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Accentia Biopharmaceuticals Licenses Targeted Technology For Treatment Of Chronic Rhinosinusitis (CRS): 37 Million Affected In The US And No Approved Pharmaceutical


10/19/2005 5:10:54 PM

TAMPA, Fla., April 13 /PRNewswire/ -- Accentia Biopharmaceuticals, a privately held Hopkins Capital Group portfolio company, announced today that it has entered into a license with the Mayo Foundation for Medical Education and Research to commercialize the Mayo Clinic's patented method of treating chronic sinusitis (chronic rhinosinusitis or CRS) in the USA and EU. CRS affects an estimated 37 million people in the USA and a similar number in the EU. Currently, there is no FDA-approved pharmaceutical for the treatment of CRS. Systemic antibiotics are used to treat acute exacerbations due to bacterial superinfection.

Investigators at Mayo Clinic have identified a novel etiology for many patients with chronic sinusitis. In published clinical studies, they have demonstrated that chronic, topical application of low-dose antifungals provides relief to many patients with this disease. Based on clinical and laboratory investigations at Mayo Clinic, it appears that saprophytic fungi (non-invasive mold) are responsible for the chronic symptoms in patients sensitized to the mold.

Under the terms of the royalty-bearing license, Accentia will file an IND on the use of a specially formulated Amphotericin B for the indication of chronic rhinosinusitis in the USA and EU.

"We are very pleased to be able to bring this product to market, which may benefit many patients suffering from this debilitating, chronic condition. It is a good example of a targeted therapeutic based on an appreciation of the fundamental causal mechanisms of a disease," said Martin Baum, CEO of Accentia's specialty biopharmaceuticals business. "Moreover, we believe that Amphotericin B, a well-characterized fungicidal, may prove to be advantageous in terms of reduced risk of acquired resistance in this chronic disease."

"This technology represents a paradigm shift in our understanding of the cause of chronic rhinosinusitis in many patients," said Dr Steve Arikian, MD, CEO of Accentia's biopharmaceutical research business. "It is analogous to the discovery many years ago that bacteria, not hyperacidity, are responsible for peptic ulcers. We are delighted to have the opportunity to assist in the validation of this paradigm shift, and to reduce the morbidity associated with this chronic disease. On an annual basis, the economic impact of CRS in the USA is substantial: over 300,000 surgeries are performed for chronic rhinosinusitis, approximately 73 million work and school days are lost each year, over 12 million physician visits, and over $5 billion are spent on 13 million prescriptions for antibiotics to treat acute exacerbations."

Accentia, Inc., a Hopkins Capital Group company, is a privately held, vertically integrated specialty biopharmaceutical company based in Tampa, Fla., that provides comprehensive biopharmaceutical services, including product commercialization, clinical manufacturing, contract sales and product distribution. For more information about Accentia, go to http://www.accentia.net/. The Hopkins Capital Group, LLC is not a part of the Johns Hopkins University. For more information on the Hopkins Capital Group, go to http://www.hopkinscap.com/.

Except for historical information, all of the statements, expectations and assumptions, including expectations and assumptions about the equity investment in Accentia, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although Accentia attempts to be accurate in making those forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause results to differ materially include the following: risks associated with the inherent uncertainty regarding the approval of development stage products, the impact of competitive products, third party reimbursement risks associated with the pharmaceutical industry, risks associated with investments, including impairments; economic conditions in the pharmaceutical, biotechnology and medical device industries; rapid technological advances that make the products and services of companies in which we invest less competitive; continued success in sales growth; and the ability to attract and retain key personnel. Accentia assumes no obligation to update information on its expectations.

Accentia, Inc.

CONTACT: Leonardo Zangani, L.G. Zangani, LLC, +1-908-788-9660, oroffice@zangani.com, for Accentia; or Martin Baum, Accentia, Inc.,+1-919-481-9020


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