CoTherix obtains U.S. rights to Ventavis
CoTherix Inc has acquired exclusive United States development and marketing rights to Ventavis (iloprost), a synthetic prostacyclin analogue for the treatment of primary pulmonary hypertension developed by Schering AG.
Ventavis was approved last month by the European Commission for marketing in all EU countries for the treatment of Primary Pulmonary Hypertension NYHA class III. Schering plans to start marketing Ventavis this year and to roll-out the product across Europe in 2004. CoTherix executives plan to meet with U.S. Food and Drug Administration before the end of the year to discuss steps required for approval in the United States.
Ventavis is the only prostacyclin product that targets the pulmonary vessels directly by inhalation. A recent European Phase 3 trial comparing Ventavis to placebo achieved the study's primary endpoint, improvement in exercise capacity and functional class for patients with primary pulmonary hypertension NYHA Class III affected by severe symptoms and heart failure.
"Establishing this important relationship with Schering AG for Ventavis exemplifies our strategy for acquiring late-stage compounds and developing them through approval and commercialization," said CoTherix CEO W. Scott Harkonen. CoTherix was formerly known as Exhale Therapeutics Inc.
The company is building a specialized commercial field force to market Ventavis once approved.
In a separate announcement, the company announced that it closed a $55 million placement of Series C Preferred Stock, appointed Chairman Scott Harkonen as CEO and added Nicholas Simon, General Partner, MPM Capital, to its board of directors. The proceeds of the fundraising will finance the development of Ventavis and acquisition and development of other late-stage products.
Pulmonary hypertension is a life-threatening disease of the blood vessels in the lung in which the pressure in the pulmonary artery is significantly higher than normal. Approximately 50,000 Americans are affected with either primary pulmonary hypertension (no known underlying cause) or secondary pulmonary hypertension that results from diseases such as scleroderma, lupus or idiopathic pulmonary fibrosis.