JW Choongwae, Dreaming of a Global New Drug, Faces Bittersweet Return of Technology After Phase 2 Failure of 'JW1601'

Export to Leopharma worth 540 billion KRW in 2018
Return decided due to failure to meet efficacy in Phase 2 clinical trial
No milestone payments received besides $17 million contract fee

JW Pharmaceutical's 'JW1601', which was being developed as a first-in-class new drug for atopic dermatitis treatment, has faced a setback. Although it was licensed out in 2018 to Danish dermatology specialist pharmaceutical company LEO Pharma for a total of $402 million (approximately 543.4 billion KRW), the pipeline was returned after failing to meet efficacy endpoints in the recently conducted Phase 2 clinical trial.

JW Pharmaceutical announced on the 20th that it had "received a contract termination notice" from LEO Pharma in Denmark and "agreed to reclaim all rights." The actual contract termination date is April 20 of next year, which corresponds to the contract clause requiring a six-month prior termination notice, and thus the termination notice was issued on this date.

JW1601 is an oral atopic dermatitis treatment with a dual mechanism of action that selectively targets the histamine H4 receptor to suppress inflammation and itching. Given that it was licensed out to LEO Pharma, the world's number one pharmaceutical company in the dermatology field and the original developer of 'Fucidin,' there were expectations that it would grow into a blockbuster, but this technology return has brought a bitter experience for now.

In August 2018, JW Pharmaceutical licensed out the global rights excluding Korea for the preclinical candidate JW1601 for a total of $402 million. This included a non-refundable upfront payment of $17 million (approximately 23 billion KRW) received the following month, and milestone payments totaling $385 million based on development, approval, and sales stages. Additionally, royalties based on net sales were also set.

Danish dermatology pharmaceutical company LEO Pharma
[Photo by LEO Pharma]

Subsequently, in 2020, JW Pharmaceutical conducted a Phase 1 clinical trial in Korea involving 88 healthy Korean, Japanese, and Caucasian subjects, confirming safety and tolerability across all dosage groups. Based on this, LEO Pharma proceeded with further development of JW1601 under the name 'Leuforant (LEO152020).' Among these, Phase 2a and 2b trials were initiated in December 2021 and completed in July of this year, involving 224 adult atopic dermatitis patients across the United States, Australia, Canada, Germany, and Japan. However, the primary efficacy endpoint, defined by the change in Eczema Area and Severity Index (EASI) over 16 weeks, was not met, leading LEO Pharma to decide on technology return for this reason.

However, JW Pharmaceutical plans to continue further development since there were no safety issues, similar to the Phase 1 trial. A JW Pharmaceutical representative stated, "Tolerability was confirmed in all drug administration groups, and no new safety issues or concerns were identified. Safety was also confirmed in separately conducted clinical results related to cardiac safety." They added, "Based on the drug's selective action on the histamine H4 receptor and the safety margin confirmed in clinical trials, we will review future development directions, including the potential for new indications, based on the translational research data accumulated so far."

This content was produced with the assistance of AI translation services.