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Lupin partners with Celnova Pharma to distribute NaMuscla in Argentina and Colombia

NaMuscla (mexiletine) to be commercialised for the treatment of non-dystrophic myotonic disorders in adults

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Global pharmaceutical company Lupin has announced that its subsidiary, Lupin Atlantis Holdings SA, has entered into a distribution agreement with Celnova Pharma for Lupin’s orphan drug, NaMuscla (mexiletine). Celnova will commercialise NaMuscla in Argentina and Colombia for the treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. NaMuscla is the first licensed product in Europe for this specific condition.

Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular conditions that cause an inability to relax muscles, leading to myotonia or muscle stiffness. NaMuscla helps reduce the symptoms of myotonia, resulting in improvements in quality of life and other functional outcomes for patients. The drug, which has been granted orphan drug status in Europe and the US, received EU marketing authorisation in December 2018.

Under the terms of the agreement, Celnova will be the exclusive distributor of NaMuscla in Argentina and Colombia, responsible for registration, importation, storage, and sales. Celnova will use its expertise in managing patient-focused initiatives, particularly in rare diseases, to ensure access to this treatment. Lupin will manufacture and supply the finished product 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,” said Dr Fabrice Egros, President of Corporate Development and Growth Markets at Lupin.

Juan Marrone, CEO of Celnova, stated, “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.”

NaMuscla will now be made available to patients in these regions through Celnova’s distribution network, expanding access to this treatment for those affected by NDM.

References:

  1. Vicart S, et al. Neuromuscular Discord 31;2021:1124-1135
  2. NaMuscla. Summary of Product Characteristics. EU/1/18/1325/001-004. 18 December 2018
  3. Emery AEH, Neuromuscular Discord 1991;1:19-29
  4. Trivedi JR, et al. Brain 2013;136:2189-200
  5. Eurostat. https://ec.europa.eu/eurostat/databrowser/view/tps00010/default/table?lang=en. Accessed 26/01/2022
  6. Matthews E, et al. Brain 2010;133:9–22
  7. Stunnenberg, BC, et al., Muscle Nerve 2020; 62:430-44
  8. Matthews E, et al. Pract Neurol 2021;0:1–10

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