Glenmark will commercialize Remogliflozin in India under the brand names ‘Remo’ and ‘Remozen’.
Mumbai: In a major relief to diabetics, Glenmark Pharmaceuticals’ has launched its novel, patent protected and globally-researched sodium glucose co-transporter -2 (SGLT2) inhibitor Remogliflozin etabonate (Remogliflozin) in India.
Glenmark is the first company in the world to launch the novel SGLT2 inhibitor Remogliflozin and India is the first country to get access to this innovative drug. Glenmark will commercialize Remogliflozin in India under the brand names ‘Remo’ and ‘Remozen’.
A month ago, Medical Dialogues had reported that Mumbai-based Glenmark Pharmaceuticals Limited had sought approval from the IND Committee of the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market Remogliflozin etabonate(RE) tablets of 100mg strength.
The genesis of Remogliflozin goes back to Japanese firm Kissei Pharmaceutical and later developed by GlaxoSmithKline (GSK) and BHV Pharma, an arm of US company, Avolynt. However, Glenmark secured certain rights to Remogliflozin via collaboration with BHV Pharma and carried out Phase-3 clinical trials on over 600 patients.
The product is indicated for the treatment of Type 2 Diabetes Mellitus (T2DM) as monotherapy and in addition to the existing anti-diabetic therapies.
Commenting on the launch, Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals said, “Globally, SGLT2 inhibitors are emerging as a preferred treatment for the management of type-2 diabetes and Glenmark is proud to introduce a novel molecule in this class, which is cutting-edge and researched extensively.”
“Diabetes is a key area of focus for Glenmark and with the launch of Remogliflozin, the company aims to improve access to SGLT2 inhibitors by providing an effective, high quality and world-class treatment option to patients in India, ” he added.
SGLT2 inhibitors are novel anti-diabetic drugs that help achieve glycemic control by acting on the SGLT2 receptors in the proximal tubule of the kidney, thereby preventing renal reabsorption of glucose and promoting excretion of glucose in the urine. SGLT2 drugs provide glycemic control, induce weight loss and reduce cardiovascular risks.
The American Diabetes Association and the European Association for the Study of Diabetes have recommended the use of SGLT2 inhibitors as an alternative first-line treatment to Metformin or as an adjunctive treatment in the management of type-2 diabetes mellitus. SGLT2 inhibitors are particularly recommended for use in patients that have certain established cardiovascular diseases.
India is estimated to have around 72 million adults living with diabetes, according to the International Diabetes Federation’s Diabetes Atlas 2017.
According to data from IQVIA, India’s diabetes market is estimated at Rs. 11,413 crores (approx. USD 1630mn) as of MAT March 2019. The market size of SGLT2 inhibitors is estimated at Rs. 574 crores (approx. USD 82mn) as of MAT March 2019.
As per a report in TOI, the drug is likely to be priced at 60 per cent lower than the price of the existing therapies. Remogliflozin will reportedly be priced at around Rs25 for daily therapy as against other drugs in the same class available in the range of Rs 55-60 per day, thereby disrupting the anti-diabetes market.