Leo Pharma Enters License Agreement for Novel Atopic Dermatitis and Asthma Drug Candidate

April 16, 2020
Pharmaceutical Technology Editors

Medical dermatology company based in Denmark, Leo Pharma, has entered into a license agreement with two Eastern-Asian companies for the development and commercialization of FB825, a novel atopic dermatitis and allergic asthma drug candidate.

Medical dermatology company based in Denmark, Leo Pharma, has entered into a license agreement with two Eastern-Asian companies for the development and commercialization of FB825, a novel atopic dermatitis (AD) and allergic asthma drug candidate.

According to an April 15, 2020 press release, Leo Pharma has signed the exclusive worldwide agreement with Oneness Biotech from Taiwan and Microbio Shanghai from China. Under the terms of the agreement, Leo Pharma will provide an upfront payment of $40 million and will offer milestone payments worth up to $530 million in addition to tiered royalties. Oneness will be responsible for the Phase IIa study of FB825 in AD patients in the United States, and Microbio Shanghai will perform the Phase IIa study for allergic asthma in China.

FB825 is a humanized monoclonal antibody that has a unique mechanism of action (MoA), whereby it targets the CεmX domain of the membrane bound IgE (mIgE) causing a depletion of mIgE positive B-cells. This MoA reportedly offers promise as a treatment of AD and is predicted to reduce disease burden by lowering relevant inflammatory mediators as well as IgE levels.

“Having seen the first-in-human data of FB825 and the reduction in eczema area and severity index scores (an indicator of AD severity), we feel that we are welcoming a promising novel drug candidate into our development pipeline,” said Dr. Kim Kjøller, executive vice-president, Global R&D, Leo Pharma, in the press release. “No two patients are alike, and as there is a high unmet need we are committed to building a diverse pipeline that represents a broad range of molecules and mechanisms of action.”

Source: Leo Pharma