Osiris

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Hans
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Osiris Therapeutics, Inc. (OSIR) August 13, 2013 9:00 am ET Executives Charles Randal Mills - Chief Executive Officer, President and Director Analysts Edward A. Tenthoff - Piper Jaffray Companies, Research Division Presentation Operator Good morning, everyone, and welcome to the Osiris Therapeutics Company Update Conference Call. Before we begin, I would like to remind everyone that this conference may include forward-looking statements that involve uncertainties and risks. Actual results could differ materially from those anticipated in the forward-looking statements for many reasons, including the factors described in the section entitled Risk Factors in our filings in the Securities and Exchange Commission. As a reminder, today's call is being recorded. I would now like to turn the call over to Dr. C. Randal Mills, President and CEO of Osiris Therapeutics. Please go ahead, sir. Charles Randal Mills Thank you very much. We are back here and better than ever this morning. We thank you for joining us after such a short break since our last call, and particularly, on such note notice. But given the data that we put out this morning, we thought it was worthy of a conference call. So thank you for waking up this morning with us and joining us early. As Nicole mentioned, we encourage you to look at the risk factors that are on file with the Securities and Exchange Commission, as any forward-looking statements I may make today may differ materially from actual results. Let's get into why this is such a big deal today, why this news is so important. Diabetic foot ulcers in the United States are a very serious health care problem for the patients, for the physicians and also for the payers. There are over 25 million diabetics in the U.S., with DFUs affecting up to 25% of all patients that have diabetes. Importantly, DFUs are responsible for more hospitalizations than any other complication of diabetes. DFUs are known to be a causal factor in amputation, and sadly, 69% of patients that have to have an amputation due to a DFU will not survive 5 years. So from a payer's standpoint and from a patient's standpoint, diabetic foot ulcers are very big deal. When we look at what's out there from a standard of care and from an advanced care standpoint, we can see that both really needs to get better. So if you look at the relative effect, that is the absolute effect divided by the control performance, for those products that had peak sales in the DFU market space of greater than $100 million, you can see that the product with the highest relative effect has a relative effect of 64%. But that's only with a healing rate of 30% versus control, which did 18%. So generally speaking, standard of care will produce somewhere between 18% to 35%, depending on the demographics of the patients, where they have chronic ulcers; while the advanced therapies will have 30% to 56% response rates. But again, in the trials where we see the higher response rates, we also see higher control rates, higher response rates in the control arm or the standard of care arm, indicating something about the population that was -- that the population was generally easier to treat. So the bottom line from this -- in this slide, in this data, is that the products that are doing really well in the DFU space still need much room for improvement, and that's what we try to do in developing Grafix. So now I'd like to talk a little bit about Protocol 302, which was the clinical trial that we ran. This was the evaluation of the efficacy and safety of Grafix in the treatment of chronic diabetic foot ulcers. This is a multi-centered, controlled, randomized, single-blinded with blinded image verification and a crossover arm. This is a very high-quality clinical trial in the wound care setting and one of the most rigorous with regards to endpoint verification ever performed. With regards to Protocol 302, as I mentioned, it's -- with a multicenter site. Now this is the list of the sites, the 20 centers that were participating. A quick look at these sites can clearly point out that these are the leading sites across the United States. They are high-quality, reputable sites that do consistent and good work. So when a patient is going to one of these sites and receiving their standard of care, they're receiving some of the best standard of care available anwhere in the world, and that was our control arm. The other thing that I'd like to point out here is that we use an academic research organization, a nonprofit, independent academic research organization, CPC Clinical Research, out of the University of Colorado, which were responsible for all of the clinical monitoring, data management and biostatistics specialty. I just -- because I recently went over there from the last call, I won't get into it in a great deal -- detail, but these are our eligibility criteria, our inclusion and exclusion criteria that we use for the trial. It's very standard, 18 to 80 years of age with confirmed diabetes, and ulcers have to be chronic, meaning they have to be there for at least 4 weeks. The patient can't be uncontrolled diabetics, they can't have diabetes and the ulcers have to be of diabetic origin. The key point from this slide is that this is very similar inclusion and exclusion criteria that's been used in the other large, multicenter trials for advanced wound care products in DFU. Looking more specifically now at the study design. The way this trial work is before patients were randomized, they were put into a run-in period, or a screening period, where they were given care. And what we were looking to do at this point was to make sure that the patients truly had a chronic wound. So these patients were treated and evaluated over a 1-week period. And any patient with a greater than 30% reduction in wound area was excluded. From that point, patients that passed the screening period were then randomized into the blinded treatment phase. The randomization was 1:1, with patients equally being randomized to receive either standard of care or Grafix. The patients were blinded to their treatment assignments, so they didn't know what they were getting. The physician here obviously did know what they were getting, because they were the one applying the treatments to the patients. So the blinded treatment phase evaluated these patients for a 12-week period. Out of this blinded treatment phase, there were basically 2 things that could happen. If the patients healed, they were entered into the follow-up phase, and that follow-up phase went on for 3 months. So any patient that healed during the treatment phase goes into the follow-up phase, and what we're looking for there is the durability of the closure and the incidence of recurrence. Patients that were in the control arm that did not heal just with standard of care after 12 weeks were crossed over to a Grafix treatment phase. So they were then switched and given 12 weeks of Grafix. And what we are looking for in that aspect of the study was to see whether or not Grafix could basically rescue the patients who do not respond to standard of care in this trial. Looking at the primary endpoint for this trial, it's the proportion of patients with complete wound closure of the index wound defined as 100% epithelialization, and that was at the 12-week prime time point. Secondary endpoints are: Proportion of patients completing the trial who had complete wound closure, so these are patients that attended every visit in either of the control arm or the Grafix arm; time to initial wound closure, so this is of the patients whose wounds closed, how long did it take for those wounds to close; the number of treatments in either group; and the closure of patients in the crossover phase. Tech InvestorSeeking AlphaThose are the secondary endpoints that we have data on today. We also have 2 other secondary endpoints where we'll be getting data in later, and that is the proportion of patients that achieved at least a 50% reduction or greater wound reduction by day 28 and the recurrence of wounds following initial wound closure. A key point that I want to make here is, that speaks to how rigorous this trial was, centers around the endpoints and verification of the endpoints. It's well known that in DFU trials, a significant challenge is the variability of the data that comes from physician assessments of wounds that closed than others would perhaps read as not closed or vice versa. And so what we did with this trial was we had our ARO take all patients' image data and send it to a blinded wound core lab. So these -- the wound core lab was getting images when a physician said the wound was closed, and actually throughout every week throughout the visit. And when the physician says the wound was closed, 2 independent reviewers, blinded of the treatment assignment, would also make an assessment on whether they thought the wound was closed or not. And so what this did for us was really remove a lot of variability that inherently comes from an otherwise somewhat subjective endpoint. The very sophisticated software using image tracing and edge detection that allowed us to get a real accurate and consistent assessment of whether or not these wounds were actually fully closed. And that give us very tight consistent data. Just going through the statistics of Protocol 302. So the study was powered to detect 20% difference, absolute difference, in healing rates. And so our assumptions going in were that the Grafix arm would have about a 50% healing rate versus the control arm of about 30% healing rate. Again, the control standard of care arm comes from what have been reported in previous trials which, as I mentioned, was between 18% and 35%, and so we conservatively put it at 30%. And the Grafix, which conservatively powered at 50%. We assumed that there would be a dropout rate of about 30%, and this was a key area. Our actual dropout rate in this trial was much lower. That interim analysis that was conducted by the data monitoring committee utilized a 2-sided O'Brien Fleming method that was conducted at approximately 100 evaluable patients, it was actually conducted at 97. And we had 4 potential outcomes out of that, as I previously mentioned: We could continue as planned; if the trial was underpowered with the number of patients, we would repower it by adding more patients to the trial; we could stop the trial for futility; or we could stop the trial for overwhelming efficacy, if data so indicated. So when we look at just graphically where this trial ended up and why it was stopped for superiority, I wanted to sort of show you in a representative way where this trial came in versus the stopping roles. And so you're seeing the distribution curve for the stopping rules of this trial. And so a z-value of less than 0 in this trial would have -- the trial would've been halted for futility. Anything between 0 and 1, the trial would've been repowered. Anything between a z-value of 1 and 2.8, and the trial would've continued as planned. In order for the trial to stopped for superiority, we actually needed a z-value greater than 2.8. Now the thing I wanted to point out here is the actual z-value that we achieved was a 4.1. And so it wasn't close in regards to crossing the stopping rules. That corresponds to a p-value of 0.00005. Also, I'll say, before we made the final decision to stop trial, we looked at a couple of other things. The first thing are baseline characteristics and demographics. And so this trial was well balanced with no differences between age, gender, BMI, wound size or wound duration. We also looked at how well the control group was performing. If the control group was performing in an unusually low manner then this would've given us best given us some pause. It was not. The control group in this trial performed well within our expectations of what we thought. We also want to see if the Grafix arm was performing in an unusually high way. Since we've started Protocol 302, we have actually completed 2 other studies, both of which have given us probability of closure rates that are nearly identical to the ones that we've seen in this trial. And so with regards to how well Grafix works, we were probably a bit too conservative in power. But with that said, the decision to stop the trial for superiority was not close from a statistical standpoint and when we looked at more -- some of the more qualitative parameters around stopping rules. Now let's get into the data. So on the primary endpoints, Grafix significantly improved closure rates, 62% versus 21%. Importantly, this is 191% relative improvement over standard of care. Again, I will remind you that standard of care here is a sum of the best wound care centers in the world. So these are patients getting excellent treatment and Grafix having 191% relative improvement. When we look at the Kaplan-Meier curve, it gives you a good idea that of the kinetics of this trial. Kaplan-Meier curve is very clear, very early divergence in these 2 curves that no point of the curves come close to each other, let alone cross. The Kaplan-Meier probability, which accounts for things like censoring and loss to follow-up has a probability of closure for this trial at 70%. Again, very consistent with the other data that we have seen in our 2 previous trials with regards to Grafix. When we look at time to closure, again, 4 weeks faster. And I will point out, this is -- when we're talking about time to closure here, we're talking about the time -- the time to close for -- of those wounds that closed. So we couldn't get a median time to closure in the control group because they were never able to close of 50% of the wound. So this is just of the wounds that closed. So if you're going to have a wound that's going to close, getting -- put on Grafix, saves an entire month off of your treatment. So that's a month of less having to go to visits in a month, getting up and being ambulatory. A very significant that we have significant reduction in time to closure. Very significant for payers and, obviously, that is an important consideration when we ran this trial. We said from the outset, we wanted to not just show that we had a better product, but we had a product that can reduce, divert on the overall health care system, was that we were able to reduce by half the number of treatments that patients needed. This, again, was also highly significant in the trial. A very interesting part of this trial was our crossover phase. So I'm going to sort of walk you through this just so you understand what we did. For patients who were randomized to standard of care, those patients received 12 weeks of therapy attempting to close the wound. If they failed their 12 weeks of therapy on standard of care, we cross them over, meaning, we gave them Grafix. Now once we cross them over, they were no longer blinded. That was -- part of the trial was known that if you fail standard of care, you would be given Grafix. But these patients were given Grafix. But the point is, this phase of the trial is looking at those patients that did not respond to standard of care. And so you can see, as soon as we switched them to standard of care, you can see their probability of closure curve jumps right up, and their probability of closure ends up being at 80%. When you compare this to the initial probability of closure that came out of the blinded treatment phase, we blew this up so that you can see some difference between the curve. Statistically, however, these curves are identical, p-value is -- I can't remember exactly, but it's something like 0.7. So what this is telling us is that Grafix is performing just as well in the de novo patients with chronic wound as it is in those patients which come in with a chronic wound, plus fail another 12 weeks of the best standard of care available. We are still able to rescue 80% of those patients. Again, if you're looking at number of treatments, probability of closure, time to closure it was all very consistent with our Grafix performed in the de novo patients. So we're very excited about that. It shows also that the patients -- there wasn't something unusual about the patients that were randomized to the standard of care arm, as Grafix was able to easily close their wounds as well. Perhaps the most interesting thing and the most unexpected piece of data that came out of this trial is the safety data. Patients were significantly more likely, 74% more likely, to experience an adverse event if they were randomized to the control group. Now I'll also tell you that patients were similarly and significantly more likely to suffer a treatment emergent adverse event in the control group. This is potentially a very big deal. But we need to understand this more. Infection is the single biggest driver of adverse events in wound care by far. Obviously, you have a chronic wound, getting that would infected and all the complications of infection are very important. So this is going to be very important for us to dig in and understand more and actually see what's driving this difference. Obviously, it will be a big deal if, not only we can close more wounds faster with fewer treatments, but if we can also reduce adverse events, and particularly infections, that will be huge. We need to do further digging on this. Obviously, in top line data that we get quickly we're not able to go through the adverse event listings in a way to fully understand what's going on here. But without a doubt, and consistently across the top line data we got, patients on Grafix have significantly fewer adverse events and treatment emergent adverse events than those receiving standard of care. So we're very pleased with that. So if we go back and look at how Grafix's relative effects or relative improvements over its controlled -- over the control group compares to the other products in the diabetic wound space that have peak sales greater than $100 million. What we see is that we have more than a 3-time improvement in relative effect over the next closest competitor. And so, we're very pleased about what this means, not only obviously for the product and the product's future going forward, but also what this means for improvement in the care of patients with diabetic foot ulcers. A question -- if you're new to the call you might be asking, "So why is Grafix performing so much better?" So we'll touch one of the reasons. We've come to know now, we've come to know through our own research, again, in Osiris, we've produced more than 100 peer-reviewed articles on stem cells, the mesenchymal stem cells. And particularly through our own development of it, I have come to learn a lot about what effects stem cells both to the upside and to the downside. And one of the things that is now very clear is that the pathology associated with diabetes negatively affects the regenerative potential of the patient's own mesenchymal stem cells. So unfortunately, diabetes compromises these patients' ability to heal their own wounds, and this is published in -- by a number of places. But in morphology, growth, differentiation, apoptosis, it's all shifted in the wrong direction once the patient has diabetes. The meaning of that is these patients are often difficult to treat and don't respond standard therapies that don't contain cells, and particularly stem cells, because they simply don't have the population to repair themselves. And so you can put a dressing or a wound covering on it, but if you don't have the cell population you need to heal, you're going to be able to heal. So Grafix is able to supply this healthy noncontroversial mesenchymal stem cell population in an optimal matrix. So we get the benefit of an ideal extracellular matrix, we get the benefit of an ideal wound covering, but we also get the benefit of a rich cell population that includes mesenchymal stem cells. And that's one of the reasons why, in the studies that we've done, we see such clear differentiation with Grafix over other things. So for people on the call from a financial standpoint, you might be asking, "So what?" So here, it centers around: One, the size of this market; and two, our ability to advance in this market. So the United States DFU market is approximately $2 billion. 20% of that is in the inpatient and VA market, so up until now and before this trial, that is the session of the pie that we've been relegated to. With this data, we are going to be able to go after and seek reimbursement decisions for the outpatient market. We think that the data here and the data that's going to be coming would clearly support coverage in the outpatient market as well. So that will expand our relative market cycles. So this is a big deal for us with regards to the number of wound care centers we're able to call on, and therefore, the number of wounds we're able to address. The one thing that I want to take a second here and pause because, obviously, the data is great the trial just works extremely well, and, in fact, better than expected. Keep in mind, coverage decisions, getting into new accounts, that's all going to take time. And so this is not going to overnight translate into an enormous increase in sales. I just want to caution everybody to take a breath. There's a lot that have to get done between generating good clinical data, getting the data published, getting in front of payers for coverage decisions, and getting it through product review committees at hospitals. That's all going to take time. We're very confident about it but it will take some time. Okay. And getting close to wrapping up here. I just wanted to give you a little bit of heads up around next steps. What we put out today is just the beginning. We have a lot more coming. And we think a lot of good things coming up after this. So first things that we're going to doing is we're going to becoming analysis for the efficacy data, this was on the first 97, there's 131 patients in this trial. We are going to be digging in immediately and try to understand the drivers of the safety benefit. As I mentioned on the that safety slide, we're very interested in knowing what's driving the safety benefit in this trial. We'll obviously be seeking coverage decisions by both government and private payers. We plan to submit this manuscript for publication in the well-respected, peer review scientific journal, and we think will be able to do that. Importantly, we are going to be evaluating Grafix in other wounds that we have pilot data in. So because the data from the blinded, randomized, controlled, multicenter trial track so well with the data we had gotten from our pilot trial, that gives us additional confidence that Grafix has the ability to demonstrate the same kind of effectiveness in other types of wounds, particularly the venous leg ulcers. And then, lastly, we are working to collect long-term outcome data of patients with diabetic foot ulcers and venus leg ulcer. Our ultimate goal here is to not just show wound closure, but actually to show more significant benefits particularly centering around lower extremity amputation rates. So we have a lot of good things going and a lot of very busy people this morning at Osiris. So to conclude here, Protocol 302 has clearly demonstrated that Grafix heals more patients. We have to heal these patients more faster with fewer treatments and with less adverse events. We could not have been more pleased with the outcome of this trial. And importantly, we think this trial is better for patients, health care providers and for payers, which was our ultimate goal from the start of this trial. So with that said, I will pause and turn the call over to the operator. Nicole, if we have any questions? Question-and-Answer Session Operator [Operator Instructions] Our first question comes from the line of Ted Tenthoff with Piper Jaffray. Edward A. Tenthoff - Piper Jaffray Companies, Research Division Well, firstly, congratulations. I mean, this is really incredible results for patients who need more active agents. You discussed about the time it's going to take to get this in -- to get this data published and to get it in front of payers, and I appreciated all of that. What kind of pull-though could we expect, though [ph], from a physician's side? And beyond publishing, are there scientific meetings where you would present this data like World Wound Healing or something like that? Charles Randal Mills Yes, so -- absolutely. We are going to be out there. I think, given how large the trial is and how many different aspects of this -- there's so many interesting things about this trial. There are so many things that surprised us, particularly the infection, the safety, the crossover data. It's just all very interesting. So yes, there are number of conferences SAWC is coming up, it's probably the largest wound care conference in the United States. Desert Foot, which is going to be November. SAWC is going to be tight, but if we can get a late breaker in there, were going to do that. Obviously, you're going to be see some stuff about this at Desert Foot, and then the publication. The other thing, too, is outside of just publications and the like, we're going to be releasing additional data on this trial as we get leads. So we've received the top line data here. There's a lot more data in this trial that we need to receive and obviously go through and fully understand. And if that comes along, so -- for example, once we understand the safety thing better, we're going to be releasing that data as well. Operator And there are no further questions at this time, I would like to turn the call back over to Dr. Mills. Charles Randal Mills Thank you, guys, very much for joining us this morning. Obviously, a very exciting morning here at Osiris despite the rainy weather we're having in Maryland, but I do hope you all have a great day. Good day. Operator Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program, you may all disconnect. Have a good day, everyone. 

Gruss Hans

Hans
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From the conference call: "So for people on the call from a financial standpoint, you might be asking, "So what?" So here, it centers around: One, the size of this market; and two, our ability to advance in this market. So the United States DFU market is approximately $2 billion. 20% of that is in the inpatient and VA market, so up until now and before this trial, that is the session of the pie that we've been relegated to." 

Also, Marktpotential von 2 Mrd. wird bestätigt, aktuell ist die Marktkap. bei ca. $ 700 Mio - etwas tief, da hat es noch jede Menge Luft nach oben!

Gruss Hans

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Osiris conference call

Danke Hans, für das Protokoll:


Okay. And getting close to wrapping up here. I just wanted to give you a little bit of heads up around next steps. What we put out today is just the beginning. We have a lot more coming. And we think a lot of good things coming up after this. So first things that we're going to doing is we're going to becoming analysis for the efficacy data, this was on the first 97, there's 131 patients in this trial. We are going to be digging in immediately and try to understand the drivers of the safety benefit. As I mentioned on the that safety slide, we're very interested in knowing what's driving the safety benefit in this trial. We'll obviously be seeking coverage decisions by both government and private payers. We plan to submit this manuscript for publication in the well-respected, peer review scientific journal, and we think will be able to do that.
 
Importantly, we are going to be evaluating Grafix in other wounds that we have pilot data in.
 
Also kann man noch mehr erwarten! Und die 2 Milliarden werden auch bestätigt, dazu kommt vermutlich auch noch der Europäische Markt.
Ich frage mich nur, schläft da Big Pharma? Es könnte ja wirklich so sein, dass die Stammzellen wirken und dann kämen noch weiter Anwendungen dazu. Wer jemals an der GV von Newventuretec eine Präsentation von Randy Mills gesehen hatte, und dann in NEV investierte, der darf wieder hoffen.
 
Wo ist der Kurs in einem Jahr? Dreistellig?
 
Geduld bringt Rosen -- und Kohle
 
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Wert von Osiris

@Hans


wie hoch müsste eine Übernahmeofferte sein?


alles ohne Gewähr!


wer käme in Frage. Novartis, AbbVie's, JNJ?? Firmen die von Osiris zukünftig konkurrenziert werden könnten.


Unten interessante Informationen Novartis, sucht neue Betätigungsfelder, das Roche Paket (rund 1/3 gehört NOV) das könnte verkauft werden um Geld zu generieren.


Für eine Firma mit 2,4 Mia Umsatz (wie Onyx) werden 130$ geboten.


da müsste für Osiris noch mehr drin liegen, sofern die Pfeiler im Köcher treffen?


Da darf man ruhig träumen und gut schlafen. Onyx hat 73 Mio Aktien, Osiris etwa die Hälfte.


Wie es unten steht der Kurs kann noch weiter steigen! I think the stock could keep climbing.


Aus Interview mit Novartis Präsident:


Novartis-Präsident Jörg Reinhardt hat in einem Interview erklärt, dass eine bis zu zehn Milliarden Dollar schwere Übernahme stemmbar sei. Von einem Kandidaten wendet sich das Pharmaunternehmen aber bereits wieder ab.

Das Unternehmen ist dabei, einige Geschäftszweige genauer unter die Lupe zu nehmen - darunter Sparten mit Fokus auf Tier- Gesundheit und Impfstoffe. Laut Reinhardt wird das Unternehmen kommende Woche auch damit beginnen, sich sein Portfolio mit Blick auf strategische Perspektiven anzusehen.


Reinhardt hatte seinen Posten als Präsident des Novartis- Verwaltungsrats in diesem Monat angetreten. Er sieht sich derzeit Aufforderungen von Investoren ausgesetzt, Kernbereiche des von seinem Vorgänger Daniel Vasella aufgebauten Konzerns zurückzubauen - inklusive einer Beteiligung an Roche.


Kein Interesse mehr an Onyx


Nicht mehr interessiert ist Novartis Kreisen zufolge am US-Biotechunternehmen Onyx - und hat sich aus dem Rennen verabschiedet. Die derzeitige Bewertung mache dieses zu teuer für Novartis, berichtete die Nachrichtenagentur Bloomberg am Dienstag unter Berufung auf einen Insider. Novartis wollte die Informationen nicht kommentieren.


Der Basler Konzern galt lange als Interessent für Onyx zusammen mit AstraZeneca und Pfizer. Ein konkretes Angebot vorgelegt hat bislang der weltweit grösste Biotechkonzern AmgenAmgen bietet 130 USD je Aktie, nachdem ein zuvor abgegebens Gebot über 120 USD beim Onyx-Management aber auf Widerstand gestossen war.


Dem Käufer von Onyx winkt die Kontrolle über das Blutkrebsmittel Kyprolis. Analysten trauen dem seit 2012 auf den Markt gebrachten Blutkrebsmittel bis 2019 Umsätze von 2,4 Mrd USD zu.


Aus Motley Fool:


The challenge for Prochymal and Chondrogen is that, even if they ultimately gain approval, the drugs would truly face giants. AbbVie's (NYSE: ABBV  ) Humira, which treats rheumatoid arthritis and Crohn's disease among other indications, currently stands as the world's top-selling drug. Johnson & Johnson (NYSE: JNJ  ) also competes in several of the same markets with Remicade, another blockbuster near the top in terms of sales.In GvHD, Osiris would battle Novartis (NYSE: NVS  ) if it wins approval for Prochymal in that indication.



 


While Osiris' path to success would probably be difficult trying to gain share from AbbVie, J&J, and Novartis, the good news announced today for Grafix paints a different picture. Assuming Grafix gains regulatory approval (which seems like a really good bet), Osiris would almost certainly leap into the pole position in treating diabetic foot ulcers.



 


The U.S. market for diabetic foot ulcer treatments now stands at $2 billion annually. With Grafix performing three times better than the current standard of care, I expect Osiris will be able to gain a large chunk of that market. Even after today's massive gains, the company's market cap is still under $800 million. I think the stock could keep climbing.

Pegasus
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Osiris vorbörslich in USA

 

Oiris z.Zt. in USA bei 28.14 $, ein + von 10.61 %;

Quelle;
http://www.nasdaq.com/symbol/osir/premarket

Nach diesen exellenten Praxis-Ergebnissen ist es nur eine Frage der Zeit,
bis Osiris auch die Zulassung dafür  erhält.


:):cool::rolleyes:;)

 

 

So wie einem das Licht nicht ohne die Dunkelheit bewusst würde, so gibt es keine Situation, in der nicht etwas POSITIVES zu entdecken wäre.

Frei nach I Ging

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Osiris Zulassungen in USA ?

@ Hallo Hans,

 

Drei Fragen an dich & alle Forumsteilnehmer;

 

1.  Wie lange geht es deiner Meinung nach in etwa noch für eine Zulassung von Grafix ?

        (ohne Gewähr)

 

2. Hat Osiris schon Zulassungen erhalten und welche ?

 

3. Siehst Du den kleinen Rücksetzer als Zukaufsmöglichkeit oder eher die Hälfte mal verkaufen,

    Gewinnsicherung, um später günstiger wieder zukaufen. Tendiere zu Ersterem.

 

Danke für deine geschätzte Antwort, mit Quellenangabe Pos. 2 wenn möglich.

So wie einem das Licht nicht ohne die Dunkelheit bewusst würde, so gibt es keine Situation, in der nicht etwas POSITIVES zu entdecken wäre.

Frei nach I Ging

Hans
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1) Grafix ist bereits zugelassen für stationäre Behandlungen - eine Verkaufscrew bearbeitet seit 3 Monaten den US-Markt, zudem ist Osiris Hoflieferant der US Army seit Jahren, Einsatz Grafix und Ovation bei übelsten Kriegsverletzungen, auf Bilder dazu verzichte ich .. Kriegsveteranen profitieren davon

US Government Services Administration (GSA), is paying these prices for Grafix and Ovation.

Grafix Core 2x2cm $1,600.75Grafix Core 5x5cm $2,400.75Grafix Prime 2x2cm $1,600.75Grafix Prime 5x5cm $2,400.75Ovation .3cc $2,000.75Ovation 1cc $3,650.75

Ab hier: http://www.osiris.com/grafix

Safety and profile testing

Grafix is regulated by the FDA under 21 CFR Part 1271 Human Cells, Tissues and Cellular and Tissue-based Products (HCT/Ps). Osiris Therapeutics, Inc. is registered with the FDA as a tissue establishment and accredited by the American Association of Tissue Banks (AATB).

Extensive donor screening, serological testing, bioburden testing and sterility testing is performed on every lot to demonstrate suitability for transplantation. Each lot is tested to confirm cellular viability post thaw.

Grafix für DFU dürfte eine FDA Zulassung bedingen, dies dürfte in abgekürztem Verfahren einige Monate dauern (ohne Gewähr)

http://www.osiris.com/2013-08-13%20Grafix%20DFU%20Trial%20Results.pdf

2) Grafix, Ovation, Prochymal in Canada, New Zealand, für die USA und die Schweiz in Prüfung

Clinical Trial siehe: http://www.osiris.com/clinical.php

Produkt Pipeline Therapeutics siehe: http://www.osiris.com/therapeutics.php

3) Habe keine Glaskugel und werde daher keine Aussage machen können Wink

Ich für mich halte Aktien - EP im einstelligen Bereich, auch wenn das Ding höchst volatil ist

PS: Die nächsten Antworten zu Fragen kosten dann echt Kohle Smile

 

So kommt's, aber nicht schon morgen!

Grafix will eventually be worth $100s of millions in Sales and that will translate into a steadily growing share price. $50 for Grafix, $50 for Ovation, $50 for Cartiform and $50 for Prochymal GvHD. Over time, this will add to up to a $200 share price, if not more.

Gruss Hans

Pegasus
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Osiris Zulassungen in USA ?

@ Hans,

Besten Dank für deine Antworten. Hoffe natürlich dass die Zulassungen

nun möglichst bald kommen, dann wird die "Kohle" in unseren

beider Keller erst richtig wachsen.

Bin seit Juni 2012 dabei, habe 2 x zugekauft.

Gruss Pegasus

Drinks

 

PS;  Im übrigen lese ich deine Kommentare hier immer mit Interesse,

weil sie gut "Fleisch am Knochen"

& grosse Fachkompetenz bis in die wichtigen Details, eindrücklich  bezeugen.

So wie einem das Licht nicht ohne die Dunkelheit bewusst würde, so gibt es keine Situation, in der nicht etwas POSITIVES zu entdecken wäre.

Frei nach I Ging

2brix
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so bin gespannt wie wir heute starten und ob wir heute im Plus schliessen Smile

Hab mir mal die Links angesehen (Vielen Dank @Hans), da hats einige sehr aussichts- (und natürlich) auch risikoreiche Informationen.

Ich schau mir das noch ein wenig an, bis sich der Kurs ein wenig eingependelt hat und werde dann vermutlich zwischendurch nochmals nachlegen. Wie immer keine Kaufsempfehlung und nur meine Meinung.

 

Edith sagt:

sieht so aus als ob sich OSIR bei ~21-22 einpendelt

Hans
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Gegen Ende Jahr wird noch ein neues Produkt lanciert, OvationOS

Gruss Hans

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Osiris, neues Produkt

@ Hans,

Merci, kannst Du den Link dazu noch reinstellen ?

 

So wie einem das Licht nicht ohne die Dunkelheit bewusst würde, so gibt es keine Situation, in der nicht etwas POSITIVES zu entdecken wäre.

Frei nach I Ging

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heute schöne Erholung von Osiris. Würde mich nicht überraschen, wenn's plötzlich nochmals eine 'kleine' Rally gibt Biggrin

Sieht vor allem so aus, als ob niemand mehr verkaufen möchte...

Hans
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Aus anderem Board:

"Take a look at this MYGN chart and pay attention to the time slightly before year 2000.

http://finance.yahoo.com/q/bc?s=MYGN&t=my&l=on&z=l&q=l&c= MYGN was just starting commercial sales at this point and they had about $4 million in quarterly Sales in 1999. Sales took off expontially and the shareprice quickly skyrocketed to $120 where they did a 2 for 1 Split. This all happened in about 12 months. MYGN was a Peter Friedli company and now Osiris just hit $4.1 million in Sales. Perhaps Mr. Friedli has a game plan that is about to be played out? The next 12 months could be a lot of fun!"

Gruss Hans

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OSIR

Schaut euch alle einmal Celegen an - Osiris könnte da sein wo CELG im 2005 war. Es brauchte 10-15 Jahre bis die Aktie durchstartete.


Man darf träumen und wenn dann der Lottogewinn eintrifft sich etwas Luxus leisten.


Aber man sollte nur so viel Kapital einsetzen, wie man auch verlieren kann, das heisst keine Kredite, man könnte jedoch vielleicht einmal auf die Ferien verzichten und dieses Geld zusammen mit dem 13. Lohn einsetzen.


Sobald OSIR Gewinne von Grfaix-Verkäufen ausweist, wird der Kurs nach Norden drehen und die Aktie kommt ins Radar der Fonds und Anleger. Wer kennt schon OSIRIS und NEWVENTURETEC, fragen sie doch einmal ihren Bankberater!


 


 


Chart forCelgene Corporation (CELG)

2brix
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wie geht das jetzt eigentlich ungefähr weiter.

Osiris hat ja bereits eine Zulassung für Grafix. Ich nehme an, dass für diesen Speziellen Bereich eine zusätzliche bzw erweiterte Zulassung nötig sein wird. Kann Osiris dies nun per abgekürztem Zulassungsverfahren erhalten? Gibt es dazu Richtwerte wie lange so was nach eingabe dauert?

Gruss 2b

Hans
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Siehe Beitrag oben, vom 14.08.2013 - 23:29

Gruss Hans

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Marktkap. von Osiris geht in die Richtung dieser Biotech-Übernahmekandidaten

http://www.boerse-online.de/aktie/empfehlung/deutschland/:Biotechnologie... Auch Osiris wird zum Übernahmekandidaten mutieren, abwarten, das wird dann sehr teuer 

Gruss Hans

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Osiris bröckelt anhaltend

 

 

 

@ Hans;

Beim Hochschiessen des Osiris-Kurses um 128 % hab ich mir noch gedacht,

1/2 mittels sofortiger Gewinnsichrung jetzt verkaufen - lag als long-Invest im Depot schlummernd -

denn erfahrungsgemäss kommt bei so einem Feuerwerk der Kurs fast immer um ca. 50 % wieder zurück,

wobei man dann ja günstiger wieder nachlegen kann, wenn man wie hier von der

Firma & deren Perspektiven überzeugt ist.

Von 25.00 $ ist der Kurs dann  innert 2 Tagen auf 20.00 abgesackt, seither bröckelt der Kurs

ununterbrochen, steht Heute schon bei 17.97 $. Von 62'000.00 $  Buch-Gewinn ist dieser auf

Heute 30'000.-- $ wieder zusammen geschrumpft,

ich denke ich werde jetzt halt 1/2 verkaufen & den Restgewinn zu 50 % mal sofort sichern.

Der Kurs wird meiner Meinung noch bis

mindesten 16-15.00 $ wieder zurückkommen, denn vor 3 Monaten erwarte ich

keine Neu-Patentierung resp. Neu-Zulassung mehr. Jene die um die Nachrichtenlage informiert

sind, konnten beim Hoch ja dann leicht Short gehen und verdienen so doppelt.

Hans wie gehst denn Du vor, kannst Du einfach zuschauen wie dein Buchgewinn so wieder schmelzt

wie Schnee an der Frühlingssonne, in der Hoffung es könnten Jederzeit sehr gute Neuigkeiten

auftauchen, dass Du dann eben schon im Schnellzug sitzen wirst ?

Osiris schlägt ja lt. Mld. vom 27.08 auch seinen Konkurrenten "Derma Science Ltd",

also müsste der Kurs doch eigentlich

wieder stabil bleiben, doch eher steigen, oder nicht ?

 

http://www.insidermonkey.com/blog/osiris-therapeutics-inc-osir-derma-sciences-inc-dsci-the-changing-landscape-in-chronic-diabetic-foot-ulcers-229703/

 

Merci für dein geschätztes Feedback, & einen schönen Abend noch

Pegasus

Dirol

 

So wie einem das Licht nicht ohne die Dunkelheit bewusst würde, so gibt es keine Situation, in der nicht etwas POSITIVES zu entdecken wäre.

Frei nach I Ging

Hans
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@Pegasus

Also ich halte in Osiris aktuell nur eine kleine Position (grössere Position liegt in NEV) , werde ev. aufstocken.

Bei deiner Stückzahl würde ich jedoch sicher nicht zuschauen bis der Gewinn wieder futsch ist Wink ...muss jeder selber wissen wie er damit umgeht ... den Einsatz rausnehmen ist sicher überlegenswert!

Gruss Hans

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Grafix - Einsatzbereiche, Potential

•Arterial Ulcers
•At-Risk Patient: Diabetic Foot Ulcers
•At-Risk Patient: Pressure Ulcers
•Bariatric Patients
•Burns, Deep Partial-Thickness (Deep Second-Degree)
•Burns, Full-Thickness (Third- and Fourth-Degree)
•Burns, Superficial (First-Degree)
•Burns, Superficial Partial-Thickness (Second-Degree)
•Chronic Wounds
•Dermal Lesions
•Diabetic Foot Ulcers: Ischemic
•Diabetic Foot Ulcers: Neuropathic
•Edema
•Infected Wounds
•Lymphedema / Phlebolymphedema
•Moisture-Associated Skin Damage (MASD)
•Necrotic Wounds
•Nutritional Support
•Pain Management
•Palliative Wound Care
•Pressure Ulcers, Deep Tissue Injury (DTI)
•Pressure Ulcers, Stage I
•Pressure Ulcers, Stage II
•Pressure Ulcers, Stages III-IV
•Pressure Ulcers, Unstageable
•Radiation Dermatitis
•Skin Graft Donor Sites
•Skin Grafts
•Surgical Wounds (Incisions, Dehisced)
•Tunneling Wounds or Sinus Tracts
•Venous Insufficiency Ulcers
•Wound Odor
•Wounds with Heavy or Purulent Drainage

Aus dieser Liste sieht man das Potenzial von nur einem Produkt von Osiris, riesig...

...weitere Produkte, wie Cartiform, OvationOS, Prochymal, etc. haben teilweise Blockbuster Potential.

Gruss Hans

Hans
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Shire bezahlte bei Übernahme für Dermagraft (Konkurrenzprodukt von Grafix im Bereich DFU) im 2011 $750 Mio, überträgt man dies auf Grafix so ergäbe dies $22,73 pro Aktie, nimmt man gleichen Wert für Prochymal, Cartiform und Ovation und setzt je $750 Mio zugrunde ergibt sich ~$90 pro Aktie ....

... dabei sind zukünftige Pipelineprodukte wie Chondrogen, OvationOS, Tactix und Quartet noch nicht berücksichtigt ... abwarten.

Gruss Hans

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Träumen ist schön!!!!

Was ich nicht verstehen kann, dass die Aktie 100% zugelegt hat, bei den letzten super news und innert einer woche schon wieder mehr als 50% verloren. Für mich riecht das merkwürdig................

Hans
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Rücksetzer sind da normal und extrem, solange keine Gewinne geschrieben werden ist's eben wie  ein Spielball den es hin und her schlägt ohne eindeutige Richtung .... das muss man aushalten.

Gruss Hans

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Dummbacken simulieren heute Kampf um $18 ... schaun wer mal 

Wenigstens stimmt das Volumen, 431K

Gruss Hans

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Ja das Volumen hat mich überrascht und der Eröffnungs-Hype. Positiv ist auch das die 18 gehalten hat. 

Hans
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Alle Aktien werden aufgesogen, demnext gibts wohl News...und dann wird man sehen wohin die Reise geht

Gruss Hans

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COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), announced today that its multi-center, randomized, controlled clinical trial evaluating the safety and effectiveness of Grafix® for the treatment of chronic diabetic foot ulcers has been accepted for podium presentation at the upcoming Symposium on Advanced Wound Care (SAWC) in Las Vegas on Friday, September 27, 2013. Dr. Larry Lavery, Principal Investigator and Professor of Plastic Surgery at the University of Texas Southwestern Medical Center, will discuss the primary and secondary endpoints as well as additional key safety data from the trial. 

Gruss Hans

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Zu Grafix und DFU

Grafix takes 5 to 6 treatments over 12 weeks and you have very few adverse events (The cost of a lower extremity amputation has been estimated to be $30,000 to $60,000, with an additional $43,000 to $60,000 for subsequent care for 3 years. There are more than 100,000 diabetic foot amputations per year. 

 Osiris is building a provable economic case for the insurance companies and that is what the Grafix 302 Trial was all about. Now, Osiris is presenting these results, on September 27th, at the most important conference of the year, the Symposium on Advanced Wound Care (SAWC) in Las Vegas. Doctors and insurance companies believe large trials that were performed at multiple centers and with the results judged by independent control centers. Less

Gruss Hans

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Osiris Q-Zahlen

@ Guten Abend Hans,

Hab vor einigen Tagen als Gewinnsicherung 1/2 meines Bestandes Osiris verkauft,

um bei ca. 15.00 $ später wieder günstiger kräftig zuzukaufen.

Am 27.09.2013 kommen doch dann die Osiris-Q-Zahlen, ich nehme mal an,

diese werden ca. 4 - 7 % besser ausfallen, also weniger Verlust

als beim Vergleichsquartal des Vorjahres, beim Umsatz sogar ca. ein + von 20-30 %.

Darf ich dich fragen, wie siehst Du ganz unverbindlich diese kommenden Osiris-Zahlen in etwa ?

Merci.

So wie einem das Licht nicht ohne die Dunkelheit bewusst würde, so gibt es keine Situation, in der nicht etwas POSITIVES zu entdecken wäre.

Frei nach I Ging

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Umsatzmässig wird sicher zugelegt, ob da mehr Gewinn rausschaut wird man sehen, das geht nicht so schnell, bis jetzt wird aber auch viel heisse Luft kommuniziert, da muss man aufpassen und zwischen den Zeilen lesen ... die Konkurrenz im Gesundheitswesen ist hart und es wird mit harten Bandagen gekämpft....

Gruss Hans

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