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[CallMeLucky]

http://www.thestreet...ug-is-fine.html

Ariad Pharmaceuticals  (ARIA) CEO Harvey Berger, sounding defiant, even angry at times, convened a marathon conference call Thursday to refute concerns about the safety and early commercial launch of the company's leukemia drug Iclusig. 

 

Berger took special aim at Ariad critic Favus Institutional Research, calling a negative report on Iclusig released Wednesday, "incomplete and replete with misinformation, innuendo and false conclusions." 

Through the first 12 weeks of its U.S. commercial launch, "more than" 325 chronic myeloid leukemia (CLM) patients are paying for Iclusig treatment, with additional, undisclosed number of patients receiving some free drug, Ariad said. 

 

 

The new disclosure led investors and analysts on the call scurrying to their Excel spreadsheets, trying to estimate first quarter sales. Ariad could have made it easy on everyone by simply pre-announcing Iclusig sales but the company chose not to. 

Analyst consensus for first-quarter Iclusig sales was $4 million prior to Thursday's call, although the "whisper number" based on existing prescription data is more like $5-6 million. 

I spoke with one institutional investor with no position in Ariad who now estimates Iclusig sales for the quarter will be $3.5 million to $5 million, depending on the conversion rate of patients from free drug to paid prescriptions. 

"If you're really bullish on Iclusig, why not pre-announce first-quarter Iclusig sales?" asks another investor who is short Ariad and isn't covering following Thursday's call. "What I heard on the call was 90 minutes of Harvey babbling and contradicting himself." 

On his call, Berger insisted Iclusig is well received by doctors and patients and that concerns about the drug's toxicity were overblown. The rate and type of side effects being reported are not different from what was seen in clinical trials or what's contained in the drug's FDA-approved label, he said. 

Iclusig's label includes a black box warning against blood clots causing fatal heart attacks and strokes, and liver toxicity including liver failure and death. 

The Favus research note negative on Iclusig published Wednesday refers to a survey of doctors treating CML patients with the drug who are finding it to be more toxic and less tolerable than expected. "Iclusig has a very small role to play in heavily pre-treated CML patients with the T315I mutation (extremely rare); as time goes on, that observation is becoming obvious," the Favus note said. 

Ariad insists Iclusig will be used broadly in all types of CML patients. The company is conducting a study comparing Iclusig to Novartis'  (NVS) Gleevec in newly diagnosted CML patients. 

Ariad shares rose 3% to $17.27 in early Thursday trading, which is still down from $22 in mid-March . The bull-bear fight over Iclusig seems far from over. 

-- Reported by Adam Feuerstein in Boston.  

[Trey]

Iclusig (ponatinib) does not have a large enough user population to adequately understand the real life (i.e., not clinical trial) side effects profile yet, so the original "negative report" from Favus seems to overstate that issue a bit, although  issues have emerged as early concerns.  And none of our CML drugs are "non-toxic" in the side effects sense.  But Oncs will be reluctant to use Iclusig as a front line drug when there are 3 other well known front line choices ahead of it (4 if you count Bosulif), especially since the FDA has not approved Iclusig for front line use yet, and it also has black box warnings on 2 separate issues (blood clots and liver).  The only other CML drug with a black box warning is Tasigna (heart QT interval prolongation), and that has not been shown to be as much of a real life issue.  For CML patients, Iclusig is a life-saver if someone has the T315i mutation, but only a small percentage of patients have it.  Otherwise, Iclusig will not likely have a rocket trajectory in usage since there is no real motivator for Oncs to prescribe it beyond T315i unless someone has previously failed all the other drugs. 

[nelnorm]

After failing on Gleevec, I am glad to be put on the new drug ponatinib if it will work ..... seems to me all have side effects and if you have a great onc and he is monitoring you closely , then go for the one that is the most promising!  Just watch Dr. Jorge Cortez explain why he feels you should go with this drug.   He is my onc and although I started out with some awful side effects, he encourage me to stick with it until my body could adjust and it sure seems that it is leveling out.   I have no orbital swelling and none of the terrible rash that I had with Gleevec.... at least at this point  I do not.    You can google Dr. Cortez and watch any number of videos of him discussing this new drug.