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Friday, May 23, 2014

Conclusions from Ariad related ASCO Conference Abstracts

The purpose of this post is to provide access to conclusions from Ariad related abstracts for upcoming presentations at the ASCO conference in Chicago. Breaking with previous tradition for this blog, there will be no editorial comments or analyses by the author or any other party.     


Abstract 1:
Title:    Economic burden of tyrosine kinase inhibitor (TKI) treatment failure in patients with chronic myeloid leukemia (CML).

Conclusions:  Although TKI failures have lower pharmacy burden, their overall economic burden is higher, primarily due to increased inpatient days. These findings suggest that minimizing TKI failure through more efficacious treatment may decrease the overall health care burden and costs of managing CML.

Abstract  2:
Title: A phase 2 study of ponatinib in patients (pts) with advanced gastrointestinal stromal tumors (GIST) after failure of tyrosine kinase inhibitor (TKI) therapy: Initial report       .

Conclusions:  Initial analysis of this ongoing trial suggests that ponatinib has activity in pts with advanced GIST after failure of prior TKI therapy. .

Abstract  3:
Title: Longer-term follow up of a phase 1 study of ponatinib in patients (pts) with Philadelphia chromosome-positive (Ph+) leukemias       .

Conclusions: Substantial and durable responses were observed with ponatinib in heavily pretreated CP-CML pts. Vascular occlusive events were observed. Risk and benefit considerations should be evaluated when utilizing ponatinib in this pt population.

Abstract  4:
Title: Clinical impact of dose modification and dose intensity on response to ponatinib (PON) in patients (pts) with Philadelphia chromosome-positive (Ph+) leukemias .

Conclusions:  Pts on PON] who undergo dose modification may still respond to treatment and dose modification may be an effective management tool. Careful consideration of the potential benefits and risks of PON should guide treatment decisions.


Abstract  5:
Title:    Ponatinib (PON) in patients (pts) with Philadelphia chromosome-positive (Ph+) leukemias resistant or intolerant to dasatinib or nilotinib, or with the T315I mutation: Longer-term follow up of the PACE trial.
Conclusions:   PON has substantial clinical activity in heavily pretreated pts with Ph+ leukemias. PON is an important treatment option for pts in whom the need and benefit outweigh the risk.


Abstract  6:
Title: EPIC: A phase III trial of ponatinib (PON) versus imatinib (IM) in patients (pts) with newly diagnosed CP-CML.
Conclusions:  While PON demonstrated early activity in frontline CP-CML, EPIC was terminated as its objectives could not be met with PON dose reductions implemented mid-trial due to safety observations in PACE. Further investigation of PON safety is warranted. PON remains an important treatment option for pretreated CML and Ph+ ALL pts in whom the need and benefit outweigh the risk.


Abstract  7:
Title: Updated efficacy and safety of the ALK inhibitor AP26113 in patients (pts) with advanced malignancies, including ALK+ non-small cell lung cancer (NSCLC).

Conclusions: AP26113 has promising anti-tumor activity in pts with crizotinib-resistant ALK+ NSCLC, including pts with brain metastases. A randomized Ph2 trial evaluating 90 mg QD vs. 90mg QD escalating to 180mg QD in crizotinib-resistant ALK+ NSCLC will begin shortly.   .


Abstract  8:
Title: Phase II study of combination of hyperCVAD with ponatinib in frontline therapy of patients (pts) with Philadelphia chromosome (Ph) positive acute lymphoblastic leukemia (ALL).


Conclusions:  Combination of hyperCVAD + ponatinib is highly effective in pts with Ph+ ALL. Due to the vascular events observed, some pts switched to alternative TKI; in the remaining, ponatinib dose was modified to 30 mg daily during consolidation with subsequent reduction to 15 mg in pts in CMR


Disclosures: I am a “long” ARIA investor. I was not paid by any party to write this blog, and have no affiliation with Ariad Pharmaceuticals. 

Thursday, May 22, 2014

Games

Having fun?


Ok, this is FUN!   CEO keeps reminding us all of commitment to "increasing shareholder value," Sir Alex the Activist Investor signs up, FDA gives thumbs up (twice!), Pona looks ready to conquer the world (GIST, four other indications), AP26113 replicates the Lazarus Effect, the "mystery molecule" is about to be unveiled ("Best in Class!") and...now.. BlackRock gets the nod to buy a gazillion shares. And still...

Down we go.

We're sinking to pre-FDA re-approval, falling faster than companies with no FDA approved drugs and no rock-star pipeline, and we can't even blame Adam at this point. (He's giggling senseless, rocking back and forth in the dark as a digital display of ARIA's PPS sinks below the dreaded 666.) 

And yet...

Just yesterday, and for nearly a few years, we were at 23. Almost four times where we are now, sans bells and whistles and the CEO mantra and Alex and (your's truly) working out that the market value for GIST is (get this) $500,000,000 annually. 

Games. Just Games. 

In time, all will be revealed. The curtain will be drawn, Japan comes on line, ASCO abstracts are broadcast from the hilltops to the tune of Julie Andrews singing The Hills Are Alive....And the only question then, I'd wager, is are you still holding your ARIA shares? 

Good Luck to All.   And on with The Games.

TC



Friday, May 9, 2014

Are you CRAZY?

Like me?

It doesn't make sense, what I'm doing.  Which is crazy.   I don't gamble, or text while driving, or behave in reckless ways or indulge too much in anything and have no substance abuse issues. And I have an advanced degree, a solid career, and have exercised good judgement (mostly) throughout my life. 

And yet. 

I should and do know better. Don't put all your eggs in one basket, diversify risk, don't gamble with money but invest. I know all that, like you, fellow Ariad investor. 

And yet. 

And yet, truth be told, my portfolio is lopsided. I have way too much Ariad, 65-75% in this single stock, which I know is completely crazy and breaks every rule about rationale investing and responsible behavior and, honestly, it feels dark. Like a secret or a flaw or weakness or some Greek tragedy in the making. 

And yet.

I don't think I'm crazy. I've done my homework, understand the pipeline, have estimated the value of future indications of Iclusig (one of them, anyway), have looked at Ariad 10 year trends read all of their SEC filings (seriously) studied the bios of their entire executive team and tried to educate myself on oncology and the epidemiology of cancer and...you name it. I've don'e my due diligence, extreme due diligence, and I can't for the life of me conclude that there's an end game other than 20. Or higher. In spite of AF and the other naysayers that, in my humble opinion, have not done their DD, I can't see any other outcome than up. Way up. 

So, I'm comfortable being crazy and breaking rules and taking the risk of putting nearly all my chips on one stock.  But help me out here. Do you have a compelling reason that I, that you, should do otherwise given everything we know about Ariad?

Or are you as crazy as me?

TC

Wednesday, May 7, 2014

OMG! ADAM IS CLUELESS

Tell me, tell me please Adam!!!!


  • Why in God's name do you not mention AP26113?
  • For what reason do you withhold information about the five additional indications of Iclusig, including GIST?
  • Can you do any, any math at all? And if you can, can you check my numbers (see previous posts from this blog) which estimate the annual GIST market for Iclusig at half a billion dollars a year?
  • Have you seriously never heard anything about the "mystery molecule" or the computation drug development platform?

TC

Tuesday, May 6, 2014

You seriously need to FORGET about tomorrow's earnings report.

Please, just forget about it. 


The earnings report tomorrow does not, will not, can not matter. And if you don't understand that, you really should not be investing in Ariad.  And I mean INVESTING.  Not day trading, or speculating, or trying to make a quick buck.

Investing.

Investing is about the future of a company.  It's about catalytic events, the latent and powerful potential of a company and its ideas and its future value. So ask yourself, are you an investor?

If you're an investor, you'll know all about the multiple indications for Iclusig - including the half billion dollar a year market for the GIST indication.

If you're an Ariad INVESTOR, you'll know about AP26113, the mystery molecule, and the raw, powerful potential of the computational platform for drug development. You'll know about Japan and Australia and expansion in the European market (once pricing schedules and other issues are sorted out).

If you're truly an Ariad investor, you will understand the raw, tremendous potential ready to explode in new life changing, paradigm changing products that will flood vast global markets.

And, dear friend, if you know about all that, you won't give a damn about tomorrow's earning report. 

Ariad is a long game. So just forget about tomorrow. However it turns out.

TC