Top-Line Results from Pivotal Trial of Dermagraft for Venous Leg Ulcers
Westport, Conn. – August 24, 2011–Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that Advanced BioHealing (ABH), its regenerative medicine business, has concluded its phase three pivotal trial of Dermagraft® in subjects with venous leg ulcers. Following preliminary analysis of the top-line results, the decision has been made not to pursue the venous leg ulcer indication.
The international pivotal trial, which enrolled more than 500 patients in eight countries, was designed as a prospective, multicenter, randomized, controlled clinical study to assess the product’s safety and efficacy in the promotion of healing venous leg ulcers.
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. 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 is a bio-engineered skin substitute, FDA approved and currently marketed for the treatment of diabetic foot ulcers (DFUs). A venous leg ulcer indication would have expanded the utility of Dermagraft in a chronic wound setting.
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Notes to editors
Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.
Dermagraft is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. Dermagraft is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine.
About Advanced BioHealing, Inc.
Advanced BioHealing (ABH), a Shire company, specializes in the development and commercialization of life-altering regenerative medicine therapies. ABH currently manufactures and markets Dermagraft®, a bio-engineered skin substitute approved by the FDA for the treatment of diabetic foot ulcers, which assists in restoring damaged tissue and supports the body’s natural healing process. The Company maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about ABH, please visit the Company’s web site at www.ABH.com.
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company’s website: www.shire.com.
24 Aug 2011 Top-Line Results from Pivotal Trial of Dermagraft® for Venous Leg Ulcers (38KB PDF)
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Posted: August 2011