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Lupin signs distribution agreement in key EU territories for orphan drug NaMuscla®

Posted On: 2020-06-03 11:05:23


Pharma major Lupin Limited (Lupin) has entered into 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 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 outcomes1. NaMuscla®, which has been designated orphan drug status, received EU marketing authorization in December 2018.

Under the agreements announced today, 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 commercialization of NaMuscla® in Germany and 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 commercialization of NaMuscla® across Europe. Collaborating with partners that are highly effective in their focus territories ensures patients will receive the drug in as 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 Europe2,3,4 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 rare nature of disease, may result in significant harm to patients5. 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.

Shares of LUPIN LTD. was last trading in BSE at Rs.872 as compared to the previous close of Rs. 848.95. The total number of shares traded during the day was 172770 in over 5330 trades.

The stock hit an intraday high of Rs. 874 and intraday low of 852.05. The net turnover during the day was Rs. 149864124.


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