• 28 Sep 2024
• Admin
• News Article

Celnova Pharma to Distribute Lupin’s Orphan Drug, NaMuscla in Argentina & Colombia

Celnova Pharma to distribute Lupin’s orphan drug, NaMuscla in Argentina & Colombia to treat myotonia in adults with NDM disorders

Overview

Global pharma major, Lupin Limited (Lupin) announced that its subsidiary Lupin Atlantis Holdings SA has entered into a distribution agreement with Celnova Pharma (Celnova) 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. 

About the NDM Disorders

• 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 US, received EU marketing authorization in December 20182. 

Terms of Agreement

• 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. 

Statement from the Lupin

“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. 

Words from the CEO: Celnova

• "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. 

About Myotonic Disorders

• 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. 

About Non-Dystrophic Myotonias

• 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 excitability. 
• 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 severely. 

Impact of Myotonia in NDM Patient’s Life

• 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 disability. 

NaMuscla: Sole Antimyotonic Agent

• NaMuscla is the only antimyotonic agent licensed to treat symptomatic myotonia in adults with non-dystrophic myotonic disorders in Europe. 
• 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 tolerated.