BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced that is has signed a worldwide exclusive licensing agreement with Oneness Biotech (Taiwan, TPEx: 4743) and Microbio Shanghai (China) covering the development and commercialization of the novel Atopic Dermatitis (AD) and Allergic Asthma drug candidate, FB825.

FB825 is a first-in-class drug candidate with a unique mechanism of action (MoA) targeting the CεmX domain of the membrane bound IgE (mIgE) causing a depletion of mIgE positive B-cells. This new MoA holds promise as a treatment for atopic dermatitis and is expected to reduce the 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 Kjoeller, Executive Vice President, Global Research & Development, LEO Pharma. “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”.

LEO Pharma and both Oneness Biotech and Microbio Shanghai see great potential in FB825. If the anticipated treatment profile can be confirmed in the upcoming trials, the product can be expected to help a significant number of patients suffering from atopic diseases.

Under the terms of the agreement, LEO Pharma will make an upfront payment of USD 40 million and offer milestone payments up to USD 530 million, followed by a tiered high single-digit to double-digit royalties. Under the agreement, Oneness will be responsible for executing the Phase 2a study for Atopic Dermatitis in the United States and Microbio Shanghai will execute the Phase 2a study for allergic asthma in China. LEO Pharma will assume all the development responsibilities after the Phase 2a studies.

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NOTES TO EDITORS

About LEO Pharma

LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million. For more information please visit: www.leo-pharma.com

About Oneness Biotech

Oneness Biotech, a listed biotech company in Taiwan (TPEx: 4743), is dedicated to fulfilling the unmet needs in diabetes-related and immune diseases. Besides FB825, Oneness Biotech has another new drug, ON101 in diabetic foot ulcer that completed recruitment of its first global Phase 3 trial. According to its interim analysis, ON101 has achieved over 60% complete healing rate within 16 weeks (p=0.0065). In the past 20 years, all Phase 3 clinical trials in DFU have failed. In addition, Oneness Biotech’s pipeline further includes fully-human antibody anti-IL 6, anti-IL 33 and other new drugs under development. For more information, please visit: www.onenessbio.com.tw/en

About Microbio Shanghai

Microbio Shanghai (“MBS”) is a company focused on immune and metabolic diseases. MBS will conduct Phase 2 trial of FB825 in allergic asthma in China. In addition, MBS is specialized in research and development into nucleic acid medicines and microbiome via its unique microbial pharmaceutical technology platforms. Its library with hundreds of unique anaerobic commensal bacteria metabolites has obtained significant findings in treatment of diabetes and immune diseases which takes it a further step into next-generation medicines.

About FB825

FB825 is a humanized monoclonal antibody that binds to the CεmX domain of membrane form IgE, leading to depletion of IgE+ B lymphocytes by inducing apoptosis and antibody-dependent cellular cytotoxicity (ADCC). FB825 is scheduled to be tested in Phase 2 trials for Atopic Dermatitis in US and for Allergic Asthma in China. In addition, FB825 is granted an orphan drug designation by US FDA in Hyper IgE Syndrom (HIES).

About Atopic Dermatitis

Atopic dermatitis (AD) – also known as ‘atopic eczema’ – is a chronic, inflammatory, heterogeneous skin disease characterized by intense itch and eczematous lesions.²

AD is the most common inflammatory skin disease in the developed world,³ affecting up to 5% of adults across the US, Canada, Europe and Japan.^{4, 5}

About Asthma

Allergic Asthma, which is the most common form of asthma triggered by inhaling allergens. The severe form of asthma affecting an estimated 300 million¹ individuals worldwide, is a debilitating, potentially fatal disease that has a significant negative impact on patients’ lives, often leading to frequent, severe attacks, reduced lung function and a poor quality of life.

References:

1. Msaoli et. al., Allergy 2004.
2. Weidinger S & Novak N. Atopic dermatitis. Lancet 2016;387:1109-1122.
3. Weidinger S et al. Atopic Dermatitis. Nat Rev Dis Primers 2018; 4(1):1.
4. Barbarot S, Auziere S et al. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy. 2018;73(6):1284-1293. doi: 10.1111/all.13401.
5. Barbarot S et al. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy 2018;73:1284-1293.

Contacts

Media Contacts

LEO Pharma A/S
Maia Fredtoft Søchting,

Corporate Communications Manager

+45 2681 4579

[email protected]