Lupin signs agreement with Macure Pharma, others to commercialise NaMuscla in Europe

Mumbai: Drug maker Lupin Limited announced that it 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 commercialize NaMuscla® for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders in certain EU territories.

NaMuscula® is the first and only licensed product for this indication.

NDM disorders are a group of rare, inherited neuromuscular disorders that 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. NaMuscla®, which has been designated orphan drug status, received EU marketing authorization in December 2018.

Under the agreements announced, Exeltis Healthcare S.L will commercialize NaMuscla® in Spain and Portugal, Cresco Pharma B.V will commercialize NaMuscla® in the Netherlands and Macure Pharma ApS in the Nordic countries. Lupin will continue the commercialization 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 commercialization of NaMuscla® across Europe. Collaborating with partners that are highly effective in their focus territories ensures patients will receive the drug in an effective manner as possible," said Thierry Volle, President EMEA, Lupin. "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."

Today, more than 7,500 people in Europe living with NDM have limited access to a licensed treatment for myotonia that can reduce the daily burden of this disabling, lifelong symptom. Limited access leads to inconsistent medication supply, administrative challenges, and associated financial burdens, which, along with low awareness and limited clinical experience among healthcare professionals due to the rare nature of the disease, may result in significant harm to patients.

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

Read also: Lupin gets USFDA approval for Meloxicam to treat osteoarthritis pain