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ImmunoGen, Inc (IMGN)
F3Q09 (Quarter End 03/31/09) Earnings Call
April 30, 2009 4:30 pm ET
Carol Hausner - Executive Director, Investor Relations, and Corporate Communications
Daniel M. Junius - President, Chief Executive Officer
Gregory D. Perry - Chief Financial Officer, Senior Vice President
John M. Lambert Ph.D. - Chief Scientific Officer
James O’Leary – Chief Medical Officer
Joel Sendek - Lazard Capital Markets
Pamela Bassett - Cantor Fitzgerald
Shiv Kapoor - Morgan Joseph and Co
Jason Kantor - RBC Capital Markets
Previous Statements by IMGN
» ImmunoGen, Inc. F2Q09 (Qtr End 12/31/08) Earnings Call Transcript
» ImmunoGen, Inc. F1Q09, (Qtr End 9/30/08) Earnings Call Transcript
» ImmunoGen, Inc. F4Q08 (Qtr End 06/30/08) Earnings Call Transcript
Thank you. At 4:00 this afternoon we issued a press release that summarizes our financial results for our third quarter ending March 31, 2009, which is the third quarter of our 2009 fiscal year. I hope you have all had a chance to review it. If not it is available on our website at www.immunogen.com. During today’s call we will make forward-looking statements. Our actual results may differ materially from the projections made. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings, which also can be accessed through our website.
With me today are Dan Junius, Chief Executive Officer, and Greg Perry our Chief Financial Officer. Dan will provide an update on ImmunoGen and Greg will discuss our financial results. We will then open the call to questions. In addition to Dan and Greg we also have our Chief Scientific Officer Dr. John Lambert and our Chief Medical Officer Dr. Jim O’Leary here as well, so that they too are available to answer your questions.
I will now turn the call over to Dan.
Thank you Carol and good afternoon everyone. Thank you for joining us today. This has been an important quarter vis-à-vis progress with T-DM1 and other pipeline compounds and let me go right to T-DM1 and provide an update there.
Genentech and Roche are implementing a broad and aggressive T-DM1 development plan. Roche has been a driver behind this program since they opted in on T-DM1 back in December of 2007. There has been quite a bit of clinical progress with Genentech reporting that they have already completed enrollment in the Phase II trial assessing T-DM1 as a third-line treatment for HER2 expressing metastatic breast cancer. This is a 100 patient study where enrollment began in July of 2008. This enrollment was completed this past March. This particular trial addresses patients whose cancer has progressed on Herceptin and on Tyker regimens and Genentech expects final results by the first quarter of 2010. They have noted that if data are compelling that we use this study to discuss an earlier approval path with the FDA which could lead to a potential U.S. launch in 2010.
Genentech and Roche also initiated a Phase III testing of T-DM1 in late February of this year which triggered a $6.5 million payment to us. This is part of $19.5 million and up front and milestone payments from various partners that ImmunoGen has received through March of this fiscal year.
This particular Phase III trial is referred to as EMILIA and it is a randomized trial comparing T-DM1 to TYKERB plus Xeloda so it is targeting second-line treatment of HER2 positive metastatic breast cancer. The trial will enroll 580 patients across 260 centers on a global basis. Roche has indicated they expect to file for T-DM1 in Europe in 2012.
T-DM1 is also being assessed as a first-line treatment for HER2 positive metastatic breast cancer in a Phase II study. This study compares T-DM1 head-to-head with Herceptin plus Taxatier in a 120 patient multi-national trial that includes U.S. centers. This trial began last summer in July.
We expect the clinical program for T-DM1 will continue to expand. There is a trial assessing T-DM1 used in combination with Genentech’s Pertuzumab that is scheduled to start this quarter, this trial is now up on clintrials.gov.
Further Genentech has indicated they are looking at testing T-DM1 in the [AGIMEN] study which is another important market. And while there are direct opportunities for T-DM1 to expand, there are also opportunities for Herceptin to continue to expand, which could potentially increase the potential for T-DM.
Recently Roche reported that Herceptin has been found to provide a significant survival benefit in advanced HER2 positive gastric cancer. The results from this Phase III study referred to as ToGA will be presented at ASCO. Roche has indicated that they plan to file for approval of this indication in Europe later this year.
At the same time Herceptin sales continue to grow. Reports for the first quarter were $1.3 billion Swiss franks of Herceptin sales which equates to about $1.1 billion and in constant currency that is about 11% over the same period last year.
In terms of upcoming T-DM1 data presentations at ASCO the final results from the Second-Line Plus Phase II trial, this is the trail that initiated in July of 2007, will be in a poster presentation at ASCO on May 30, plus an oral discussion session. This focuses on patients with HER2 positive metastatic breast cancer that progressed on Herceptin plus chemotherapy, many of whom also progressed on TYKERB plus Xeloda and its filed interim interest findings that were presented at the San Antonio Breast Cancer Symposium in December.