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Ariad Pharmaceuticals CEO Harvey Berger on the company’s effort to get FDA approval of its drug Ponatinib to treat Chronic Myeloid Leukemia.
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My next guest company is waiting for the FDA to approve -- drug that analysts are saying could be a cancer miracle.
The company's stock up more than 95%.
Over the last year doctor Harvey Berger is the -- humans via an area pharmaceuticals nice to have you on the show up.
You got so much faith tied to this one -- you put years and years of helping your life into this right this drug.
To treat.
Leukemia how close are you now.
Well I think Carol we're very close we filed for approval of the Food and Drug Administration.
Earlier this week.
It say you know -- to the final stretch having to way to look at it.
We work closely with the agency and we have great data and I think that's gonna lead to.
And approval soon but -- So put that net is the is the drug tree by -- like leukemia now other companies have come out with treatments for this but you were telling me before the show began that.
Your belief is based on the clinical trials that those -- haven't efficacy rate of what 50% you balloon.
By what we've seen so far in the trial in patients who have really failed the other drugs who who really have no choice.
A response rate in the chronic form of the disease of over 50%.
And that's rather remarkable outcome in patients who have really no options -- You know have artists came out the drug -- back on his -- that was the first of this type to treat best.
And at the same time this is back in 2001 of -- -- time magazine cover and -- called the miracle pill by the end all be all this is getting care can't write that did happen.
If you look at at this story like that we've act 2001.
It does does that give you -- times and he kind of go through this process.
Well I think if you look back -- -- effect it's truly a pioneering tried to change the way we think -- back cancer treatment.
What we've learned over the last decade is the patients fail the drug eventually not all but some and what connect live offers is an opportunity.
Two treat the patients who were resistant intolerant can't.
Work with not just.
-- that but other drugs there are several second generation drugs and what we've done this tested and ended in this setting a patients who have failed.
-- you've got a market cap a three billion dollars and you're gonna be commercially launch and a strike.
If -- can you believe that's gonna happen you know this year in fourth quarter first quarter of next year.
That's a big risk what what take that in what make them.
Because we want to build a sustainable.
Oncology business this is not our only product we have other products to follow.
A big drug for.
Lung cancer is coming soon behind.
And the only way to be successful as a business long term is that not only discover and develop the drugs that sell them worldwide.
I -- to tell -- sometimes they go back to that pressure we put so much of yourself and then the company behind this is that one analyst called the -- This drug is a major breakthrough it's thought of as a sure thing -- analyst communities -- the price target you can.
Risen on you doesn't buy does not perform.
Do you does that does so in your book in your thinking at all you think about like my got the analysts are stuck behind a -- -- -- Well we absolutely do you know we we have got to deliver we've done that we've run the trials we've filed when we said we were gonna file.
We've applied for priority were review and accelerated approval in the US.
We've accelerated assessment in Europe.
I mean there's a lot of momentum building around ten that -- been I'm very very helpful and very encouraged based upon the clinical data that will be able.
Bring this to patients with chronic -- -- leukemia.
And -- this year beginning and.
Actually asked checking into that -- second it is -- we should also point out that Europe -- and that renegade U -- And to make -- US in this well plus -- -- -- -- track.
Sure I -- we expect to -- in Europe for approval in about a month.
And and then expect to be.
Potentially on the market in some countries in Europe in the second half of next here doctor Harvey Berger founder chairman CEO of ARIAD Pharmaceuticals the stock -- an eighteen dollar and seventy cents right now.
We're going to be watching think angry and I'm.
