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Author: Fuma102 Big red star, 1000 posts Old School Fool CAPS All Star Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: of 192  
Subject: ARIA, re-eval Date: 8/8/2011 11:18 PM
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Still a bit richly valued, it was under $5 not too long ago. On positive P2 data from ponatinib & positive initial results from AP26113, it gets bought out. just a matter of at what price. I'm in a holding pattern, given that at $7, its still a 1b cap company. A little too much unknown at this point. not buying until possibly Sept after the ASH meeting (see below).


PONATINIB
-P2 started, CML, or ph+ ALL, single arm trial with those resistant or intolerant to dasatinib or nilotinib, or with T315I … endpoint: cytological response, duration, progresion free survival, overall survival.
- over enrolled, 450
- nearly complete enrollment, 6 months ahead of schedule, will submit to FDA 2H2012
- submitted interim data to ASH meeting for Dec 2011, mostly on tolerability & safety
Updated data from the ongoing Phase 1 clinical trial of ponatinib in patients with resistant and refractory CML will be presented at the International Chronic Myeloid Leukemia Foundation Conference in September. The presentation will include data on the maturity of response rates to ponatinib, long-term durability of response, and time course of response. This presentation is expected to be the last one on the Phase 1 trial prior to submission of the study for publication in a peer-reviewed medical journal.

Chronic phase pts who failed 3 prior tx from P1 trial:
Major Cytogenic response: 46%
complete cytogenic response: 31 %
complete hematologic response: 85%
11/12 without disease progression at 1 yr, 9/12 responses cytologically confirmed
T1315I with 89% complete hematologic response, 67% with major cytogenic response

First time tx:
Tasigna BID 43% major molecular response at 12 months, CCyR: 80%
Gleevec QD 22% major molecular response at 12 months, CCyR: 65%
Sprycel QD 46% major molecular response at 12 months, CCyR: 83%%

T315I mutation resistant to gleevec & sprycel

If I'm reading it right, put ARIA's med in Sprycel territory. Gleevec sold 3b last year, Sprycel's sales are growing at a 40% clip, up to 400m last quarter.

looks good, but, lets face it, its a phase one trial. If Sept ASH meeting data looks good, lets rock. Ponatinib is wholly owned by ARIA at this point. Possible 1b drug, though more likely 500m. It can be a legit best in class drug.

Partner test with MolecularMD for T315I mutation.

RIDAFOROLIMUS
--Merck submitted for Europe (triggers 25m payment for submission, additional $10m for approval), US coming soon (approval triggers another $25m
-first molecularly targeted drug for the treatment of patients with metastatic sarcomas and the first sarcoma drug to be approved for use in the maintenance setting. (market is ~6500 soft tissue sarcomas and ~2500 bone sarcomas)
- for sarcoma: the study achieved its primary endpoint of a significant improvement in progression-free survival compared to placebo, with an approximately thirty-percent reduction in the risk of progression due to ridaforolimus. The data also showed a positive trend favoring ridaforolimus in an interim analysis of the secondary endpoint of overall survival.

- results of the P2 endometrial cancer look meh :
~28% response rate, with insane side effects with everolimus having 21% with signficantly less side effects (like 65% grade 3 vs 40% grade 3)

competitors (temsirolimus-500mill, everolimus-150mill last year)

The Merck deal: 10% of US sales, 7.5% of out of US sales, merck pays for everything from here forward. 2,000 sarcoma patients at $50,000 a year equals maybe 10 million a year with luck.



AP26113

ARIAD will begin a Phase 1/2 clinical trial of AP26113 this quarter. ARIAD scientists designed AP26113 as a highly potent dual inhibitor of ALK and EGFR with best-in-class potential. As an ALK inhibitor, in preclinical studies, AP26113 has been shown to be substantially more potent than crizotinib, Pfizer's investigational ALK inhibitor, and to overcome crizotinib-resitant mutations that are now being seen in patients who received crizotinib. As an EGFR inhibitor, AP26113 inhibits the oncogenic form of EGFR in preclinical studies including the major mutation that causes resistance to erlotinib, Roche/Astellas' marketed EGFR inhibitor.

Crizotinib numbers: In a phase 2 clinical trial reported in a plenary session here at the American Society of Clinical Oncology 2010 Annual Meeting, the investigational drug crizotinib (under development by Pfizer), which is a specific ALK inhibitor, showed an objective response rate of 57% and a disease control rate of 87% in NSCLC patients whose tumors had a rearrangement of the ALK gene.
Alk mutations are 3-5% of lung cancer. 5% of 200,000 at 60k a treatment is 600m, but again, early in the game on this one.
-------------------------------


-Burning 20 million a quarter, with 80 on hand.
-Ridaforolimus might add 10m a year.
-expecting good news from pontanib in the next year: partner deal, phase 2 results, end of 2012 with FDA submission, cant go at it alone, and they are going against Novartis' Gleevec & Tasinga and BMS' Sprycel. Potential 600m annually.
-AP26113 is too early to call, but a nice potential bonus.

--------------
sources:
http://www.mdanderson.org/publications/leukemia-insights/iss...

http://phx.corporate-ir.net/phoenix.zhtml?c=118422&p=iro...

http://seekingalpha.com/article/248175-genie-about-to-come-o...

http://phx.corporate-ir.net/phoenix.zhtml?c=118422&p=iro...

http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=ab...

http://www.pharmatimes.com/article/11-05-18/Pfizer_submits_f...

http://seekingalpha.com/article/210288-ariad-pharmaceuticals...
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