The target indication for CIRARA is large hemispheric infarction (LHI), a severe form of ischemic stroke where brain swelling (cerebral edema) often leads to a disproportionately large share of stroke-related morbidity and mortality.
The U.S. Food and Drug Administration (FDA) recently granted CIRARA Orphan Drug Designation for severe cerebral edema in patients with acute ischemic stroke. The FDA has also granted CIRARA Fast Track designation.
Each year approximately 1.7 million ischemic strokes occur across the U.S., Europe and Japan, and approximately 15 percent of these are LHI strokes. In pre-clinical studies, CIRARA has been shown to block SUR1-TRPM4 channels that mediate stroke related brain swelling.
Clinical proof-of-concept studies have demonstrated the potential of CIRARA to reduce brain swelling, disability and the risk of death in patients with LHI.
Michael Ehlers, M.D., Ph.D., Executive Vice President, Research and Development at Biogen, said: “We see an opportunity to make a major difference in patient care by advancing new treatments for stroke. CIRARA represents a potential breakthrough stroke treatment that accelerates our efforts to build a portfolio of new therapies for neurologic diseases.
“We believe the data supporting the potential of CIRARA are compelling and that CIRARA can be a first-in-class therapy that gives physicians the ability to meaningfully improve patient outcomes in an area where effective treatments have been few and far between.”
This transaction complements Biogen’s broader efforts to build a portfolio of best-in-class treatments for acute ischemic stroke and further strengthen its leadership in neuroscience. Biogen currently is conducting a Phase 2b study to determine whether its monoclonal antibody natalizumab, as a potential neuroprotective, can help patients with acute ischemic stroke improve functional outcomes and cognition.
Biogen plans to continue the development and commercialization of CIRARA. Under the terms of the agreement, Remedy will share in the cost of development for the target indication for CIRARA in LHI stroke. Biogen will make an upfront payment of $120 million to Remedy and may also pay additional milestone payments and royalties.