Accentia Biopharmaceuticals Acquires Exclusive License for an Additional Late-Stage Respiratory Product.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 ) announced today that it has entered into an exclusive license with Collegium col·le·gi·um n. pl. col·le·gi·a or col·le·gi·ums 1. An executive council or committee of equally empowered members, especially one supervising an industry, commissariat, or other organization in the Soviet Union. Pharmaceuticals, Inc. (Collegium) to market in the U.S., a branded intranasal in·tra·na·sal adj. Within the nose. steroid intended for the symptoms of seasonal and perennial allergic rhinitis Allergic Rhinitis Definition Allergic rhinitis, more commonly referred to as hay fever, is an inflammation of the nasal passages caused by allergic reaction to airborne substances. . This product will be marketed by Accentia's specialty pharmaceutical division, TEAMM Pharmaceuticals. This license will expand Accentia's pipeline of innovative products for respiratory diseases and enable Accentia to enter the large intranasal steroid market. Collegium plans to file a Supplemental New Drug Application (sNDA) in 2006 for this patent-pending aqueous nasal spray formulation. "The intranasal steroid market in the US represents approximately $2.7 billion dollars in annual sales. The primary competition for this market has been prescription non-sedating oral antihistamine antihistamine (ăn'tĭhĭs`təmēn), any one of a group of compounds having various chemical structures and characterized by the ability to antagonize the effects of histamine. products which have annual sales in excess of $4 billion dollars in the US. We anticipate that over the next several years many of the non-sedating antihistamines Antihistamines Definition Antihistamines are drugs that block the action of histamine (a compound released in allergic inflammatory reactions) at the H1 will migrate to the over-the-counter (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). ) marketplace. This anticipated shift in the market may benefit growth in the intranasal steroid prescription market," said Michael Heffernan, President of Collegium. "We believe that our new product will have a favorable profile within the nasal steroid market." "This is an excellent addition to our focus on innovative products to treat respiratory diseases. Our respiratory product portfolio includes the recently announced launch of our CRSFungal Profile(TM), a unique non-invasive test for confirmation of the diagnosis of 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 and differentiation of it from allergic rhinitis," said Martin Baum, President and COO of specialty pharmaceuticals at Accentia. "In early 2006, we expect to launch MDTurbo(TM), a unique, patented delivery device for metered dose inhalers used to treat asthma and chronic obstructive pulmonary disease chronic obstructive pulmonary disease n. Abbr. COPD A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced. . In addition, our pipeline includes an intranasal antifungal which we are developing for chronic sinusitis under an Investigational New Drug Application (IND)." 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. The company's SinuNase(TM) product is a novel application and formulation of a known anti-fungal to treat chronic sinusitis (rhinosinusitis) licensed from the Mayo Foundation for Medical Education and Research, and BIOVAXID(TM) 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-Hodgkins' lymphoma non-Hodgkins' lymphoma A lymphoid cancer that is not Hodgkins disease: NHL ALL, B cell lymphoma, Burkitt's lymphoma, diffuse cell lymphoma, follicular lymphoma, immunoblastic large cell lymphoma, lymphoblastic lymphoma, mantle cell lymphoma, mycosis fungoides, . BIOVAXID, which is being developed by our subsidiary Biovest International, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :BVTI), is currently in Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. . In addition, Accentia has a growing specialty pharmaceutical business, TEAMM Pharmaceuticals, with 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: http://www.accentia.net About Collegium Pharmaceutical Collegium Pharmaceutical, Inc. is a privately held pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through product improvement and line extension strategies protected by intellectual property (IP). Collegium applies customized pharmaceutical formulations and IP strategies to active ingredients that have been shown to be safe and effective, creating a portfolio of improved pharmaceutical products with potentially less development risk and shorter times to market. Collegium uses its broad expertise in IP development, drug formulation, manufacturing, basic science (chemistry, biology, bioengineering), marketing and clinical trials management to identify and execute product opportunities for itself and its partners. For more information, visit the Company's website at http://www.collegiumpharma.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 AllerNase and any other statements relating to Accentia's products, product candidates, and product development programs. Such statement 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 Accentia's actual results 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 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 Accentia's filings with the Securities and Exchange Commission. All forward looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. |
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