Pharma Focus Asia

Zydus and Lupin Enter into a Licensing Agreement to Jointly Promote Saroglitazar Mg, an Essential Therapy for Chronic Liver Diseases in India

Saturday, November 04, 2023

Zydus Lifesciences Limited and Lupin Limited have recently unveiled a collaborative licensing and supply agreement. This partnership aims to co-market Saroglitazar Mg in India, a medication designed for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH). Saroglitazar Mg, administered as a once-daily 4mg dose, offers enhanced patient compliance, reduced pill burden, and increased convenience.

Lupin will hold semi-exclusive rights to co-market the product in India under the brand name LINVAS® as per the agreement's terms. Zydus originally launched the drug under the brand names Lipaglyn® and Bilypsa®, and they will continue their marketing efforts. Under this agreement, Lupin will make upfront licensing payments and milestone payments based on the achievement of specific milestones.

NAFLD is on the rise in India, affecting not only obese individuals or those with Diabetes Mellitus but also non-obese individuals, referred to as "lean" NAFLD. The increase in NAFLD/NASH cases can be attributed to the growing prevalence of obesity and other lifestyle-related health issues.

Zydus Lifesciences Ltd., remarked, "Our groundbreaking discoveries empower patients, helping them lead healthier and more fulfilling lives. Saroglitazar Mg is a vital treatment for NAFLD and NASH patients, significantly improving their quality of life. We are delighted to collaborate with Lupin to expand access to this innovative drug."

Lupin, added, "We are thrilled to partner with Zydus in marketing Saroglitazar Mg for NAFLD/NASH treatment. This partnership underscores our commitment to expanding our offerings and addressing the unmet needs of patients in India. It will further enhance our gastroenterology portfolio, offering improved healthcare options to patients and medical professionals."

Non-Alcoholic Liver Disease (NAFLD) encompasses a spectrum from non-alcoholic fatty liver (NAFLD) to Non-Alcoholic Steatohepatitis (NASH), which can progress to liver cirrhosis and hepatocellular carcinoma (HCC), a leading cause of liver transplant. In India, it is estimated that nearly 25-30% of the adult population suffers from NAFLD, and around 59.10% of these individuals are estimated to have NASH. NAFLD is a progressive liver disease that starts with fat accumulation in the liver in individuals who do not consume alcohol or do so in minimal amounts but have risk factors such as being overweight or obese, having diabetes mellitus, high blood pressure, or abnormal blood lipids.

Saroglitazar Mg stands out with its unique dual properties of PPAR alpha and gamma. Initially launched in India in September 2013 for treating diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not adequately controlled by statins alone, over 1.5 million patients have benefited from this medication since. It addresses co-morbidities such as dyslipidemia, hypertriglyceridemia, and diabetes mellitus. In January 2020, Saroglitazar Mg received approval for treating Type 2 Diabetes Mellitus. In March 2020, it gained approval for NASH treatment, and later that year, it was also approved for NAFLD treatment. Saroglitazar Mg now offers a safe and effective solution for addressing NAFLD and NASH. Zydus continues to market the drug under the brand names Lipaglyn® and Bilypsa®.



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