Shire plc (NSDQ:SHPGY) became the latest firm to abandon its pursuit of a leg ulcer indication for the Dermagraft artificial skin patch, after a clinical trial failed to pan out.The Irish biopharmaceutical firm, which acquired the product in a $750 million buyout of Advanced BioHealing in June, said a Phase III clinical trial examining Dermagraft in treating venous leg ulcers failed to meet its primary endpoint: Complete healing after 16 weeks.
“When combined with compression therapy Dermagraft achieved a higher closure rate of venous leg ulcers than compression therapy alone. However, the data did not meet the primary end point mutually agreed upon with the FDA and EMA,” according to a press release. “The primary end point of the trial was complete healing (100% re-epithelialization, with no presence of scab or drainage) of venous leg ulcers by 16 weeks. In addition, there was a need to show a minimum absolute level of superiority over compression therapy.”
Dermagraft, which is cleared for treating diabetic foot ulcers, was owned by Smith & Nephew plc (NYSE:SNN), before it abandoned the product in 2005 after the FDA rejected it as a leg ulcer treatment. SNN then sold the rights to Advanced BioHealing in 2006.
Shire’s pickup of that company, just before ABH launched a projected $200 million IPO, was lauded as a “monster home run” for backers of the Westport, Mass.-based regenerative tissue products maker. It’s not clear what the Dermagraft decision means for Shire’s plans to build Advanced BioHealing into its regenerative tissue division.
The news sent Shire shares down nearly 2 percent to $94.83 today on Wall Street and nearly 3 percent on its home exchange in London.
