphoma A heterogeneous group of NHLs arising in follicular center cells, which comprises 50% of all NHLs in adults–US, for entry into the European Community's Drug Register for Rare Diseases. This designation significant offers benefits to Biovest in its development and marketing of BiovaxID[TM] in the European Union (EU). This acceptance follows the previously announced recommendation by the Committee on Orphan Medical Products (COMP) of the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. : www.emea.eu.int/) that BiovaxID[TM] be granted designation as a treatment for a rare disease. The COMP concluded that "C*the condition is chronically debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction and life threatening due to the occurrence of relapses and the increasing resistance to treatments resulting in possible fatal evolution of the diseaseC*justifications have been provided that (BiovaxID) may be of significant benefit to those affected by the condition." In the EU, products targeted to treat disorders that affect fewer than 5 in 10,000 people are eligible for designation as a Drug to Treat a Rare Disease. Such status provides significant advantages and assistance to Biovest toward final approval to market BiovaxID[TM] in the EU. These include: ten year market exclusivity in the EU once the product is approved; direct assistance from the EMEA in preparing the final protocol for drug approval, and access to EMEA centralized filing procedures for approval in the EU; and, reduced fees for EMEA filings. Dr. Steve Arikian, Biovest CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and Chairman commented: "We are extremely pleased by this acceptance on the part of the Commission of the European Union, coming as it does shortly after the positive recommendation by the Committee on Orphan Medical Products (COMP) of the European Medicines Agency. This acceptance will provide Biovest with access to valuable resources and input from the Agency while we complete our Phase 3 Clinical Study and prepare to file our Marketing Authorization Application in the EU." 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[R] and BiovaxID[R]. The Company's SinuNase product, in development to treat chronic sinusitis chronic sinusitis Chronic sinus infection ENT Inflammation of the sinuses that empty into the nasal cavity Etiology Allergic rhinitis, nasal obstruction, deviated nasal septum, tooth abscesses, URIs (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 fol·lic·u·lar adj. 1. Relating to, having, or resembling a follicle or follicles. 2. Affecting or growing out of a follicle or follicles. non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma . BiovaxID, which is being developed by Accentia's subsidiary Biovest International, Inc., is currently in a Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. . 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, please visit our web site: 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. (NASDAQ: ABPI - News), 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 medical centers throughout the U.S. For further information, visit the Company Web site at www.biovest.com. Forward-Looking Statements 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 BiovaxID[TM] and any other statements relating to products, product candidates, and product development programs. 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. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia and/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 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 neither Accentia nor Biovest undertakes any obligation to revise or update this news release to reflect events or circumstances after the date hereof. |
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