Sanofi Walks Away from a $613 Million Multiple Sclerosis Pact with Glenmark Pharma
October 30, 2015
By Alex Keown, BioSpace.com Breaking News Staff
PARIS – After experimental multiple sclerosis drug vatelizumab failed to meet its primary endpoints in a mid-stage trial, Sanofi AG said it has dropped plans to develop the drug with India-based Glenmark Pharmaceuticals.
During a second-quarter results analysis with media members, Glenmark revealed that Sanofi was terminating the development agreement for vatelizumab, also known as GBR 500, the Press Trust of India reported. Glenmark said it will look for a new partnership to develop the drug. Vatelizumab is being developed for the treatment of relapsing-remitting multiple sclerosis. Vatelizumab is a monoclonal antibody that targets VLA-2, a collagen-binding integrin expressed on activated lymphocytes. Although its mechanism of action is not known, Sanofi said at the time it was enrolling patients in a Phase II trial, that it believed the drug would “block VLA-2 on activated immune cells, leading to interference with collagen-binding in areas of inflammation, and thus may reduce the inflammatory cascade in MS.”
Sanofi struck a development deal with Glenmark in 2011 for up to $613 million. So far, Glenmark has only received about $55 million from Sanofi. The remaining payments were to be made as the drug got closer to regulatory approval. Under the terms of the deal, Sanofi was to have marketing rights for products developed using GBR 500 in North America, Europe, Japan, Argentina, Chile and Uruguay. Sanofi and Glenmark had a deal to co-market any products in Russia, Brazil, Australia and New Zealand, the Press Trust reported.
According to a recent report on MS therapeutics by GBI Research, the global market for MS treatments is expected to hit $17.9 billion by 2019. GBI expects a number of new drugs and monoclonal antibodies (mAbs) to hit the market in the next couple years.
Numerous drug companies are working on treatments for multiple sclerosis, including Genentech , which is planning to seek regulatory approval for its multiple sclerosis treatment ocrelizumab sometime next year, the company said.
There are currently a number of treatments on the market, including Teva Neuroscience’s Copaxone, which had global sales in 2012 of $4 billion. Other drugs include Novartis' Gilenya and Biogen, Inc. 's Tecfidera. Biogen’s drug has received some negative press after Dutch doctors published a report in the “New England Journal of Medicine ” saying more cases of brain infections may occur in patients taking drugs similar to the company’s top multiple sclerosis treatment. In their report, the doctors noted that patients who take dimethyl fumarate, which Biogen markets as Tecfidera, are at “risk for opportunistic infections, ” including progress multifocal leukoencephalopathy (PML), which may initially present as new or worsening weakness in the body.
In addition to its MS drug, Glenmark is developing treatments for cancer, autoimmune diseases and chronic pain. Multiple sclerosis is a chronic disease that affects an estimated 2.3 million people around the world, for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around the nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage, which can cause a wide range of symptoms, including muscle weakness, fatigue, difficulty seeing, and may eventually lead to disability.