HQ Team
April 10, 2023: Cipla Ltd has agreed with Novartis Pharma AG to market and manufacture the Swiss-based company’s Galvus brand for treating type 2 diabetes.
The Mumbai, India-based Cipla has signed a “perpetual license” agreement to make and market both Galvus and its combination brands from January 1, 2026, according to a BSE filing. “The agreement is subject to satisfaction of certain conditions precedent.”
Cipla will continue to “market and distribute Galvus branded products during the interim period.” Galvus is an oral anti-hyperglycemic agent used to control blood sugar. It contains an active substance, vildagliptin.
Galvus has the potential to contribute significantly to Cipla’s portfolio in the diabetes care space, with reported sales of INR 2.7 billion, according to data released by research firm IQVIA in February 2023.
“This deal is expected to further bolster Cipla’s position in India as one of the top players in the diabetes category.”
Patent expires
The patents for vildagliptin in India, held by Novartis, expired on December 9, 2019. Novartis sells Vildagliptin in India under the brand name Galvus.
Vildagliptin is available under brands Zomelis, Jalra, and Vyosov, marketed by Abbott, USV Private, and Cipla under sub-licenses from Novartis.
In 2021 the European Medicines Agency stated that studies have shown Galvus to be effective as an add-on to metformin and other combined therapies. Metformin stops your liver from producing sugar and releasing it into your blood.
According to an EMA statement, the EMA decided that Galvus’ benefits were greater than its risks and could be authorized for use in the EU.
The side effects of Galvus were mostly mild and resolved over time, according to the agency.
FDA recall
In May 2020, the Food and Drug Administration announced a voluntary recall of extended-release metformin tablets over concerns over higher-than-acceptable levels of the potential cancer-causing contaminant N-nitroso dimethylamine.
The agency’s laboratory testing had revealed nitrosamine impurity N-nitroso dimethylamine levels above the agency’s acceptable intake limit in several lots of the extended-release formulation of metformin.
According to studies conducted on animals, if the contaminant is taken in high doses, it may cause liver, lung, and kidney problems. It can also lead to gastric or colorectal cancer, according to the WHO.
In India, an estimated 77 million people over 18 years have type 2 diabetes, and nearly 25 million are pre-diabetics, who are at a higher risk of developing diabetes soon, according to the WHO.
More than 50% of people are unaware of their diabetic status, which leads to health complications if not detected and treated early. Adults with diabetes have a two- to threefold increased risk of heart attacks and strokes.
