So many of you have seen prior data on this particular compound as well as 424 and the data across RA patients has been very consistent. It’s a very potent JAK inhibitor; has a competitive profile and obviously looks very comparable to the data that’s been presented by Pfizer for tofacitinib. Our numbers are much smaller obviously so it’s early on. But it looks very promising it’s very encouraging; the data we presented on Friday in the late breaker session at ULR and then we hope later this year to show the six months data with Lilly, hopefully at ACR. And the next step would be to initiate the Phase III program and we also expect that to happen this year.
Maybe just flashing out some of the details, I mean clearly the efficacy side it seems that it is on the higher end of the ACR presented etcetera; on the appropriate doses it may look a little better than tofa at least in these early patients effects. On the same side, on the safety side I mean it seems like we saw a couple of things that we haven’t seen before like the creatinine increase on the drug. And so just want to get your thoughts of like you know do you think it’s possible to differentiate from tofa, from this week, like where do you think the differentiations will be eventually in the marketplace as the data holds out?Pat AndrewsSo I think that there will be a number of places that the products could differentiate; it’s a little bit difficult to say what all of them would be now, because they finished the Phase III and while we’ve seen quite a bit of data, we just have the Phase II data with a smaller number of patients. But some things that come to mind are very obvious such as 050 is a once-a-day drug versus tofa is a twice-a-day drug and 050 seems to not have many drug-to-drug interactions versus tofa had some and we have benefit from seeing the questions raised during the AdCom for tofa and there are some learnings from that that we could take in the design of the Phase III that should start later this year.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV