- Biogen on Wednesday said it has exercised an option to buy an experimental drug from Japan's TMS Co. that may widen the window for treatment of stroke.
- A mid-stage study showed the drug, called TMS-007, could help patients within 12 hours of an acute ischemic stroke, which is caused by a blocked blood vessel. The standard therapy tPA, sold by Roche as Activase, is approved for treatment within three hours of the onset of symptoms and recommended for a smaller group of patients within four-and-a-half hours.
- The deal has Biogen paying $18 million to TMS. The privately held Japanese drugmaker will also receive royalties if the drug reaches the market and as much as $335 million in payouts if TMS-007 reaches certain developmental and commercial milestones.
Biogen has long seen a major market opportunity in stroke, which affects some 13 million people around the world each year and kills 5.5 million. The company tested its Tysabri multiple sclerosis drug to treat stroke but abandoned the effort in 2018 after the failure of a Phase 2b study.
TMS-007 is designed to break through clots that choke off blood supply to the brain, the cause of about 85% of all strokes. It also may block inflammation that occurs around a blockage, Biogen said.
The Food and Drug Administration hasn't approved a clot-busting medication for stroke since the 1996 clearance of tPA. While tPA is highly effective, it isn't used enough because of the short treatment window and the need to screen patients before giving them an infusion.
To be eligible, patients must get to a medical care facility quickly after symptoms begin. Then, doctors have to make sure that the patients aren't suffering from a hemorrhagic stroke, which is caused by a broken blood vessel, or other types of internal bleeding.
Biogen said studies suggest TMS-007 can improve on the risk-benefit profile of tPA. In the Phase 2a study of 90 patients, the average time to dosage was 9.5 hours after the onset of symptoms. Researchers saw no cases of symptomatic intracranial hemorrhage, a concern if tPA is given to patients too late.
The drug fits into Biogen's larger focus on neuroscience. At the moment, however, Biogen investors are intensely focused on the future of the company's experimental Alzheimer's disease drug, aducanumab. After years of ups and downs, the FDA is due to rule on the medicine by June 7.