TAMPA, Fla. - (Business Wire) Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) today announced that
Med Ad News, a leading pharmaceutical business and marketing magazine, has published a cover story featuring SinuNase
™, as an intranasal therapy for chronic sinusitis expected to garner FDA approval and break the annual billion-dollar sales barrier.
The article, entitled, “Eighth Annual Report – Future Blockbusters”, reports that SinuNase is anticipated to become the first product to be approved for fungal-induced inflammation chronic sinusitis, a debilitating disease that affects more than 60 million people in the U.S. and Europe.
To access the article, which is posted on the Accentia website with permission from Med Ad News, February 2008, please visit: http://www.accentia.net/media/MedAdNews2008.pdf
Accentia expects to publicly-release results on the primary end-point for its Fast Track pivotal Phase 3 clinical trial for SinuNase this month, and is scheduled to present at the BioCentury “Future Leaders in the Biotech Industry” Conference on March 27th in New York City at the Millennium Broadway Hotel & Conference Center.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase™, a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune™, to treat numerous autoimmune diseases with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. (OTCBB:BVTI) and a royalty interest in Biovest's lead drug candidate, BiovaxID™ and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry.
For further information, please visit: http://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 Revimmune™, SinuNase™, BiovaxID®, AutovaxID™, SinuTest™, AllerNase™ and any other statements relating to products, product candidates, product development programs, the FDA or clinical study 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. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
Accentia Biopharmaceuticals, Inc., Tampa
Corporate Contacts:
Douglas Calder, Director of Investor Relations
& Public Relations, 813-864-2554, ext.258
Email: dwcalder@accentia.net
or
Susan Bonitz, Ph.D., Director, Program Coordination
813-864-2554, ext.277
Email: sbonitz@accentia.net
