West Coast Editor

Less than a month after starting the second Phase III trial with its insomnia drug Silenor, Somaxon Pharmaceuticals Inc. has filed for an initial public offering that would raise as much as $86.25 million.

All shares would be sold by the company, though San Diego-based Somaxon's prospectus did not say how many would be sold or at what price.

The company plans to use 60 percent of the proceeds from the IPO to fund clinical trials for three development programs, 20 percent for marketing, general and administrative expenses, and 20 percent for other research and development expenses.

Somaxon began the second Phase III study with Silenor (doxepin) in September, planning to test the drug over a three-month period in elderly patients with primary chronic insomnia. The primary endpoint of the trial is waking after sleep onset, which is the sleep maintenance endpoint recommended by the FDA. Somaxon launched its first Phase III trial in adults in June, and said at the time that the second would specifically target elderly patients. (See BioWorld Today, June 10, 2005.)

Silenor's active ingredient, the tricyclic antidepressant doxepin from New York-based Pfizer Inc., is available in generic form, sold under the brand names Adapin, Sinequan and Zonalon. Some physicians prescribe it off label for fibromyalgia and chronic pain.

Aside from Silenor, Somaxon has oral nalmefene for impulse-control disorders, partnered with BioTie Therapies Corp., of Turku, Finland. The product is in a Phase II/ III clinical trial for the treatment of pathological gambling and a Phase II clinical trial for smoking cessation.

A third product, acamprosate calcium, is being prepared for clinical trials to treat movement disorders. Approved in Europe for 15 years and in the U.S. since the beginning of this year, the drug is used to help alcoholics abstain from drinking.

The underwriters of Somaxon's IPO will be the sole book-runner and lead manager Morgan Stanley & Co., of New York, and J.P. Morgan Securities Inc., also of New York, serving as co-lead manager, as well as Piper Jaffray & Co., of Minneapolis, and Thomas Weisel Partners LLC, of New York, acting as co-managers.

CoTherix Raises $52M for Ventavis

In separate financing news, South San Francisco-based CoTherix Inc. disclosed its follow-on public offering of 4.5 million shares of its common stock at $13 per share, is raising $58.5 million. Of those shares, 500,000 will be sold by stockholders of the company, leaving CoTherix with $52 million of the proceeds.

CoTherix and the selling stockholders have granted to the underwriters a 30-day option to purchase up to 675,000 additional shares of common stock to cover over-allotments, if any, and 337,500 of these shares may be sold by stockholders of CoTherix.

The firm was not at liberty to talk about the offering under SEC rules, but said in a prospectus it plans to use the proceeds for continued commercialization of Ventavis, the inhaled product for pulmonary arterial hypertension approved in December by the FDA, plus clinical development of the drug in combination with other therapies and in new indications. It also work on an extended-release formulation of iloprost, the active ingredient in Ventavis, which was in-licensed from Schering AG, of Berlin, in the fall of 2003. (See BioWorld Today, Jan. 4, 2005.)

Also, in other SEC paperwork filed recently by CoTherix, the company noted the approval by the FDA last month of Profile Therapeutics plc's I-neb inhaler, which will allow patients to administer Ventavis with the device. Respironics Inc., of Murrysville, Pa., acquired Profile in July 2004.

CoTherix upped its revenue guidance from its second-quarter earnings report, estimating net sales for Ventavis this year at $18 million to $20 million (the previous range was $14 million to $16 million), with combined cash and investments at the end of the year expected to top out between $34 million and $39 million (the previous range was $28 million to $33 million).

CIBC World Markets Corp. and UBS Investment Bank, both of New York, are acting as joint book-running managers. Piper Jaffray and New York-based Needham & Co. LLC are acting as co-managers of the offering.

CoTherix's stock (NASDAQ:CTRX) closed Friday at $13.30, down 13 cents.