Healthcare Industry News: Biovest
News Release - December 21, 2006
Accentia Biopharmaceuticals in Discussions with Pharmaceutical Companies on SinuNase Partnership
SinuNase is Fast-Tracked and the First and Only Phase 3 Product for Chronic SinusitsTAMPA, Fla.--(HSMN NewsFeed)--Accentia Biopharmaceuticals (NASDAQ: ABPI ) has entered into mutual confidentiality agreements with several pharmaceutical companies that have established respiratory care franchises. These companies have approached Accentia regarding SinuNase(TM), a unique formulation of low-dose intranasal amphotericin B, in development for the treatment of chronic sinusitis. Accentia believes that potential relationships with appropriate pharmaceutical partners could provide upfront and milestone payments as well as enhance the commercial opportunity for SinuNase, especially within the primary care market in the U.S. and in international markets.
Interest from pharmaceutical companies to partner has been stimulated by the fact that Accentia has commenced a Phase 3 clinical trial for SinuNase in patients with severe chronic sinusitis that are refractory to sinus surgery. SinuNase is the first and only product in a Phase 3 clinical trial for chronic sinusitis. Moreover, SinuNase has been granted Fast-Track status by the Food and Drug Administration (FDA). There is currently no approved pharmaceutical available for chronic sinusitis, a condition that affects 31 million patients, and represents a market almost twice the size of the asthma market, which is the next largest among respiratory diseases. To date, 43 clinical trial sites have been initiated and 29 have been cleared to enroll patients.
Upon the anticipated approval of SinuNase by the FDA, Accentia plans to focus its commercial efforts using its respiratory sales force on the approximately 15,000 U.S. ear nose & throat (ENT) and allergist specialists who treat patients with the most severe cases of chronic sinusitis. These specialists are considered opinion leaders in the diagnosis and management of chronic sinusitis. Relationships with these specialists have been facilitated by Accentia's ongoing marketing of MD Turbo(TM), an FDA-cleared medical device that optimizes the use of metered dose inhalers (MDIs) for asthma patients, a condition that is found in at least 60% of chronic sinusitis patients, and CRSFungal Profile(TM) test, the only lab test available for the diagnosis of chronic sinusitis. Additionally, all of the physician investigators in the current Phase 3 trial are ENTs or allergists.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development of late-stage "disruptive" clinical products. Accentia has a portfolio of currently marketed respiratory products and a pipeline of products in clinical development. The company's lead respiratory product candidate is SinuNase(TM), which is under clinical development to treat chronic sinusitis (rhinosinusitis). SinuNase is a novel application and formulation of a known anti-fungal exclusively licensed from the Mayo Foundation for Medical Education and Research. The product has been Fast Tracked by the FDA and we will commence Phase 3 trials soon. The Company's other lead product is BiovaxID(TM), a patient-specific anti-cancer vaccine for the treatment of follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia's subsidiary Biovest International, Inc., (OTCBB:BVTI ) is currently in a Fast-Tracked Phase 3 clinical trial. Additionally, the Company has a family of respiratory specialty pharmaceutical products, including MDTurbo(TM), an FDA approved, commercially available product that transforms over 90% of dispensed metered-dose inhalers into a breath-activated, dose-counting inhaler. For further information, please visit 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 SinuNase(TM), BiovaxID(TM), AutovaxID(TM) and any other statements relating to products, product candidates, product development programs the FDA or clinical trial 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. 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 undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Source: Accentia Biopharmaceuticals
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