January 8, 2016 7:37am
Alliance will focus on development and commercialization of regenerative medicine products for stroke and other potential Indications using new regulatory framework in Japan
Healios is recognized as a leading regenerative medicine company in Japan, with a technology portfolio that includes the development of retinal pigmented epithelia cells produced from induced pluripotent stem cells for the treatment of age related macular degeneration (“AMD”).
ATHX closed at $1.03 which was UP +$0.03. The morning open will drive the shares upward – the pre-market indication <so far> is +$0.24 - I see a $3.00 share pricing over the next few days/weeks.
Healios K.K. and Athersys (ATHX) have announced a partnership and license agreement that will focus on the development and commercialization of novel cell therapy treatments, including MultiStem® for the treatment of ischemic stroke and potentially other indications, in Japan. The partnership involves MultiStem, a proprietary, patented off-the-shelf stem cell therapy being developed by Athersys, with an initial focus on treating ischemic stroke.
Under the terms of the agreement, Healios will gain exclusive rights for the development of MultiStem for treating ischemic stroke in Japan. Healios will develop and commercialize the product in Japan, and
- Athersys will provide the manufactured product and support to Healios, while retaining all rights outside of Japan;
- In addition, Healios will obtain an exclusive option for development of two additional MultiStem clinical indications in Japan, including the treatment of Acute Respiratory Distress Syndrome (“ARDS”), which is currently in clinical development by Athersys in the United States (“U.S.”) and the United Kingdom (“U.K.”), and another indication in the orthopaedic area;
- Healios will also obtain an exclusive license to incorporate Athersys technology in the development and commercialization of its proprietary Healios “organ bud” technology, initially for transplantation to treat liver disease or dysfunction, which may be expanded upon exercise of the option.
The Bottom Line: Stroke represents a major problem, both in Japan and globally.
- As part of the license, ATHX will receive an initial license fee of $15 million, as well as have the opportunity to earn milestone and royalty payments upon the successful accomplishment of specific development and commercialization objectives, including the achievement of certain sales milestones;
- Development and approval milestones for stroke could total $30 million;
- in addition to sales milestones that could reach $185 million based on successful commercialization and the achievement of substantial sales of an approved product for treating stroke in Japan;
- Athersys will also receive tiered, double-digit royalties increasing into the high teens on product sales and will be responsible for providing manufactured product to Healios, subject to receiving reimbursement under a manufacturing supply arrangement;
- Furthermore, if Healios elects to expand the partnership following the successful completion of Athersys’ ongoing clinical trial in ARDS, Athersys will receive a license expansion fee of $10 million for the exclusive rights to two additional indications in Japan, with the corresponding potential for further milestones based on successful achievement of specific development and commercialization objectives;
- As part of the expanded alliance, Healios will also have the right to incorporate Athersys technology in other organ bud indications.
Currently available treatments such as tPA and mechanical thrombectomy must be administered within the first several hours after the stroke occurs, limiting treatment to a small percentage of patients, and such interventions may also pose certain risks.
Healios and Athersys have already met jointly with PMDA and plan to complete additional preparations for initiation of a clinical study in Japan for stroke, with commencement of the study expected in the second half of 2016.
Healios is recognized as a leading regenerative medicine company in Japan, with a technology portfolio that includes the development of retinal pigmented epithelia cells produced from induced pluripotent stem cells for the treatment of age related macular degeneration (“AMD”). Healios obtained a license to the technology from RIKEN to develop a novel treatment for AMD in 2013. Healios has also licensed additional technology from Yokohama City University related to the development of organ buds for transplantation indications. Healios is partnered with Sumitomo Dainippon Pharma Co., Ltd. and SHIBUYA CORPORATION (a leading robotics company in Japan), as well as NIKON CORPORATION and Osaka University who are focused on the joint development of advanced manufacturing capabilities for regenerative medicine therapies.
ATHX closed at $1.03 which was UP +$0.03. The morning open will drive the shares upward – I see a $3.00 share pricing over the next few days