CoTherix Inc. submitted a new drug application requesting approval of Ventavis as a therapy for patients with pulmonary arterial hypertension.
Ventavis, an inhaled formulation of iloprost, a prostacyclin analogue, is sold in several European countries by Schering AG, of Berlin. CoTherix, formerly Exhale Therapeutics Inc., licensed U.S. rights to Ventavis from Schering last fall. (See BioWorld Today, Oct. 15, 2003.)
CoTherix - which postponed its initial public offering, citing adverse market conditions, in mid-June - is in an SEC-imposed quiet period and could not comment. The company filed for its IPO in March, hoping to raise $70 million. (See BioWorld Today, March 16, 2004.)
That amount, combined with roughly $20.5 million in cash, was expected to keep the company running for 12 months, CoTherix said in its filing.
Meanwhile, on acquiring Ventavis, CoTherix indicated that it would seek regulatory clearance in the U.S., based largely on Schering's clinical work, including a pivotal Phase III study that hit its primary endpoint of improvement in exercise capacity and functional class. The "p" value was 0.007.
CoTherix, of South San Francisco, will owe Schering a $7 million milestone if the FDA accepts the new drug application. CoTherix paid Schering $6 million upon signing the deal, which includes an additional $30 million in milestones.
Pulmonary arterial hypertension (PAH) is characterized by severe constriction of the blood vessels of the lungs. The disorder afflicts about 50,000 people in the U.S., of which an estimated 15,000 are diagnosed and undergoing treatments with drugs such as prostacyclins and endothelin receptor antagonists. Existing therapy is estimated to cost about $100,000 per patient per year.
CoTherix also is evaluating Ventavis in combination with Tracleer (bosentan) in a 60-patient Phase II study initiated in mid-June. Tracleer, an endothelin receptor antagonist for PAH, is made by Actelion Ltd., of Allschwil, Switzerland.
Elsewhere in its pipeline, CoTherix is developing CTX-100, an inhaled hyaluronic acid solution, in early stage research for emphysema due to smoking and genetic emphysema. The drug has completed two Phase I trials and is due for a Phase I/II study in the second half of this year, also scheduled to be funded by IPO proceeds.