Indian pharma major Lupin and Zydus Lifesciences have entered a licensing and supply agreement for co-marketing Saroglitazar Mg, a therapy for chronic liver diseases in India.

Saroglitazar Mg is indicated for the treatment of chronic liver diseases like non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

As per the terms of this agreement, Lupin will have semi-exclusive rights to co-market the product in India under the Linvas brand.

Zydus introduced the drug under the brand names Lipaglyn and Bilypsa and will continue to commercialise them.

In addition to upfront licence fees, Lupin will provide Zydus with milestone payments contingent upon fulfilling predetermined milestones.

Lupin managing director Nilesh Gupta said: “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 offerings 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.”

According to Lupin, the once-daily 4mg dose regimen of Saroglitazar Mg allows better compliance, lowers pill burden, and provides more convenience to patients.

Launched in India in September 2013, the medication is poised with its dual PPAR alpha and gamma properties.

It was unveiled to treat diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone.

In 2020, Saroglitazar Mg was authorised to treat Type 2 Diabetes Mellitus and NASH. Later that year, the therapy was also cleared for the treatment of NAFLD.

Zydus managing director Sharvil Patel said: “Saroglitazar Mg which is one of the critical treatments for patients with NAFLD and NASH has substantially improved the patients’ quality of life.

“We are pleased to join hands with Lupin to enable access to this novel drug and thereby expand the reach.”