Global pharma major, Lupin Limited (Lupin) announced today that 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. 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 patients¹. NaMuscla®, which has been designated orphan drug status, received EU marketing authorization in December 2018².

Under the agreement announced today, Medis will initially focus on the commercialization of NaMuscla® in the Central and East European countries, namely Croatia, Czech Republic, Hungary, Slovakia, and Slovenia in the first phase. Lupin will continue commercialization of NaMuscla® in Germany, France, and the UK.

“The distribution agreement represents an important milestone for Lupin as we continue the roll out of NaMuscla® across Europe. 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.

"At Medis, we are very excited to partner with Lupin and are further committed to using our expertise in comprehensive commercialisation to provide new, innovative treatment options like NaMuscla® that address patients' unmet needs. For us, each patient counts," said Martina Perharič, CEO of Medis. "As a pioneer in full-service pharmaceutical distribution for the CEE region, we have gained extensive knowledge of the complex markets in the region. This allows us to launch NaMuscla® quickly and effectively in selected countries and provide excellent support to our partner Lupin."

Today, 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^3-5. Limited access leads to inconsistent medication supply, administrative challenges, and associated financial burdens. Coupled with low awareness and limited clinical experience among healthcare professionals due to the rare nature of the disease, may result in significant harm to patients⁴.

Lupin has recruited the first study participants in a pediatric trial as part of the pediatric investigation plan for NaMuscla® in children (NCT04624750) and a post-authorization study to address long-term safety and treatment effects on patient-reported outcomes in adults (NCT04616807).