Italfarmaco and Medis, a leading pharmaceutical commercialisation company in Central and Eastern Europe, today announced an exclusive distribution agreement for Givinostat (Duvyzat), 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 (Duvyzat) 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). [Read More: What is Duvyzat (Givinostat)?]
In Which Countries Will Givinostat Be Available?
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.
About Givinostat
Givinostat was discovered through Italfarmaco’s research and development efforts in collaboration with Telethon and Duchenne Parent Project (Italy). Givinostat is an orally administered histone deacetylases (HDAC) inhibitor. HDAC is activity upregulated in DMD muscle and has the potential to modify the expression of certain genes and biological processes involved in muscle repair and inflammation.
