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TOPIC: ATHX deal in Japan

ATHX deal in Japan 08 Jan 2016 09:07 #5949

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Healios and Athersys Enter Into Regenerative Medicine Partnership for Treatment of Stroke Using MultiStem® Therapy

Alliance to Focus on Development and Commercialization of Regenerative Medicine Products for Stroke and Other Potential Indications Using New Regulatory Framework in Japan

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Athersys, Inc.
4 hours ago

GlobeNewswire





CLEVELAND and TOKYO, Jan. 08, 2016 (GLOBE NEWSWIRE) -- Healios K.K. (“Healios”) (Tokyo Stock Exchange: 4593) and Athersys, Inc. (“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.

“Stroke represents a major problem, both in Japan and globally. 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,” observed Dr. Kiyohiro Houkin, Chairman and Professor of Neurosurgery of Hokkaido University Medical School, and President of Hokkaido University Hospital. “The recently conducted international clinical study by Athersys in the U.S. and the U.K. suggests that intravenous administration of MultiStem within 36 hours of the occurrence of a stroke is safe, well-tolerated, and is a beneficial and effective treatment. The off-the-shelf administration of the product could be a simple and universal approach for treating acute stroke patients. Furthermore, it could be administered to patients that do not arrive at the hospital in time to receive current standard of care, or alternatively could be administered in addition to tPA or mechanical reperfusion, potentially enhancing outcomes for patients that have suffered significant strokes. If efficacy is confirmed in additional studies, it is possible that this therapy could become the new standard of care for treating stroke,” concluded Dr. Houkin.

As part of the license, Athersys 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.

Japan currently represents the second largest national market for prescription biopharmaceuticals in the world. The country is also experiencing a significant demographic shift that is resulting in a rapid and unprecedented expansion of the elderly population in Japan, which threatens to pose significant challenges for the national healthcare system over the next several decades. In order to help address the challenges posed by the potential increased demand for healthcare resources as a result of this expanding population, over the past two years policy-makers in Japan have revised the regulatory framework to focus on promoting the development of innovative new therapies that are demonstrated to be safe and that also provide promising signs of effectiveness. These recently implemented regulatory reforms, which are specifically designed to promote development of novel regenerative medicine therapies, are intended to speed the development of promising new medicines for patients where there is substantial unmet medical need.

Athersys’ proprietary cell therapy product, MultiStem, has been evaluated in a Phase 2 clinical study for ischemic stroke in the U.S. and U.K. and is also in clinical development in several other indication areas, including the treatment of ARDS, myocardial infarction, and for transplant support, including prevention of Graft versus Host Disease and liver transplant support. Athersys has begun preparations for clinical development in Japan, including engagement with the Pharmaceuticals and Medical Devices Agency in Japan (“PMDA”). 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.

“I am very pleased that an exclusive licensing contract has been concluded with Athersys over development and distribution in Japan of MultiStem, a candidate pharmaceutical product for innovative cytotherapy having undergone phase 2 clinical trials in U.S. and U.K. There seems to be a large market need for MultiStem that can expand the period allowed before the start of treatment for ischemic stroke. Successful development of this product under the new regenerative medicine framework in Japan could accelerate Healios’ ability to help patients, achieve profitable operations and deliver substantial value to our shareholders,” commented Dr. Tadahisa “Hardy” Kagimoto, President of Healios. “Beyond stroke, the technology by Athersys is expected to improve the efficiency of production also when we prepare the organ as a platform for clinical transplantation programs. In essence, Healios has acquired a catalyst that can accelerate commercialization in the field of iPSC-based regenerative medicine products.”




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4:14 am Athersys and Healios form alliance focusing on development and commercialization of regenerative medicine products for stroke in Japan
Briefing.com 5 hrs ago

Athersys, Inc. Earnings Analysis: Q3, 2015 By the Numbers
Capital Cube q 17 days ago


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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.

“Athersys is excited to be working with Healios for the development of MultiStem in Japan with an initial focus on treating patients that have suffered an ischemic stroke. Healios has an experienced and accomplished leadership team that recognizes the importance and transformational potential of the regenerative medicine field. They also have a compelling vision for our collaboration that includes the potential to work together across several important indication areas in a highly focused and efficient manner, which is why we selected them as our new partner,” said Dr. Gil Van Bokkelen, Chairman and CEO at Athersys. “They have a strong balance sheet, an excellent network of institutional partners and collaborators, and they are committed to rapid and efficient development under the new regulatory framework in Japan, all of which are key factors for success.”

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ATHX deal in Japan 08 Jan 2016 10:13 #5950

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Hedge, I guess ATHX has read the generative law and understands it. Not sure if Cytori has finished reading it yet, Remind me this law was put into action a year ago November ?

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ATHX deal in Japan 08 Jan 2016 10:13 #5951

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Interesting news...

I would guess the 15 Million is the same smoke screen as Chugai's 10 million... HOWEVER, I think since the Helios will be handling most of the work it could be a hit.... IF the TECHNOLOGY actually work... (the last trial was a disaster, I thought)..

Could be a good short term trade, if the market was in a better shape... I am keeping an eye on it.

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ATHX deal in Japan 08 Jan 2016 10:35 #5952

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It is funny that ATHX has been able to sell the same indication twice now and we still wait for news out of Japan. :bash:

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ATHX deal in Japan 08 Jan 2016 11:40 #5953

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Healios confirmed, with $15,000,000 of cold hard cash, that the post-hoc analysis of the Phase II stroke data was legitimate. Something that the market hasn't accepted. This is a big deal because it is a relatively short road to revenues in Japan if Athersys can demonstrate signs of efficacy in a small Japan trial. Stroke is one of the biggest unmet medical needs known to man.

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ATHX deal in Japan 08 Jan 2016 11:51 #5954

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Hedge,

I think the primary reason Cytori has been unable to attract a partner is the autologous nature of the treatment. That hasn't stopped the burgeoning stem cell industry in the U.S. from growing and patients getting treated but it not as desirable as off-the-shelf assuming they both work. Even the CIRM is slanted against autologous. Also, the team at Athersys is top notch and more credible, in the way it has managed its business.

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ATHX deal in Japan 08 Jan 2016 14:37 #5955

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If you look at ATHX's chart, you can see that it NEVER broke down, the way CYTX did... Another sign that the Market always knows.

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ATHX deal in Japan 13 Jan 2016 08:58 #6009

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CEO's of ATHX and Meso talk about recent developments. Hosted by Jason Kolbert.

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ATHX deal in Japan 13 Jan 2016 11:01 #6011

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Thanks WST- I watched the first 23 Minutes of the video with Itescu, Van Bokkelen and Kolbert.

I think Jason is right- data is going to drive the development of regen medicine and yes- I am slowly starting to believe ATHX has a more than fair chance to be successful in stroke. With MSB the jury still seems to be out- the reduction in trial size without loosing statistical power is something, somebody should have thought of before...I believe and not something which relates to the technology. :whistle:

Wish at Cytori we had a good CEO back in 2002...if they went for data than instead of solely fighting everybody on IDE versus IND regulation, we would have been a lot further down the road of becoming a big Company.

ADRCs work as platform tech- and with MultiStem and Resvescor nobody really knows if that statement applies to them although they are obviously much further down that road of becoming a big Company. :bash:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

ATHX deal in Japan 14 Jan 2016 21:33 #6032

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Fas,

I am slowly starting to believe ATHX has a more than fair chance to be successful in stroke.


Well so far they have obtained $25,000,000 for a stroke program, solely for the rights to Japan. $10MM from Chugai, $15MM from Healios. $25,000,000 in non-dilutive capital within the last year and very lucrative milestone and royalty terms going forward. I think you are correct in your assessment that the odds of success are reasonable. The ultimate upside on getting approval in stroke is incredible. Chugai played hardball and Athersys didn't blink and it worked out well. Healios is extremely well connected in Japan and solely focused on reg med.

I'm not recommending that anyone buys the stock but I'm happy to be invested. Everyone on this board KNOWS the game well enough and is more than capable of doing their own DD. I've written several SA articles on Athersys if anyone wants a head start. A very extensive article going past the SA paywall to the general public on January 21st. The stock is still priced like stroke is a real long shot.

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ATHX deal in Japan 20 Jan 2016 15:24 #6065

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For those interested, here is a very in depth article about Athersys and the stroke data that I believe is very promising and I expect that at some point Wall Street will see it that way: http://seekingalpha.com/article/3769446-top-stock-idea-for-2016-athersys-a-beaten-down-stem-cell-stock-with-great-upside

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ATHX deal in Japan 21 Jan 2016 14:14 #6076

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WST,

Nice job again, Maybe I should get the boys ready for a run?

Any thoughts on PSTI?

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ATHX deal in Japan 22 Jan 2016 15:14 #6087

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Thanks cytxer. What boys are you referring to? No thoughts on PSTI at this time.

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ATHX deal in Japan 28 Jan 2016 17:39 #6124

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Wall Street Titan wrote: Thanks cytxer. What boys are you referring to? No thoughts on PSTI at this time.



Boys = Algo and $

It is active right now, I am watching both ATHX and CYTX... This is the fun part of it.


PSTI looks very interesting to me - The Japan deal.

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ATHX deal in Japan 16 Feb 2016 12:16 #6408

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For those interested, the AHA has given Athersys 6 slots at the largest stroke conference in the world, starting tomorrow:

CLEVELAND, Feb. 10, 2016 (GLOBE NEWSWIRE) -- Athersys, Inc.(ATHX) announced today that six presentations featuring Athersys’ MultiStem® cell therapy treatment for ischemic stroke will be made at the 2016 International Stroke Conference hosted by the American Heart Association, to be held February 17-19, 2016 at the Los Angeles Convention Center, located at 120 South Figueroa Street, Los Angeles, CA. Athersys(ATHX) has recently completed a Phase 2 clinical study of its proprietary cell therapy for the treatment of ischemic stroke and is planning for the next phase of clinical development. A collaboration with Athersys(ATHX) and HEALIOS K.K. was recently announced to develop and commercialize MultiStem for the treatment of stroke in Japan.


The presentations will be made by several of Athersys’ clinical collaborators and experts in the field, as follows:


February 17 (Session 109) 8:45 am Dr. David Hess,
Co-moderator One, Two, Three Steps toward Cell Therapy for Stroke, and in the Future (Debate) Room 151

February 17 1:30 pm Dr. David Hess Final Results of the B01-02 Phase 2 Trial testing the Safety and Efficacy of MultiStem in Treatment of Ischemic Stroke Room 502 B

February 18 2:18 pm Dr. Lawrence Wechsler MultiStem Treatment Reduces Length of Hospitalization When Administered Within 36 Hours After Onset of Ischemic Stroke: Implications On Lowering Stroke Related Health Care Costs Room 408

February 18 6:15 pm Dr. Sean Savitz Acute Intravenous MultiStem Infusion Restores Hemeostasis of Immune and Spleen Responses After Ischemic Stroke Hall H

February 19 7:12 am Dr. Wayne Clark Exploratory Results From the B01-02 Trial: Administration of MultiStem Results in Decreased Circulating CD3+ Cells and Lower Levels of Inflammatory Cytokines Room 152

February 19 (Session 41) 9:23 am Dr. David Hess Safety and Efficacy of IV Stem Cell Therapy in Acute Stroke: What is the Evidence from the MultiStem Trial? Room 515 B


Dr. David Hess is a stroke specialist and Chairman of the Department of Neurology at the Medical College of Georgia Regents University, and served as the lead principal investigator in the MultiStem stroke study. Dr. Lawrence R. Wechsler, Henry B. Higman Professor of Neurology/Neurosurgery and Chair, Department of Neurology, University of Pittsburgh Medical Center, and Dr. Wayne M. Clark, Director of the Oregon Health and Science University Stroke Center, were also clinical investigators in the MultiStem study. Dr. Sean I. Savitz, Director, Vascular Neurology Program & Fellowship at the University of Texas Medical School and members of his team will present additional pre-clinical data about the mechanism of action of MultiStem in a poster session.

“The B01-02 clinical trial represents the largest randomized clinical study of intravenous cell therapy to date. I am encouraged that the treatment with MultiStem was well tolerated and safe, and that there was reduction in life threatening adverse events, infections and mortality among subjects receiving cell therapy, in comparison to placebo. Overall, we did not find significant evidence of efficacy when looking at patients treated within a 24 to 48 hour window; however, it was encouraging that we observed benefit when MultiStem was administered within 36 hours of the stroke, consistent with the initial study design,” commented Dr. Hess. “In the one year follow up results that will be presented, we are particularly interested in evaluating the proportion of subjects that achieve an Excellent Outcome, as reflected by excellent improvement in each of the three clinical rating scales used. Such an outcome reflects the ability to recapture a high quality of life and live independently, and is what patients, families, clinicians and healthcare providers care most about.”

About the Conference

The International Stroke Conference is the world’s largest meeting dedicated to the science and treatment of cerebrovascular disease. The conference features more than 1,500 presentations that emphasize basic, clinical and translational sciences, as they evolve toward a more complete understanding of stroke pathophysiology with the overall goal of developing more effective prevention and treatment. Sessions in clinical categories will center on stroke community risk factors, emergency care, acute neuroimaging, endovascular and nonendovascular treatment, diagnosis, cerebrovascular occlusive disease, in-hospital treatment, and outcomes of stroke. Sessions in basic science categories focus on vascular biology in health and disease, experimental mechanisms and models, and basic and translational neuroscience of stroke recovery. Further specialized topics include rehabilitation and recovery, pediatric stroke, intracerebral hemorrhage, nursing, preventive strategies, vascular cognitive impairment, aneurysm, subarachnoid hemorrhage and other neurocritical management, vascular malformations, and ongoing clinical trials. Cutting-edge presentations on these topics attract a wide range of healthcare professionals and investigators spanning the fields of cerebrovascular function and disease.
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