Call Start: 08:00
Call End: 08:26
Array BioPharma Inc. (NASDAQ:ARRY)
UBS Global Healthcare Conference
May 20, 2014 08:00 AM ET
Ron Squarer - CEO
Good morning. Welcome to the UBS Global Healthcare Conference. My name is (Joseph Gonzal) [ph] and I'll be your host for this session. Our speaker is Ron Squarer, CEO of Array BioPharma. And as a friendly reminder, there's a breakout session immediately after this in Liberty 1 and 2.
Thank you very much and good morning. I'm going to be making forward looking statements today, I'd encourage everyone to take a look at our 10-K and relevant SEC filings for discussion of risk related to forecast that I'll be making today. It is certainly a very exciting time for Array right now, a lot of focus on our MEK inhibitors too invented by Array, one with AstraZeneca, one with Novartis; partly because of ASCO coming up in just a couple of weeks where we look forward to seeing some new data related to both of these agents, although the headline really is the six on-going pivotal trials between the two of them, three each. But also looking forward to life-cycle opportunities that might emerge from the data and the on-going work have been conducted AZ and Novartis. The other reason, the MEK inhibitors are of interest these days because some of the news around Pfizer and AstraZeneca and Novartis and GSK. And I will be touching on those two topics today.
We do have in addition to the MEK inhibitors, a wholly-owned multiple myeloma program, which we hope to progress into Phase III this year, and we have actually just initiated another trial from our program -- our planned program just a few weeks ago, I'll talk a little bit about the filanesib program as well. In addition, I have just mentioned that we do have a product in a study, enrolling patients now for a rare cardiovascular disease. This is ARRY-797 for LMNA-related dilated cardiomyopathy. We do have an MDS program for which data is maturing and we're engaging regulatory bodies to determine or forward plan. We also have a highly selective oral HER2 which is in clinical trials right now. I look forward to being able to present data on that program over time. And we did start another clinical staging program, should be our 15th at this point with a pan-track that has just entered the clinic, say in cancer.
Now this is a product that is in a company we recently formed together with a series of investors called Loxo Oncology. So a lot of very exciting progress and potential catalysts coming up soon for Array. So let’s start with binimetinib and Novartis. So, as many of you know, Novartis and GSK have entered into a definitive agreement for Novartis to acquire the GSK programs, and that does include both MEK and NRAS inhibitor. Our first priority, of course was to understand that Novartis is acting business as usual. We received that commitment that everything is remaining the same in the current level of investment and progress are continuous and we’re very pleased with that.
But in the event, that binimetinib is returned to Array which we think is a very exciting prospect, we, through our existing contract will receive on-going support from Novartis. Parts of the contract are redacted but there are certainly provisions in there for on-going support. And this is separate of course from any obligations that regulatory bodies like the FTC may have for Novartis in this if these were to occur. There are three pivotal trials running, but there is over 20 additional trials running which are signal searching, that we're very interested in seeing the data from. In fact, (some of the) [ph] important point is that Novartis reaffirmed when they made this announcement that they do expect the NRAS-mutant melanoma pivotal trial to be filed in 2015. So there is a prospect of product being returned (to us just) [ph] within close proximity of first filing.
Now, as I mentioned portions of our contract are redacted but I'll point out that there are provisions for that are in effect currently that are related to anti-competitive or exclusivity around MEK. There are also, as I mentioned, trailing obligation in the case that the product is returned and in this particular situation where Novartis is acquiring a series of assets. They do not have the right to assign binimetinib onwards to a third-party. This is in a situation where there has been a merger or Novartis has been acquired, so for those reasons we think that there may be a scenario in which binimetinib is returned to us within proximity of a first filing, very exciting.
On the selumetinib front, a product being developed, as I mentioned three pivotal trials by AstraZeneca. There’s been a lot of news about Pfizer having interest in AstraZeneca, it's possible that that has run its course, but there's still plenty of speculation that it might occur. In this case, for clarity, AstraZeneca would have the right to assign all rights and responsibilities to the acquirer, in this case Pfizer, and that would of course include their responsibility for double-digit royalties assuming commercial success and milestones as well as the diligence provisions that are common in these types of agreements. And we're waiting to see how that works out, but whether it’s in the hands of Pfizer or in AstraZeneca. We think it would be good hands for the program which is making great progress.
And I will point out, that at the last call AZ did, for the first time indicate they expect to file in 2015, first with UVL melanoma, a study which is now enrolling patients and they expect according to the statements to move fairly quickly. So we’re looking potentially to MEK inhibitors being filed next year potentially very catalytic for Array.
So I mentioned ASCO just around the corner and what I would point to is potentially is the potentially areas of interest with binimetinib starting really is in NRAS mutant melanoma. I mentioned it because it is our first likely filing in 2015 and here in combination with the very innovative CDK4/6 called LEE011 at Novartis they’ve indicated they’re seeing encouraging clinical activity in this population. So, we’ll have more data to look at ASCO but to the extent that addingCDK4/6 would enhance the activity of binimetinib in NRAS that could be very meaningful to patients and then and the patient would be able to benefit potentially from binimetinib for a longer period of time.
The other interesting data is with BYL719, this is an alpha selective PI3K and this study for which data is being presented did include a number of types of patients but specifically also included some ovarian cancer patients. And ovarian is in fact the one of the three pivotal trials that are currently on-going for binimetinib, in this case small dataset, but of four patients that were treated with combination of BYL719 and binimetinib, of those four patients, three did show a response, so small sets but could be exciting moving forward and represent lifecycle opportunity.
Selumetinib there are an enormous number of trials on-going right now, 52 in total, over 30 in Phase II and so data does emerge on an on-going basis beyond the data that supported initiation of the three Phase IIIs that AZ is running. Pleased to see some new data coming out of that neurofibromatosis and F1, there was some data presented at a small specialty congress last year and this appears to be a broader dataset for this very challenging disfiguring and disabling disease.
So just to give an overview of the MEK program at the highest level, binimetinib as I mentioned has three pivotal trials, NRAS, mutant melanoma being the first 2015 filing. But perhaps an even larger opportunity is in BRAF melanoma which represents 40% of melanoma versus 20% roughly for NRAS and that study is currently enrolling. There is another study in ovarian cancer which I mentioned interesting because it’s lifecycle potential with the PI3K. And this is a study that happens to be run currently by Array although it’s part of our co-development agreement, we are running it in the U.S., Europe, Canada and Australia.
And then there are a number of other studies underway as I mentioned, a very robust signal searching lifecycle considerations here. These are -- what we’re displaying here are only investigator sponsored trials, I’ll point out that one area of interest for us in MEK is in colorectal cancer, heavily driven by KRAS no MEK has yet really cracked that disease as a single agent. We’re pleased to see a company sponsored trial at Novartis in combination with panitumumab, there is also an investigator sponsored trials not listed here with [indiscernible] in colorectal, so I’d say the two largest opportunities that MEK hasn’t yet well sort of addressed or penetrated is colorectal and then pancreas also heavily driven by KRAS mutations and could be part of the future of these important agents.
Turning to selumetinib, AstraZeneca and whether it’s in the hands of AstraZeneca or Pfizer we’d be pleased in either case, as I mentioned looking forward to double digit royalties assuming success and pleased to see the 2015 filing estimate for UBL melanoma, an absolutely devastating disease where there is great result shown just at the last ASCO, a greater than doubling highly statistically significant improvement in PFS.
The largest commercial opportunity actually of any MEK inhibitor including the AstraZeneca and Novartis MEK is KRAS mutant non-small cell lung cancer representing as much as 25% of non-small cell lung cancer. Astra currently running a large over 600 patient docetaxel combination study and look forward to seeing that data as early as July of 2016. It is very, very large population and one with great unmet need.
There is also a thyroid cancer study where selumetinib is being given in addition to radioactive iodine similar timing as to lung cancer. But what’s very impressive is that 52 trials on-going 32 are Phase II or III. And we’re very pleased to see how well in fact selumetinib combines with cytotoxics and this is very important because there has been a number and this is just a selection of the on-going trails, there's been a number of combination trials being run in non-small cell lung cancer by AZ not with docetaxel but with other commonly used first line lung cytotoxics, GEM, SIS carbo, PEK and pemetrexed and we’re pleased to hear couple of weeks ago on their call that they did in fact expect to make a decision this year on a first line non-small cell lung cancer program also KRAS-mutant driven, and that could have a tremendous value both to those patients and could represent a doubling or greater than doubling of value for that indication alone. I look forward to seeing additional data emerge for selumetinib over time even beyond ASCO.
So I mentioned we do have our wholly-owned multiple myeloma program which we are looking forward to, and have plans to enter Phase III this year. It is a unique mechanism, different from IMiDs or proteasome inhibitors and so we've seen one of each new of those class in the last couple of years with Kyprolis a new proteasome inhibitor and Pomalyst, a new IMiD. But this is a mechanism that is distinct, and we believe has utility after IMiDs and proteasome inhibitors have failed. And ideally when used in combination with them and we’re initially focused on our ability to enhance the activity of proteasome inhibitors, I’ll describe why in a moment.
We do have a patient selection marker which we believe could be important in the eventual use of the drug AAG, and tends to select for the majority of patients, roughly 70% to 75% of patients most likely to benefit, may be able to exclude patients who are less likely to benefit, good for patients and physicians and payers. But, pleased to see important single-agent activity after failure of PIs and IMiDs and that’s what encouraged us to move forward into combination studies. And the results of both are, Kyprolis and Velcade PI combination studies were presented at ASH just a few months ago, slightly different populations with Filanesib - Kyprolis group being 100% Velcade refractory and tolerant, 80% RAVE refractory and tolerant and a full 30% actually haven’t seen either Filanesib or Kyprolis, so pretty tough population, pleased to see a response rate in this study of 37% higher than you’d expect to see in a similar population with Kyprolis alone.
In the Velcade side, 100% pretreated with Velcade and RAVE and a full 42% formally Velcade refractory, 68% RAVE refractory and so overall a 42% response rate encouraging higher than you’d expect with these agents alone but we’re particular and it should in the formally Velcade refractory patients where we saw 30% response rate. If you look at data available with Kyprolis as a single-agent in Velcade refractory patients, it’s about 16% so that could represent a doubling, and presumably Velcade after you have dealt Velcade, it could at least in theory do even more poorer than that; so excited about that. As I mentioned, looking forward to a Phase III study later this year, combination with Kyprolis. And we’re running currently at Phase II which is sort of mini version of the Phase III with the primary objective at this time to confirm and understand combinability prior to initiating the full Phase III efficacy data will come over time. We will be able to share that first response rates and then PFS, but the initial goal is simply to understand a profile combining with Kyprolis prior to starting with Phase III.
A few weeks ago we did start our AfFIRM trial which is a single agent trial, looking at a very high unmet need population. These were patients that have failed either Pomalyst or Kyprolis and in some cases especially in the U.S. we would expect them to have failed both and looking here to use the selection marker Phase although we will be enrolling all patients so we'll both high and low AAG patients and looking to show a robust activity. They could eventually support regulatory filings end use. This design is not too dissimilar from the way Pomalyst and Kyprolis received provisional approval in these single-agent trials. So looking forward to that data emerging over time.
I mentioned that we’re focused initially on PIs and initially on Kyprolis. So if you look at the landscape here of novel agents being combined with standards of care, and what you’ll see is we are the only novel agent being combined currently with Kyprolis in a pivotal trial. There’s a number that are being combined with Velcade. And our data with Velcade is impressive and could represent life-cycle opportunity for us. We currently we believe Kyprolis is somewhat less crowded. There is also a very unique opportunity in the Europe to recruit patients very quickly as the only way they can access Kyprolis in Europe is through a clinical trial. And so we’re initiating in taking advantage of that window of opportunity. But there is potential, as I mentioned with Velcade. We're also doing enabling work to explore the potential with IMiDs, we did present data at ASH which some very impressive, it added to being synergistic evidence in combination with IMiDs. So there’s a number of life-cycle opportunities, where we believe Kyprolis is the quickest path to market.
I do want to touch quickly on some other important, relatively near-term catalyst. The first is the 797 program in a rare cardiovascular disease known as LMNA-related dilated cardiomyopathy. And dilated cardiomyopathy is a quite large disease, a quarter of million patients in the U.S. alone. But we are estimating based on work we've done that the lamin A/C or LMNA-related DCM is about 6,000 to 8,000 patients. Currently we’ve only got about 1,000 people, who know they have the mutation. There is really no reason to know you have it, as there is no change in treatment paradigms. It’s a very tough disease. By age 45, 70% of patients, roughly, would expect to have either a major cardiac event, a transplant or to have died from the disease. So very serious and these patients typically don’t respond to traditional therapies.
We do believe that the disease is mediated by the activation of P38 in patients with this mutation which ultimately affects both cardiac or lead to cardiac remodelling and loss of function and by blocking P38, we’re actually blocking an apoptosis cascade and what we’ve seen certainly in animal models is a fairly rapid change, physical change and a reversion back to something close to normal at least for the animal model.
We did have the benefit of a single patient IND patient with this disease who had the opportunity to use the drug and while we’re not in a position to share that data for confidentiality reasons at this point, suffice to say that the response that we saw was encouraging enough to have us go to the FDA and then to enter into a study which we’re running right now which we think we'll be able to definitely -- will represent a definitive proof of concept for the program.
So 12 patient study at two different doses. Patients on the lower dose would have an opportunity to cross over to the high dose if they don’t respond with the classic primary endpoint of a change in a six minute walk, but a number of secondary endpoints as well, we’ve got great sights including Harvard, John Hopkins, and Maribor and University of Colorado and this study is enrolling patients at this time and we look forward to sharing results ideally by the end of this year for 797, could be a very important program.
And so just to review the catalyst that I’ve discussed here today, perhaps the biggest inflection or potential inflection point for our company could be the potential return of binimetinib to Array just within a reasonable timeframe before filing. And we don’t have clarity on that yet but hope to as we progress forward. But the important point is, three pivotal trials running, NRAS melanoma with an expected filing in 2015 within BRAF melanoma but double the number of patients, longer duration and then of course the ovarian study which Array is conducting that is part of our co-development agreement.
Mentioned filanesib collecting data from our Phase II to inform a Phase III and having just initiated a single agent study which could be important long term to support single agent use in addition to the PI enhancing strategy that we’ve laid out.
Selumetinib, again Pfizer in, Pfizer out in way, it doesn’t matter terribly to us as we believe that the rights and responsibilities or obligations would convert to Pfizer. And the most important study here of all the MEKs as I mentioned was KRAS mutant lung cancer a very, very large population where AZ is well ahead in the second line running the 600 plus patient Phase III but really looking forward to a decision this year in first line which we think could be very exciting, we imagined that AZ wouldn’t announce their decision, the fact that they have a decision this year if they weren’t intending to move forward, but we’re going to have to wait and see how that emerges. And then of course UView for the first time AZ has said they are filing in 2015 on UView and then we have the thyroid program underway in addition to those 50 plus programs that continue to generate data.
The rare cardiovascular disease I discussed LMNA related DCM, expect to have results this year, could be a very exciting opportunity for Array and for patients with this devastating disease. MDX just letting our data mature, wrapping up discussions with regulatory authorities to determine how to move forward. The most prominent effect we’ve seen now in two different studies is in specifically patients who are dependent on transfusions for platelet disease which can be a poor prognostic indicator for outcomes and in both studies we’ve run, we’ve seen an important reduction in transfusion dependence taking people who were dependent and making them independent.
I mentioned at the start that we do have a highly selective oral HER2 program. It is partnered with Oncothyreon and it’s currently progressing in three different clinical trials. Through that agreement we do control commercialization, book sales around the world, but do have an important co-commercialization and profit share arrangement with Oncothyreon, we’ve been pleased with the speed in which they’ve entered the new trial and are looking forward to having results over time. These trials include combinations with trastuzumab, [indiscernible] and a separate trial in combination with TDM-1.
Finally, great news on starting a clinical program with our PAM track program with Loxo. Just exciting, if for no other reason that the company was formed just a few months ago. It’s supported by investors such as initially as Aisling and OrbiMed. Array does own a significant portion of the company and also will receive milestones and royalties, but it’s a very impressive company and advisory committee.
And they recently raised additional money and are doing very-very well. We look forward to seeing that program emerge, it’s a very exciting new science, that's they’re emerging science around track and we'd like to see if this can benefit patients. We do have an internal program which is a selective program that we are readying for the clinic and we'll make decision on how we would proceed with that over time.
And with that we’re out of time here in the general session, but look forward to taking questions just around the corner in about five minutes.
And with that I'll close this portion of the presentation. Thank you.
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