Yuhan Corp. said that it has licensed out YH12852, a gastrointestinal motility disorder treatment, to Processa Pharmaceuticals, a U.S. pharmaceutical firm.

Yuhan has licensed out its gastrointestinal treatment, YH12852, to Processa Pharmaceuticals. (Yuhan)

YH12852, a synthetic new drug developed by Yuhan, is an agonist that exhibits excellent selectivity to a receptor (5-HT4) that plays an essential role in the regulation of intestinal movement and sensory.

"While cisapride, an existing licensed drug, showed therapeutic effects in various gastrointestinal motility disorders, the drug has reported serious cardiovascular side effects due to low selectivity to 5-HT4 receptors,” the company said. "Such adverse effects have led to the cancellation or limited indication of cisapride-based drugs."

However, YH12852 has already performed preclinical toxicity and phase 1 clinical trial in Korea. It has confirmed excellent bowel movement improvement effects without cardiovascular side effects.

Under the accord, Yuhan can receive up to $415 million and receive $2 million worth of Processa Pharmaceuticals shares as a down payment. At the same time, Processa will secure exclusive rights to the development, manufacturing, and commercialization of YH12852 worldwide except for Korea.

Besides, Yuhan can receive additional payments, including milestones for development and approval, and royalties for a certain percentage of net sales after commercialization.

Processa plans to conduct a phase 2 clinical trial in functional gastrointestinal motility diseases that require better treatments, such as postoperative intestinal obstruction or opioid-induced constipation, starting from a clinical development meeting with the U.S. Food and Drug Administration in 2021.

"We are happy to have met a partner with the expertise necessary for the development of the new drug YH12852, and we hope that the future development will proceed smoothly," Yuhan Corp. CEO Lee Jung-hee said. "Functional gastrointestinal disease is a disease that greatly affects the quality of life, and we hope that YH12852 will be able to provide patients with more effective treatment options than conventional treatments."

Processa Pharmaceuticals CEO David Young said, "The YH12852 license agreement with Yuhan is part of Processa's strategy to find innovative treatments for diseases with high medical unmet needs."

Processa, which has substantial scientific expertise in gastrointestinal therapy, plans to demonstrate the potential of treatment for patients suffering from severe, chronic, or recurrent gastrointestinal diseases through future development of YH12852, Young added.

corea022@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>