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JCR and Italfarmaco inked a multipurpose smart deal

Italfarmaco and JCR Pharmaceuticals have signed an exclusive licensing agreement to develop and market givinostat for Duchenne muscular dystrophy (DMD) treatment in Japan.

Category: Business Published Date: 30 December 2025
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Announcement

Italfarmaco S.p.A and JCR Pharmaceuticals Co., Ltd. excitedly announced their exclusive licensing agreement for the marketing and development of givinostat in Japan. Alongside, both companies are in collaboration for rare disease area as well.

Terms of the strategic deal

According to the terms of the agreement, Italfarmaco will give exclusive authority to JCR to marketise givinostat for the Duchenne muscular dystrophy (DMD) treatment in Japan, and the company will also be liable for the local implementation of any of the clinical development activities and regulatory submissions as well. Givinostat is commercialised as Duvyzat® in the EU, UK and the US.

It's an orally positioned histone deacetylase inhibitor established by Italfarmaco to cure DMD with or without an underlying dystrophin gene mutation. It has achieved regulatory rights throughout numerous crucial markets involving the UK, EU and US. Japan might be the next one for Italfarmaco. The deal also develops a spacious strategic partnership between the two companies to discover more joint opportunities to achieve milestones in the treatment of rare diseases.

Statements of the healthcare leaders

Head of Business & Portfolio Development and Vice President at Italfarmaco, Antonio Nardi, said, “This collaboration is a major success for our universal strategy of extending the reach to givinostat and intensifying our impact in rare diseases. JCR’s dedication to innovating the robust local expertise and focus on patient-oriented science makes them a perfect partner for extending our rare disease portfolios across Japan and worldwide.”

President, CEO and Chairman of JCR Pharmaceuticals, Shin Ashida, said, “Joining hands with Italfarmaco is a crucial step for JCR as we have stepped into the next phase of growth and may be the first ever in investing in a long-term partnership with Italfarmaco. This partnership might expand into a next-generation research and development joint initiative and lead us to cross-licensing opportunities further.”

“We stay committed towards establishing new therapies for the rare disease population, and givinostat is a support and expansion to our dedication to meet and serve the larger number of patients with rare diseases in Japan.”

Chairman of Italfarmaco Group, Francesco De Santis, said, “Together with JCR, we are extending access to a main DMD therapy for the Japanese Duchenne population. We are also building a base for future innovations in rare diseases. We are dedicated to serving the significant solutions ehere its meant to reach.”

Author

Chandni Pathak

Chandni Pathak

Holding M.Pharm in Pharmaceutical Chemistry, Chandni crafts cutting-edge, research-driven healthcare news for Towards Healthcare, combining scientific depth with innovative storytelling to simplify complex topics for global readers.