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ARIAD Pharmaceuticals, Inc. (ARIA)
April 04, 2013 8:00 am ET
Maria E. Cantor - Senior Vice President of Corporate Affairs
Harvey J. Berger - Principal Founder, Chairman of the Board, Chief Executive Officer, President and Chairman of Executive Committee
Jim Birchenough - BMO Capital Markets U.S.
Michael G. King - JMP Securities LLC, Research Division
Michael J. Yee - RBC Capital Markets, LLC, Research Division
Rachel L. McMinn - BofA Merrill Lynch, Research Division
Jonathan Eckard - Citigroup Inc, Research Division
Terence C. Flynn - Goldman Sachs Group Inc., Research Division
Howard Liang - Leerink Swann LLC, Research Division
Matthew J. Lowe - JP Morgan Chase & Co, Research Division
Philip Nadeau - Cowen and Company, LLC, Research Division
Matthew Harrison - UBS Investment Bank, Research Division
Ying Huang - Barclays Capital, Research Division
Y. Katherine Xu - William Blair & Company L.L.C., Research Division
Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division
Ryan Martins - Lazard Capital Markets LLC, Research Division
Previous Statements by ARIA
» Ariad Pharmaceuticals' CEO Presents at Barclays Global Healthcare Conference (Transcript)
» Ariad Pharmaceuticals Management Discusses Q4 2012 Results - Earnings Call Transcript
» ARIAD Pharmaceuticals' CEO Presents at Lazard Capital Markets Healthcare Conference (Transcript)
At this time, I would like to introduce Ms. Maria Cantor, ARIAD's Senior Vice President, Corporate Affairs. Please go ahead.
Maria E. Cantor
Good morning, and thank you for joining us. This morning, we will provide an update on important progress being made by the company across its R&D programs and commercial operations. A press release outlining this progress was issued earlier this morning. Joining me on the call are Dr. Harvey Berger, ARIAD's Chairman and Chief Executive Officer; Dr. Tim Clackson, our President of R&D and Chief Scientific Officer; and Marty Duvall, our Senior Vice President for Commercial Operations.
Dr. Berger will provide an update on our recent progress and related topics, and then we'll take calls from analysts. Please note that, since the company will be announcing its first quarter financials, we just want to point out that we are close to that period and will only be able to answer questions that will not impede our ability to report results at the time on May 7.
We will be making forward-looking statements this morning. These statements are subject to factors, risks and uncertainties, including those detailed on our Form 10-K for the year ended December 31, 2012, and other SEC filings that may cause actual results to differ materially from the results expressed or implied by such statements.
Now here's Harvey.
Harvey J. Berger
Thanks very much, Maria. And good morning, everyone. I'd like to take this opportunity to provide important updates on our recent progress in R&D and on the commercial launch of Iclusig. I also want to correct certain statements about both of these topics that we have heard over the past few weeks that are untrue, misleading or incomplete. These have been a distraction to all of us at ARIAD as well as to our shareholders, and I believe that this is the time to set the record straight with accurate statements of fact.
As I look at the list of investors who have dialed in to this call, I note that this is the largest number of investors, I think, we have ever had on a call, so I guess there's great interest in what we have to say this morning.
So let me start with the commercial launch of Iclusig in the U.S. We are extremely pleased with the progress of the Iclusig launch during the first 3 months. As stated in our press release issued earlier today, more than 325 patients in the U.S. are now being treated with Iclusig, which does not include any patients using the initial no-charge 30-day Quick Start supply. In just the first 12 weeks since commercial launch, there are more than 225 unique physician prescribers of Iclusig and nearly 200 unique accounts using Iclusig. Importantly, approximately 2/3 of Iclusig prescribers are community-based physicians, with the remaining 1/3 being academic physicians. This 2-to-1 distribution in favor of the community prescribers is the opposite of what many would have predicted for this point in time. This clearly shows that Iclusig is being prescribed broadly among hematologists and oncologists in diverse clinical settings, not just the investigators who participated in our clinical trials.
Further, approximately 1/4 of the patients receiving Iclusig since launch have failed only one prior tyrosine kinase inhibitor, thus representing a substantial portion of earlier-stage patients being treated with Iclusig in the second line.
Taken together, these data reaffirm that Iclusig is not being niched as a salvage therapy for patients with the T315I mutation or those who have failed 3 or more TKIs. It is clear that Iclusig is being prescribed widely, consistent with its broad label, its robust efficacy and its excellent tolerability, and we expect this to increase further as the launch progresses.
Nearly all of the patients who were in the expanded access program in the U.S. have now been transitioned to commercially supplied drug. Many of these patients are still using the initial Quick Start supply, which is not included in the audited IMS prescription data. And while there has been great focus on prescription data during the past few months, it's important to appreciate that day-to-day and week-to-week fluctuations are anticipated. Our commercial team has visibility on virtually every bottle of Iclusig being shipped and virtually every prescription being written. We are extremely pleased with the launch trajectory of Iclusig over the past 3 months and look forward to reporting our first quarter revenues of Iclusig on our upcoming investor call in about a month, on May 7, as Maria pointed out.
Turning to the EU. The CHMP adopted a positive opinion for full approval of Iclusig in 2 closely related indications. The recommendation is for the use of Iclusig in adult CML and Philadelphia positive ALL patients and provides a broad indication statement for Iclusig in resistance and intolerant patients with Philadelphia positive leukemias. Importantly, this indication specifically includes many patients who have failed only one prior tyrosine kinase inhibitor. What this means to us is that, once the recommendation of the CHMP is adopted by the European Commission, Iclusig will be indicated for second-line use in patients who are resistant to the second-generation medicines dasatinib or nilotinib or in patients who have the T315I mutation of BCR-ABL, as well as all of the patients who have failed multiple lines of prior TKIs.
Our internal market research, along with independent third-party research, shows that approximately 40% of chronic-phase patients and approximately 50% of advanced-phased patients in Europe with newly diagnosed CML are being treated at the onset by -- with 1 of these 2 second-generation TKIs as their initial treatment. We expect these percentages to continue to increase, similar to the trends seen in the U.S, as greater adoption takes place. And this, in turn, will create a growing and broader opportunity for Iclusig in second-line patients in Europe.