namuscla: Lupin enters pact with Medis to distribute orphan drug in Europe

Drug maker Lupin on Wednesday said it has entered into a distribution agreement with Medis for Lupin’s orphan drug NaMuscla (mexiletine).

Medis will commercialize NaMuscla for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders in Central and Eastern European countries.

Under the agreement, Medis will initially focus on the commercialization of NaMuscla in Croatia, Czech Republic, Hungary, Slovakia, and Slovenia in the first phase. Lupin will continue commercialization of NaMuscla in Germany, France, and the UK.

NaMuscla is the first and only licensed product for this indication.

NDM disorders are a group of rare, inherited neuromuscular disorders which is characterized by the inability to relax muscles following voluntary contraction. NaMuscla reduces myotonia symptoms in people with NDM, resulting in a significant improvement in quality of life and other functional and

clinical outcomes for patients.

NaMuscla, which has been designated orphan drug status, received EU marketing authorization in December 2018.

“We know that collaborating with partners which are highly focused in their territories means patients receive medicines in the most efficient way,” said Thierry Volle, president EMEA, Lupin.

Around 1,000 people in Central and Eastern Europe living with NDM have limited access to a licensed treatment for myotonia that can reduce the daily burden of this disabling, lifelong symptom.

Lupin said it has recruited the first study participants in a pediatric trial as part of the pediatric investigation plan for NaMuscla in children and a post-authorization study to address long-term safety and treatment effects on patient-reported outcomes in adults.