TAMPA, FL--June 1, 2007--Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI; Accentia) reports that the Mayo Medical and Graduate Schools and the Virginia Bioinformatics Institute have been awarded a National Institute of Health (NIH) grant of $2.4 million for a project entitled "The Pathogenesis of Chronic Rhinosinusitis." The grant, in part, is to support identification of which antigens of the Alternaria fungus are responsible for the inflammation of chronic sinusitis (CS). Accentia is the exclusive licensee to the Mayo patents covering the use of intranasal antifungals to treat chronic sinusitis using an already-approved antifungal, amphotericin B. for the life of the patents in the US and EU Accentia has also extended its exclusive option agreement with Mayo for worldwide rights to any and all other prescription antifungals for CS until December 6, 2008. Moreover, Accentia has a right of first refusal on any immunologic treatments developed based on identification of the specific fungal antigens responsible for CS and asthma.
The grant includes research on Alternaria alternata, the fungus that triggers the inflammatory response in susceptible patients with CS. The grant project will focus on identifying which antigens of Alternaria are the cause of CS. The funding of the program is a significant commitment of resources by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health. Because awarding of this grant is a peer-reviewed process, it represents a significant indication of the growing acceptance of the fungal etiology for CS.
The goal of the project is to positively impact treatment, clinical decisions, and medical care costs involving CS, as well as develop a better understanding of the mechanisms of the disease. Principal Investigator Hirohito Kita, professor of medicine at the Mayo Medical and Graduate Schools, will lead the project at Mayo Clinic, while Dr. Chris Lawrence, associate professor at VBI, will head the work at VBI in collaboration with VBI assistant professor Dharmendar Rathore. Researchers at Mayo, including clinical assistant professor Jens Ponikau, who is now at the University at Buffalo School of Medicine & Biomedical Sciences, and Hirohito Kita, professor of Immunology and the director of the Allergic Diseases Laboratory at Mayo, carried out extensive research at the Mayo Clinic which identified a fungal origin for CS.
Accentia Biopharmaceuticals is commercializing a diagnostic and developing a treatment for CS based on the published technology discovered at the Mayo Clinic. Investigators at Mayo discovered that a ubiquitous, normally innocuous mold, Alternaria, colonizes the mucus of the nose and sinus of virtually everybody, but in patients with CS, this non-invasive mold elicits an eosinophilic inflammatory response characterized by release of eosinophil major basic protein (eMBP) in the mucus, which then damages the mucosal epithelial lining of the nose and sinuses and leads to the inflammatory mucosal changes characteristic of CS.
Dr. Jens Ponikau, Assistant Professor of Clinical Otolaryngology, University at Buffalo, commented: “Research supported by the National Institutes of Health had previously shown that CS patients have an exaggerated immune response to certain fungi, specifically Alternaria species. The patients reacted to the fungi with the production of the inflammatory mediators, which are crucial for the inflammation in CS, whereas healthy subjects were not reacting. The renewal of the NIH grant will allow Dr. Kita and Dr. Lawrence to further pinpoint the mechanism by which the fungus causes the inflammation, and specifically what fungal products are involved. Both are important milestones to deepen our understanding about CS, and will help us to better understand the mechanism of action of newer treatment approaches, such as anti-fungal therapy.”
As previously announced, Accentia has received Fast Track status from the Food and Drug Administration (FDA) for SinuNaseTM, and it is conducting a randomized, double-blind, placebo-controlled Phase 3 clinical trial with severe CS patients at more than 50 sites across the U.S. To the knowledge of the Company, this is the first and only Phase 3 clinical trial for CS and the only intranasal antifungal that has been submitted to the FDA as an Investigative New Drug (IND). The initial study population is with patients that have severe CS who have undergone sinus surgery, but who are struggling with recurrent CS. Accentia intends to provide an update on the Phase 3 trial on June 27th.
Despite the fact that there are an estimated 31 million affected U.S. patients, and that CS is by far the most common chronic respiratory disease with a commercial market approximately twice the size of asthma, there is currently no approved prescription pharmaceutical available. If approved, SinuNase will be the first therapy available to treat sufferers of CS.
About Accentia: Biopharmaceuticals, Inc. Accentia Biopharmaceuticals, Inc. and its subsidiaries (collectively referred to as the “Company” or “Accentia”) 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. (“Biovest”), (BVTI.OB) 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.
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(TM) SinuNase(TM), BiovaxID(TM), AutovaxID(TM), CRSFungal Profile(TM) 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.
CONTACT: Accentia Biopharmaceuticals, Inc., Tampa, FL Susan Bonitz, PhD 813-864-2554 - Extension: 277 sbonitz@accentia.net
The Investor Relations Group, New York Investors: Adam S. Holdsworth 212-825-3210 aholdsworth@investorrelationsgroup.com