Lupin has entered into a new distribution agreement with Celnova Pharma, enabling the launch of its orphan drug NaMuscla (mexiletine) in Argentina and Colombia.
In a press statement on Friday, the pharmaceutical giant informed that the partnership will provide access to NaMuscla, which is approved in the European Union for the treatment of myotonia symptoms in adults with non-dystrophic myotonic (NDM) disorders.
NaMuscla is the first and only approved treatment in Europe for these rare neuromuscular disorders, which are characterised by the inability of muscles to relax after voluntary contractions, leading to muscle stiffness (myotonia). Under the agreement, Celnova Pharma will handle the registration, importation, and commercialisation of NaMuscla in Argentina and Colombia. Lupin will manufacture and supply the product, while Celnova will leverage its expertise in managing patient-centric initiatives, especially in the area of rare diseases.
The agreement marks an important step in addressing unmet medical needs in Latin America for patients with non-dystrophic myotonic disorders. These rare conditions, which affect around 1 in 100,000 people, result from mutations in ion channels in skeletal muscles and significantly impact patients' quality of life by causing chronic muscle stiffness. NaMuscla has been shown to reduce myotonia symptoms, improving both functional outcomes and overall quality of life for patients.
Dr. Fabrice Egros, President of Corporate Development and Growth Markets at Lupin, highlighted the importance of the partnership, saying, "This collaboration with Celnova allows us to bring NaMuscla to two important Latin American markets, addressing the needs of patients with NDM disorders. Our goal is to create market-specific solutions while working with healthcare authorities, providers, and patient advocacy groups to make a meaningful difference for patients suffering from myotonia."
Juan Marrone, CEO of Celnova Pharma, expressed enthusiasm for the partnership: “We are excited to work with Lupin to introduce NaMuscla to patients in Argentina and Colombia. This agreement offers a significant opportunity to meet the needs of those living with NDM disorders, delivering an innovative therapy that can greatly enhance their quality of life. Our commitment to improving outcomes for patients with rare diseases aligns perfectly with this collaboration.”
Non-dystrophic myotonic disorders are a subset of rare, inherited neuromuscular conditions where patients experience chronic muscle stiffness or myotonia. The disorder manifests when muscles cannot relax properly after voluntary movements, such as walking or climbing stairs. Myotonia can affect different muscle groups, including those in the legs, arms, and face, causing discomfort and disability in daily activities.
Symptoms typically appear in childhood and persist throughout a person’s life. Because the condition is rare and complex, diagnosis and treatment are often delayed, exacerbating its impact on patients’ well-being. NaMuscla offers relief by reducing myotonia symptoms, which helps improve muscle function and enhances patients’ ability to perform everyday tasks.
NaMuscla (mexiletine) is the only approved treatment in Europe for symptomatic myotonia in adult NDM patients. By blocking voltage-gated sodium channels, NaMuscla reduces skeletal muscle hyperexcitability, thereby minimising the occurrence of muscle stiffness. Clinical trials have demonstrated its efficacy, with significant improvements in patient quality of life. Gastrointestinal discomfort has been reported as the most common side effect, with the treatment generally considered safe and well tolerated.
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