By Kim Coghill
Professional Detailing Inc. will provide prelaunch and commercialization services for beraprost, a novel compound under development by United Therapeutics Corp. for peripheral vascular disease patients in the United States.
The companies signed a five-year agreement under which Upper Saddle River, N.J.-based PDI will provide marketing and sales services utilizing the capabilities of LifeCycle Ventures, PDI's wholly owned subsidiary.
"We believe that beraprost has blockbuster potential and we chose to partner with an organization that can help us achieve that potential," said Fred Hadeed, chief financial officer for Silver Spring, Md.-based United Therapeutics. "PDI will build a sales force including reps and management, a highly trained and highly motivated sales force that we will pay the cost of."
PDI has been contracted on a fee-for-service basis, but United Therapeutics potentially may develop a revenue-sharing arrangement, Hadeed said.
Beraprost is in Phase III pivotal studies and United Therapeutics expects the last patient to complete in mid-2001. The company anticipates submitting a new drug application in late 2001 and launching it a year later.
In June, United Therapeutics signed a $23 million deal with Toray Industries of Japan, gaining exclusive North American rights to develop and commercialize beraprost. (See BioWorld Today, June 30, 2000.)
The product is approved in Japan, where it was discovered and first developed by Toray Industries, for the indications of peripheral arterial occlusive disease and primary pulmonary hypertension. "Beraprost has been approved in Japan for five years and there are more than 100,000 patients on it at present," said Hadeed. "It is yielding about $300 million annually in revenues."
Beraprost is used in patients with peripheral vascular disease who experience leg pain as a result of hardened arteries and restriction of oxygen-rich blood flow to the muscles in their lower limbs. The estimated 6 million Americans who suffer from this condition have a reduced quality of life and an increased risk of heart attack and stroke.
United Therapeutics in mid-October filed a new drug application for Uniprost, a drug that has been granted orphan status for use in the treatment of pulmonary hypertension. Company officials anticipate approval in mid-2001 and plan to launch it immediately thereafter.
United Therapeutics' stock (NASDAQ:UTHR) closed Thursday at $66, up $9.25, or 16.30 percent. PDI's stock (NASDAQ:PDII) closed at $85, down $1.437 or 1.66 percent.