Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as Zydus) a discovery-driven, global lifesciences company and Lupin Limited (Lupin), a global pharma major, on Friday announced that they have entered into a licensing and supply agreement to co-market, Saroglitazar Mg for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steato Hepatitis (NASH) in India, the company announced through an exchange filing.
With a once daily, 4mg dose regimen, Saroglitazar Mg enables better compliance, reduces the pill burden and offers the patient more convenience.
Under the terms of this agreement, Lupin will have semi-exclusive rights to co-market the product in India under the brand name LINVAS. Zydus launched the drug under the brand names Lipaglyn and Bilypsa and will continue to market them. Lupin will pay Zydus upfront licensing fees and milestone payments based on the achievement of pre-defined milestones.
In India, NAFLD is not only a concern for obese or patients with Diabetes Mellitus, but it has also been observed that NAFLD can develop in the absence of obesity, which is termed "lean" NAFLD. The number of NAFLD/NASH patients has significantly increased due to the growth in obesity and other lifestyle-related illnesses.
Managing Director, Zydus Lifesciences Ltd., Dr. Sharvil Patel said, “Our life changing discoveries are empowering patients, enabling them to live healthier and more fulfilled lives. Saroglitazar Mg which is one of the critical treatments for patients with NAFLD and NASH hassubstantially improved the patients’ quality of life."
"We are excited to partner with Zydus to market Saroglitazar Mg for the treatment of NAFLD/NASH. This partnership reaffirms our commitment to grow and expand our innovations to meet the unmet needs of patients in India. This partnership will further enhance our gastroenterology portfolio, offering better access to healthcare options to our patients and medical professionals," said Nilesh Gupta, Managing Director, Lupin.
About Saroglitazar Mg
Saroglitazar Mg is uniquely poised with its dual PPAR alpha and gamma properties. The novel drug was launched in India in September 2013, for the treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone. Since then, over 15 lac patients have benefitted from this drug. It reduces co-morbidities (dyslipidemia, hypertriglyceridemia, and diabetes mellitus).
In January 2020, Saroglitazar Mg was approved for treating Type 2 Diabetes Mellitus. 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. It now offers a safe and efficacious way to treat NAFLD and NASH. Zydus continues to market the drug under brand names Lipaglyn and Bilypsa.
