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Roivant and Poxel announce strategic agreement for development and commercialization of imeglimin in the U.S., Europe, and additional countries worldwide.

Roivant Sciences, a global healthcare company focused on biomedical research, and Poxel SA, a biopharmaceutical company focused on the development of treatments for metabolic disorders, including type 2 diabetes, have signed a strategic development and license agreement for imeglimin, an investigational oral therapy which has been developed by Poxel for the potential treatment of type 2 diabetes, in the U.S., Europe, and all other countries not covered by Poxel’s existing agreement in East and Southeast Asia.1 

This partnership enables Roivant to add a late-stage development program to its pipeline and Poxel gains a strategic development and licensing agreement for imeglimin beyond the company’s partnership with Sumitomo Dainippon Pharma.

Under the terms of the agreement, Poxel is entitled to receive an upfront payment of $35 million (approximately €28 million) and Roivant will invest $15 million (approximately €12 million) in Poxel through a subscription to 1,431,399 newly-issued ordinary shares at €8.5 per share.

Poxel is entitled to receive potential future development and regulatory milestone payments and sales-based payments of up to $600 million (approximately €486 million) subject to the successful clinical development and commercialization of imeglimin. Furthermore, after launch Poxel will be entitled to double-digit royalties on net sales.

Roivant will be responsible for development and commercialization costs and Poxel will contribute $25 million (approximately €20 million) to the development program. The parties will decide on a potential co-promotion prior to commercialization.

“We are very pleased to partner with Roivant, an emerging leader in biopharma with proven commitment to developing innovative therapies in major disease areas," said Thomas Kuhn, CEO of Poxel. "Roivant’s vision complements Poxel’s strategy of bringing novel treatments for type 2 diabetes and other metabolic disorders to patients.

"The imeglimin Phase 3 TIMES type 2 diabetes program in Japan is underway with a target Japanese New Drug Application submission in 2020, and imeglimin is ready to advance into late-stage development in the U.S. and Europe," Kuhn continued. "2018 will be a transformative year for Poxel as we advance the TIMES program in Japan, collaborate with Roivant on imeglimin, and increase our focus on our earlier-stage pipeline.”

Activities in 2018 to support initiation of the Phase 3 program will include differentiation studies to confirm imeglimin’s potential in sensitive patient populations, such as those with chronic kidney disease, as well as manufacturing of the drug product for use in the Phase 3 program, according to the companies. The goal is to initiate the Phase 3 program in the U.S. and Europe in 2019.

Imeglimin has completed Phase 1 and Phase 2 development in 18 clinical studies involving over 1,200 subjects with type 2 diabetes in the U.S., Europe, and Japan, and met its primary and secondary endpoints, including a statistically significant decrease of HbA1c and fasting plasma glucose versus placebo, with a favorable side effect profile.

(Source: Poxel SA)

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