By Lisa Seachrist

Washington Editor

United Therapeutics Corp. (UTC) signed a deal worth roughly $23 million with Toray Industries, of Japan, for the exclusive North American rights to develop and commercialize sustained-release formulations of the oral prostacyclin, Beraprost.

The deal, mostly in stock, grants UTC, of Silver Spring, Md., the right to develop the sustained-release form of Beraprost for all vascular and cardiovascular indications and extends a relationship that began three years ago when UTC licensed the rights to an immediate-release form of Beraprost from Toray.

"This is an old relationship," said Fred Hadeed, chief financial officer for UTC. "We have a very good working relationship with Toray and really value this relationship."

Under the terms of the agreement, UTC will pay Toray $1 million plus 200,000 shares of UTC's common stock. At Thursday's closing price for UTC stock (NASDAQ:UTHR) of $108.06, up $8.125, the stock portion of the deal alone is worth $21.6 million. Once the deal takes place, UTC will have approximately 18.8 million shares outstanding.

UTC also is offering Toray the option to purchase an additional 500,000 shares when Toray delivers the sustained-release formulation for clinical trials sometime in 2001. Toray will receive $750,000 in milestones from UTC, as well as a daily-dosage fee and a variable percent of revenues from North American sales.

UTC currently is conducting the second of two Phase III studies of an immediate-release form of Beraprost for early stage peripheral vascular disease, as well as a Phase III study of the same drug in early stage pulmonary hypertension. Peripheral vascular disease (PVD) causes leg pain ranging from intermittent pain when walking to severe leg pain even at rest. In its most severe form, PVD may lead to foot and leg amputations. Pulmonary hypertension causes breathlessness, fainting and, in some patients, right heart failure.

Hadeed said the company likely will pursue pulmonary hypertension as an indication for the sustained-release Beraprost in order to offer patients a more convenient and effective form of the drug. However, the PVD indication is likely to offer the biggest opportunity for UTC.

"The big market for us is PVD," Hadeed said. "There is a much bigger need for Beraprost in this indication because there really isn't much available to treat it."

Beraprost is an orally available form of prostacyclin, a naturally occurring molecule that is produced in the body's blood vessels to keep them dilated and free of platelet clustering. The drug already has been approved in Japan and Korea for the treatment of chronic arterial occlusion and pulmonary hypertension.

UTC also is developing Uniprost, a stable structural analogue of prostacyclin. The company has completed Phase III studies in pulmonary hypertension and expects to submit an NDA within the next couple of months, and is anticipating a 2001 approval.

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