UTHR--Positive news out right on the close tonight
Company Press Release
SOURCE: United Therapeutics Corporation
Shearwater Polymers and United Therapeutics Sign Licensing, Manufacturing And Supply Agreement for Sustained Release Prostacyclin Delivery Technology
HUNTSVILLE, Ala. and SILVER SPRING, Md., Oct. 1 /PRNewswire/ -- Following the successful completion of pre-clinical research studies, Shearwater Polymers, Inc. (''Shearwater'') and United Therapeutics Corporation (''UT'') announced today their signature of an agreement to develop and produce a new generation of sustained release prostacyclin molecules for the possible treatment of cardiovascular diseases and other illnesses. Shearwater is a leading drug delivery firm and UT is a leading pharmaceutical company in the field of pulmonary hypertension. Prostacyclin is a powerful but very short- lived naturally occurring molecule which can be made synthetically in the laboratory.
Dr. Michael Bentley, Shearwater's VP of Research, commented, ''We are very excited to be working on such an important project with UT. The potential for prostacyclins is enormous, and our pre-clinical data indicate that Shearwater's clinically proven drug delivery technology is likely to contribute some significant benefits.''
''We are truly honored to have teamed-up with Shearwater,'' said Martine Rothblatt, Chairman & CEO of UT. ''Their reputation for world-class excellence in sustained-release drug delivery technology brought us to them for help in extending the duration of action of prostacyclin.''
Prostacyclin was discovered in the late 1970s under the leadership of Sir John Vane, Chairman of the Scientific Advisory Board of UT. This discovery was cited in the Nobel Prize in Medicine awarded to Sir John in 1982. A continuous, 24-hour-a-day life-long intravenous form of prostacyclin was approved by the Food and Drug Administration for the treatment of primary pulmonary hypertension, a life-threatening heart-lung disorder. A pill form of a variant of the prostacyclin molecule was approved in Japan for the treatment of peripheral vascular disease, a condition that causes tens of thousands of leg amputations annually. UT is currently conducting clinical trials of a subcutaneous form of a variant of the prostacyclin molecule for several manifestations of pulmonary hypertension. To date, all of the forms of prostacyclin taken by people have a half-life of about one hour or less, necessitating frequent or continuous dosing.
Founded in 1992 and located in Huntsville, Alabama, Shearwater is a research-based drug delivery and cGMP manufacturing company focusing on healthcare applications of poly(ethylene glycol) (PEG). Currently, the Company's corporate partners have nine PEG products utilizing Shearwater's proprietary technology in thirteen clinical trials. Three of these nine products have now finished Phase III clinical trials and are in the pre- marketing approval stage. In addition, Shearwater has fifteen products currently in pre-clinical development, most of which have resulted from the efforts of the Drug Delivery Division which was formed in 1997. Shearwater offers its partners a unique, ''one-stop-shop'' service for their PEGylation requirements. The service includes basic research, optimization of the PEG- product, full-scale cGMP manufacturing and a full regulatory package, including the Drug Master File. The Company is actively seeking new partners for its clinically proven drug delivery technology.
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