JW Pharmaceutical and LEO Pharma A/S announced that they have signed a global licensing agreement for JWP’s novel atopic dermatitis drug candidate, JW1601, under which, LEO Pharma, a global leader in medical dermatology, will gain the exclusive rights to develop and commercialize JW1601 globally excluding Korea where JWP will maintain its exclusivity. JWP will receive US$ 17 million as upfront fee and stepwise development and sales milestone in sum of up to US$ 385 million. Therefore, JWP will receive a total of up to US$ 402 million which is equivalent to 450 billion KRW. Apart from the milestone payments, JWP will receive up to two digit royalty based on the net sales.
JW1601 is an innovative new drug candidate developed by C&C Research Laboratories, a research and development company which is one of the affiliates of JWP. In May 2017, JWP acquired the global exclusive rights to develop and commercialize JW1601 and plans to submit Investigational New Drug application (IND) for Phase 1 clinical trial within this year.
JW1601 has a dual mechanism of action that blocks the activation and migration of the immune cells that cause atopic dermatitis by selectively acting on the histamine H4 receptor and inhibiting the histamine signaling that causes itching. The drug is expected to show good efficacy because it has both anti-pruritic (anti-itch) and anti-inflammatory effect whereas the competing substances only show the efficacy in anti-inflammatory. Also, it is expected to demonstrate a good safety profile due to its high selectivity towards H4 receptor.
“We see a high unmet need for safe and effective oral treatments for people suffering from atopic dermatitis. It is therefore with great excitement that we partner with JW Pharmaceutical on their novel oral atopic dermatitis drug candidate, JW1601. At LEO Pharma, we continuously seek to expand our pipeline with new innovative solutions with the ultimate aim of bringing real life-changing medicines to the many patients we serve. This compound is a perfect fit with our existing biologics currently in phase III (Tralokinumab) and phase I (LP0145) and our topical Delgocitinib currently in phase II,” said Kim Kjoeller, Executive Vice President, Global R&D, LEO Pharma.
Kyoung June Lee, Executive Vice President, Chief of Drug Discovery Center commented that “We find it very positive that LEO Pharma, a global leader in medical dermatology, recognizes the value of JW1601. We have confidence in successful development and global commercialization of JW1601 and we see LEO Pharma as the right partner for this project. JWP will do our best so that the other innovative new drug candidates under development at JWP also can show tangible result.”