France-based Neovacs has entered a licensing agreement with South Korea’s Chong Kun Dang (CKD) Pharmaceutical Corp. to market IFNα-Kinoïd for lupus and dermatomyositis in South Korea.
In South Korea lupus is considered an orphan disease, with an estimated market just below 20,000 patients. CKD says it plans to start the registration process with the South Korean health authority by the end of 2017, following successful completion of an ongoing Phase IIb trial, which includes five investigation centers in South Korea.
“This first partnering has a great priority for Neovacs as it should enable market access by early 2018 for IFNα-Kinoïd. We are very confident that with CKD we have the right partner for South Korea. More than one-thousand Korean patients are expected to be treated and followed between 2018 and 2020, in parallel to the Phase III trials—Europe and America—which should also include approximately one-thousand patients. When filing for registration in Europe, U.S. and Asia, Neovacs should therefore have data concerning safety, tolerability and efficacy from more than two-thousand patients,” said Miguel Sieler, chief executive officer, Neovacs. “The valuation of the product agreed with CKD on the basis of the South Korean market size is very promising.”
“CKD is one of the largest pharmaceutical companies in South Korea, with a leading position in the market of immune suppressive treatments. As a consequence, CKD has already established close ties with doctors who treat lupus patients. We have the strong ambition of a rapid market penetration with this innovative treatment, and are proud to strengthen our competency in immunotherapy thanks to this ground breaking French technology,” said Young Joo Kim, president, CKD.
Neovacs will receive €5 million in total, with one million as down-payment followed by milestone payments until first sales.
