Sanofi has backed away from a multiple sclerosis treatment developed alongside Indian drugmaker Glenmark Pharmaceuticals after the antibody came up short in a midstage trial.
A licensing deal between India's Glenmark Pharmaceuticals and France's Sanofi has ended after the multiple sclerosis (MS) drug Sanofi was testing failed to meet its efficacy expectations. Glenmark is now seeking to relicense the monoclonal antibody vatelizumab (GBR 500), according to a report by NDTV.
The European unit of India's Glenmark Pharmaceuticals has applied to move into Phase I clinical trials for GBR 1302, a HER2xCD3 bispecific antibody that the company said in preclinical work demonstrated superiority over current antibody therapies against most HER2-positive cancers, including breast cancer.
India's Glenmark Pharmaceuticals lost a bid before the country's top court to clear existing stocks of sitagliptin as it awaits a ruling over whether it can sell copies of Januvia and Janumet, Merck's innovative version of the Type 2 diabetes drug.
India regulators have cleared Glenmark Pharmaceuticals to sell as much as 49% of its shares to foreign institutional investors, up from its former 40% limit, and paving the way for major investors such as Singapore's Temasek Holdings.
Sun Pharmaceutical Industries, Glenmark Pharmaceuticals and Intas Pharmaceuticals, all India-based, are getting a collective investment infusion of $567.7 million, all from Singapore's government.
India's Glenmark Pharmaceuticals has moved to pull in the rupee equivalent of $151 million from an offshore unit of Singapore sovereign wealth fund Temasek in a deal put forth by the board last week and awaiting shareholder approval, the company said on Monday.
India's Glenmark Pharmaceuticals began this new fiscal year with an outlook of a turnaround in its U.S. fortunes that experienced a slowdown in the just-ended FY 2015. The days-old $25 million settlement of U.S. Medicaid fraud allegations did not figure in the analysts' estimates of company prospects.
Glenmark Generics, the U.S. unit of Glenmark Pharmaceuticals, has signed a settlement agreement to pay $25 million to be split by the federal government and the state of Texas for alleged Medicaid fraud.
India's highest court has granted an injunction against Glenmark Pharmaceuticals, blocking it from producing and marketing a generic of Merck's Januvia (sitagliptin) for treating diabetes. A patent-infringement suit was not affected by the decision.