Glenmark & Torrent sign licensing agreement for co-marketing of Remogliflozin Etabonate in India

Glenmark & Torrent sign licensing agreement for co-marketing of Remogliflozin Etabonate in India

Glenmark Pharmaceuticals Ltd. (Glenmark), and Torrent Pharmaceuticals Limited have announced that they have entered into a non-exclusive sub-licensing agreement to co-market sodium glucose co-transporter-2 (SGLT2) inhibitor, Remogliflozin Etabonate (Remogliflozin) in India. Under the terms of the agreement, Glenmark will receive an upfront payment, license fees and royalties for the non-exclusive sub-license rights from Torrent. Glenmark will manufacture and supply Remogliflozin while Torrent will market the drug under its own trademark ‘Zucator’ in India.

In April 2019, Glenmark received approval from the Drugs Controller General of India (DCGI) for Remogliflozin Etabonate after successfully completing Phase-3 clinical trials in which Remogliflozin demonstrated good efficacy and safety profile in a head-to-head comparison against Dapagliflozin. Subsequently, Glenmark launched Remogliflozin indicated in the treatment of Type 2 Diabetes Mellitus in adults under the brand names ‘Remo’ and ‘Remozen’ while Torrent will commercialize Remogliflozin under the brand name ‘Zucator’.

Moreover, Remogliflozin is available at a breakthrough price that is significantly lower and cost effective over other SGLT-2 inhibitors available in the country. Infact, Remogliflozin is the only SGLT2 inhibitor to be manufactured in India from active pharmaceutical ingredient (API) to formulation.

“We are pleased to partner and work closely with Torrent to provide access to innovative solutions for efficient diabetes management in India. The burden of diabetes in India is growing at an alarming rate and through this collaboration, we aim to improve access to the latest, novel and globallyresearched SGLT2 inhibitor by providing an effective, high quality and world-class treatment option to patients in India. This partnership will also lay the foundation for a long term collaboration with Torrent for Remogliflozin in terms of its additional line extensions and further clinical development,” said Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals.

Dhruv Gulati, Executive Director (India & ROW), Torrent Pharma, said “We are pleased to collaborate with Glenmark for the novel anti-diabetic drug Remogliflozin. The drug will augment the Type 2 Diabetes Mellitus treatment armamentarium in the country and this partnership will be an important step towards enhancing access to the growing needs of diabetic patients.”

Glenmark Pharmaceuticals receives ANDA approval for Ranolazine Extended-Release Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Ranolazine Extended-Release Tablets, 500 mg and 1,000 mg, a generic version of Ranexa Extended-Release Tablets, 500 mg and 1,000 mg, of Gilead Sciences, Inc. According to IQVIATM sales data for the 12 month period ending May 2019, Ranexa Extended Release Tablets, 500 mg and 1,000 mg market2 achieved annual sales of approximately $929.0 million.

Glenmark’s current portfolio consists of 158 products authorized for distribution in the U.S. marketplace and 57 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.