JW Pharma CEO Jeon Jae-kwang (left) and Professor Kim Kjoeller, Leo Pharma’s head of global R&D, shake hands after signing the licensing agreement at JW Pharmaceutical headquarters in Seocho-dong, Seoul, on Friday.

JW Pharmaceutical said Friday that it has licensed out JW1601, an atopy treatment candidate, to Leo Pharmaceutical, a Denmark-based multinational pharmaceutical company.

JW1601 has a dual mechanism of action that selectively inhibits histamine H4 receptors, which blocks the activity and migration of immune cells that cause atopic dermatitis, and histamine signaling that causes itching. In particular, as an oral agent, the treatment has a new mechanism of inhibiting itching and inflammation caused by atopic dermatitis.

Through this agreement, Leo Pharma will acquire global exclusive development and commercialization rights for JW1601 except for Korea. JW will have exclusive rights in Korea.

Also, JW will receive up to $385 million in milestone payment, which includes clinical development, licensing, commercialization, and sales as well as a $17 million in fixed settlement payments, from Leo Pharma. JW can also receive additional royalties of up to double-digit percentage depending on the global net sales of the product.

“The agreement is significant as it recognized a new drug candidate at pre-clinical levels for its future commercial value,” the company said.

With the support from Korea Drug Development Fund (KDDF), the company has been conducting preclinical toxicity testing and clinical drug production at the FDA investigational new drug (IND) level. JW plans to apply for IND until the end of this year.

“Atopic dermatitis is a disease with high unmet needs for a safe and effective oral remedy,” said Professor Kim Kjoeller, head of global R&D for Leo Pharma. “We are very pleased to have secured a global license for JW1601, an innovative drug candidate.”

JW1601 will create synergies in perfect harmony with the new drugs currently under development by Leo Pharma, he added.

Lee Kyung-jun, director of JW’s new drug research center, also said, “The agreement is meaningful as it shows that Leo Pharma, a world leader in dermatology, has recognized the value of JW1601.”

The company is confident that the cooperation between the two companies will lead to successful development and commercialization, Lee added.

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