Phase 2 Combination Study in Metastatic Melanoma
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Phase 2 Combination Study in Glioblastoma Multiforme
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Myriad Genetics is currently conducting Phase II trials for Azixa. If successful these results could lead to Phase III registration trials for the compound, which would trigger a milestone payment for EpiCept.
Azixa a $3 billion merket just in US alone.
EpiCept holds key strategic partnerships with leading members of the pharmaceutical industry which both support and validate the Company’s development efforts. Future milestone payments associated with these agreements have the potential to reach over $125 million as well as substantial royalty payments.
The Company is eligible to receive up to $27 million in milestone payments from Myriad for the development of Azixa.
EpiCept's licensing agreement with Myriad for Azixa includes milestonepayments, and sublicensing income as well as future royalties.
For an investor, the ONLY data that BEGINS to matter is final Phase II and then only if large enough to be susceptible to rigorous statistical analysis AND fully controlled to either placebo, SOC, or BOC.
Phase I, "ongoing", "interim" Phase II, or even IIa doesnt give an investor a true insight.
If the phase II data is positive then they will file for a NDA at the FDA with a fast track status to speed the review process and it could hit the market as early as late 2010. Let's see the outcome of the phase II data first and so far the data looks really promising.
By the way it's interesting to see that the market cap for Myriad Pharmaceuticals ("new company") with just three compounds in clinical trials in their product portfolio Azixa phase II, MPC-4326 phase II,MPC-3100 phase I is a billion dollar.
"Shareholders of record of Myriad Genetics will receive a pro-rata dividend of 1/4 share of Myriad Pharmaceuticals common stock for each share of Myriad Genetics common stock,The common stock is expected to begin "regular way" trading under the ticker symbol MYRX at the start of trading on July 1, 2009"
Link to their "new" homepage
That's interesting, I will look into it more thoroughly. Some comments:
1 - More specifically, I believe what you describe, to be more accurate, is accelerated approval which may or may not include priority review. It will depend on the design of the phase II study and the strength of the results as to whether it is eligible.
2 - While glioblastoma is an unmet need, it isn't totally unmet, given that DNA/Roche just received acc. app. of Avastin for that indication. Whether or not that may mean that azixa would be precluded, or be required to demonstrate non-inferiority, I am not sure at this point.
3 - I would not assume that the market cap for the new entity MYRX once it actively trades in July will be a billion. They are shares as dividend. Though I did notice that the new entity is being funded with 188 Mill, a significant fact I had missed.
Thanks for the heads-up, I scanned the MYGN-MYRX info only minimally. It is still too early to determine the net effect to EPCT at this point in time.
I don't want to get into a detailed discussion of azixa technically, because its inconsequential at this stage in my opinion.
But previously, I had noted that I was not sanguine as to its prospects. Briefly, in addition to being a VDA, it acts within the AKT pathway to disrupt the microtubule stabilization process (an "MDA") that cells need to multiply. There are similar compounds that utilize this approach in various oncology applications, most notably the EXEL-BMS XL184 reported disappointing PII results in glioblastoma.
The EXEL preliminary data was also very promising initially, but has begun to fade in terms of response rate. Admittedly, their study had some dosing issues thus one can't compare across trials with much success. My only point is that EXEL is much further along in that pathway (AKT) in glioblastoma and is encountering difficulties.
Axiza supposedly has "dual" activity as a VDA as well, though that supposed superiority in combination with a MDA approach isn't entirely clear.
Just getting that out there, I just wanted to offer a grossly oversimplified explanation of why I'm not overly optimistic in its application to glioblastoma and even less so its potential in melanoma.
Also, in general, you see more success in the acc app/PR path with liquid tumors as compared to tough to treat solid tumors.
OT: Jonaustin and others, I was curious about your thoughts on Celegene (CELG) and Seattle Genetics (SGEN) as far as biotech/oncology companies go?
If EPCT ever gets its act together, should they emulate these two companies, especially the former, it terms of operations, product development, marketing, partnerships, etc? Celegene is quite successful in this space.
Thanks in advance!
Being primarily a biotech catalyst player, CELG, though a good company, is a little big for my taste.
I do like the prospects of their aprelimast drug which has some data due out soon (I think), though I would only play it as an options straddle, and then pretty tightly, since because of its size, I'm not confident that it move great enough either way to be profitable.
As far as a general buy and hold? Maybe. Only thing is, me personally, am winding out of any long position that is not expected an imminent catalyst. Reason being that I anticipate a significant leg down in the overall market soon, in fact, we may be on the edge of it now. (I've made some dough on some short ETFS this week.) But with all the MAs colliding this week, its gonna get dicey out there!
I am a big fan of and hold both SGEN and IMGN, though in recognition of the above mentioned reasoning, I have exited half those positions. They had a good run and it was time to take some dough off the table. I like the ADC approach and believe one will get taken out. In fact, if Roche/DNA hadn't miscalculated their colon cancer outcome recently, which made the entire DNA takeover over-priced, I would have expected them to go ahead and scoop up IMGN.
But now, their board will be a bit gun shy on acquisitions for awhile.
Hope this helps.
I should add just for grins: I plan on sitting on a minimum 40% cash through the upcoming earnings period. And will only play very strategic and pinpoint catalyst plays, with no more than 25% long.
With the MA situation, bank downgrades, overbought overall market, earnings season looming, and intl troubles - the next month or so could be extremely volatile, which is not a time for investors, but nimble traders.
I wish I could understand that stuff. I need to get a book on understanding pharma...I laughed my ass off when you wrote that phase I is really just a fund raiser, still laughing at that one.
Jon - I think you should give me an idea of pharma's that you think have promising technologies so I can run numbers on them :)
Strange day today, seems like we are coming down to more intermediate support, there's no reason for it to move again until there is more news - hopefully the news that emerges won't come from the meeting on 07/02, this will be a scary day for EPCT longs if nothing is released before then.