Replies to post #1600 on Spectrum Pharmaceutecals Inc (SPPI)

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Sure. Hopefully tomorrow. maybe Wednesday.

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My take on the RBC Healthcare Conference on Feb 23rd. First, I gotta say I love the format of the Analyst directly asking questions to Dr. Raj. As opposed to Dr. Raj picking and choosing what he wants to tell us. It’s much harder to skirt around a Q but the analyst can only persist so much in getting an answer if Dr Raj dances around it. The Qs and answers were mostly on advancing 3 drugs of the future. That in itself was interesting since I thought there were only 2; Rolontis (SPI-2012) and Poziotinib. Well, Raj included Qapzola too. And not only that but he mentioned that each could be a billion $ drug. I think that is a stretch even with a vivid imagination.

So regarding Rolontis, I could see it capturing 50 – 500M of a 4 billion market depending on the competition. I recently posted that Novartis’ Neulasta biosimilar was withdrawn removing one competitor and the Coherus BioSciences Neulasta biosim BSUFA action date is June 9, 2017; it will be interesting to see if they have any difficulties in getting approval but one has to assume Coherus will get approval. Of course, Raj keeps saying that they won’t be a problem since Rolontis will have its own J code and not be competing on price w any biosim. Spectrum used to say that Rolantis would be competing in a $6B market which includes the EU and Neupogen so I’m glad they are more realistic on the market potential. The analyst also asked about adverse events and Raj indicated there aren’t any more than you would expect w Neulasta which is reassuring. Also, the analyst asked if approval is based on just the SPA P3 trial currently running or do they need the new smaller international trial that rec’d feedback from the EU and is soon to start. Raj indicated they just need the SPA P3 trial. The analyst asked him several times since Raj wasn’t totally clear on it so hopefully the analysts ask again at the quarterly. So I’m pretty optimistic on Rolontis. Just think if Rolontis gets $200M in sales it would more than double current revenue. I don’t need a billion; I’d be as happy as a clam w 200M in additional revs from Rolontis.

Regarding Poziotinib, last year at this very conference, Raj was effusive w regards to the Korean P2 trial in metastatic breast cancer. That open label study stopped recruiting in Feb 2016 so you would think we may have heard something by now. In an earlier post, I mentioned that if we didn’t hear anything by ASCO in June than the Korean results are nothing to get excited about. And every time, prior to this CC, they talked about poziotinib, they mentioned a P1 study where poziotinib was given to TEN HER2 metastatic BC pts and had a 60% ORR. Fast forward to this conference, and Dr Raj does a pivot. Now we hear about a ‘Eureka’ moment about poziotinib where EGFR exon 20 insertions in an in vitro study done at MD Anderson shows promise, and it was given via a compassionate use protocol to 1 pt w NSCLC where it appears to be working, and that they have agreement w the FDA on a TEN patient P1 study and have the pts lined up and results could come in near the end of the year. BUT it sounds like a repeat of last year regarding data that was expected in metastatic BC. I mean it does sound exciting since PFS for these pts is less than 2 months on existing therapy and the in vitro study was done at renowned cancer center MD Anderson adding some credibility to Raj’s claims and if efficacious in this patient group could very well make poziotinib a billion $ drug but I won’t start getting excited until more into the program. (Ps I just posted that clinTrials is showing a new P2 trial - Poziotinib in EGFR Exon 20 Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)).

Meanwhile, what to make of this pivot w regards to poziotinib away from metastatic BC? I don’t think the results they got in the Korean P2 study will be applicable to the US P2 in mBC since the pts in the US trial are getting double the dose. Still Raj barely mentioned it so it makes one wonder. Hopefully we’ll hear more at the quarterly.

Regarding Qapzola (apaziquone) and it being mentioned prominently as one of the keys of their drug development I was shocked as could be. For some history, in the fall of 2015, they got a SPA for a new P3 trial. The theory was that they were combining data from the previous 2 failed P3s to submit as part of their NDA application while running this new trial. The NDA wasn’t approved and the new SPA P3 stopped recruiting pts. My thoughts on that from post 1536

The ongoing apaziquone P3 trial has gone to 'Active, not recruiting' on Sept 27th which is a year after they started the trial. Considering it took ~2.5 years to recruit ~1600 pts for the previous P3 trials this is basically saying they stopped the trial of 1869 pts. This is EXCELLENT! I've been advocating all along that if the FDA was not going to consider a new tool in the shed based on the work-up of the existing data Spectrum should stop the trial and conserve resources especially with a patent that may expire around the time the ongoing P3 finishes.

Now, we hear during the CC, that they have reached agreement w the FDA on a new SPA P3 trial w less than 500 pts, implementing the learnings from the other trials, and they are doubling the dose from 4 to 8mg and the FDA could give them approval based on the results of this trial. Are you kidding me? Don’t get me wrong I think the drug is efficacious and as Raj said it’s safe and effective and “the drug didn’t fail, the trial failed”. But by the time this trial is completed and the NDA submitted and reviewed I would think that the patent on the drug would be expiring around that time. The only way this makes sense if the patent doesn’t expire in the 2021-2022 timeframe but is extended to after 2026 or so. It would also make sense if they got a 7 yr exclusivity as an orphan drug but they need to spell it out for us. If they don’t explain it well at the quarterly, then I think they are just protecting themselves somehow from all the lawsuits as a result of the unsuccessful NDA. I do love this drug and believe it’s efficacious and just as importantly very safe so I hope they are not faking it but they need to provide better justification than we heard at this conference.

Till the quarterly (will be posting my guesstimates on revenue sometime prior to then)