Chinese firm will take responsibility for bridging trials and regulatory activities.
Lee’s Pharmaceutical negotiated exclusive rights to commercialize and market United Therapeutics’ FDA-approved prostacyclin analogue Remodulin for the treatment of pulmonary arterial hypertension (PAH) in China. Under terms of the deal China-based Lee’s will have responsibility for carrying out any necessary bridging trials and negotiating the regulatory pathway for clearance for the drug in China.
The FDA- approved formulation of Remodulin is administered as either a continuous subcutaneous or continuous intravenous infusion. United Therapeutics is also carrying out a Phase III trial program evaluating an oral formulation of the Remodulin active ingredient treprostinil using sustained release technology licensed from Supernus Pharmaceuticals. There are currently no oral prostacyclin therapies approved either in the U.S. or Europe, United Therapeutics points out. Regulatory filing of the oral treprostinil will not be before 2012, the company adds.
Oral treprostinil is separately undergoing Phase II evaluation for use in reducing the frequency and severity of ulcers located on the fingers and toes of scleroderma patients.
United Therapeutics reported Remodulin-related revenues of $95,769 for the three months of March 2010, up 24.7% on the equivalent quarter of 2009.