Washington Editor

Falling in step with others in the industry, Myogen Inc. Thursday afternoon said it registered for an initial public offering, estimating it would raise $75 million.

Before disclosing the IPO plans, Myogen said it closed a $40 million private placement of additional shares of its Series D preferred stock to a group of current institutional investors led by New Enterprise Associates.

Myogen's proposed IPO follows public offerings filed in the last week by Nitromed Inc., of Bedford, Mass.; Pharmion Corp., of Boulder, Colo.; Acusphere Inc., of Cambridge, Mass.; and TolerRx Inc., of Cambridge. (See BioWorld Today, Aug. 28, 2003, and Aug. 22, 2003.)

Myogen, a Denver-based company with 50 employees, markets one product in Europe and is developing three other candidates in different cardiovascular indications.

The marketed product is an intravenous formulation of enoximone, called Perfan IV, for acute decompensated heart failure. Rights to the IV formulation and the capsule form, currently the subject of a Phase III program, were acquired from Hoechst Marion Roussel AG, now Aventis SA, in 1998.

Other product candidates are ambrisentan, for the treatment of pulmonary arterial hypertension, and darusentan, for the treatment of uncontrolled hypertension.

Enoximone capsules are being evaluated in heart failure in three Phase III trials scheduled to be fully enrolled by the end of the year. Enoximone is a small organic molecule that exhibits highly selective inhibition of type-III phosphodiesterase, or PDE-III, an enzyme that is present in the heart and plays a role in cardiac function, according to Myogen's prospectus.

The Phase III program includes four trials collectively evaluating nearly 1,800 people. The trials include:

EMOTE, a randomized, double-blind, placebo-controlled study of about 200 patients with the most advanced state of chronic heart failure who are dependent on intravenous inotrope therapy. Enrollment began in June 2000 and was completed in July.

ESSENTIAL I, a randomized, double-blind, placebo-controlled pivotal trial including 700 patients with Class III and IV chronic heart failure who are being treated with beta-blockers and other therapies. Patient enrollment began in February 2002 and is expected to be completed by the end of the year.

ESSENTIAL II, a pivotal Phase III trial identical in design and size to ESSENTIAL I. Enrollment began in April and should be completed by the end of the year.

EMPOWER, a three-arm, randomized, double-blind, placebo-controlled Phase III study of 175 patients with Class III and IV chronic heart failure.

The company believes if the ESSENTIAL trials are successful, they would be adequate for U.S. and European regulatory approval.

Meanwhile, ambrisentan, an ETA selective endothelin receptor antagonist, is being developed as an oral therapy for patients with pulmonary arterial hypertension. The company recently completed a Phase II clinical trial of the product and intends to begin pivotal Phase III trials in the first half of next year.

Darusentan, also an ETA selective endothelin receptor antagonist, is being developed as an oral therapy for patients with uncontrolled hypertension. Myogen intends to start in 2004 a Phase IIb trial evaluating the compound in patients with uncontrolled hypertension associated with moderate to severe chronic kidney disease.

Financially, at the second quarter ended June 30, Myogen reported $17.35 million in cash and $57.25 million pro forma. The company posted a net loss of $19.36 million.

Major shareholders are New Enterprise Associates, of Menlo Park, Calif., which owns 28.5 percent of the company, and J.P. Morgan Partners LLC, of San Francisco, which owns 20.4 percent.

Participating in the private financing along with New Enterprise were J.P. Morgan; InterWest Partners, of Menlo Park, Calif.; Sequel Venture Partners Ltd., of Boulder, Colo.; Perseus-Soros Biopharmaceutical Fund LP, of New York; CMEA Ventures, of San Francisco; and Pacific Rim Ventures, of Estes Park, Colo.

Underwriters acting as joint book-running managers for the public offering are Credit Suisse First Boston LLC, of New York, and J.P. Morgan Securities Inc., of New York. CIBC World Markets Corp., of New York, and Lazard Freres & Co. LLC, of New York, are co-managers.