Pharmaceutical companies Italfarmaco S.p.A. and JCR Pharmaceuticals Co, Ltd (TSE 4552) on Wednesday announced an exclusive licensing agreement granting JCR Pharmaceuticals rights to develop and commercialise givinostat in Japan for the treatment of Duchenne muscular dystrophy.

Under the agreement, JCR Pharmaceuticals will lead local clinical development, regulatory submissions and commercial execution in Japan, where givinostat is not yet approved. Givinostat, marketed as Duvyzat in the US, UK and European Union, is an orally administered histone deacetylase inhibitor developed by Italfarmaco to treat Duchenne muscular dystrophy irrespective of dystrophin gene mutation.

Deal terms also establish a broader strategic collaboration focused on rare diseases, with both companies set to explore joint opportunities leveraging JCR Pharmaceuticals' research and development pipeline and platform technologies to strengthen their respective portfolios.

Duchenne muscular dystrophy is a severe, progressive neuromuscular disorder primarily affecting boys, leading to loss of ambulation and life-limiting cardiac and respiratory complications. The condition affects an estimated 3,500 patients in Japan, representing a significant unmet medical need.