Glenmark Pharmaceuticals announces first in the world launch of its novel, globally-researched, latest-in-class diabetes medicine “Remogliflozin” in Tamil Nadu


Glenmark Pharmaceuticals today announced the launch of its novel, patent protected and globally-researched sodium glucose co-transporter (SGLT2) inhibitor Remogliflozinetabonate (Remogliflozin) in Tamil Nadu
 
  • According ICMR-INDIAB study, prevalence of diabetes in Tamil Nadu is around 10.4%. In South Chennai, the prevalence of diabetes in people under 50 years was more than 20% and over 65% of the known diabetics have uncontrolled sugar values of >200 mg/dl according to a study published in the International Journal of Community Medicine and Public Health
  • India is the first country to get access to Remogliflozin, aninnovative, patent-protected sodium glucose co-transporter-2 (SGLT2) inhibitor indicated in the treatment of type-2 diabetes mellitusin adults
  • Glenmark’s Remogliflozin is priced over 50% lower than the existing SGLT2 inhibitors in India

Chennai, India; May 15, 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 Remogliflozinetabonate (Remogliflozin) in Tamil Nadu. The drug is indicated in the treatment of type-2 diabetes mellitus in adults.
 
(L-R) Jason D’Souza, Senior Vice President-Corporate Communications, Investor Relations, 
Corporate Strategy and Alok Malik, Senior Vice President
- India Formulations, Chronic Cluster
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 Remogliflozinand India is the first country to get access to this innovative drug. Glenmark has launched Remogliflozin in Indiaunder brand names “Remo” and “Remozen”. Remogliflozinis the only SGLT2 inhibitor to be manufactured in India from active pharmaceutical ingredient (API) to formulation.

The company has launched Remogliflozinat 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.
 
(L-R) Alok Malik, Senior Vice President- India Formulations, Chronic Cluster and Jason D’Souza, Senior Vice President-Corporate Communications, Investor Relations, Corporate Strategy
Glenmark received regulatory approval for Remogliflozinetabonate 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 2017.1According to Indian Council of Medical Research’s (ICMR) – INDIAB study on prevalence of diabetes and pre-diabetes published in the Lancet Diabetes Endocrinology 2017, the prevalence of diabetes in Tamil Nadu was around 10.4%.2In October 2018, the International Journal of Community Medicine and Public Health published a study involving 1361 subjects on prevalence of undiagnosed and uncontrolled diabetes mellitus among adults in South Chennai. According to this study, nearly 22% of the subjects were known diabetics and 10.3% were newly diagnosed diabetics. It also revealed that over 65% of the known diabetics had uncontrolled sugar values of >200 mg/dl and the prevalence of diabetes in people under 50 years was more than 20%.3


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.

About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. It is ranked among the top 75 Pharma& Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2018). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory.

The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark has 16 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.

Reference:
IDF Diabetes Atlas 2017

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