Italfarmaco S.p.A. and Medis announced an exclusive distribution agreement for givinostat, Italfarmaco’s drug for the treatment of Duchenne muscular dystrophy (DMD). Once approved by the EMA and relevant regulatory bodies, this partnership will facilitate patient access to givinostat across 17 EU and non-EU countries covered by the agreement. No financial terms were disclosed.
Givinostat has already received regulatory approval in the US and UK, with an evaluation ongoing by the European Medicines Agency (EMA).
Under the terms of the agreement, Italfarmaco grants Medis exclusive distribution rights for givinostat in Poland, Romania, Czech Republic, Hungary, Bulgaria, Slovakia, Croatia, Slovenia, Lithuania, Latvia, and Estonia. The non-EU countries within the agreement include Serbia, Albania, Kosovo, Bosnia and Herzegovina, North Macedonia, and Montenegro. Medis will be responsible for the full commercialisation of givinostat, including market access, medical, sales and marketing activities, and supply.
Antonio Nardi, Vice President and Head of Business & Portfolio Development of Italfarmaco, said, “We understand the challenges that families affected by DMD face every day. Ensuring that patients in Central and Eastern Europe have access to givinostat is not just important - it’s essential. By partnering with Medis, which has deep expertise and a strong infrastructure in rare diseases, we can help bring this much-needed treatment to patients who need it most.”
Martina Perharič, Chief Business Officer at Medis, added, “Living with DMD is incredibly challenging for patients and their families, and access to effective treatment can make a real difference in their lives. With our deep regional knowledge and strong local presence, Medis will ensure a seamless and timely introduction of givinostat across Central and Eastern Europe as soon as approvals are in place. We are dedicated to supporting patients every step of the way.”
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