Lupin has announced that its subsidiary Lupin Atlantis Holdings SA has signed a distribution agreement with Celnova Pharma for Lupin’s orphan drug NaMuscla (mexiletine).

Celnova will commercialize NaMuscla in Argentina and Colombia, for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. NaMuscla is the first and only licensed product in Europe for this indication.

NDM disorders are a group of rare, inherited neuromuscular disorders, characterized by the inability to relax muscles due to voluntary contraction resulting in myotonia or muscle stiffness. 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 in Europe and the US, received EU marketing authorization in December 2018.

As per the agreement, Celnova will be the exclusive distributor of NaMuscla in Argentina and Colombia, and drive the registration, importation, storage, and sales. Celnova will leverage its regional expertise in managing patient-centric initiatives, particularly in the area of rare diseases, to ensure patients have access to this treatment. Lupin will manufacture and supply the finished products to Celnova.

“This is a significant step for Lupin as we introduce NaMuscla in two of our key Latin American markets. This is aligned to our commitment of meeting the needs of NDM patients by creating tailor-made solutions for each market, working with health authorities, healthcare providers, patient advocacy groups to help patients suffering from myotonia diseases,” said Dr. Fabrice Egros, President – Corporate Development and Growth Markets, Lupin.

“We are excited to partner with Lupin to bring NaMuscla to patients in Argentina and Colombia. This collaboration addresses a significant unmet need for those living with non-dystrophic myotonic disorders, offering an innovative treatment option that can greatly improve quality of life. At Celnova, we are dedicated to providing advanced therapies that enhance patient outcomes, and this agreement reinforces our commitment to making a positive impact in rare diseases,” said Juan Marrone, CEO, Celnova.