With one product in Phase III trials and another set to begin, Accentia Biopharmaceuticals Inc. filed for a proposed $86.2 million initial public offering.

The price and number of shares to be offered has not yet been set. If completed, Accentia would list on Nasdaq under the symbol "ABPI." Jefferies & Co. Inc., of New York, is acting as book-running manager, with Chicago-based Robert W. Baird & Co.; Baltimore-based Ferris, Baker Watts Inc.; and Stifel, Nicolaus & Co. Inc., of St. Louis, as co-managers.

Tampa, Fla.-based Accentia focuses on late-stage therapeutic products for respiratory diseases and oncology. According to its prospectus, proceeds from the offering would go toward repaying $5.9 million in principal and accrued interest on an outstanding loan, with the remainder to fund ongoing clinical development of the company's lead products, SinuNase and Biovaxid.

SinuNase, an amphotericin B suspension administered into a patient's nasal cavity, is being developed as a treatment for chronic rhinosinusitis, a long-term inflammatory condition of the paranasal sinuses. Accentia said it plans to file an investigational new drug application, and then begin Phase III trials this year.

Biovaxid, already in Phase III trials, is designed as a patient-specific cancer vaccine for the treatment of follicular non-Hodgkin's lymphoma. A previous 20-patient open-label study of Biovaxid resulted in 18 patients in complete remission for 42 months, and, after follow-up at a median of seven years following vaccination, 18 patients survived and 10 of the 20 remained in complete remission.

The Phase III trial of Biovaxid is designed for patients who have been diagnosed with the indolent, or low-grade, form of B-cell follicular NHL. Started in 2000, the trial has a primary endpoint of time to tumor progression between Biovaxid vs. control.

Accentia has several products in development with third parties, and the company sells 10 products, including Xodol, a narcotic pain formulation and Respi-TANN, a prescription antitussive decongestant for temporary relief of cough and nasal congestion. Accentia also has six Histex products in the cough, cold and allergy prescription market. Revenues from those specialty products totaled $11.9 million in fiscal year 2004.

For the year ending Sept. 30, Accentia posted a net loss of $22.8 million. The company has about $23.8 million in total debt. Cash and cash equivalents as of Sept. 30 total about $1.9 million.

Since its April 2002 inception, Accentia has raised about $42.6 million in private funding.

The company began business by acquiring Analytica Group Ltd., for $3.7 million cash, $1.2 million in convertible promissory notes and the issuance of 8.1 million shares of Series B preferred stock. In October 2002, Accentia acquired the assets of American Prescription Providers Inc. and American Prescription Providers of New York Inc., which since has operated under the name AccentRx. Assets and liabilities of American Prescription Providers were obtained for $200,000 cash and the issuance of 10.3 million shares of common stock.

Accentia sold AccentRx in December 2003 for $4.2 million.

The company acquired Teamm Pharmaceuticals Inc. through another merger in April 2003, for $13.8 million in 9.7 million shares of preferred stock. In June 2003, Accentia invested $20 million in Biovest International Inc., of New York, in exchange for an 81 percent equity stake. Under the agreement, Accentia paid $2.5 million cash at closing and $2.5 million in 90-day notes. The remaining $15 million was in the form of a non-interest-bearing promissory note to support Biovest's vaccine development activities and fund general corporate expenses.

Accentia then acquired IMOR GmbH in October 2003, for $600,000 cash and assumption of $300,000 in net liabilities. The company also issued options to purchase 2 million shares of IMOR preferred stock.

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