Lupin signs distribution agreement in EU territories for orphan drug NaMuscla

Reportedly, NaMuscula is the first and only licensed product for myotonia in adults with non-dystrophic myotonic disorders

Lupin has entered into a distribution agreement with three companies for its orphan drug NaMuscla (mexiletine). Exeltis Healthcare S.L, Cresco Pharma B.V and Macure Pharma ApS will commercialise NaMuscla for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders in certain EU territories.

Reportedly, NaMuscula is the first and only licensed product for this indication. NDM disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. NaMuscla reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional and clinical outcomes, informed Lupin in a statement.

NaMuscla, which has been designated orphan drug status, received EU marketing authorisation in December 2018. Under the agreements, Exeltis Healthcare S.L will commercialise NaMuscla in Spain and Portugal, Cresco Pharma B.V will commercialise NaMuscla in the Netherlands and Macure Pharma ApS in the Nordic countries. Lupin will continue commercialisation of NaMuscla in Germany and the UK and will launch the product in Austria and France later this year.

“These distribution agreements represent an important milestone for Lupin as we roll out the commercialisation of NaMuscla across Europe. Collaborating with partners that are highly effective in their focus territories ensures patients will receive the drug in an as effective manner as possible. Lupin is committed to addressing the unmet needs of patients with NDM through the establishment of country-specific solutions and to ensuring patient access across Europe in alignment with national health authorities, healthcare providers and patient advocacy groups,” said Thierry Volle, President EMEA, Lupin.

Lupin recently obtained approvals to begin a paediatric trial as part of the paediatric investigation plan for NaMuscla and a post-authorisation [safety] study to address long-term safety and treatment efficaciousness on patient-reported outcomes. Both trials will begin later this year.