Take on 2018 RBC Global Healthcare Conference-Pozi/Rolontis/Qapzola (Part 2)
Last thing I want to say about pozi is regarding the confidence I get from JT regarding pozi while not trying to over promise. Actually, you have to get used to that when compared to Raj. Raj would make it sound like something is right around the corner whereas JT, for example, didn’t play up the MD Anderson AACR abstract or that BTD is imminent. I remember Raj’s last CC he was taking about meeting w the agency about BTD and the worst that could happen is they throw us out in the street whereas JT will understate it “All I can say is that we’re working extremely closely w the agency.” Or “Working extremely closely w the agency on an ongoing basis”. Refreshing and different than Raj.
Regarding Rolontis, it was last year at this same venue that Raj stated we only needed the RECOVER trial in order to submit the application. He also gave the same answer at a later conference. I realized in September that that was BS when Raj stated they would submit the application in the 4th Q of 2018. That didn’t mesh with the RECOVER trial finishing recruiting in September of last year. I heard JT somewhat say it at one of the CCs but today he stated it clearly that you need 2 well controlled trials to submit with your application. Back in September when Raj said they would submit the application in the 4th Q of 2018 instead of the last Q of 2017 or 1st Q of 2018 that timeline drove me crazy. I couldn’t understand it based on what he said about only needing one trial and assumed the 2nd trial was needed. I wonder if this delay was the reason he was replaced as CEO. Anyhow, I’m putting that one to rest.
JTs answer to what makes you think you’ll be successful in marketing Rolontis was a smidge different than the usual song & dance answer we normally hear which is ‘I worked on rolling out Neulasta and believe you me this will be successful’. This time he talked about that they model the biosimilars that may be competing in that space and they plan on competing w them but we’re not going to tell you our secrets on how we are going to do that, and since ours is a novel molecule so we won’t be lumped w any biosims and the innovative product, and they’re fighting their own ASP and reimbursement battles, and that we will be on our own and that’s a great position to be in, etc and whatever happens it’s going to be transformational.
One of my pet peeves about Rolontis was Raj saying they were competing in a $6B market. Sure if you include the rest of world and include Neupogen sales that might be but here in the US it’s a $4B market which is what they were saying today. Was that too hard to do?
Finally, the analyst asked about Qapzola. There was the usual talk about the changes/ improvements to the trial such as smaller trial, no 2nd trial, will be for low and intermediate risk pts, 2:1 drug to placebo, a window to give the drug, and primary endpoint change from progression at 2 yrs to ongoing progression (he didn’t mention double the dose which is another) and this was a case of the previous trial failing not the drug’. What I found interesting was that he said several times that we continue to recruit pts but I like to realistically see what the market looks like given the IP situation, etc. Hmmmm.
Also interesting was the analyst’s next Q. Let me begin by saying that prior to the FDA rejecting the NDA in 2016, I used to argue (AVII don’t get agita) that even though the 2 registrational trials didn’t meet its primary endpoints, the drug should be approved based on the observation that when you excluded patients who were determined to have blood in the bladder (blood enzymes deactivate apaziquone) each trial met statistical significance or if you combined the 2 studies as one, even including pts who had apaziquone deactivated in the bladder, it also met statistical significance. My argument was you could give it AA based on that, and that it’s a safe drug, and then let them run a new confirmatory trial for full approval. That made total sense to me even though that wasn’t the way the FDA did things back then. Well, the Advisory committee shot that idea down and I had to wipe the egg off my face. Well, what does this analyst ask? Based on the views of the ‘new’ FDA, is there any discussion that the FDA will reconsider AA being that it’s a safe drug too? And run your current confirmatory trial for full approval? JT gave a very generic non-conclusive answer but I still almost dropped my shorts.
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