SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced today that it has entered into a license agreement with Clinuvel Pharmaceuticals Limited of Melbourne, Australia. Under the agreement, the Company's SurModics Pharmaceuticals unit has licensed certain of its biodegradable polymer implant technology to Clinuvel for the treatment of sun-induced skin disorders. Terms of the agreement were not disclosed.
“Clinuvel is delighted to further our partnership with SurModics through the signing of this agreement”
SurModics and Clinuvel have been collaborating on the development of Clinuvel's sustained release SCENESSE® (afamelanotide) implant formulation for several years. The implant is being developed as a prophylactic treatment for a range of UV and light-related skin disorders. Clinuvel's implant is currently being evaluated for a variety of skin disorders in several clinical trials in Europe and Australia. In addition, Clinuvel has recently announced initiation of a Phase II trial in the United States for the treatment of erythropoietic protoporphyria (EPP), an orphan disease which affects around 3,000 Americans. Independent estimates from RBS (Royal Bank of Scotland) place SCENESSE's potential market for all UV-related disorders being investigated by Clinuvel in excess of seven million patients worldwide.
SurModics' biodegradable polymer drug delivery technology enables the drug afamelanotide to be released in a sustained and tightly controlled manner. This elegant release stimulates the production of melanin in the patient's skin, to protect the patient from UV and light exposure.
"We are very pleased to announce the execution of this important license agreement with Clinuvel," said Phil Ankeny, interim CEO of SurModics. "This announcement demonstrates the value of our sustained drug delivery technologies and reinforces how we partner with our customers to develop and bring to market compelling products that leverage our core technologies. It also further validates the progress we are making in securing license agreements with our customers for pharmaceutical products that incorporate technology developed by our SurModics Pharmaceuticals business. Additionally, Clinuvel has become yet another potential customer for our new cGMP manufacturing facility in Alabama."
"Clinuvel is delighted to further our partnership with SurModics through the signing of this agreement," said Philippe Wolgen, M.D., CEO of Clinuvel. "The launch of our clinical trial program for porphyria in the United States is a significant milestone for our company, and our partnership with SurModics reflects not only the company's best-in-class enabling technology, but also their impressive track record of progressing technology through the rigorous regulatory process, from clinical trials to commercialization. We look forward to continuing our work together to develop effective therapies for patients suffering from severe UV-related skin disorders."
"Today's announcement represents a natural progression of our relationship with Clinuvel," said Arthur J. Tipton, Ph.D., senior vice president & chief scientific officer of SurModics. "Together, our teams have solved numerous scientific and technical issues over the years culminating in the signing of this licensing agreement. Clinuvel's product provides a novel way to treat serious skin disorders. We are excited to support Clinuvel as they continue with their U.S. clinical trials, and are also encouraged by the positive clinical results Clinuvel has generated to date."