ARIAD Pharmaceuticals, Inc. (ARIA)
Lazard Capital Markets Healthcare Conference
November 14, 2012 1:30 PM ET
Harvey Berger – M.D, Chairman, and CEO
Ryan Martins - Lazard Capital Markets
Ryan Martins - Lazard Capital Markets
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Thanks very much Ryan. It’s a great pleasure to be here this afternoon. We were chatting beforehand, and I’ve been to every one of the Lazard Healthcare conferences, and it’s a real pleasure to have a chance to come back this year. And to share with you the excitement of Ariad, over the last I guess since nine years that they’ve been in these conferences, we’ve certainly made incredible progress over that period of time, we’ve really focused the company virtually exclusively on oncology, and are on the way to building a global, commercial oncology business.
Before I get started, let me just read a reminder that some of the statements in the presentation constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995, and I encourage everyone to read our periodic filings with the SEC and recognize that actual results may differ materially from those expressed or implied by these forward-looking statements.
Well, 2012 coming to an end, is the year in which we’ve taken our science to the next step. We’ve made the clear transition from a discovery and development company in oncology to one now that is building a global commercial organization focused entirely in oncology.
Well there’s been – there’s certainly significant momentum ongoing in Ariad as Ponatinib is under review in the US and EU. Our Phase III EPIC trail to expand the indications of Ponatinib is enrolling patients. We expect completion of enrolment by next year.
A Phase 1/2 trail of Ponatinib is ongoing in Japan. That’s leading the way to Ariad having complete control and ultimate approval of Ponatinib in Japan. Our second oncology – targeted oncology product AP26113 is a clinical proof of concept data presented recently at the European Society of Medical Oncology meeting. And importantly, as I stand here today, we are absolutely ready for commercial of Ponatinib in the US. If we had approval today, we could be out there in ten days or two weeks, commercializing Ponatinib. So we are ready and ready to go.
And we are in the process of building the organization in Europe as well, and I’ll talk more about these in the next couple of minutes.
So Ponatinib starts and ends with patients. It’s all about what we can do for the patient with chronic myeloid leukemia. Initially, with acute lymphoblastic leukemia and then as we’ll discuss briefly, where Ponatinib can lead us.
So we believe this is a potential first-in-class new therapy for chronic myeloid leukemia, a pan-Bcr-Abl inhibitor, a small molecule drug as you see, shown in the illustration on your right, in which Ponatinib nudges down into the crevices of Bcr-Abl and selectively binds to really all of the forms that have been tested of Bcr-Abl, the naturally occurring form that is the cause of the disease, as well as subsequently all of the many resistants, mutations that have cropped up.
It’s clear that although the currently available Bcr-Abl inhibitors have many mutations that have been observed in the clinic, well over 50 for imatinib, 70 each for nilotinib and dasatinib, and we’ve seen none with Ponatinib. So Ponatinib, really this can been distinguished from the other CML drugs that currently are available as it overcomes all the clinical mutations that have been tested.
The paradigm for development and commercialization of new oncology medicines have certainly changed over the last years. We believe Ponatinib will move from the clinic initially to potential approval in the US in under five years. That’s really the hallmark of a targeted therapy in which we nowhere headed before we start the clinical trials, and we are able to move from first-in-man to potentially US approval in a matter of years.
That paradigm I think is going to become increasingly the model of new targeted medicines in cancer; certainly that’s the approach of what we envision for our second product which I will talk about in a few moments, 113.
But let’s start with CML. Even with the availability initially of three and now five different CML medications, there is a significant unmet medical need. Patients without Ponatinib don’t have all of their options met. And we believe Ponatinib will really fit into a major need clinically for patients with chronic myeloid leukemia.
As you look at those patients, really we can think about the disease in the setting of two broad groups; those who are newly diagnosed, that is, those who are treatment naïve and those who are resistant or intolerant to one and more of the available therapies. And there are many patients, who have become and currently are resistant or intolerant to available therapies, and thus really provides us with an opportunity to make a real difference in the lives of CML patients.