Lupin Ltd and Zydus Lifesciences have agreed to co-market Saroglitazar Mg used to treat Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steato Hepatitis (NASH) in India.
Zydus will get an upfront licensing fee and milestone payments based on the achievement of pre-defined milestones from Lupin, the note said. “With a once daily, 4mg dose regimen, Saroglitazar Mg enables better compliance, reduces pill burden, and offers greater convenience for patients,” it added.
Lupin will have semi-exclusive rights to co-market the product in India under the brand name LINVAS. Zydus already markets it as Lipaglyn and Bilypsa and will continue to market them, said the company.
In India, NAFLD is a concern in people with obesity, diabetes and in lean people, and the number of both conditions have increased due to the growth in lifestyle-related illnesses, the note said.
Nilesh Gupta, Lupin Managing Director, said the partnership would enhance their gastroenterology portfolio, offering better access to healthcare options to patients and medical professionals. Sharvil Patel, Zydus Managing Director, added that Saroglitazar Mg was a critical treatment for patients with NAFLD and NASH and had substantially improved the quality of life for patients.
Non-Alcoholic Liver Disease includes NAFL and NASH and could progress to become liver cirrhosis and hepatocellular carcinoma, a leading cause of liver transplant, the note said. Saroglitazar Mg 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 lakh patients are on the drug, the note said. 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, the note added.