The deal builds on several years of collaboration between the companies. Australia-based Clinuvel is developing sustained release Scenesse (afamelanotide) implant formulation which uses SurModics’ biodegradable polymer drug delivery technology.
SurModics’ technology enables the sustained, controlled release of afamelanotide. This stimulates production of melanin which protects the patient’s skin from exposure to light.
"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”, said Phil Ankeny, interim CEO of SurModics.
Clinuvel has initiated a Phase II trial investigating use of Scenesse in the treatment of erythropoietic protoporphyria (EPP), an orphan disease which affects around 3,000 Americans. Treatment of a number of other skin disorders is also being investigated in clinical trials.
SurModics technology was selected in part because of the company’s development experience. Philippe Wolgen, CEO of Clinuvel, said SurModics has an “impressive track record of progressing technology through the rigorous regulatory process, from clinical trials to commercialisation”.
SurModics in Alabama
Progression of Scenesse to commercialisation could be beneficial to SurModics. In January it opened a 90,000 sq ft manufacturing and development site in Birmingham, Alabama US and the licensing deal makes Clinuvel “yet another potential customer” for the plant, said Ankeny.
The Alabama plant gives SurModics commercial scale capacity and it believes this will help clients shorten the time to market. This also supports the progression of products to the royalty-generating phase of SurModics’ business model.
In May the Birmingham site was certified to be in compliance with ISO 9001:2008 by outside auditing body Det Norske Veritas.