Italfarmaco and JCR Pharmaceuticals have announced an exclusive licensing deal to develop and commercialize givinostat in Japan, marking a major step forward for patients with Duchenne muscular dystrophy (DMD) in the country.
Under the agreement, JCR will hold exclusive rights to market givinostat for DMD in Japan and will lead local clinical development and regulatory submissions. Givinostat, sold as Duvyzat in the US, UK, and EU, is an oral histone deacetylase inhibitor designed to treat DMD regardless of the underlying dystrophin mutation. While approved in several major markets, it is not yet available in Japan.
The partnership also sets the stage for broader collaboration on rare disease treatments.
“This partnership is a key milestone in our global strategy to expand access to givinostat and deepen our impact in rare diseases,” said Antonio Nardi, Vice President and Head of Business & Portfolio Development of Italfarmaco.
“JCR’s commitment to innovation, strong local expertise, and focus on patient-centred science make them an ideal partner for the expansion of our rare disease portfolios, not only in Japan, but also globally.”
“Partnering with Italfarmaco is an important step for JCR as we enter the next phase of our growth and may be the first step in a long-lasting relationship between both companies that may extend into future research and development partnerships and cross-licensing opportunities,” said Shin Ashida, Chairman, President and CEO of JCR Pharmaceuticals.
"We remain dedicated to developing therapies for the rare disease community, and givinostat extends this commitment to an even broader group of patients with rare diseases in Japan.”
Francesco De Santis, Chairman of Italfarmaco Group, added: “By joining forces with JCR, we are expanding access to an important DMD therapy for the Japanese Duchenne community and also laying the groundwork for future innovations in rare diseases. Together, we are committed to delivering meaningful solutions where they are needed most.”
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