- Biogen has added a second stroke medication to its pipeline through an asset deal with Remedy Pharmaceuticals.
- The drug of interest, Cirara (intravenous glyburide), aims to treat large hemispheric infarction (LHI), a type of ischemic stroke that is characterized by often fatal swelling of the brain. Roughly 800,000 people in the U.S. have a stroke each year, and Biogen estimates about 15% of those are LHIs.
- The big biotech is giving Remedy an upfront payment of $120 million, which it is paying in cash, according to a company spokesperson. Additionally, the two drugmakers will split development costs, though Biogen is shouldering the majority and will also take on all commercialization expenses, the spokesperson added. Cirara has recently entered a Phase 3 trial in LHI, with a primary completion date scheduled for May 2019.
Cirara is an important gain for Biogen because it diversifies both the company's general neuroscience pipeline as well as its stroke candidates. Currently, the drugmaker only has one other stroke candidate, natalizumab, which is marketed as the multiple sclerosis drug Tysabri and is in Phase 2b testing as a medication for acute ischemic stroke (AIS).
There is only one drug on the market for AIS: Genentech's Activase (alteplase), a tissue plasminogen activator (tPA) considered by many as the "gold standard" for stroke treatment. With that it mind, Biogen appears to be mulling the idea of enrolling patients who have already received tPA treatment in the Phase 3 trial of Cirara, according to a May 15 note from Mizuho Securities analyst Salim Syed.
The drug will have to perform well in late-stage, though, if there's any hope for it passing to market. Previously, it failed a Phase 2 safety and efficacy study, with 41% of patients in the experimental arm and 39% of patients in the placebo arm reaching the primary outcome of a modified Rankin Scale (mRS) score of 0–4 at 90 days without decompressive craniectomy.
Biogen, however, remains optimistic. In fact, the company "initiated talks with Remedy, a move in line with the company’s renewed focus to identify external innovation opportunities in neuroscience," a spokesperson wrote in an email to BioPharma Dive.
It makes sense that Biogen would want to continue to double down on neurological disorder drugs, given they're responsible for the vast majority of its income. Of the $2.38 billion in revenues the company raked in during the first quarter, nearly 92% came from its multiple sclerosis franchises. The company has been turning back to its roots after divesting its hemophilia business and having its CEO step down.
“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," Michael Ehlers, Biogen's head of R&D, said in a May 15 statement.