Halozyme Therapeutics Inc (HALO)

[maumar]

"MabThera and Rituxan in oncology grew at 3%. That growth was essentially driven by increased demand in the U.S., EU and international. I do want to point out that the MabThera subcutaneous sales contributed around half the sales growth. The subcutaneous formulation was launched in the first quarter in additional 18 countries in quarter one, bringing the total to 41 countries."

"On Slide 32, on March 29, we had an FDA ODAC committee on the subcutaneous. It was 11-0 vote in favor of the benefit-risk of rituximab subcutaneous for all proposed blood cancer indications. If you remember, initially, our subcutaneous for MabThera was originally focused on an ex U.S. development. But we had since filed, now the PDUFA date is set for June 26. Just to remind you, I mean, the original decision not to launch the subcutaneous in the U.S. is based predominantly upon previews regulatory and market considerations and both of those have changed now. And in particular, on the market considerations side, there is a difference in administration fees for subcu versus IV, with IV being more generous in terms of the administration fees.

However, no differences of decreased, and importantly, the capacity constraints that many practices have increased. So there are market research shows the practices realize the benefit of the subcu if they're capacity constrained and the benefit comes in terms of significant time savings. You can see it here, from 2.5 hours down to around 15 minutes or so. It's a significant dynamic change. So this is with some of this just in the market practice, this is why we're now pursuing subcutaneous program in the United States and hope to be launching that very shortly."

"On the adjuvant setting, oh, yes, specifically related to the subcutaneous coformulation Herceptin and Perjeta, so yes, this is really interesting. We initially thought that this is going to be more challenging from a technical development standpoint. We're certainly not out of the woods yet. But we've got a Phase I trial going on, we are looking at the dosing of this.

Bottom line is that we think this could potentially, potentially be a convenience for patients that would be significant. So but I wouldn't I would say that it would be -- it would be applicable across the different regimen."

https://seekingalpha.com/article/4066526-roche-holdings-rhhby-ceo-dr-severin-schwan-q1-2017-results-earnings-call-transcript?auth_param=75ovl:1cg5cms:d5a6e7d664d084d0d7dda9e961548018&uprof=45