National Editor

Gearing up for three Phase III trials testing its lead product in separate indications, Peninsula Pharmaceuticals Inc. filed for an initial public offering that would raise about $86.25 million.

The Alameda, Calif.-based firm, focused on developing antibiotics for life-threatening infections, has not specified the number of shares to be offered or the price per share.

In the spring, Peninsula in-licensed its lead product doripenem from Shionogi & Co. Ltd., of Osaka, Japan, gaining rights to develop and sublicense the compound, which is a member of the carbapenem class of antibacterials. It works by disrupting cell wall synthesis. (See BioWorld Today, May 28, 2003.)

The company is in a quiet period as required by SEC rules, but the IPO prospectus states Peninsula has completed a Phase II trial of doripenem for complicated urinary tract infections and plans to start Phase III trials in three separate indications in the first half of next year.

Proceeds will be used to advance product candidates, for general corporate purposes, and possibly for acquisitions of new products or product candidates, although no agreements are yet in place.

"We believe that the net proceeds of this offering, along with existing cash and cash equivalents, will be sufficient to meet our capital requirements for at least the next 24 months," the company said in the prospectus, noting that "management will have broad discretion in applying" the IPO funds.

As of Sept. 30, Peninsula had about $10.5 million in cash, cash equivalents and short-term investments.

Two more antibiotics are in the pipeline: doripenem for inhalation in pulmonary infections in cystic fibrosis patients, and PPI-0903 (formerly TAK-599), an intravenous broad-spectrum antibiotic for severe and difficult-to-treat infections, including resistant Gram-positive ones. Peninsula aims to begin clinical trials for both candidates in the first half of next year.

Peninsula has exclusive rights to doripenem in the U.S., Canada, Mexico, Puerto Rico, and all countries in South America and Europe. It has worldwide rights, excluding Japan, to PPI-0903. The company expects to build its own direct sales force to market the products in North America, but might partner with third parties in other parts of the world, according to the prospectus.

Underwriters for the IPO are Credit Suisse First Boston, U.S. Bancorp Piper Jaffray, Citigroup and First Albany Capital, all of New York.