I remember someone (cold?) posting something a while back about stem cells, and the potential $40M - $60M contract but I was busy at the time. Here’s the (edited) question from the cc:
Matthew Frankel (Cowen)
. . . I Just want to know if there is any way you feel comfortable quantifying the revenue potential, revenue opportunity from BLA. The BLAs you expect to be filed over the next year, the commercialization opportunities to the next year. Anyway to puts some numbers around that? And what it means for you guys?
Mark Sawicki
Yeah, I can give some color on it. You know guys, so as we had stated, we anticipate an addition two to four filing next year which obviously would have a lead time in regards to commercialization. But I think using the same measure in particular for any of the autologous treatments as you would observe with either than Novartis or the Kite expectations which Jerry commented about in the earnings calls is probably reasonable. Ramp rate and timing would be similar to any of these types of launches. But we also have a number of programs which are allogeneic in nature and if those allogeneic therapies you know filed and are approved, the volumes of these units will be in order of magnitude or too higher than that of a say autologous therapy. So, we would anticipate seeing numbers that could easily drive into the $40 million to $60 million range at full absorption if they were approved and were approved through a broader application. And it depends on the nature of the therapy approved in the timing of it.
Is he talking about their client Tigenix (TiG) and Cx601? It’s an allogenic stem cell treatment for patients with Crohn's disease that could receive a decision by the CHMP at its next meeting December 11th-14th and then by the EMA in Q1 2018. In the U.S., this is one of the 20 phase 3 trials Cryoport supports that launched in June or July and has recently been granted orphan status by the FDA and now has an expedited pathway for the submission and review process. I think the trial was reduced from 52 to 24 weeks, so this may be one of the anticipated BLA filings next year. I don't think it's that large of a patient pop though.
I think Cryoport is also supporting another phase 2 trial for their allogeneic cardiac stem cells for acute myocardial infarction.
I think Bellicum's BPX-501 allogenic stem cell treatment is in a phase 2 trial that should have a read out next year but probably won't file until 2019.
