Biotech / Medical | ARIAD Pharmaceuticals


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To: Biomaven who wrote (1891)5/9/2012 3:54:23 PM
From: bellweather   of 2580
 
Thanks for the link-

Suggests to me that if 113 shows anything like the hoped for efficacy , the regulatory path may be trimmed considerably-

Big plus!

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To: bellweather who wrote (1892)5/9/2012 4:56:46 PM
From: Biomaven   of 2580
 
Couple of nuggets from the call:


On '113 this is perhaps significant given they have seen the early data and EGRF is both potentially much larger and much riskier than ALK :
So given that this is sort of two drugs in one and we're going to understand both flavors of the drug at the same time from the same trial and then be at a pivot point to make decisions with respect to EGFR, which we are just as enthusiastic about as ALK

On pona:

No patient in the Phase 1 trial, dose escalation trial, who was on a therapeutic dose of ponatinib has come off treatment due to resistance or intolerance. They stay on and we don't know how long they are going to be on, but three years and rolling.

Peter

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From: iandy5/10/2012 9:09:57 AM
   of 2580
 
A few items of interest from the Ariad first quarter presentation:

Ponatinib:

The Japan phase 1 trial will begin in the 3rd quarter 2012 followed by a mini PACE trial (small number of patients to confirm results of larger trial)

They will be "launch ready" in the US by the end of October.

Do not expect much from the ASCO abstracts.
The 6 month follow up data presented at ASCO will provide more Ponatinib efficacy over time data.
They will likely have all 12 month follow up data ready for ASH.

AP26113:

Harvey: "We have early clinical proof of concept in the dose escalation trial."

They will present as much clinical data as they have at the end of September.

They may initiate a separate arm in the Phase 2 trial or have a separate study to explore the ability of 113 to penetrate the blood brain barrier (not sure I understood this correctly).

ALK is popping up in a wide variety of solid tumors. They have the ability to bring other indications into the Phase 2 trial.

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To: Biomaven who wrote (1893)5/10/2012 9:43:15 AM
From: ariadough   of 2580
 
biomaven i keep going back to this statement

On pona:

No patient in the Phase 1 trial, dose escalation trial, who was on a therapeutic dose of ponatinib has come off treatment due to resistance or intolerance. They stay on and we don't know how long they are going to be on, but three years and rolling.

just mind boggling when you really think about it. in few years i see no reason why any doctor would ever choose not to start there patients on pona FRONTLINE.

these are sick patients and after 3 years they continue to do well. this is great for the patients.

but as a investor aria is still cheap at these levels imho!

dough

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To: ariadough who wrote (1895)5/10/2012 9:48:32 AM
From: iandy   of 2580
 
Harvey:
"...preventing the emergence of mutations to resistance is the key to long term benefits."

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To: Biomaven who wrote (1893)5/10/2012 9:53:01 AM
From: DonShimoda   of 2580
 
It was nice to hear the M.D. Anderson trial in newly diagnosed CP patients is already enrolling. With just 50 patients, I suspect it may provide early insight into the larger, Ariad sponsored, 500 patient trial. One difference - the primary endpoint for the Anderson trial is CCyR while MMR was mentioned yesterday as the most likely primary endpoint in the Ariad trial.

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To: DonShimoda who wrote (1897)5/10/2012 10:43:30 AM
From: Biomaven   of 2580
 
One difference - the primary endpoint for the Anderson trial is CCyR while MMR was mentioned yesterday as the most likely primary endpoint in the Ariad trial.


The FDA is more focused on CCyR. The experts mostly seem more impressed with MMR (which is a tougher hurdle), although I have heard dissenting voices who say that in practice CCyR seems the best test of durability.


Peter

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From: ariadough5/10/2012 12:48:13 PM
   of 2580
 
thanks to rkrw here is the latest jefferies report on aria. interesting to note they still are not giving 113 anyvalue.

also they model sales of pona at 37 million in 2013. imho i think we will have 37 million in sales of just those that were already in the trials along with the expanded use programs imho


T
Post # of 18758





http://tinyurl.com/7wansyy

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From: ariadough5/11/2012 6:05:45 AM
   of 2580
 
This from Rachel McMinn and Merrill Lynch yesterday. A price objective change. She went from 16 to 17. Stayed neutral.

ARIA continues to execute on its objectives
ARIA reported 1Q12 results and provided a comprehensive overview of its
development pipeline that is consistent with our expectations, and show continued
execution: (1) updated results from the PACE Phase 2 study for lead drug
ponatinib (PON) for last line CML will be presented at the June ASCO meeting,
with limited new information in the abstract available next week (2) ARIA remains
on track to file for approval of PON in 3Q12 in both the US and EU; ARIA remains
committed to launch PON globally on its own and is continuing to build
infrastructure (3) PON Phase 3 for newly diagnosed CML remains on track to start
3Q12 (4) ALK/EGFR inhibitor ‘113 is progressing through the dose escalation
Phase 1 trial, now in a fourth cohort of 120 mg, and ARIA continues to expect the
Phase 2 portion of the study to start mid-year following dose selection (5) initial
data from the ‘113 study is planned for the ESMO meeting this fall, and ARIA
plans to present as much data available from the Phase 1/2 study at that time.
Minor model changes, our focus is ALK landscape
Operating expenses were consistent with our model, although we had
overestimated the share count slightly which drove the variance in EPS vs our
estimate. We believe that the stock is keyed to updates on the ALK inhibitor
program. Competitor data will become available at ASCO this year (Chugai and
Novartis), both at the same early stage of development as ARIA. This meeting
and ESMO will provide the first look at second generation ALK inhibitors. We
have increased our PO from $16 to $17, based on a slightly increased probability
of success from 15% to 25% for ‘113 based on the program continuing to
progress.

Price objective basis & risk
Ariad Pharmaceuticals, Inc. (ARIA)
Our $17 PO is based on a risk-adjusted sum-of-parts DCF analysis that includes
$16/share for ponatinib, $3/share for 113 and $2/share for cash, which is further
adjusted for 18% dilution. We use the following assumptions in our DCF: 1)
WACC of 11%, 2) peak PON global sales of $442M in 2016, 3) sales out to 2030
and no terminal value, and 4) 18% dilution from outstanding warrants, dilutive
options and potential future equity financing. We see potential upside to our
valuation from: 1) pipeline expansion, and 2) partnership for ponatinib in EU and /
or Asia. Downside risks to valuation are: 1) disappointing results in the PACE
study that could put accelerated approval at risk, 2) execution risks following the
ponatinib launch in the resistant/intolerant settings, 3) data disappointments for
ongoing/anticipated ponatinib trials, and 4) unexpected clinical strategy
requirements for future ponatinib trials

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To: Biomaven who wrote (1893)5/11/2012 11:20:34 AM
From: bellweather   of 2580
 
Thanks Peter,

Still haven't had a chance to listen to the call(but expect it to be an encouraging experience when I do).

If Hs equal enthusiasm for EGFR is warranted(poor choice of words), short of ALK being a disappointment(highly unlikely), more positive surprises should be in the offing.

Personally, I wonder about how much of erlotinib's effectiveness is, despite the attendant side effects, due to it's role in inhibiting native EGFR-

To the degree that it is, 113s (single drug)EGFR performance, though involving less side effects, may be less efficacious than hoped for.

Are you aware of any updated data relating to this issue?

Re: Pona-Well, it just seems to be continuously onward and upward, and we haven't even seen any data(which should be forthcoming) on other tumor types!


Best,

bw

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