Global pharma major Lupin Limited and Zydus Lifesciences 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. With a once daily, 4mg dose regimen, Saroglitazar Mg enables better compliance, reduces pill burden, and offers greater convenience for patients.

Under the terms of this agreement, Mumbai-based firm Lupin will have semi-exclusive rights to co-market the product in India under the brand name LINVAS^®. Ahmedabad-based 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.

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 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.