French biotech firm Neovacs (Alternext Paris: ALNEV) has signed an exclusive licensing agreement with Chong Kun Dang (CKD) Pharmaceutical to market the IFNα-Kinoïd for the indications Lupus and dermatomyositis, in South Korea.
In South Korea, Lupus is considered as an orphan disease, with an estimated market just below 20,000 patients. This should enable CKD to start the registration process with the South Korean health authority by the end of 2017, following successful completion of the 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 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 thousand patients. When filing for registration in Europe, USA and Asia, Neovacs should therefore have data concerning safety, tolerability and efficacy from more than two thousand patients,” said Miguel Sieler, chief executive of Neovacs, adding that “the valuation of the product agreed with CKD on the basis of the South Korean market size, is very promising.”
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