Lupin Limited, a leading global pharmaceutical company, has announced that its subsidiary, Lupin Atlantis Holdings SA, has entered into a distribution agreement with Celnova Pharma for the commercialization of its orphan drug, NaMuscla® (mexiletine). Celnova will be responsible for distributing NaMuscla® in Argentina and Colombia, where it will be used to treat myotonia in adults with non-dystrophic myotonic (NDM) disorders. NaMuscla® is the only licensed treatment in Europe for this specific condition.
NDM disorders are rare inherited neuromuscular conditions marked by the inability to relax muscles after voluntary contraction, leading to muscle stiffness or myotonia. NaMuscla® effectively alleviates myotonia symptoms in individuals with NDM, significantly enhancing their quality of life and other functional outcomes. The drug received orphan drug designation in both Europe and the US, and it gained EU marketing authorization in December 2018.
Under the terms of the agreement, Celnova will act as the exclusive distributor of NaMuscla® in the two countries, overseeing its registration, importation, storage, and sales. Celnova plans to utilize its regional expertise in managing patient-focused initiatives, particularly in the realm of rare diseases, to ensure access to this crucial treatment. Lupin will handle the manufacturing and supply of the finished product.
Dr. Fabrice Egros, President of Corporate Development and Growth Markets at Lupin, stated, “This partnership marks a significant milestone for Lupin as we introduce NaMuscla® to two key markets in Latin America. We are committed to addressing the needs of NDM patients by developing tailored solutions, collaborating with health authorities, healthcare providers, and patient advocacy groups to support those suffering from myotonic disorders.”
Juan Marrone, CEO of Celnova, expressed enthusiasm about the partnership, stating, “We are thrilled to collaborate with Lupin to make NaMuscla® available to patients in Argentina and Colombia. This agreement meets a critical unmet need for individuals living with non-dystrophic myotonic disorders, providing an innovative treatment that can significantly enhance their quality of life. At Celnova, we are dedicated to offering advanced therapies that improve patient outcomes, and this partnership reinforces our commitment to positively impacting rare diseases.
