Accentia Biopharmaceuticals' Development Partner Requests Meeting with FDA to Gain Clarification of Non-Approvable Letter for Emezine(R).TAMPA, Fla. -- 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 ) has received notification that its third-party developer  It has been suggested that First-party developer, Second-party developer be merged into this article or section. for Emezine(R) (prochlorperazine maleate prochlorperazine maleateBuccastem (UK), Compazine (CA), Proziere (UK), Stemetil (CA) (UK) Pharmacologic class: Phenothiazine Therapeutic class: Antiemetic, antipsychotic, anxiolytic ), BioDelivery Sciences International Inc., was issued a non-approvable letter from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for BioDelivery's New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) submitted under Section 505(b)(2) in May 2005. The letter, delivered February 28, 2006, recommended that BioDelivery provide additional information to the FDA. In response, BioDelivery requested a meeting with the FDA. Accentia's Chairman and Chief Executive Officer, Frank O'Donnell Francis Joseph "Frank" O'Donnell (August 31 1911 — September 4 1952) was a Scottish professional footballer. He was the older brother of fellow footballer Hugh O'Donnell, who also played for Blackpool and Preston North End. , M.D., commented, "We continue to be excited about the long-term prospects of our Specialty Pharmaceutical business' development pipeline. While we are disappointed, Emezine represents only one of twenty products which our Specialty Pharmaceutical business is either currently marketing or developing through third parties." Accentia's Specialty Pharmaceutical business currently markets and sells ten pharmaceutical products through its dedicated sales force. Accentia's Specialty Pharmaceutical business also has a pipeline of eleven products, including Emezine, under development by third parties. Accentia has the exclusive U.S. distribution rights to Emezine through its agreement with Arius Pharmaceuticals Inc., a subsidiary of BioDelivery. 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 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 Inc., 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. 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 Accentia and any other statements relating to products, product candidates, regulatory approval, product launches 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 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 Accentia does not undertake any obligation to revise or update this news release to reflect events or circumstances after the date hereof. |
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