Athersys and Chugai Enter License Agreement and Collaboration to Develop MultiStem(R) Cell Therapy for Ischemic Stroke in Japan - Seite 2

As part of the collaboration, Chugai will be responsible for the development and commercialization of MultiStem for ischemic stroke in Japan, and Athersys will have responsibility for product supply. Under the financial terms of the agreement, Athersys will receive an up-front cash payment of $10 million from Chugai and would receive additional payments as the program is further advanced. Athersys is eligible to receive milestone payments from Chugai of up to $45 million upon the successful achievement of certain development and regulatory milestones, and sales milestones of up to 17.5 billion Yen (approximately $150 million based on the current exchange rate).  Athersys would also receive from Chugai tiered, double-digit royalties on any net sales, as well as payments for product supplied to Chugai.

In Athersys' ongoing Phase 2 clinical study, it is evaluating the administration of MultiStem cell therapy to patients who have suffered an ischemic stroke. Based on preclinical research to date, administration of MultiStem has shown significant benefits through several mechanisms, including 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, in contrast to thrombolytic tPA treatment, which is limited to the first three to four hours following the stroke. Preclinical studies have demonstrated that administration of 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.

About Ischemic Stroke

Stroke represents an area where the clinical need is particularly significant, since it represents a leading cause of death and significantly lowers Quality of Life for stroke patients. Currently, there are more than 15 million people that suffer a stroke globally and more than two million stroke victims per year in the United States, Europe and Japan, combined. Ischemic strokes, which represent the most common form of stroke, are caused by a blockage of blood flow in the brain that cuts off the supply of oxygen and nutrients and can result in tissue loss and neurological damage, as well as long-term or permanent disability. Unfortunately, current therapeutic options for ischemic stroke victims are limited, since the only available therapy, a clot dissolving agent, or "thrombolytic," must be administered within several hours of the occurrence of the stroke. As a consequence of this limited time window, only a small percentage of stroke victims are treated with the currently available therapy-most simply receive supportive or "palliative" care. The long-term costs of stroke are substantial, with many patients requiring extended hospitalization, extended physical therapy or rehabilitation (for those patients that are capable of entering such programs), and many require long-term institutional or family care.