Date: 2013-07-04
Type of information: Development agreement
Compound: olokizumab
Company: UCB (Belgium) R-Pharm (Russia)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Type agreement: development
licensing
production
commercialisation
Action mechanism: monoclonal antibody. Olokizumab is a humanized monoclonal antibody targeting the IL-6 cytokine. IL-6 is involved in several autoimmune and inflammatory pathways. Olokizumab is the first of a new type of IL-6 inhibitor that selectively blocks the final assembly of the IL-6 receptor signaling complex.
Disease: all indications, including rheumatoid arthritis
Details: * On July 4, 2013, UCB and R-Pharm, a privately owned pharmaceutical company based in Moscow, Russia, have announced that they have entered into a world-wide exclusive license grant to R-Pharm to develop and commercialize olokizumab in all indications, including rheumatoid arthritis. Under the terms of this agreement, R-Pharm will develop, register, manufacture, distribute and book sales globally. UCB receives an upfront payment and is entitled to receive payments on development and commercialization milestones and royalties. Further details of the agreement are not disclosed.
Last september 2012, UCB announced top-line results from a phase 2b study of olokizumab (CDP6038) in adult patients suffering from rheumatoid arthritis (RA) having previously failed anti-TNF therapy. The primary objective of this study was to evaluate the efficacy of various doses and dose administration frequencies of olokizumab relative to placebo. This phase 2b study met its primary endpoint of demonstrating a significant reduction in the disease activity score at week 12 across all olokizumab dose groups relative to placebo. All doses of olokizumab demonstrated statistically significant improvement in disease activity score (DAS 28) (p<0.001) when compared with placebo. Olokizumab was well tolerated across all doses and demonstrated a safety profile consistent with known effects of IL-6 inhibitors.
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