Shire discontinues Dermagraft for venous leg ulcers

Shire plc (LSE:SHP; NASDAQ:SHPGY) said it will discontinue development of Dermagraft to treat venous leg ulcers after the engineered skin substitute missed the primary endpoint in the Phase III DEVO trial. In over 500 patients, weekly Dermagraft combined with Profore compression therapy did not lead to complete healing -- defined as 100% re-epithelialization with no presence of scab or drainage of ulcers -- by week 16 vs. compression therapy alone. Dermagraft contains live human fibroblasts grown on an absorbable Vicryl mesh.

Shire's Advanced BioHealing Inc. unit markets Dermagraft in the U.S. to treat full-thickness diabetic foot ulcers. Advanced BioHealing's TransCyte, a skin substitute for full and partial thickness burns, is approved in the U.S. but not yet marketed. Shire gained both products through its acquisition of Advanced BioHealing in June (see BioCentury, May 23). ...