Organogenesis acquires Dermagraft from Shire

Organogenesis announced that it has acquired Dermagraft assets from Shire.

Dermagraft, a human fibroblast-derived dermal substitute, is approved in the US and Canada for treating nonhealing diabetic foot ulcers, according to a press release. Organogenesis, which did not release financial details of the transaction, will continue to manufacture and distribute Dermagraft from its La Jolla, Calif., facilities.

“We are now the proud owners of two products containing living cells that are FDA-approved for wound healing [Apligraf and Dermagraft],” Geoff MacKay, president and chief executive officer of Organogenesis, said in the release. “In the midst of a CMS coverage decision which limits access to FDA-proven technology, this deal was necessary to keep both assets on the market and available for patient treatment.”

Dublin-based Shire reported in a separate press release that it would receive no upfront payment from Organogenesis for the Dermagraft assets but is entitled to receive up to $300 million in cash “should Organogenesis meet certain annual net sale targets between now and 2018.”

“Due to the recent Medicare ruling regarding reimbursement for Dermagraft, the business environment has changed, and the prospects for the product have reduced significantly,” Flemming Ornskov, MD, chief executive officer of Shire, said in the release. “We believe the best path forward for the patients who benefit from Dermagraft is to transfer it to new ownership in order to provide continued care and availability of their treatment.”

“In the US alone, more than 3 million people are suffering from chronic leg and foot wounds,” Robert S. Kirsner, MD, PhD, department of dermatology and cutaneous surgery, University of Miami Miller School of Medicine, and dermatology chief, University of Miami Hospital, said in the Organogenesis statement. “As a physician dedicated to healing these wounds, this is very exciting news.”