Ahmedabad: Torrent Pharmaceuticals Limited, a global specialty pharmaceutical company, and Zydus Lifesciences Limited, a global discovery-driven life sciences company, have announced that they have entered into a licensing and supply agreement to jointly commercialize Saroglitazar Mg for the treatment of non-alcoholic diseases. Steatohepatitis (NASH) and Non-alcoholic fatty liver disease (NAFLD) in India.
As the only drug approved for NASH and NAFLD in the country, Saroglitazar Magnesium is likely to play a key role in the management and mitigation of these progressive and prevalent liver disorders.
With a dosing regimen of 4 mg once daily, Saroglitazar Mg allows for better compliance, reduces pill burden, and offers greater convenience for patients.
Under the terms of this agreement, Torrent will have semi-exclusive rights to co-market the product in India under the VORXAR brand. Zydus launched the drug under the brand names Lipaglyn and Bilypsa and will continue to market them. Torrent will pay Zydus upfront license fees and milestone payments based on the achievement of predefined milestones.
Saroglitazar Mg, is an innovative drug from Zydus approved by the DCGI to treat chronic liver diseases such as non-alcoholic steatohepatitis (NASH) and Nonalcoholic fatty liver disease (NAFLD). India is the first country to have an approved medicine for these unmet medical needs. Currently, there are no medications approved for the treatment of NASH and NAFLD anywhere else in the world.
Speaking on the development, Zydus Lifesciences Ltd. Managing Director Dr. Sharvil Patel said, โThis partnership with Torrent is testimony to our long-term vision of expanding the reach of our drug. Our vision is to help empower patients with life-changing discoveries driven by innovation. โSaroglitazar Mg is one of the critical treatments for patients with NASH and NAFLD and fills an unmet healthcare need.โ
Aman Mehta, Director, Torrent Pharmaceuticals Ltd., said: โIn NASH and NAFLD, disease areas with high prevalence and limited therapeutic options that are supported by clinical evidence, Saroglitazar Magnesium represents a significant advancement. We are delighted to partner with Zydus and add Saroglitazar Magnesium, under the Vorxar brand, to our portfolio. โThis will further grow our gastroenterology franchise and help address emerging unmet patient needs.โ
Nonalcoholic liver disease (NAFLD) is a spectrum ranging from nonalcoholic fatty liver (NAFLD) to nonalcoholic steatohepatitis (NASH), which has a propensity to progress to liver cirrhosis and hepatocellular carcinoma (HCC), one of the main causes of liver disease. transplant. It is estimated that 25-30% of India's adult population suffers from NAFLD. Of them, it is estimated that almost 59.10% suffer from NASH. A progressive liver disease NAFLD begins with the accumulation of fat in the liver in patients who do not consume alcohol or drink it in negligible amounts, but who have risk factors such as overweight or obesity, diabetes mellitus (high blood sugar) , hypertension (high blood sugar). blood pressure) or dyslipidemia (abnormal blood lipids).
Saroglitazar Mg has a unique position with its dual PPAR alpha and gamma properties. In March 2020, Saroglitazar Mg received approval for the treatment of NASH. Later that year, the drug was also approved for the treatment of NAFLD. Now offers a safe and effective way to treat NASH and NAFLD. Zydus continues to market the drug under the brand names Lipaglyn and Bilypsa. The new drug was launched in India in September 2013 for the treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with type 2 diabetes who are not controlled by statins alone. Reduces comorbidities (dyslipidemia, hypertriglyceridemia and diabetes mellitus). In January 2020, Saroglitazar Mg was approved for the treatment of type 2 diabetes mellitus.
