Exelixis, Inc. (
Citi Global Health Care Conference
February 28, 2012 10:00 AM ET
Charles Butler – Executive Director, Corporate Communications & Investor Relations
Mike Morrissey – President and CEO
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Over to Mike, I will just read the FLS quickly; during the course of this presentation we will be making forward-looking statements regarding future events and our future performance of the company. Actual events and results of course could differ materially. We refer you to the documents that Exelixis files from time to time with the Securities and Exchange Commission, specifically the company’s most recent 10-Q filed on February 22, 2011. These documents contain and identify under the heading Risk Factors important factors that could cause actual result to differ materially from those contained in any forward-looking statements including risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing, our ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion, the sufficiency of Exelixis’ capital and other resources and any uncertainty of the FDA review and approval process.
With that I turn it over to Mike.
Again, thank you Charles, good morning everybody. Thanks for joining us today. I will start this morning briefly framing the Exelixis opportunity and then move into some data that we have as a lead compound, cabozantinib and prostate cancer and tumor types. I think the opportunity we have today moving forward in 2012 is really based upon I think a lot of the emerging data that came up early this year and last year around a variety of different tumor indications for cabozantinib. Our focus is of course in prostate cancer, that’s really have certainly the most robust effect today and certainly a very unique clinical profile that we hope to now convert into unique and differentiated commercial activity. That being said, cabo is more than just a prostate cancer compound and it's more than just a prostate cancer bone drug.
Has a variety of different activities that we have seen today, we have seen objective responses in 12 of 13 different tumor types to-date. We have seen broad activity in nodal disease, this will be these bone disease, visceral disease and we built a unique methods of action that we think is driving the activity both in terms of its primary activity on tumors but also in blocking resistance and I think we cannot – last Friday in counter discovery talking about the roles that both met and they just play in terms of simultaneously driving tumor growth but how important it is important to block (inaudible) in terms of really blocking a primary resistance to a variety of different types.
Very interesting papers that came out with one of our collaborators from USF (ph) that came out with one of our collaborators from USF I doubt which I think helps frame the opportunity that cabo has been broadly active in sense of compound but I will challenge right now is to really take this forward now and provide significant clinical differentiate in pivotal trials that will allow us into differentiate commercially and make that franchise as high value as possible.
So how this cabo is different, what have seen today, again our overall adjusted response is being very broad and again talk to 13 different tumor types. We have I think for the first time shown very rapid inconsistent resolution of metastatic bone lesions. This has been a real challenge going back now for almost 20 years to address this compartment, we are going to test these off of the Trial II (ph).
We have very broad activity in the bone, we have seen that today in prostate cancer, renal cell carcinoma, thyroid cancer, melanoma, as well as others. So, really again very good activity here again not just in terms of prostate cancer but broad bone activity across multiple tumor types.
We have been able to shown with some data we had last year in June, last year that this bone scan resolution appears to correlate with various signs of clinical benefit including extension of PFS by six months. Pain reduction, opioid reduction, et cetera, so, very good overall emerging correlations or associations between the ability of cabo to resolve existing metastatic bone lesions and then having that lead to clinical benefit in patients.
And one of the big breakthrough that we made over the last few months is using the prostate cancer opportunity to look to a fill those response in the clinic, again to do this really exhaustibly you want to have a tumor type in the clinic that is highly prevalent and prostate cancer is certainly is that, but has the bio-marker, so you will be able to let you rapidly look at different doses and get a relevant read out quickly.
And certainly with the fact that most prostate cancer patients have bone metastases and most of those patients respond to cabo with resolving bone metastases. We have been able to then rapidly with collaborations with Mass General, Matthew Smith there be able to define what we think are the important lower active doses with much improved tolerability.
I will talk about that in a few minutes but we have always had good insight into being able to maintain a response by lowered in doses and classic introduction format but now looking at lower starting doses, either 60 milligrams or 40 milligrams, provides much better overall tolerability and very good activity as well.