Athersys will co-develop and co-commercialize its MultiStem® cell therapy for ischemic stroke in Japan by bringing in a partner, Chugai Pharmaceutical, in a deal that could net Athersys up to $205 million-plus.
MultiStem is under Phase II clinical study for ischemic stroke in the U.S. and Europe. In Japan, where the deal is centered, Athersys has begun preparations for clinical development, having engaged with the Japanese Health Authority.
Athersys said it hopes to tap into Chugai’s expertise and experience in late-stage development and commercialization in Japan, the companies said. Chugai is majority-owned by Roche.
“Chugai has been a leader in the development and introduction of innovative biologics and has successfully established one of the top sales forces in the prescription drug field in Japan, which we believe represents a key competitive advantage that can help both companies maximize value,” Gil Van Bokkelen, Ph.D., Atherys’ chairman and CEO, said in a statement.
Chugai will oversee the development and commercialization of MultiStem for ischemic stroke in Japan, with Athersys having responsibility for product supply.
In return, Chugai agreed to pay Athersys $10 million in upfront cash, plus up to $45 million in payments tied to achieving development and regulatory milestones, and sales milestone payments of up to ¥17.5 billion (about $150 million). Athersys will also receive from Chugai tiered, double-digit royalties on any net sales, plus payments for product supplied to Chugai.
Athersys says MultiStem has potential for treating multiple disease conditions—including cardiovascular, inflammatory, and immune diseases, as well as neurological disorders such as ischemic stroke. MultiStem is designed as an “off-the-shelf” stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression.
In its ongoing Phase II clinical study, Athersys is evaluating the administration of MultiStem cell therapy to patients who have suffered an ischemic stroke. According to the company, preclinical research to date has shown that administration of MultiStem has resulted in reduction of inflammation and immune system modulation in the ischemic area, and the protection and rescue of damaged or injured cells, including neuronal tissue.
Athersys is treating patients one to two days after the stroke has occurred, compared with thrombolytic tissue plasminogen activator (tPA) treatment, which is limited to the first three to four hours following a stroke. Athersys says preclinical studies have shown that administering a single dose of MultiStem therapy, even one week after a stroke, provides significant and durable improvements relative to controls.
Enrollment in Athersys' double-blind, placebo-controlled trial is complete, and interim safety and initial efficacy results following the ninety-day patient data are expected to be announced in April 2015, following analysis and receipt of the unblinded clinical data.