Lupin rose 1.40% to Rs 759.70 after the company said that the Spanish Ministry of Health (MSCBC) has approved the reimbursement of its NaMuscla for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders.
NaMuscla (mexiletine) reduces myotonia symptoms in people with NDM, resulting in a significant improvement in quality of life and other functional and clinical outcomes for patients. It received EU marketing authorization in December 2018, which has been designated orphan drug status.NaMuscla is the first and only antimyotonic agent licensed to treat symptomatic myotonia in adults with non-dystrophic myotonic disorders in Europe. It will be commercialized by Lupin's partner Exeltis Healthcare S.L in Spain.
Thierry Volle, president EMEA, Lupin said, NDM patients in Spain will now be able to access NaMuscla in a sustainable way. Lupin's transformational journey into specialty disease areas continues, with future investments planned for neuromuscular diseases, to meet the unmet needs of patients.
This news allows us to distribute NaMuscla quickly and effectively and strengthen our position in the central nervous system area, said Alberto Fregas Gil, director general Spain and Portugal, Exeltis.
Lupin said that it's pediatric trial, part of the pediatric investigation plan for NaMuscla in children with myotonic disorders, is ongoing and successfully concluded patient enrolment in a first patient cohort group who were offered and rolled over into a 2-year follow-up study.
A post-authorization study to address long-term safety and treatment effects of NaMuscla on patient-reported outcomes in adults with NDM has concluded patient enrollment and will provide 3 years prospective data on NaMuscla in a real-life setting, Lupin added.
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Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
On consolidated basis, Lupin reported net profit of Rs 129.73 crore in Q2 FY23 as against net loss of Rs 2,098.04 crore in Q2 FY22. Revenue from operations rose 2.2% to Rs 4,091.16 crore in Q2 FY23 as against Rs 4,003.42 crore in Q2 FY22.
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