2020-04-17| Asia-PacificLicensing

LEO Pharma Strikes Deal with Asian Firms to Develop Atopic Dermatitis & Allergic Asthma Drug

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

On April 15th, Denmark-based LEO Pharma, a global leader in medical dermatology, made a worldwide exclusive licensing agreement with Oneness Biotech & Microbio Shanghai to co-develop and commercialize FB825, its latest atopic dermatitis, and allergic asthma candidate. Oneness Biotech, headquartered in Taipei, Taiwan, focuses on developing drugs for diabetes-related and immune diseases. An interim analysis revealed that its new drug ON101 shows a complete healing rate of over 60% within 16 weeks, in patients with diabetic foot ulcers. The company plans to continue substantiating drug efficacy through its first, global Phase 3 trial. Chinese company, Microbio Shanghai, specializes in developing nucleic acid medicines and microbiomes via its special microbial pharmaceutical technology platforms. It owns hundreds of different anaerobic commensal bacteria metabolites to set foot in the area of next-generation medicines.

The cooperation between the three firms is built on exchanging technical support. According to the terms of the agreement, LEO Pharma will pay $40 million upfront and up to $530 million as milestone payments and royalties. Oneness, in turn, will conduct a phase IIa trial for atopic dermatitis in the U.S. And, Microbio will perform a phase IIa for allergic asthma in China. Once the phase IIa studies and trials are completed, LEO Pharma will take the lead of all future developments. In addition, FB825 has gained global patent protection, granted by the majority of countries like the U.S., Japan, China, E.U. and Taiwan. The FDA had granted orphan drug designation to FB825 in 2017, for hyper IgE syndromes (HIES), rare primary immune deficiencies triggered by a high level of IgE, rash and recurrent bacterial infections of skin and lungs. The Taiwan Food and Drug Administration (TFDA) also granted the phase II approval in atopic dermatitis for the drug.


FB825 – An Atopic Dermatitis & Allergic Asthma Drug

About 5% of adults worldwide suffer from Atopic dermatitis, a chronic, heterogeneous, inflammatory skin disease usually accompanied by eczematous lesions and intense itch. Allergic asthma, on the other hand, is incurred by inhaling allergens and victimizes approximately 300 million people. The frequent, severe attacks, leads to reduced lung function and a poor quality of life.

FB825 is a humanized monoclonal antibody that interacts with the CεmX domain of membrane-bound immunoglobin E antagonist (IgE) such that it induces apoptosis and antibody-dependent cellular cytotoxicity through eliminating IgE positive B-cells. This novel action of mechanism indicates a potential treatment for atopic dermatitis by appeasing the disease symptoms through lowering the inflammatory factors and IgE levels (> 1500 IU/mL). The executive vice president of global research & development at LEO Pharma, Kim Kjoeller, M.D., felt very optimistic toward the novel drug entering their development pipeline, after reviewing the first-in-human data of FB825 and the reduction in the Eczema Area and Severity Index score (a measurement of atopic dermatitis severity).

According to Oneness’, FB825 seems to be effective both as a preventive and therapeutic drug with mild side-effects. It can achieve optimal efficacy with a reduced drug dosage when administrated in combination with Omalizumab or other anti-allergy drugs. Furthermore, the drug is expected to be administered only once every 2 to 3 months for lowering the medical cost and enhancing the convenience of patients.

Related Article: Regeneron & Sanofi’s Phase 3 Dupixent Data on Children Under Regulatory Review



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