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Accentia Biopharmaceuticals, Inc. Diversifies Pain Product Portfolio With New FDA Approval

Posted on: Thursday, 30 March 2006, 06:00 CST

Accentia Biopharmaceuticals Inc.'s (NASDAQ:ABPI) manufacturing partner received approval from the U.S. Food and Drug Administration (FDA) for a new dosage of Xodol(R) (hydrocodone bitartrate and acetaminophen tablets, USP), the Company's unique dosage of this combination pain product. This new dosage affords physicians additional choices in the dose of hydrocodone for patients without exceeding the maximum daily dose of acetaminophen. TEAMM Pharmaceuticals Inc., Accentia's wholly owned specialty pharmaceutical subsidiary, holds the exclusive U.S. license for the marketing and sale of this product.

"Xodol is a unique dosage product in that it combines an effective narcotic, hydrocodone, with a very commonly used analgesic, acetaminophen, in a lower dose of acetaminophen than is available in other combination pain medications. This addition to our pain franchise allows the physician to prescribe Xodol and tailor the dosing to effectively manage the individual patient's pain threshold," said Gary Cantrell, TEAMM Pharmaceuticals Executive Vice President of Sales and Marketing. "Now, with greater diversity in dosing alternatives, physicians have more options for managing pain in their patients."

Martin Baum, TEAMM President and CEO, adds: "This approval is another important milestone for TEAMM and Accentia and demonstrates our ability to efficiently move novel products through the development pipeline to commercialization. Physicians want to provide their patients with pain medication in a dose that alleviates the patient's pain while reducing the risk of toxicity. Patients prescribed chronic pain medication typically require an upward titration of the dose the longer they remain on this type of medicine. Now that we have an entire Xodol family, it will be attractive for physicians to make a switch from other hydrocodone combinations with higher acetaminophen doses to Xodol."

About Xodol

Xodol combines hydrocodone, a narcotic widely used for pain, and the lowest effective dose of acetaminophen, the most commonly used analgesic. This formula provides physicians with a effective pain-management combinations, reducing the possibility that the patient will exceed the recommended daily allowance of acetaminophen. The recommended daily dose of acetaminophen is up to 4,000 mg per day for less than 10 days, and no more than 2,600 mg per day for longer-term use. Higher cumulative doses of acetaminophen have been shown to predispose patients to serious adverse effects including liver damage.

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. Two of these products are SinuNase(TM) and BiovaxID(TM). The Company's SinuNase(TM) product, in development to treat chronic sinusitis (rhinosinusitis), is a novel application and formulation of a known anti-fungal licensed from the Mayo Foundation for Medical Education and Research. BiovaxID is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia's subsidiary, Biovest International, Inc., is currently in a Phase 3 clinical trial. In addition, Accentia's growing specialty pharmaceutical business, TEAMM Pharmaceuticals, Inc. has 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: 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 Xodol and any other statements relating to products, product candidates, and product development programs. 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 does not undertake any obligation to revise or update this news release to reflect events or circumstances after the date hereof.

Source: Business Wire

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