Propylene glycol in blood is a bad thing. But my question is about the market size for CE-Melphalan. How Spectrum came to the number $100M?
"Could this possibly increase the amount sold since it could be beneficial to administer more?" Are they going to address your question with clinical trial(s)?
In August presentation it is $100M.
"It is roughly based on the market it would be competing in and the drug that it could replace if approved and what it currently draws in earnings."
It is competing with generic Melphalan. Before to become generic, global sales of Melphalan were $70-80M. Remember that besides ASCT in MM, Melphalnn is used in many other indications.
"Did you also notice that Apaziquone, on the pipeline chart from presentation, is nearing completion for P3?"
Same thing with Ozarelix which on the chart is close to the end of Phase 2.
#6-Shows history of really important milestones, not like silly GO no-GO
#9- Steps in ASCT
#10-Other indications where ASCT is used, new potential indications for CE-Melphlan
#17-Expenses vs revenues for last 6 quarters
It looks like a brand new presentation, recommend to download.
"what would be the superiority measurement?" For example, SPPI-2012 is much safer, less adverse events with same efficacy.
"SPI-2012 is needed one third less than Neulasta" See doses of SPPI-2012 which are used in Phase 2 trial. Only one dose of 2012 is lower than standard dose of Neulasta, less then 2 times. Other two doses are higher. One of them 3 times higher, not lower. Why are they testing higher doses if only one-third is enough?
I guess we need to see the results of Phase 2 trial before to discuss 2012 further.
Yes, it was already discussed here.
"On July 3, 2014, the Company received further notifications from the FDA regarding the post marketing requirements (“PMRs”) for each of Beleodaq and Folotyn ® . With respect to Folotyn, the two previous Folotyn PMRs for the Phase 3 PTCL trial and the Phase 3 cutaneous Tcell lymphoma (“CTCL”) trial have been released by FDA. The new PMRs for Beleodaq and Folotyn include a main study that evaluates the comparative efficacy and safety of Folotyn when used in combination with the treatment regimen cyclophosphamide/vincristine/doxorubicin/prednisone (“CHOP”) or the combination of Beleodaq plus CHOP, versus CHOP alone for the initial therapy of patients with PTCL"
"they likely were highly conservative at the time". Problem is that time is working against Spectrum in terms of revenue from SPI-2012.
Are you challenging Samsung's analyst opinion? Because you are Spectrum's investor? Samsung's analyst did nor know that "Neulasta took 60% of the neupogen market in three years with a weekly dosage improvement"? I think, $400M/year is generous enough. Anyway, it is good to have some input from independent source.
...assuming approval in 2015. When do you think SPI-2012 will be approved? How many competitors, biosimilars and biobetters, will be on the market by then? At least one biobetter, Lonquex, was approved in Europe after Samsung's coverage.
Two years ago Samsung Securities initiated coverage of Hanmi Pharmaceutical. Interesting read on LAPS-GCSF. They projected peak sales of $400 M in 2018 assuming approval in 2015.
I agree that less frequent dosing is an advantage. My point was that AMGN will not just be "milking what they got". They will aggressively protect Neulasta market share even if the competitor is "biobetter". BTW, I doubt Spectrum will run superiority trial against Neulasta to market SPI-2012 as biobetter. Too costly and too risky. Most likely, it will be non-inferiority trial.