Amarantus BioScience Holdings, Inc. has announced that it has completed the acquisition of Cutanogen Corporation ("Cutanogen") from Lonza Walkersville, Inc. ("Lonza"), a subsidiary of Lonza Group Ltd. Cutanogen has an exclusive worldwide license to intellectual property rights associated with Engineered Skin Substitute ("ESS"), an autologous full thickness skin replacement product in development for the treatment of severe burns.
ESS has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of hospitalized patients with deep partial and full thickness burns requiring grafting. With this agreement, Amarantus has engaged Lonza via a long-term services agreement to manufacture ESS under Good Manufacturing Practices for human clinical trials, and subsequent commercial distribution.
"The completion of the acquisition of Cutanogen from Lonza represents a cornerstone of Amarantus' therapeutics acquisition strategy as the company prepares for its upcoming listing on a national exchange," said Gerald E. Commissiong, President & CEO of Amarantus.
Commissiong continued, "ESS is a potentially revolutionary solution for the treatment of severe burns that has demonstrated initial human proof-of-concept in an investigator-initiated setting. Going forward, Amarantus plans to take this program through a stringent corporate-sponsored regulatory development program under an already open IND with the FDA, to gain marketing approval, initially for the treatment of severe burns in the United States. The company intends to work closely with US regulatory authorities under the orphan drug designation pathway to achieve this objective."
Details regarding the financial components of the transaction are available on Form 8-K filed with the Securities Exchange Commission ("SEC") and may be accessed on the SEC's website at www.sec.gov.