Leo Pharma A/S, of Ballerup, Denmark, has eyed a stronger company presence in Asia during the past year and took a giant step to achieving it by signing a worldwide exclusive licensing agreement with Oneness Biotech Co. Ltd., of Taipei, Taiwan, and Microbio Shanghai Co. Ltd. to develop and commercialize FB-825 for treating atopic dermatitis and allergic asthma.

“There is growing pressure by the population to get more access to more recent treatments, so the government is looking at how to allow it,” Catherine Mazzacco, Leo’s CEO, told BioWorld during the J.P. Morgan Healthcare Conference in San Francisco last January. “They are doing it quite effectively. Companies like us have a huge opportunity. That’s not to say there are not challenges, but at least there are opportunities.”

Catherine Mazzacco, CEO, Leo

Mazzacco noted specifically that the Chinese government is looking for new and different ways to approach the marketing authorization of products and the standards used in clinical trials.

Leo will pay $40 million up front and up to $530 million in milestone payments, to be followed by a tiered high single-digit to double-digit royalties. Oneness is to execute a phase IIa trial for atopic dermatitis in the U.S., and Microbio will conduct a phase IIa for allergic asthma in China. Once the studies are complete, Leo takes the development reins.

In its 2019 annual report, Leo noted that its total sales in China that year grew by 9%, driven by higher in-market sales. Building for future growth in Asia, the company noted the establishment of a new R&D Asia-Pacific Hub, in Japan, in order to be able to explore the rapidly developing opportunities in the Asia-Pacific area – especially Japan, China and South Korea.

Oneness’ FB-825 is an immunoglobin E antagonist used in hematologic, immune and dermatologic therapies, according to Cortellis. It is designed to target the CεmX domain of the membrane bound IgE (mIgE) causing a depletion of mIgE-positive B-cells. The goal is to lower relevant inflammatory mediators as well as IgE levels.

Oneness said it sees a potential $20.8 billion market in allergic disease/allergic asthma by 2024. The FDA granted FB-825 orphan drug designation for hyper IgE syndromes, rare primary immune deficiencies characterized by elevated serum IgE, rash, and recurrent bacterial infections of the skin and lung.

FB-825 came to Oneness by way of its merger with Fountain Biopharma Inc., a subsidiary of the Microbio group, in August 2019. Oneness had already been around for 11 years, researching treatments for diabetic foot ulcers. In 2009, its company stock was approved to be registered and traded over the counter and in 2011 the stock was approved to be traded on the Taipei Exchange.

In 2017, Oneness and Microbio agreed to develop a hepatoma drug in China, Hong Kong and Macao. The two companies, that same year, also agreed to develop a drug for treating chronic foot ulcers in China, Hong Kong and Macao. Oneness said it recently concluded recruitment for a phase III trial for its ON-101 cream. The randomized, evaluator-blinded, active-controlled, multicenter study is comparing the efficacy and safety of the cream and Aquacel Hydrofiber dressing. It expects to enroll 236 participants and conclude the study by September 2020. According to an interim analysis from the company, ON-101 achieved a more than 60% complete healing rate within 16 weeks (p=0.0065).

Microbio specializes in R&D of nucleic acid medicines and the microbiome using a library of anaerobic commensal bacteria metabolites. The company has FB-825 in a phase II open-label study of adults with atopic dermatitis to be conducted at a medical center in Taiwan. Microbio expects 12 subjects will be enrolled in the single-arm study.

Novartis AG and Roche Holding AG, both of Basel, Switzerland, have Xolair (omalizumab), which also targets IgE. In December, Japanese regulators approved Xolair’s pollen allergy indication. The European Commission approved it in December 2018 for self-administration in severe allergic asthma and chronic spontaneous urticaria.

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