Biogen signed a deal for an exclusive chance to acquire TMS’ treatment for restoring blood flow after acute ischemic stroke, which is currently being evaluated in a placebo-controlled phase 2 study in Japan.
The agreement’s $4 million upfront payment could grow by an additional $18 million if Biogen decides to exercise its option, and possibly balloon by $335 million more if the drug hits its development, commercialization and sales targets.
TMS’ plasminogen activator, TMS-007, uses a novel mechanism of action to break down blood clots, and is thought to inhibit inflammation at the clotting site, according to the Tokyo-based company, which believes the drug could have an extended treatment window compared to other thrombolytic agents.
“TMS-007 complements our broader efforts in stroke, including our phase 3 ready asset BIIB093 (intravenous glibenclamide), which targets prevention and treatment of edema in large hemispheric infarction, one of the most severe types of stroke,” Biogen’s executive VP of R&D, Michael Ehlers, said in a statement. The option deal also includes the small molecule’s backup compounds.
“By growing our acute neurology portfolio, we aim to make new advances in a disease that in the past decades has seen limited therapeutic innovation.”
In a phase 1 study, TMS-007 demonstrated an acceptable safety profile, according to Biogen, and has also reduced area of dead tissue resulting from failure of blood supply in rodent and primate embolic and thrombotic stroke models.
The ongoing double-blind phase 2 study, launched in February, is designed to investigate safety and efficacy of a single IV administration in 60 to 90 patients up to 12 hours after onset of acute ischemic stroke.
Last year, Biogen paid $120 million upfront for BIIB093, then known as Cirara, from Remedy Pharmaceuticals. Cirara had also received an FDA Fast Track designation.
Biogen plans to launch a new phase 3 trial of BIIB093 by the end of this month, estimating an enrollment of 680 participants and scheduled to be completed by September 2020. The study will measure improvement in function after 90 days in patients with acute ischemic stroke.