AOB Pharma and Maruho enter into an Exclusive License Agreement for AOB Pharma's Topical Biologic B244 for the Treatment of Inflammatory Indications including Atopic Dermatitis in Japan

• The license is exclusive for the territory of Japan and contains rights for future indications
• Maruho is responsible for conducting and bearing costs for development in Japan, which will be conducted jointly with AOB Pharma as part of a Global Phase 3 Study for Atopic Dermatitis encompassing Japan, the US, and EU
• The deal includes upfront payments, milestone payments and ongoing royalties.

CAMBRIDGE, Mass., Jan. 5, 2024 /PRNewswire/ -- AOBiome Therapeutics Inc. ("AOB"), a leading clinical-stage microbiome company focusing on inflammatory conditions, announced today that is has entered into an exclusive license and development agreement with Maruho Co., Ltd., to develop and commercialize AOB's topical biologic B244 (currently preparing for global Phase 3 clinical trials), a therapeutic treatment for dermatological indications including Atopic Dermatitis, for both appearance and pruritus (itch). The license is for all indications treated by the B244 platform.

Under the license agreement, Maruho will commercialize the product exclusively in Japan. Based on the license agreement, AOB will supply the product to Maruho, and Maruho will make an upfront payment and may also make additional milestone payments depending on achievement of development and commercialization milestones. Maruho also has the rights to AOB's B244 for all additional indications including later stage programs related to inflammation.

"B244 offers an opportunity to extend our portfolio for the treatment of Atopic Dermatitis as well as other inflammatory indications. It's unique safety profile and efficacy will allow us to continue our leadership in treating Atopic Dermatitis while improving patients' lives. We look forward to continuing to develop the treatment in collaboration with AOB Pharma." says Atsushi Sugita, President and CEO of Maruho.

"We are excited to be partnering with Maruho as they are the leading dermatology player in Japan. We view this as validation of B244's potential to address unmet market needs, not just in Japan but globally. We could not have found a better collaborator as we develop our programs for Japanese patients. This model will serve as an example as we fill out our worldwide strategy." says AOBiome's President & CEO, Todd Krueger.

AOB is in the process of planning global Phase 3 studies for B244 in Atopic Dermatitis, for which it aims to start recruiting patients in the second half 2024. The Japanese portion of the Phase 3 trials will be run in Japan by Maruho.

About B244

AOB's B244 platform is a patented, proprietary, topical formulation. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. B244 has been observed to be well-tolerated in clinical studies to date.

Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31. See full article at: https://www.nature.com/articles/s41598-021-93299-1.

About AOB Therapeutics, Inc.

AOBiome Therapeutics Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing topical therapeutics for inflammatory conditions. AOB is advancing a pipeline of multiple, clinical-stage therapeutic candidates. Learn more at AOBPharma.com.

About Maruho

Maruho Co., Ltd. has its head office in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,547 employees (as of the end of September 2022), and net sales were approximately 85.67 billion yen in its fiscal year ended September 30, 2022. With the mission "More smiles, brighter life for you.", Maruho aims to help realize a society where everyone can live with a smile.

For more information, please visit https://www.maruho.co.jp/english/

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SOURCE AOBiome Therapeutics