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Spectrum Pharmaceuticals, Inc. Message Board

  • ouch_yikes ouch_yikes Jul 11, 2014 2:01 PM Flag

    Apaziquone...Spectrum's darkhorse blockbuster....

    Bladder cancer is the sixth largest type of cancer...

    OTHER drugs, their biotech manufactures, the disease, patients diagnosed, and cost per treatment:
    1) Myozyme, Sanofi, Pompe, 7500 patients, $545,000
    2) Solaris, Alexion, PNH, 1,500 patients, $440,000
    3) Gattex, NPS, Short Bowel Syndrome, 3000 to 5000 patients, $295,000
    4) Kalydeco, Vertex, Cystic Fibrosis, @1200 patients, $294,000

    Its an $86 BILLION market with drugs treating relatively few patients...

    Crunch the numbers.....What would be the valuation of APAZ entering into sixth largest type of cancer market with market exclusivity....Ka-ching!!!!!!

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    • The Street (even AF) estimates $200M to $300M in Annual Peak Aqaziquone revenues:

      "The bladder cancer drug aqaziquone blew up Thursday after two late-stage clinical trials failed. Spectrum was counting on seeking U.S. approval for apaziquone later this year. That plan now seems dead, as is the $200-300 million in peak annual revenue Spectrum hoped to generate from the drug."

    • Too optimistic. You mentioned drugs in ultra-orphan category, therefore prices are high. Then you said that bladder cancer is sixth largest type of cancer, therefore no way apaziquone belongs to ultra orphan category. Price should be much lower than for the drugs that you mentioned. Not sure whether apaziquone even has an orphan status.

      • 1 Reply to dcaf7
      • Too optimistic about what? No one even knows APAZ's exact potential price point, and this is particularly frustrating because one could {X} the cost-per-treatment by the percentage of patients diagnosed per year with bladder cancer and then the percentage that might be needing(or using) the treatment and come up with its' overall potential....

        What we DO know is that Apaz had been given "fast-track" status and this usually means that its considered an unmet need...Orphan status or not, as far as costs are concerned, doesn't matter(all orphan means is a guaranteed seven/eight year period of sales exclusivity). What matters is its perceived importance and efficacy.....QCOR's Acthar does $28,000 a vial and everyone knows DNDN's Provenge cost nearly six-figures, PCYC has a drug even higher in cost per treatment than DNDN's Provenge, as far as I can recollect, none of those are considered orphan drugs....

    • Ouch, Thank you for the numbers. I have never considered Apaziquone a darkhorse. It is a horrible disease and always ends in death. Finally, a drug that will not lead to multiple surgeries and damage caused by radiation.. Even if two or more instillations are required to make it effective, its safety alone merits approval.
      This is now the sixth cause of cancer death in the world. I seriously doubt it will remain at 6. Too many drugs cause this cancer, not only Actos. This new cause is alarming because it increases the chance of bladder cancer by 50%. This drug is used to treat type 2 diabetes. Point is, younger people who need drugs to control diabetes . If they have used it for two years and switch, it doesn't change the percentage. Not a pleasant thought..

    • My thoughts on Apaz haven't changed but I did find interesting both BCG and Mitomycin are on the shortage list.

    • yeah but we are not looking at 2014 nor 2015 for apaziquone nda submission are we ? off hand, my recollection says no. i might be incorrect though. we have been thru the wondrous concept of direct instillation into the bladder thereby averting adverse side effects otherwise expected if simply injected thru the bloodstream. we also have been thru the excitement of the large bladder cancer population and its potential economic upside to sppi. however we got fda rejection for apaziquone already. so....... im not attributing value to sppi corp mkt cap for apaziquone at this time, personally. if we get new trial data that is encouraging then thats a step in right direction. sppi corp presentations recently ( actually quite a while) have laid low on touting apaziquone...........so................

      • 5 Replies to stringandtwocups
      • String, I stand corrected. NDA end of year and provisional approval while (no blood in bladder) clinical trials are ongoing. This new upper management is very aggressive.

      • String, There is an enzyme in blood that deactivates Apaziquone. This makes it safer. I think we are looking at an earlier date, certainly in 2015. The FDA accepted pooled data and will approve it. Please look up all the stuff I have already written.

      • String, NO ONE is attributing any value to APAZ...In fact, no one seems to want to include it in their future estimates. It is almost as if it doesn't even exist....It almost seems to have less enthusiasm going for it then Zevalin. They(SPPI) claim a new trial protocol that involves a dry bladder(to which I ask, why on earth weren't they thinking that way on one of the FIRST phase III's?!!??). I am really hoping its treated a lot like Belinodaq, that is, the FDA accepts the combined, pooled data and that it gets early approved, but still needing further trialing.....I understand that they have so many other things going on in their pipeline that this could easily take a back seat to it all, but Raj needs to start adding color & clarity, and most especially visibility to this drug's situation. I wouldn't mind he leading with it and elaborating on it at the top at their next investment conference, for friggin' once.....

      • Yes, slide 23 of the July 2014 SPPI Presentation indicates that the one of the Company's milestones is for Apaziquone NDA and Phase 3 ito be filed and started, respectively, in 2014.

      • I dunno string, the most recent corporate slide deck from July 1st says we file NDA and start Phase III for Apazaquone by end of this year?

 
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