Italfarmaco and JCR Pharmaceuticals announced an exclusive licensing agreement for the development and commercialisation of Duvyzat (Givinostat) in Japan.
Under the terms of the agreement, JCR receives exclusive rights to commercialise givinostat for the treatment of Duchenne muscular dystrophy (DMD) in Japan and will be responsible for the local execution of clinical development activities, as well as regulatory submissions. >> What is Givinostat?
Givinostat (marketed as Duvyzat® in the US, UK and EU) is an orally administered histone deacetylase inhibitor developed by Italfarmaco to treat DMD, regardless of the underlying dystrophin gene mutation. It has obtained regulatory authorisation across several major markets, including the US, EU and the UK; it is currently not approved in Japan.
The agreement also establishes a broader strategic collaboration between the two companies to explore joint opportunities for the treatment of rare diseases.
“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.”
Read More: Clinical Trials for Duchenne (List of All Researches)
