On February 9, 2022 Global pharma major, Lupin Limited (Lupin) reported that it hasentered into a distribution agreement with Medis for Lupin’sorphan drug NaMuscla (mexiletine) (Press release, Lupin, FEB 9, 2022, View Source [SID1234607945]). 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 .
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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 representsan 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 symptom3-5. 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).
Notes for Editors
About Myotonic Disorders and Non-Dystrophic Myotonias (NDM)
Myotonic disorders are a group of heterogeneous, inherited, neuromuscular disorders characterized by a shared symptom called myotonia. Myotonia can be described as an inability to relax a contraction of skeletal muscle which originates from a voluntary muscular contraction such as shaking someone’s hand and blinking, or everyday activities such as walking across a street and climbing stairs.
Non-dystrophic myotonias (NDM) are a sub-set of rare (prevalence of 1:100,0003), inherited, myotonic disorders which are caused by mutations within ion channels in the sarcolemma membrane of skeletal muscles. Non-dystrophic myotonias exhibit both sodium and chloride channelopathies which result in altered membrane excitability6. For patients with NDM, myotonia is the most prominent symptom and demonstrates different phenotypes in subgroups of NDM disorders, and can affect different parts of the body, such as legs, arms, or facial muscles, more severely6.
Myotonia in NDM patients has an onset in childhood and persists across their lifetime. Patients perceive that myotonia increases in severity over time, impacting daily life. Myotonia is described by patients in a variety of ways (stiffness, cramps, pain, difficulty releasing a fist, or difficulty swallowing or eating) which can contribute to substantial delays in diagnosis and treatment, leading to decreased patient quality-of-life and often significant disability4, 7.
About NaMuscla (mexiletine)
NaMuscla is the first and only antimyotonic agent licensed to treat symptomatic myotonia in adults with non-dystrophic myotonic disorders in Europe8. In randomized controlled trials, NaMuscla (167 to 500 mg/day) has been shown to significantly reduce myotonia compared to placebo, reducing skeletal muscle hyperexcitability through its use-dependent, voltage-gated, sodium channel blocking actions which are independent of the cause of channel function. This resulted in an improvement in patient quality-of-life and other functional outcomes, with gastro-intestinal discomfort reported as the most common adverse event, demonstrating NaMuscla to be safe and well tolerated1, 2, 8.