Lupin Limited, a global pharmaceutical leader, has taken a significant step forward in expanding its presence in Latin America through a new partnership with Celnova Pharma. The partnership focuses on the distribution of NaMuscla® (mexiletine), an orphan drug approved in Europe for treating myotonia in adults suffering from non-dystrophic myotonic (NDM) disorders. This agreement will bring the life-changing treatment to patients in Argentina and Colombia, where access to such specialized medications is limited.
NaMuscla® holds the distinction of being the first and only licensed treatment in Europe for non-dystrophic myotonia. This rare, inherited neuromuscular disorder prevents muscles from relaxing after voluntary contraction, causing significant muscle stiffness and discomfort. By targeting the root cause of these symptoms, NaMuscla® improves patients’ quality of life and addresses various clinical challenges associated with the disease.
Non-Dystrophic Myotonic (NDM) Disorders: A Rare Condition
NDM disorders are rare conditions with a prevalence rate of just 1 in 100,000 people. These disorders are caused by genetic mutations in the ion channels of skeletal muscles, which result in impaired muscle relaxation after voluntary contraction. This condition, known as myotonia, affects the legs, arms, and facial muscles, with the severity of symptoms varying across different patients. Symptoms can start in childhood and continue throughout a person’s life, impacting their daily routine and overall mobility.
Myotonia is often described by patients as muscle stiffness, cramps, or difficulty releasing a contracted muscle. These symptoms are more than just physical discomfort—they can lead to significant delays in diagnosis, resulting in a decrease in quality of life and, in some cases, permanent disability. Patients often struggle with simple daily activities like walking, climbing stairs, or even shaking hands.
NaMuscla®: A Game-Changer for NDM Patients
NaMuscla® addresses the debilitating symptoms of myotonia by reducing muscle hyperexcitability. This helps relieve the stiffness and discomfort experienced by patients, providing much-needed relief. Through its voltage-gated sodium channel blocking mechanism, the drug allows muscles to relax more easily, significantly improving patients’ daily function and overall well-being. NaMuscla® has been widely recognized for its effectiveness and safety, with gastro-intestinal discomfort being the most common side effect reported during clinical trials. The drug has received orphan drug status in both Europe and the U.S., further underscoring its importance in treating rare diseases like NDM.
Distribution Agreement with Celnova
The agreement between Lupin and Celnova Pharma ensures that NaMuscla® will now be available in Argentina and Colombia, two key markets in Latin America. Celnova will be responsible for the registration, importation, storage, and sales of the drug, leveraging its expertise in managing patient-centric initiatives for rare diseases. This partnership will enable patients in these regions to access much-needed treatment for a condition that has long been underdiagnosed and undertreated.
A Commitment to Improving Patient Outcomes
Speaking about the partnership, Dr. Fabrice Egros, President of Corporate Development and Growth Markets at Lupin, emphasized the company’s commitment to addressing the unmet needs of NDM patients. “This is a significant step for Lupin as we introduce NaMuscla® in two of our key Latin American markets. We are committed to working with healthcare providers, authorities, and patient advocacy groups to help those suffering from myotonia,” he said.
Juan Marrone, CEO of Celnova, echoed these sentiments, highlighting the importance of providing innovative treatments for rare diseases. “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 NDM disorders and reinforces our commitment to improving patient outcomes.”
