Agreement enables access of EU-approved treatment for myotonia symptoms
in non-dystrophic myotonic disorders to patients from Argentina and Colombia

Mumbai, Zug, Sept 27, 2024: Global pharma major, Lupin Limited (Lupin) announced today 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.

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 patients¹. NaMuscla®, which has been designated orphan drug status in Europe and US, received EU marketing authorization in December 2018².

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.

Notes for Editors

About Myotonic Disorders and Non-Dystrophic Myotonias (NDM)
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.

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 excitability⁶. 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 severely⁶.

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 disability⁴,⁷.

About NaMuscla® (mexiletine)
NaMuscla® is the only antimyotonic agent licensed to treat symptomatic myotonia in adults with non-dystrophic myotonic disorders in Europe⁸. 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 tolerated¹, ², ⁸.

About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

For further information or queries please contact –

Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com

About Celnova
Celnova Pharma is a pharmaceutical company with a strong focus on complex therapeutic classes, including rare diseases, oncology, central nervous system disorders, diabetes, and critical care. The company collaborates with multinational pharmaceutical and biotech companies to bring innovative treatments to patients across Latin America, improving access to advanced therapies.

Celnova operates in Argentina, Colombia, Chile, Peru, and Uruguay, commercializing a range of products through its own sales force, targeting specialist doctors and institutional buyers. The company aims to expand through organic growth and strategic partnerships.

Please visit www.celnova.com for more information.
Follow us on LinkedIn: https://www.linkedin.com/company/celnova-pharma

Contact for media inquiries:

Clara Ruiz
Manager – Marketing and Communications
cruiz@celnova.com

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