FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development / Commercial Operations

UCB, Sanofi to Develop Autoimmune Disease Drugs

March 12, 2014
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French drugmaker Sanofi and Belgium’s UCB said Tuesday that they are putting together a team of scientists in the hopes of discovering and developing new therapies for autoimmune diseases such as ulcerative colitis, rheumatoid arthritis and Crohn’s disease.

The drugmakers plan to split development costs and future profits equally, though UCB will receive an initial, upfront payment, as well as preclinical and clinical milestone payments potentially in excess of $138.5 million, says Sanofi.

UCB’s Cimzia (certolizumab pegol) is a tumor necrosis factor blocker approved by the FDA as a second-line treatment for moderate to severe Crohn’s disease and for rheumatoid arthritis. In Europe, it is indicated as a second-line treatment for psoriatic arthritis. The drug is currently in Phase III trials for juvenile idiopathic arthritis. UCB also has epratuzumab in Phase III for systemic lupus, as well as CDP7657 in Phase II targeting the same indication.

Sanofi currently has sarilumab in Phase III for rheumatoid arthritis, as well as Lemtrada, which is approved in the EU for relapsing-remitting multiple sclerosis. The FDA approved it for B-cell chronic lymphocytic leukemia, but in December, rejected the drugmaker’s sBLA for relapsing multiple sclerosis until Sanofi completes additional active comparator trials. — Lena Freund

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