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ImmunoGen, Inc. (IMGN)
Citi 2013 Global Healthcare Conference
February 25, 2013 11:05 AM ET
Daniel Junius – President and CEO
Previous Statements by IMGN
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» ImmunoGen's CEO Discusses F1Q13 Results - Earnings Call Transcript
I would point you to our regulatory filings about risk associated with investing in ImmunoGen. We see ourselves as being on the forefront of developing therapies that we think will be transformative in terms of how cancer is treated and we had a major event on Friday.
This is the first public forum at which I am able to say that we have a compound that’s been approved by the FDA for treatment in patients. Kadcyla was approved, it’s a compound in development by Roche for HER2-positive breast cancer. I will spend more time on that later.
In addition to being simply watershed event for the company and for the technology, obviously from an economic standpoint it affords us the opportunity, both to be realizing milestones within the transaction and generating significant royalty revenue over the life of this particular compound.
Beyond that, we are in the process of moving forward on proprietary programs. We have three compounds in development today. We have a fourth that we expect to go in the clinic over the course of 2013 and more that we are working on pre-clinically.
We do that in an environment where we think we have sufficient resources to take our clinical compounds through to proof-of-concept. We have over $200 million in cash as of our last reporting period, no debt. And the opportunity to generate additional cash from other partnerships we have with major companies who are advancing compounds in oncology.
Let me start and talk a little bit about Kadcyla for a number of reasons. One the brand name is, at this point three days old. We think it’s the start of a, what will be a new era in HER-2 positive breast cancer is treated. There is considerable efficacy that’s been demonstrated through the clinical study, the process, as well as improvement in terms of tolerability for patients.
Importantly, it’s the first antibody drug conjugate to be approved for a prevalent solid tumor and that’s important because, 90% of all cancers are represented with solid tumors. So having a compound that’s shown the benefit that we’ve seen with Kadcyla through clinical studies and getting it approved makes that a very significant event.
And from the management standpoint, I reference to revenue implications, but obviously from a technical standpoint this represents a new threshold of validation. I think that there had been technical validation as people looked at the data that was being generated through the various clinical studies but getting regulatory approval represents an entirely new threshold of validation.
As I said, Kadcyla is now approved for marketing in the US. It will be approved to treat HER-2 positive metastatic breast cancer for patients who have failed in earlier therapy of Herceptin Plus a Taxane and what that represents, it will include some patients who would have received that therapy Herceptin Plus Taxane in the adjuvant setting, if they progressed while on therapy or within six months.
So that would open up some first line metastatic patients to receive the therapy. But then for those in second line or later metastatic, they would all become eligible because the assumption is, they would have received Herceptin Plus a Taxane when first diagnosed with metastatic disease.
So the data that Roche has indicated would say that it’s at least 14,000 patients would immediately become available and importantly for late-stage patients, today who have no other targeted therapy available and then for some percentage of first line metastatic patients.
I talked about efficacy plus tolerability, what we saw in the EMILIA study which was the data that supported the filing was a significant improvement in both progression free survival and overall survival. The overall survival benefit was adding six months to overall survival versus the control of taker of Tykerb plus Xeloda, plus a more favorable safety profile and that you saw about two-thirds of the grade-3 in greater adverse events versus the control arm, as well as events that led to a reduction in dose or drug discontinuation.
The compliance rate in the study with T-DM1 and that was called then was almost 100%, 99.9% with 90 plus percent for Tykerb compliance, but only 77% complaint with Xeloda. So I think that that’s reflective of the tolerability with this particular compound versus the standard of care for those patients.
The Kadcyla approval is the first step in what we see as a broad registration pathway that’s being undertaken by Roche. This particular patient population really does represent a new segment for Roche for HER-2 positive breast cancer patients and that these are patients who failed in earlier Herceptin-based therapy.
For those who are currently receiving a Herceptin plus Taxane or even a Herceptin plus Taxane plus Perjeta therapy, there is a study underway that will read out in early 2014 that would make it – assuming the data supports it and there is approval you would have T-DM1 or Kadcyla available for all first line metastatic patients.