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Biogen Exercises Option To Acquire TMS-007 For Acute Ischemic Stroke - Quick Facts

Neuroscience company Biogen Inc (BIIB) announced Wednesday that it has exercised its option to acquire TMS-007, an investigational drug for acute ischemic stroke, from privately-held Japanese peer TMS Co., Ltd. Biogen's decision to acquire TMS-007 was based on positive data from a Phase 2a study.

Biogen will make a one-time payment of $18 million to TMS. They will also make payments of up to an additional $335 million to TMS in potential post-acquisition development and commercial payments should TMS-007 achieve certain developmental milestones and sales thresholds.

TMS is also eligible to receive tiered royalties in the high single digits to sub-teen percentages on annual worldwide net sales. Biogen will be solely responsible for the costs and expenses related to the development, manufacturing and commercialization of TMS-007 following the acquisition.

Acute ischemic stroke is caused by a blockage of blood supply to the brain, and current thrombolytics are limited in use due in part to increased risks of bleeding.

The study met its primary safety objective with no incidence of symptomatic intracranial hemorrhage (sICH) and demonstrated positive impacts on both blood vessel reopening in the brain as well as patient functional recovery.

For the randomized, placebo-controlled, ascending dose Phase 2a study, patients were dosed up to 12 hours after the onset of stroke symptoms; average time to treatment was 9.5 hours for patients who received TMS-007 and 9.3 hours for those who received placebo. All patients who received TMS-007 were dosed beyond the time window of approved thrombolytic agents.

TMS-007 has the potential to be a next generation thrombolytic with an improved benefit-risk profile. Biogen is currently evaluating the next steps for the clinical development of TMS-007, including plans for global studies.

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