Lupin launches authorized generic version of Antara in the US

Lupin announced the launch of the authorized generic version of Antara (Fenoflbrate) capsules, 30 mg and 90 mg, of Lupin Atlantis Holdings, S.A. Corporation, a wholly-owned subsidiary of Lupin.

Fenoflbrate Capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoproteln cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG), apolopoprotein B (Apo B), and to increase high-density fipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemla. As per IQVIA MAT September 2021 data, Fenofibrate Capsules (RLD: Antara Capsules) had estimated annual sales of $7 million in the U.S.

On Thursday, 4 November 2021, Lupin intimated that the National Institute for Health and Care Excellence (NICE) has issued the Final Appraisal Determination (FAD) recommending the routine funding of Namuscla (mexiletine) in England and Wales. NICE recommends Namuscla (mexiletine) within its marketing authorisation, as an option for treating the symptoms of myotonia in adults with non-dystrophic myotonic disorders. Lupin has agreed a confidential patient access scheme with NHS England (NHSE).

NDM is a group of rare genetic neuromuscular disorders caused by mutations in sodium or chloride ion channels, 2 affecting approximately 400 patients in England. 3 Clinically, NDM manifests with myotonia, a muscle stiffness which makes it difficult to perform daily activities. Myotonia can severely affect different parts of the body with pain, weakness and fatigue being the main symptoms, among others, that accompany the disease. Namuscla is licensed in the European Union and the UK for the symptomatic treatment of myotonia in adults with NDM.

The drug maker reported a consolidated net loss of Rs 2,098.04 crore in Q2 September 2021 as against net profit of Rs 211.02 crore in Q2 September 2020. On a consolidated basis, net sales rose 5.86% to Rs 4,003.42 crore in Q2 September 2021 over Q2 September 2020.

Lupin is an innovation-led transnational pharmaceutical company. The company 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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

Shares of Lupin fell 0.09% to end at Rs 933.95 on BSE in the special one-hour Muhurat trading session on Thursday, 4 November 2021.

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