Pune, India; May 07, 2019: Glenmark Pharmaceuticals Ltd (Glenmark), a research-led global integrated pharmaceutical company, today announced the launch of its novel, patent protected and globally-researched sodium glucose co-transporter (SGLT2) inhibitor Remogliflozin etabonate (Remogliflozin) in India. The drug is indicated in the treatment of type-2 diabetes mellitus in adults.
SGLT2 inhibitors are novel anti-diabetic drugs that help achieve glycemic control by acting on the SGLT2 receptors in the proximal convoluted tubule of the kidney, thereby preventing renal reabsorption of glucose and promoting excretion of glucose in the urine. Along with providing glycemic control, SGLT2 inhibitors help induce weight loss and reduce cardiovascular risks.
Glenmark is the first company in the world to launch Remogliflozin and India is the first country to get access to this innovative drug. Glenmark has launched Remogliflozin in India under brand names “Remo” and “Remozen”. Remogliflozin is the only SGLT2 inhibitor to be manufactured in India from active pharmaceutical ingredient (API) to formulation.
The company has launched Remogliflozin at a breakthrough price of Rs. 12.50 per tablet, twice daily, which is over 50% lower than the existing SGLT2 inhibitors available in India. Currently, the average per day therapy cost of SGLT2 inhibitors in India is about Rs. 55. Remogliflozin offers saving of about Rs. 11,000 per year for diabetes patients on SGLT2 inhibitors.
Glenmark received regulatory approval for Remogliflozin etabonate 100 mg after successfully completing Phase-3 clinical trials in which Remogliflozin demonstrated good efficacy and safety profile in a head-to-head comparison against Dapagliflozin.
Remogliflozin has been studied in 26 clinical trials globally, covering around 2,500 patients from various ethnicities. Remogliflozin was discovered and developed by Japanese firm Kissei Pharmaceutical Co. Ltd. and later developed by GlaxoSmithKline plc and Glenmark collaborator BHV Pharma, a wholly owned subsidiary of Avolynt, Inc. which is based in North Carolina, USA.
Glenmark secured certain rights to Remogliflozin through a licensing collaboration agreement with BHV Pharma, and conducted the Phase-3 clinical trial, which included the largest number of Indian patients tested for any SGLT2 inhibitor.
“Globally, SGLT2 inhibitors are emerging as a preferred treatment for management of type-2 diabetes and Glenmark is proud to introduce an innovative molecule in this class, which is cutting-edge and researched extensively. Glenmark has been a pioneer in providing access to the latest treatment options to diabetes patients in India at a relatively low cost and with the launch of Remogliflozin, the company aims to increase patients’ access to SGLT2 inhibitors as this class of drugs have proven benefits for effective diabetes management,” said Alok Malik, Senior Vice President, India Formulations, Chronic Cluster at Glenmark Pharmaceuticals.
In 2015, Glenmark transformed the diabetes market by launching its dipeptidyl peptidase-4 (DPP4) inhibitor Teneligliptin at a price that was approximately 55% lower than the other DPP4 inhibitors available in India at that time. Since then, the access to DPP4 inhibitors has increased significantly and currently more than 100 brands of Teneligliptin from several companies are available in the country.
India is estimated to have around 72 million adults living with diabetes, according to the International Diabetes Federation’s Diabetes Atlas 2017.1
According to data from IQVIA, India’s diabetes market is estimated at 11,413 crore as of MAT March 2019. The market size of SGLT2 inhibitors is estimated at 574 crore as of MAT March 2019.