Biogen has entered into an exclusive option agreement with TMS Co., Ltd. to acquire TMS-007 and backup compounds. The agreement includes an upfront payment of $4 million and an additional $18 million payment if Biogen exercises its option, with up to $335 million in potential development and commercialization milestones as well as tiered royalties.

TMS-007 is a plasminogen activator with a novel mechanism of action associated with breaking down blood clots, and is believed to inhibit local inflammation at the site of thrombosis. This unique combination could position TMS-007 as a best in class thrombolytic for individuals with acute ischemic stroke (AIS) with potential for an extended treatment window as compared to current thrombolytic agents.

“Stroke represents a compelling opportunity that takes advantage of our deep expertise and capabilities in neuroscience as we seek to make a meaningful difference in patients’ lives. Stroke impacts millions of people every year, and is a leading cause of death and long-term disability worldwide,” said Michael Ehlers, executive vice president, research and development, Biogen. “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. 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.”

Stroke is the fifth leading cause of death in the U.S. with AIS accounting for approximately 85% of cases and large hemispheric infarction accounting for approximately 15% of AIS cases.

TMS-007 is a small molecule which has previously demonstrated an acceptable safety profile in a Phase 1 study and has also reduced infarct volume (area of dead tissue resulting from failure of blood supply) in experimental rodent and primate embolic and thrombotic stroke models.

TMS-007 is currently being evaluated in a double-blind, placebo-controlled Phase 2 study in Japan, designed to investigate the safety and efficacy of a single IV administration of TMS-007 in approximately 60-90 patients with AIS up to 12 hours after stroke onset. The Phase 2 study initiated with the first patient dosed in February 2018.