Lupin, Medis ink pact for Orphan Drug NaMuscla
NaMuscla reduces myotonia symptoms in the people with NDM, resulting in a significant improvement in quality of life and other functional and clinical outcomes for patients.
Mumbai: Global pharma major, Lupin Limited has announced that the company 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.
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.
Under the agreement announced, 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. 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 patients.
Lupin 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.
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