Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Several takeaways from the last two CCs.

Let me get through the somewhat disappointing takeaway 1st and that is Dr. Raj saying at the Rodman & Renshaw CC that they’ll submit the Rolontis BLA in the 4th Q 2018. That’s the 1st we heard 4th Q. Why they can’t do it around the time of ASCO is beyond me. Actually, my original expectation was submitting a BLA a year earlier in late 4th Q 2017. And even though they were saying sometime in 2018 I was still thinking end of 2017 and they were just saying in 2018 to show they accomplished their goal sooner rather than later. My reasoning was based on finishing recruiting pts in September (they actually finished recruiting in early August adding salt to the wound), waiting a month to get the ANC primary and secondary endpoint data (all taken in cycle 1 or after 21 days), analyze the crap out of it for a month, and putting that data in the trial report in cookie cutter fashion which they should have been working on and ready to go beforehand and submitting it as part of an already prepared BLA package to the FDA in the 4th Q (They could almost predict what the data would be since it’s somewhat dose proportional from looking at the P2 data). While all this was going on they should have had their QA staff auditing all the patient files to make sure all was verified. They stated numerous times that they don’t need the 2nd smaller EU P3 trial which will end in the ~1st Q 2018 for the US filing so why will it take it another 9 months. Now, do you want to add another 3 months to gather safety data as Joe T indicated the other 3 cycles were for even though safety is not listed as a secondary endpoint in the protocol? Sure I’ll give you that but that’s still takes us to the end of 1st Q – beginning of 2nd Q and before ASCO. I suspect the delay has to do with the PK study they started recruiting on May 11th. Here is a previous post of mine from before the study started recruiting.

Initially stumped by a new SPI-2012 PK study (NCT03135951) that hasn't started recruiting patients yet with results due by Dec 2017. A PK (pharmacokinetic) study is submitted as part of the NDA submission package and usually is one of the 1st clinical studies that is done before more extensive P2 and P3 studies are carried out so why was SPPI doing this study now? Hanmi already did an extensive PK study but it dawned on me that for the P3 they decided on a higher dose than was looked at by Hanmi. So it looks like they'll need this basic study to make sure they dot their I's and cross their T's for a more complete NDA submission package. Luckily, someone noticed that they didn't have this covered (SPPI or from communication w the FDA) and quickly slapped a study together. Can you imagine getting a CRL for lacking basic PK data? You can see a little sloppiness in the description of the study. The Purpose describes looking at serum while the Endpoints discuss looking at plasma. It also doesn't describe what concentrations they will be looking at. I assume it's ANC. I think we just dodged a bullet. One edit to what I stated previously and that is this new PK study is in BC pts whereas the Korean PK study was in healty volunteers

That last sentence of that post reverberates with me “I think we just dodged a bullet” Well, I suspect we might have been grazed by this bullet. At least they realized ahead of time that this may have been needed to avert a CRL. Anyhows, that’s my theory on why it’s delayed.

The very positive takeaway for me was Joe T, at the Annual NewsMakers in the Biotech Industry CC, explaining, how they will be differentiating the marketing of Rolontis against Neulasta and any biosimilars that pop up. And that is by Rolontis giving longer protection to the patient. I calculated 6.72 hrs for the Rolontis 4 mg Pegfilgrastim dose. Assuming dose proportionality for the 3.6 mg dose that should be about 6hrs of more protection compared to Neulasta. JT explained that to treat an infection you’re in the hospital for an average of 4.5 days getting antibiotics and that you need to get off your chemo for that time and currently that 1 in 10 pts will die of sepsis and treatment costs are high. So now we know how they are going to differentiate the product. Last week on the Seeking Alpha article by Decision Analytics, I gave an example of possible Rolontis sales of $489M as follows.

Regarding Rolontis, I am glad you pointed out that it will be competing in $4.6B market, as opposed to the 6B they reference all the time. I think that is disingenuous. But it’s even less than that as per Amgen’s Q2 2017 results where it generated $1087M (or $4.348B/yr). Still, knowing that, I am excited about Rolontis’ potential. Just doing a back of the envelope calculation, if they sold it as 75% of the cost of Neulasta and got 15% of the market, that’s $489M in sales. I’ll take that although it could easily be more than that. Heck, Coherus’ biosimilar of Neulasta was forecast by EvaluatePharma to reach $648m in sales by 2022. And, as you mention, “there is a reasonable chance they achieve superiority on reducing duration of severe neutropenia, as they did in the high dose of the phase 2 study”, Rolontis could do considerably better than what I’m hoping for.

Now that I see JTs roadmap on how they will capture sales from Neulasta and any of its biosimilars, I’m revising that $489M figure upwards by $250M to $739M (4.348B/yr x 20% market share x 85% of the price of Neulasta). Now we have a roadmap on how they are going to market it. And regarding yesterday’s CC w Dr Raj, he must be listening. I always get on SPPIs case for saying Rolontis will be competing in a $6B market. We know that Amgen in the last Q, sold $4.348B in the US and EU. Well, Dr. Raj, at yesterday’s CC, stated “over $4B” Yeah!

Lastly, JT mentioned they are looking to start the pozi and TDM1 combo in 2nd line breast cancer at the beginning of next year. They were mentioning this combo a lot in the 1st and 2nd Q CC even indicating they had a protocol ready to go. Then they stopped talking about it and I speculated that it was put on the back burner to make room for new pozi studies in Exon 20 insertion mutation studies and since there is only so much money to go around it was set aside. The Rolontis studies will be completing by that time so they’ll be able to dedicate their resources (money and manpower) to moving the combo study along.