On August 5, 2021 Athersys, Inc. (NASDAQ: ATHX) and HEALIOS K.K. (Healios) (TSE Mothers: 4593) jointly reported expansion and deepening of their partnership to optimize and better align the collaboration structure to drive therapeutic reach and commercial success in Japan for the MultiStem (invimestrocel) product following potential regulatory approval (Press release, Athersys, AUG 5, 2021, View Source [SID1234585953]). The changes and new agreements reflect improved clarity regarding Japanese regulatory, manufacturing, and commercial requirements gained in recent years and better enable the optimal investments and efforts in manufacturing and commercialization. The agreements will facilitate the regulatory approval process for MultiStem in Japan, prepare the companies for commercial manufacturing and supply and expand the overall scope of collaboration between the companies.
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"We are happy to have reached this Comprehensive agreement with Healios which strengthens the alignment, commitment, and motivation of both companies and improves the potential for MultiStem commercial success in Japan," stated Mr. William (B.J.) Lehmann, Jr., President, and Interim CEO of Athersys. "This is an important step for us as it brings us closer to achieving our first regulatory approval and providing supply for commercialization in a key market and meeting our goal of bringing life-saving therapies to patients worldwide."
Dr. Hardy TS Kagimoto, Chairman and CEO of Healios, commented, "We have come a long way in building a stronger, mutually beneficial, win-win partnership between Athersys and Healios. With the improved relationship and clarification of the roles, responsibilities, and incentives as reflected in the new agreements, we aim to accelerate the development, regulatory approval, and delivery of life-saving treatments for patients. We are committed to achieving our mission: ‘Life Explosion!’ by delivering cures for patients with unmet medical needs."
"I would like to compliment and express my appreciation to the boards and management of both Healios and Athersys for their dedication and commitment in working through challenging issues to achieve this important milestone for the benefit of patients dealing with severe medical issues such as acute respiratory distress syndrome and stroke and for the benefit of shareholders of both Athersys and Healios," added Dr. Ismail Kola, Chairman of the Board of Athersys. "This is truly a win-win enhancement to the partnership."
Key elements of the improved collaboration include:
Providing Healios access to Athersys’s manufacturing technology to enable Healios to manufacture MultiStem products, using a qualified manufacturer, for a potential commercial launch in Japan and allow Athersys to focus resources on advanced commercial manufacturing development.
Clarifying Athersys’s role in providing support services necessary for regulatory approvals, manufacturing readiness, and commercial launch in Japan.
Sharing investment in commercial preparation and product supply through planned investment by Healios in certain manufacturing preparation activities and additional production capacity for Japan and, through deferrals and certain adjustments to financial terms of the license agreement, including milestones and royalties, during the early commercial phase.
Expanding Healios’ license in Japan to include two new additional indications under certain conditions to enable Healios to further leverage its investment in MultiStem while providing Athersys the opportunity for additional revenues from this market.
Increasing alignment between the companies and creating incentives for accelerated execution and investment, through $8 million in new milestone payments available to Athersys tied to certain Japan commercial manufacturing activities and the establishment of large scale manufacturing relevant to Japan, and through warrants issued to Healios to purchase up to a total of 10 million shares of Athersys common stock at a premium to the current market price and exercisable for 60 days following regulatory approval for ARDS and ischemic stroke, respectively.