Pharma majors Lupin Ltd and Zydus Lifesciences Ltd on Friday said they have entered into a licensing and supply agreement to co-market Saroglitazar Mg for the treatment of non-alcoholic fatty liver disease and nonalcoholic steato hepatitis in India.
Under the 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, the two companies said in a joint statement.
Saroglitazar Mg, approved by the DCGI, is an innovative drug from Zydus to treat chronic liver diseases such as, non-alcoholic fatty liver disease (NAFLD) and Nonalcoholic Steato Hepatitis (NASH).
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India became the first country to have a drug approved for these unmet medical needs, it added.
"Lupin will pay Zydus upfront licensing fees and milestone payments based on the achievement of pre-defined milestones," the statement added.
"This partnership reaffirms our commitment to grow and expand our offerings to meet 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," Lupin Managing Director Nilesh Gupta said.
Zydus Managing Director Sharvil Patel said the partnership with Lupin will enable access to this novel drug and thereby expand the reach.
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"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, has substantially improved the patients' quality of life," Patel added.
With a once daily, 4mg dose regimen, Saroglitazar Mg enables better compliance, reduces pill burden, and offers greater convenience for patients, the statement 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 have benefitted from this drug, the companies said.