If Multistem (MAPC) is the best, there is no "biosimilar" threat. Multistem would command the market like any therapeutic until its patent runs out and generics are produce.
Even after the patent expires, enhancements protected by additional IP that reduces manufacturing costs could undercut generics.
Most important, Multistem is poised to be first to market for stroke.
By my calculations, with the PCYC lesson fresh on big pharma's minds, we could face a hostile takeover in the coming days:
57 Institutional Holders with 7,681,755 Total Shares Held.
% of Shares Held by All Insider and 5% Owners = 19%
If Chugai Pharmaceutical Co., Ltd. gambled on Japan, it would be well worth the gamble of Roche to gamble on the rest of the world for a mere 20 PPS. Would you give your shares away for 20 PPS right now, risk free? Otherwise, Athersys could work with the FDA to gain early approval and quickly run beyond 100 PPS.
Pfizer would be left look at Roche like JNJ is looking at AbbVie which now owns PCYC.
Take a look at what Roche has been doing. Even if stroke fails, Multistem is something they would like to add to R&D considering Mesoblast and Teva are not stopping with their bone marrow cells.
"Modulation of mesenchymal stromal cell characteristics by microcarrier culture in bioreactors"
Roche Diagnostics GmbH, Penzberg, Germany
These findings may be useful for the generation of MSCs with tailored properties for clinical applications.
Thanks for all the comments. Its very interesting to think about. IMO, the bottom line appears to be that the "Golden Hour" is more like "The Fleeting 60 Minutes".
From WebMD - "Many people who suffer strokes have them while they are asleep, which may prevent them from getting clot-busting treatment in the critical first few hours after a stroke, a study shows.
Such strokes, referred to as wake-up strokes, account for about 14% of all strokes, according to the study. Previous research estimated the percentage of wake-up strokes between 8% and 28%."
Other reports link excess sleep with stroke...great something else to worry about while trying to go to sleep..."Could sleeping too much make you have a stroke? A new study indicates sleeping more than 8 hours a day can increase your risk by 46%."
1/3 of stroke patients miss the Golden Hour for meds or stents that help dissolve or remove blood clots.
Multistem meets this group's unmet medical need within a window of, hopefully 24 to 48 hours. While this is no substitute for missing the Golden Hour, Multistem can hopefully reduce/reverse a siginicant amount of damange caused by stroke-induced immunodepression caused by spleen atrophy, lung bacterial infection, etc. Simvastatin provides some of the benefits of Multistem but likely not all, Stroke 2013 Apr; 44(4): 1135–1143.
As for using Multistem 3 days (72 hours) following stroke, Multistem will need to be evaluted in another study because the current trial does not inlcude a 72 hour time point. The intervention of the current trial is a single infusion 1-2 days following ischemic stroke.
This is enough time for all pateints to make it into the hospital, so our market of helping patients is primarily this 1/3 of stroke patients.
'Golden Hour' Care Unlikely for One-Third of Americans
-Too few stroke centers sited in rural areas.
Even under an optimistic scenario, as many as 114 million people in the U.S. would be unable to reach a comprehensive stroke center (CSC) using ground transportation within the critical treatment "golden hour," researchers estimated.
Source Reference: Mullen MT, et al "Optimization modeling to maximize population access to comprehensive stroke centers" Neurology 2015; 84: 1196-1205.
Reviewed by Henry A. Solomon, MD, FACP, FACC Clinical Associate Professor, Weill Cornell Medical College and Dorothy Caputo, MA, BSN, RN, Nurse Planner
They have to. They are partners now. PCYC's terms and condition are now Abbvie's. The question is: Why did JNJ allow this happen? At some point, JNJ said no to PCYC.
Oh, now that#$%$ below the belt. You must either be short or working for a day trading operation.
I give you a thumbs down for this behavior.
But on a serious note, yes. Pfizer's single dose to cure 10 year old Crohn's was purely a biomarker level experiment, IMHO. The chances of achieving any therapeutic outcome was zero. We know this.
What is unknonw is Pfizer's motivation. My guess is that they like Mesoblast/Teva's approaches, and they want to keep a finger in the pie, but on the cheap.
Well nothing is cheaper than a company with a failed one trick pony stroke trial.
This is the harsh reality. But also a reality is that little guys like us are like ants on a sugar cube, dreaming big without knowing the sugar cube is on a busy freeway of fast moving luxury cars driven by people who already have what we want. Eat, drink, and be merry for tomorrow the results come in.
If they like what they see, we need the backstop to bad stroke data.
As it looks now, Pfizer is holding this card.
Obviously the Crohn's trial was designed to provide research data...with clinical success from a single dose of 10 years Crohn's being a remote afterthought.
Chugai is gambling nothing.
They can use MultiStem for GvHD and cover their losses if the stroke trial fails.
Meanwhile retailers suckered in by the mirage of $10 million in confidence could lose everything in addition to spiking the price for the warrants.
Did Gil say we have 50% institutional ownership? What else did he say....
Chugai holds all the Multistem cards in Japan.
Their agreement with Athersys does not end with stroke but includes all therapeutic indications for Multistem.
For just $10 million, Chugai bets on stroke and simultaneously gets a GvHD insurance policy to cover all losses in the event of stroke trial failure.
Fore shareholders though, GvHD will not be enough to right the ship. If the stroke trial fails, Athersys will rapidly sink to the bottom of the north Atlantic.
It will then be salvaged for scrap by Pfizer with golden parachutes for management.
But, if the Athersys stroke trial is a success...all will be right in the world...but when does this ever happen?
JCR Pharmaceuticals is focusing on the commercialization of Prochymal in Japan for the treatment of patients with GvHD. Chugai could be giving chase, knowing the 10 million could be returned over time for GvHD. With this in mind, the gamble is not quite that big for Chugai. The stroke results are still a big unknown, but in the event of success, would you not predict a PCYC scenario playing out with the likes of JNJ or Pfizer? If MAPC is that potent, then the sky is the limit.
Twitter, yes, that is what Gil was doing while having his coffee.
Athersys Inc athersys
Athersys and Chugai Enter License Agreement & Collaboration to Develop MultiStem® Therapy for Stroke in Japan
about an hour ago
I think you are right. More details from Athersys tomorrow.
Everyone will be sleeping easy except for the shorts!
Something tells me the press release coordination was lost in translation.
Somebody needs to call Gil and let him know that the party is on early.
Athersys website went to bed early....
Osiris Receives Milestone Payment for Prochymal Development Progress in
COLUMBIA, Md. -- April 28, 2010
Osiris Therapeutics, Inc. (NASDAQ:OSIR), announced today that it has achieved
a $1 million milestone payment from its Japanese commercial partner, JCR
Pharmaceuticals, for development progress made advancing Prochymal for the
treatment of acute graft vs. host disease (GvHD) in Japan.
In 2003, Osiris formed a partnership with JCR Pharmaceuticals focusing on the
commercialization of Prochymal in Japan for the treatment of patients with
GvHD. The collaboration provides for additional milestone payments for
regulatory and sales milestones, as well as significant royalty payments on
sales of the drug in Japan.