Shire is paying $750 million in cash to buy Advanced BioHealing as the foundation for establishing a regenerative medicine business unit headed by the acquired firm’s bioengineered skin substitute Dermagraft®.
Dermagraft is a cryopreserved human fibroblast-derived dermal substitute that is already approved in the U.S. for the treatment of diabetic foot ulcers and is in late-stage development for treating venous leg ulcers. Shire says it will continue to invest in the development of new indications for Dermagraft in additional countries and use its international commercialization and marketing expertise to increase sales of the product. The firm expects the acquisition will represent a springboard for the potential purchase of additional regenerative medicine assets.
Once the transaction is complete the Advanced BioHealing business will become part of Shire’s specialty pharmaceuticals business and be able to leverage biologics manufacturing expertise from Shire’s existing human genetic therapies business to improve Dermagraft manufacturing capacity and technical expertise. Under Shire’s ownership Advanced BioHealing will also expand its existing manufacturing facility in La Jolla, California.
Kevin Rakin, Advanced BioHealing chairman and CEO, said the acquisition by Shire represents “an exciting chapter,” in its evolution. “Four years ago, we started with a vision to transform the regenerative medicine marketplace... This is a very exciting opportunity for all of us at Advanced BioHealing to develop the business and deliver continued growth within a new environment that is highly complementary and will provide great leverage for us.”
Dermagraft made $146 million in U.S. sales in 2010, and has already cornered a 5% share of the $3 million slow-healing diabetic foot ulcer market, Shire claims. A U.S. filing for Dermagraft in the treatment of venous leg ulcers is projected for the first quarter of 2012. The product has also been approved, but is not yet marketed, for the diabetic foot ulcer indication in Israel, South Africa, and Singapore. A regulatory submission was made to the Canadian regulatory authorities in March. Additional submissions for the diabetic foot ulcer indication are planned in multiple territories.