Healthcare Industry News: Xodol
News Release - May 8, 2006
Accentia Biopharmaceuticals Receives FDA Approval for Three Unique Dosage Combination Pain Product ANDAsAccentia's Portfolio Expands to Six Products Intended to Reduce the Risk of Toxicity
TAMPA, Fla.--(HSMN NewsFeed)--May 8, 2006--Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI ) and its development partner have received approval from the United States Food and Drug Administration (FDA) for three additional combination pain product ANDAs (Abbreviated New Drug Applications), broadening the Company's pain product portfolio to better serve physicians in managing their patients, especially those with chronic pain. TEAMM Pharmaceuticals, Inc., Accentia's wholly owned specialty pharmaceutical subsidiary, holds the exclusive U.S. license for the marketing and sale of these three new formulations.
"Our sales force has been very effective in establishing our presence in the pain market with our Xodol (hydrocodone bitartrate and acetaminophen tablets, USP) brand for the treatment of moderate to moderately severe pain," said Gary Cantrell, TEAMM Pharmaceuticals Executive Vice President of Sales and Marketing. "The addition of these three new combination narcotic and analgesic products increases our comprehensive pain product portfolio to six, positioning the Company to more effectively compete in an even larger segment of the chronic pain market."
Each year, in the United States alone, 45 million pain product prescriptions are written for the treatment of pain, ranging from mild and acute to severe, debilitating and chronic.
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 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, 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.
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: Accentia Biopharmaceuticals
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