@4Seasons - to your question "why don't you think the Osiris technology is not a big market."
I was specifically referring to aGHVD when I made my comment. From mesoblast's site they quote "there are approximately 30,000 allogeneic BMTs globally per year". They go on to say that approximately "50% of all allogeneic BMT patients develop aGVHD". So that would be 15,000 a year. It also seems unclear how effective it is in adults and, as children account for 25% of these cases, that market is < 4,000 a year. Health Canada reported there are 50 children cases a year.
The US expanded access trial consists of "More than 240 pediatric patients suffering from steroid-refractory aGVHD have been treated with MSC-100-IV under an EAP in the United States, Canada and several European countries" The ongoing phase 3 trial is 60 pediatric patients. Clearly from a "life-saving" perspective these are completely justifiable, however I don't know of anything going on with adults except in Japan.
I know the aghvd treatment is available for all ages in Japan but this is the latest trial I know of in that country https://upload.umin.ac.jp/cgi-open-...ws&recptno=R000007942&type=summary&language=E. This was a phase 2/3 trial of 25 patients in 2011, After 8 infusions, 12 of the 25 had a complete response (defined as 28 consecutive days of durable response) but 40% of the group were deceased within 6 months of the first infusion. These results are by no means bad, we are talking about some extremely ill people here, but the trial seems so statistically small
I have asked here if there are other trials and I have noticed you do have a "better than most" understanding of these matters. so if I am missing something in the above I would welcome the correction.
Chronhs disease is another point of confusion for me relegated as it is to a tier 2 product. If Celgene step up and promote this one then I agree that changes things.
All this stands in stark contrast to the chf program. The market is massive with over 5.1 million people in USA alone, costs > $30 billion a year to that nation alone. The phase 2 reports - while clearly they were an exercise in getting data and learning from it- were still well run and the the survival after 36 months of patients who would almost certainly have died were extraordinary. Even with that, a sceptic like me would be circumspect, except for the fact that the one-time unwilling partner Teva is so heavily involved. They could have flipped this away if they weren't happy with what they saw, they did it with other programs they inherited. Any time a big pharma does something positive, when previously they looked like walking away, you have to sit up and take note. I have no doubt that they have turned these reports every which way and discussed this independently with medical experts outside of msb; if any of it had not worked out they would have dropped it like a stone - they certainly would not spend time discussing options with the FDA. We will see soon enough if that is the right assessment.
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