Sanofi Message Board
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New Patent: Regeneration and augmentation of bone using mesenchymal stem cells
by scistats •May 15, 2013 1:33 PMPublication Date: 05/15/2013
Filing Date: 04/17/1997Sentiment: Strong Buy
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New product?
Disclosed are compositions and methods for augmenting bone formation by administering isolated human mesenchymal stem cells (hMSCs) with a ceramic material or matrix or by administering hMSCs; fresh, whole marrow; or combinations thereof in a resorbable biopolymer which supports their differentiation into the osteogenic lineage. Contemplated is the delivery of (i) isolated, culture-expanded, human mesenchymal stem cells; (ii) freshly aspirated bone marrow; or (iii) their combination in a carrier material or matrix to provide for improved bone fusion area and fusion mass, when compared to the matrix alone. The material or matrix can be a granular ceramic or three-dimensionally formed ceramic implant. The material or matrix can also be a resorbable biopolymer. The resorbable biopolymer is an absorbable gelatin, collagen or cellulose matrix, can be in the form of a powder or sponge, and is preferably a bovine skin-derived gelatin. The implants can be shaped as a cube, cylinder, block or an anatomical site. The compositions and methods can further include administering a bioactive factor such as a synthetic glucocorticoid, like dexamethasone, or a bone morphogenic protein, like BMP-2, BMP-3, BMP-4, BMP-6 and BMP-7.Sentiment: Strong Buy
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Congratulations!
Sentiment: Strong Buy
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Current US Cartilage Repair Market $2.2 Billion Annually
Sentiment: Strong Buy
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Time for JNJ to bag Osiris.
Sentiment: Strong Buy
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Daniel your statement, "A partner willing to deliberately wade into a massive Intellectual Property battle." speaks volumes.
If Osiris lands the partnership that Randy has alluded to despite the pending massive intellectual property battle, it would suggest that Osiris is battle-ready. Landing a Prochymal partnership in this environment would suggest that Osiris has a distinct advantage.
Looking forward, if the Prochymal partnership comes to fruition, it will be a game changer for those who respect the formidable forces behind Athersys/Pfizer and Mesoblast/Teva.
i.e. Partnership news would be huge.Sentiment: Strong Buy
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No, I think we do have value in biosurgery and some value in Prochymal as well. The triple digits may be a bit too much though.
I think $25 PPS is a good buyout price until Randy explains exactly how Prochymal stacks up against the clear and present danger of MultiStem. We need direct and specific explanations of how both compare in terms of efficacy and cost.
As long as he continues to paint broad brush strokes on this issue, there will be uncertainty considering the long term process Prochymal is taking. This delay just gives Athersys time to catch up. Biosurgery is growing, but not at triple digits rates. Epifix is taking market share away at some level. Cartiform may be the true game changer, but there is also competition in cartilage repair.
Taking all of this into consideration, I think $25 is the buyout price, and right now, the PPS agrees with me 100%. I am on the right board in terms of reality, not fantasy. In fact predicting 100% plus gains is optimistic.Sentiment: Strong Buy
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Pfizer is betting on Athersys.
Why would they do this if it is folly?
Do they lack critical thinking skills...maybe, but not likely.
If in fact Multi-Stem is superior, it will rise to the top.
Comparing drug coated stents, Taxus vs. everolimus. Taxus came out first with Boston Scientific and then we had a copycat Abbott parallel with their own flavor, Xience. Check out who won. It was Abbott with the Xience stent coated with everolimus. Slowly but surely the trials proved beyond any doubt that Xience was superior. Taxus retreated to holding onto claims that there might be niche applications for Taxus for diabetics, but I think they have even lost this battle.
If Multi-Stem is superior, the data will accumulate and crush Prochymal. This leaves a very short window to generate a profit in a regulatory environment that is painfully slow. Osiris may be hacking a path through the jungle only to have Athersys drive in an air conditioned car behind them, cracking the window occasionally to yell out, "Faster lads! Randy, clear the jungle faster!" Any partner is probably thinking about this, and it may explain why Sanofi decided to abandon the collaboration.
Second, patents are a funny thing. If there is sufficient profit to be made, competitors can simply ignore the law and pay the fines while still making a vast profit, especially internationally.
Prochymal 1.0 is in a crack at the moment in more ways than one. Now, Prochymal 2.0 may be an entirely different story. Whatever Prochymal 2.0 is, it must beat Multi-Stem.Sentiment: Strong Buy
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OSUP, Athersys is farther along than this, and they have a good partner, Pfizer. Can they go expanded access and damage Osiris' bottom line in this way? Where do they think they are taking their program if Osiris can shut them down in court? Is this why they are focusing on stroke? The Mesoblast ruling is big.
"MultiStem cells are currently in phase II clinical studies for treatment of ischemic stroke and ulcerative colitis, with Phase I studies completed in acute myocardial infarction and for GvHD prophylaxis in allogeneic HSCT, demonstrating that MultiStem administration was well tolerated while the incidence and severity of GvHD was reduced."
Front Immunol. 2012; 3: 345.Sentiment: Strong Buy
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j.ellis84, they are two different cell types. Athersys may get away with it, or the Osiris patents may hold. It is hard to say what might happen. From below, "Both cells are adherent bone marrow-derived stem cells, but due to different culture conditions they adopt different phenotypes." Is a different culture condition enough justification for violating an Osiris patent?
Prochymal is made from mesenchymal stromal cells (MSC) whereas Multistem is made from Multipotent adult progenitor cells (MAPC).
Multipotent adult progenitor cells (MAPC) are bone-marrow-derived non-hematopoietic adherent cells that were first described by Jiang et al. (2002). The MultiStem clinical product is based on MAPC isolation and expansion protocols (Boozer et al., 2009).
Mesenchymal stromal cells (MSC) may use similar immunosuppression mechanisms (Gebler et al., 2012) and although MAPC and MSC exert comparable activity in an in vitro T-cell suppression assay (Jacobs et al., 2012), it is evident that they are distinct cell types.
Both cells are adherent bone marrow-derived stem cells, but due to different culture conditions they adopt different phenotypes (Roobrouck et al., 2011b). The cells express distinct cytokine profiles which may explain the observations that MAPC can induce tube formation by HUVEC cells in in vitro assays while MSC lack this pro-angiogenic effect (Lehman et al., 2012).
Moreover, MAPC are able to induce functional blood vessels in vivo when the cells are implanted in a Matrigel plug with VEGF and bFGF under the skin of nude mice, where vessels induced by MSC appeared leaky (Roobrouck et al., 2011a).
This is why Athersys CEO suggested they can beat Osiris at AMI.
All of this info is from:
Front Immunol. 2012; 3: 345.Sentiment: Strong Buy
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Cartiform, Grafix, and Ovation are strong products. A big pharma may be willing to take on the Prochymal program and evolve it, but Athersys' Multi-Stem is a clear and present danger that is backed by Pfizer.
Can Osiris legally stall Multi-Stem as they did Mesoblast in Australia? I don't think so because Multi-Stem is a bit different. Unfortunately, it looks like Osiris is doing the heavy approval lifting, building a bridge for Athersys to take a Sunday stroll across at will.
Osiris has a head start, they could enhance Prochymal to compete with Multi-Stem and go economy of scales to beat down Multi-Stem, but there is no way they can remotely begin to pull this off alone. It is going to get very interesting.
Is cell production a bottle neck or not? Probably not for GvHD. Is Multi-Stem really superior...Athersys thinks so.Sentiment: Strong Buy
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I am just throwing it out there for debate. Obviously Randy and Athersys' CEO are going head-to-head. Athersys' CEO says has data proving Multi-Stem is superior to Prochymal...he especially suggests this may be the case for AMI. It would appear that Athersys has the upper hand across all Prochymal indications, plus stoke.
Listen to Athersys talk. He talks after Randy at the meeting. It would appear that Prochymal is toast in my opinion, especially because Multi-Stem is much cheaper. This negates what Randy was saying about saving the healthcare system money. It looks like Randy is going to have to bow down to Multi-Stem, tap-out, and beat a hasty retreat to the biosurgery line-up. I would go as far to say that the Prochymal partnership may not go through at all. Why invest only to get beat by Multi-Stem? Multi-Stem is different enough to win any patent challenge.Sentiment: Strong Buy
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Listen to Athersys CEO refer to Randy's talk at the Needham 12th Annual Healthcare Conference. He explains how MultiStem is superior.
Osiris is rapidly transitioning to a biosurgery company because of this.
Prochymal 1.0 is toast, and Osiris is now ENTIRELY reliant upon (in this order):
1. Cartiform
2. Grafix
3. Ovation
With this lineup, we can probably reach $25 PPS at current operational expenses. Buyout at $30 if Cartiform is as good as advertised. Prochymal will have some time, but it will take a Prochymal 2.0 to beat MultiStem. MultiStem is scaring away some potential partners.Sentiment: Strong Buy
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Osiris jumped out of bed one morning and looked out across the way to find someone was growing coconuts in the adjacent field. On a big blue sign read the words P-F-I-Z-E-R....Pfizer. What was this?
As quickly as his leg would carry him, Randy ran with his coconuts to the market to find that the villagers had coconuts everywhere....high AND low.
A wise old man crossed the street, and Randy asked him, "Kind sir, what is this?" The old man replied, "My dear son, its competition." Adjust your earning estimates, and you will find salvation in a partnership or buyout. And whatever you do my son, don't forget the Epifix."Sentiment: Strong Buy
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OSIR not the only game in town.
ATHX. This answers some questions.Sentiment: Strong Buy
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Osiris was a small biotech company that purchased a small coconut seedling from a man named Mr. Caplan.
Osiris was happy and took the little coconut tree home and planted it.
For years, Osiris looked after the coconut tree, until it grew high and strong.
After many years, the coconut tree became loaded with coconuts!
Excited, a young man named Randy scurried up the tree and collect a bountiful harvest.
However, try as he might, he could not get at the tender meat and luscious coconut water on the inside.
He spent energy trying to husk each nut and break the massive seed open, but the sun was hot and the husk was too strong. Then he had an idea. He would share his coconuts with people in the village that had sticks and stones to husk and crack the nuts. Randy shared his coconut, and in exchange, drank the rich water and ate the flesh until he was full. Then, he planted more trees, until one day the villagers asked if he would sell all of his coconut trees in exchange for much riches. Randy agreed. The end.Sentiment: Strong Buy
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$25 PPS is about right for a buyout.
A 1000 person sales crew would run Osiris $100 million per year or more, and therein lies the problem.
Osiris lacks the critical mass, even with the stocking stuffer biosurgery extras yet to come, to put cash on the bottom line. To get the sales numbers that they need, they would simply have to spend too much money get there.
The time is coming when turning Osiris' few products over to JNJ will make a lot of sense, and everyone will be happy to do so.
Right now, we are like gerbils on a spinning wheel. Randy's salary alone is 600K, so we keep coming up short with a loss. This pattern will continue because, as the dedicated sales force penetrates, so do their commission based salaries. Six of one half dozen of the other, slice it, dice it, it all comes out the same...break even.
We don't have economies of scale. What we have is buyout preparation.
The only thing that could change this equation is Prochymal AMI. Speaking of which, the Prochymal revenue does not seem to be a deal maker at this point, and I don't think the AMI data is coming out anytime soon.
There will be a time when $25 PPS will be a deal that everyone will gladly accept.Sentiment: Strong Buy
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MFC, on the flip side, it looks like Randy is preparing Osiris for a buyout. He cannot seriously believe that a sales force this small can effectively launch anything, but they can generate the interest needed for a bidding war and massive buyout.
Five thumbs down for my post. The entire sales team is steaming! I am sure their contract has a sweet deal built in for the buyout, shares and cash?Sentiment: Strong Buy
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1. We want to protect the product, and it takes time to educate our Cartiform sales team of FIVE PEOPLE so they can educate doctors.
2. Our 15 person Grafix sales force build out is sluggish due to protecting the asset.
3. $75 to $130 million annual bio-surgery revenue estimate that we made is just a "bracket", not something to hold us to.
4. Prochymal is ahhhhhhhhh waiting on a partnership....ahhhh.Sentiment: Strong Buy
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Dedicated sales force of 15 PEOPLE needs to "STEP UP BIG TIME!!!"
Cartiform sales needs "RAMP UP!!!"
RANDY, "WE AIN'T JNJ", and we CANNOT distribute like them.
LOOK FOR A BUYOUT END GAME.
Three months ended March 31, 2013 Gross profit $2,900,000
Three months ended December 31, 2012 Gross profit $2,100,000
Three months ended September 30, 2012 Gross profit $1,400,000
Three months ended June 30, 2012 Gross profit $1,100,0000
Three months ended March 31, 2012 Gross profit $750,000
Three months ended December 31, 2011 Gross profit $443,000
Three months ended September 30, 2011 Gross profit $192,000
Three months ended June 30, 2011 Gross profit of $75,000
Three months ended March 31, 2011 Gross profit of $22,000
Three months ended December 31, 2010 Gross profit of $56,000
Three months ended September 30, 2010 Gross profit of $65,000
"We commenced limited sales of our Biosurgery products during the third quarter of 2010"Sentiment: Strong Buy