Biogen’s business development team has been on the march.
The big biotech has struck a deal to buy a Phase III drug for ischemic stroke for $120 million up front, looking to oversee the late-stage program aimed at expanding its portfolio of neuroscience drugs.
Biogen bought the drug from Remedy Pharmaceuticals, which completed the mid-stage effort and gathered orphan and fast track status for Cirara. The drug tackles SUR1-TRPM4 channels, hitting a pathway involved in brain swelling, or cerebral edema. And it will now be put alongside natalizumab, a Biogen therapy now in Phase IIb for inflammation related to ischemic stroke.
Remedy isn’t backing away, though. It will help finance the program for large hemispheric infarction, a severe form of ischemic stroke and also stands to earn a slate of unspecified milestones if the effort proves successful.
Here’s what Remedy found in Phase II that attracted Biogen’s attention:
Of the 77 patients in the primary analysis, there were 19 deaths within the first 30-day period, 6 of 41 in the CIRARA group (14%), versus 13 of 36 (36%) in the placebo group (p=0.03), corresponding to a reduction in mortality of 60%. Within the 90-day follow up period, there were a total of 20 deaths, 7 of 41 subjects in the CIRARA group (17%), versus 13 of 36 (36%) in the placebo group (p=0.06), a reduction in mortality of 53%.
“In the previous Phase II GAMES-RP study,” noted Baird’s Brian Skorney, “CIRARA failed to show a benefit on the primary endpoint of proportion of patients achieving an mRS score of 0-4 at 90 days. However, Biogen is more interested in the potential benefit on mortality and inflammation, indicating that both adjudicated neurological mortality and death from edema saw statistically significant results in Phase 2 versus placebo. Though the current Phase III design calls for use of improvement in mRS at 90 days as the primary endpoint again, Biogen intends to meet with the regulatory authorities and potentially alter the study design, if necessary, in order to initiate a Phase 3 study in 2018.”
During JP Morgan newly named Biogen CEO Michel Vounatsos signaled that he was ready to start doing some deals to help relieve analysts’ fretting about the company’s pipeline and prospects. Biogen scored big with Tecfidera under the old George Scangos regime. But the franchise drug is coming under increased pressure and Biogen has been putting a lot of its eggs in the Alzheimer’s basket, where the payoff is high and the risk of failure even higher.
This deal with Remedy isn’t nearly enough to resolve worries about the pipeline, but if it can replicate the pact with more late-stage acquisitions, Vounatsos will be ready for his next JP Morgan closeup.
Biogen clearly has high hopes for its latest addition to their Phase III pipeline.
“Building on our leading position in multiple sclerosis, spinal muscular atrophy, and Alzheimer’s disease research, we see a compelling opportunity in stroke where we can leverage our core expertise in neuroscience to make a major difference in patient care. CIRARA represents a potential breakthrough stroke treatment that accelerates our efforts to build a portfolio of new therapies for neurologic diseases,” remarked Michael Ehlers, the executive vice president of R&D at Biogen, in prepared text. “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.”
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