- LEO Pharma will obtain exclusive rights to develop and commercialize JW1601 in the global market excluding Korea.
- JW Pharmaceutical will receive upfront and milestone payments of up to US$ 402 million. Apart from such milestone payments, a royalty will be awarded.
- JW1601 is a novel atopic dermatitis drug candidate intended for oral treatment of atopic dermatitis which is expected to maximize efficacy by dual action of anti-pruritus (anti-itch) and anti-inflammation and minimize adverse events by high selectivity on the target.
- Expected to lead the histamine H4 targeting market as the best-in-class drug.
Seoul, South Korea and Ballerup, Denmark August 24, 2018 – JW Pharmaceutical (“JWP”) and LEO Pharma A/S (“LEO Pharma”) announced today, 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.”
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About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 130 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,200 people worldwide.
About JW Pharmaceutical Corporation
JW Pharmaceutical Corporation has been leading Korean medicine and medical supplies market over its 70 years of history. The company focuses on the field of research and development of anti-cancer drug and etc.; manufacture and sales of hospital fluid, antibiotic and other ethical pharmaceuticals. JW Pharmaceutical Corporation was founded in 1945, and listed on the Korea Exchange Market under the symbol "001060 ". More information is available at http://www.jw-pharma.co.kr/pharma/en/main.jsp.
JW1601 is an orally available histamine H4 receptor inverse agonist with anti-pruritic and anti-inflammatory dual effect. It shows anti-chemotactic activity in eosinophil shape change and therapeutic effect in spontaneous NC/Nga AD model. JW1601 is currently conducting pre-clinical toxicity study and looking for phase 1 IND submission in 2018 in Korea.