As per the terms of the agreement OEP will be responsible for clinical study expenses related to an ASC-J9 Phase IIb multi center trial in acne vulgaris. Scheduled to commence in September 2010, the 180 patients, double-blinded, placebo controlled efficacy study will be jointly conducted at clinical sites in Taiwan and the US.
Under this agreement OEP is expected to secure rights to the ASC-J9 acne product as the exclusive commercialisation partner for the core territories of Taiwan, Hong Kong, S Korea, New Zealand, Australia, and other select markets served by OEP throughout Asia Pacific.
ASC will support market approval of the ASC- J9 acne product in OEP designated territories by providing new drug approval materials following successful regulatory submission of the product in the US or Europe.
ASC said that it has recently initiated active discussions with US and European based multinational pharmaceutical companies to license the ASC-J9 acne product in major global markets.
Further, upon completion of Phase IIb study the ASC-J9 acne program will require ASC partnering with a multinational pharmaceutical company to support future large-scale clinical trials, regulatory approval process, and product launch in the US or EU. Business development professionals are directed to contact ASC or evaluate the ASC corporate website for additional information on the acne program.
Charles Shih, president, founder and CEO of ASC, said: “We are very impressed with OEP’s clinical development and drug commercialisation expertise. Aligning with OEP allows access to the capital resources necessary to complete a critical milestone towards demonstrating ASC-J9 as a safe and efficacious acne treatment. We maintain that ASC has secured a favorable agreement with a partner focused on long-term strategic goals for the ASC-J9 topical acne product.”