Indian pharmaceutical majors Torrent Pharmaceuticals Limited and Zydus Lifesciences Limited have joined forces through a licensing and supply agreement to co-market Saroglitazar Mg in India, which targets Non-Alcoholic Steato Hepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD).
As the only approved drug for NASH and NAFLD in the country, Saroglitazar Magnesium is likely to play a key role in managing and mitigating these liver disorders, according to a press release.
Under this agreement, Torrent gains semi-exclusive rights to co-market the product as VORXAR. Zydus, the original developer, will continue marketing the drug under the names Lipaglyn and Bilypsa. Torrent will compensate Zydus with upfront licensing fees and milestone payments linked to predefined achievements.
Saroglitazar Mg, approved by India's Drugs Controller General, is a breakthrough in treating chronic liver diseases like NASH and NAFLD. It stands as the first approved drug for these conditions in any country. Currently, no other approved drug exists globally for NASH and NAFLD.
“This association with Torrent is testament to our long-term vision of expanding the reach of our drug. Saroglitazar Mg is one of the critical treatments for patients with NASH and NAFLD and bridges an unmet healthcare need,” said Zydus Lifesciences' Managing Director Sharvil Patel.
Aman Mehta, Director, Torrent Pharmaceuticals Ltd. said: “In NASH and NAFLD, disease areas with high prevalence and limited therapeutic options that are backed by clinical evidence, Saroglitazar Magnesium represents a significant advancement. This will further augment our gastroenterology franchise and help address emerging unmet patient needs.”
NAFLD encompasses a range from fatty liver to NASH, which can advance to severe liver issues. A substantial portion of India's adult population suffers from NAFLD, with a high percentage affected by NASH. Saroglitazar Mg, with its unique properties, addresses these conditions by receiving approvals for NASH treatment in 2020 and later for NAFLD. Its effectiveness in managing these diseases has been evident, benefitting over 1.5 million patients since its launch in 2013.
Additionally, in 2020, it received approval for treating Type 2 diabetes mellitus, highlighting its expanding applications.
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