Ron Squarer – CEO
Andrew Peterson – UBS
Array BioPharma, Inc. (ARRY) 2013 UBS Global Life Sciences Conference Call May 21, 2013 8:30 AM ET
Andrew Peterson – UBS
Hello and good morning. Welcome everyone to the second day of the 2013 UBS Global Life Sciences Conference. My name is Andrew Peterson, I’m a member of the biotech research team here at UBS. It’s my pleasure this morning to introduce Ron Squarer, CEO of Array BioPharmaceuticals. After his presentation there is going to be a breakout session in the Liberty 3 Room. Thank you.
Great. Good morning everyone and thanks for joining here today. As I’ve been saying for the recent past that’s certainly going to be a very pivotal year for Array this year and I’m going to talk about some of the reasons why. Before I start I’m going to be making forward-looking statements that involve risks and I ask everyone to consult with our 10-K for full discussion of risk associated with the company. With that as we stand here today we have visibility to five potential pivotal trials starts across our wholly-owned MEK portfolio that’s both with MEK162 our Novartis partnered MEK inhibitor where we expect to see pivotal trials in NRAS melanoma, BRAF melanoma and just last week we announced Array’s first ever Phase 3 trial in low-grade serous ovarian cancer. With our AstraZeneca partnered MEK selumetinib we are still looking forward to the start of a KRAS non-small cell lung cancer pivotal trial as well as a thyroid trial and data continues to emerge on both of these very impressive assets.
Turning to our wholly-owned portfolio that would include both our multiple myeloma product ARRY-520 where we’re expecting combination data to really mature both with Kyprolis or carfilzomib and Velcade or bortezomib as well as the completion of our Dex combination study. And we do anticipate completing discussions in the near term with the FDA. With 614 as we mentioned in the past we are in an expansion phase of that trial looking forward to seeing the results to drive our forward clinical plan by the end of this year. I’ve had a long history of partnering great products with great companies for great economics that we have nine clinical stage partner-funded programs in total eight of them in Phase 2 with as much as $3.1 billion in potential milestone and up to double-digit royalties with a number of these collaborations. We’ve always looked to non-dilutive sources of capital through partnership as a way to fund the company having raised over $175 million in just the last three years and we continue to believe this would be part of our business strategy moving forward. In fact looking at a – the partnering opportunities that we see now we are looking both – at both of our wholly-owned programs both 520 and 614 initially for really geographic partnership opportunities to the extent that they can help to maximize the value of these programs and to Array.
We have a very exciting read-out this summer with an asthma program CRTh2 where we’ve carefully selected the population to maximize the probability of success, it is a randomized-blinded trial so we’ll have the results over this summer and could represent a very substantial partnering opportunity. We continue to be in discussions on 797 and we’ve targeted the end of the year for a decision on how to move forward with that program. There is other early stage programs including a Trk inhibitor that we are in discussions with companies on in addition to other clinical stage programs that we are looking to move forward with.
Part of our business plan has always been also to share our world class discovery capability with other companies, some of you may recall the Clovis deal which we announced recently where we’re essentially providing discovery services to them and we have other agreements like this and seek to enter into these collaborations on an ongoing basis. So at the highest level in terms of catalyst for the rest of this year with both our wholly-owned Hem/Onc programs looking for decisions by the end of the year. We will be at EHA and may have some additional data to share on 520 probably focus more on the combinability than efficacy at this point with carfilzomib. And we continue as I mentioned with the expansion on 614 looking forward to Phase 3 starts on both MEK inhibitors over this summer and then in the fourth quarter of course multiple Phase 3 starts and then looking forward to additional data merging over time. And then I spoke of the two large partnering opportunities as well.
So jumping into MEK with ASCO really just around the corner. I’ll remind folks that MEK has proven to be one of the really most active mechanisms out in cancer for very long time. It acts on the RAS/RAF/MEK/ERK pathway and has already shown outstanding breakthrough results in KRAS mutant lung cancer in various types of melanoma specifically parts of melanoma that had not responded to therapy earlier, ovarian, thyroid, biliary and other high unmet need populations very broadly active agent, we’re very unfortunate to have two great molecules in the mix here. I’ll start with Novartis, Novartis is one of our partners, economics with Novartis are very healthy meaning then in the U.S. especially we expect a high double-digit royalties, we also have co-commercialization or co-detailing rights and very importantly a co-development agreement where our contribution to the alliance has really kept both annually and in total at a pretty reasonable level so essentially as we would have expected to meet our MACS in any case the cost associated with the Phase 3 in a low grade serous ovarian we don’t expect there to be any incremental cost over what we’re already anticipating to contribute. And so the three Phase 3 trials we look forward to starting this year include the ovarian trial, the NRAS and the BRAF combination with LGX818 this is Novartis’s RAF inhibitor and MEK162.
I’ll pass for a moment on the BRAF melanoma combination and the full data of the LGX818 MEK162 combination will really only be available at ASCO. But if you look at the abstract that was published couple of days ago you certainly see very healthy activity and that’s very important. But I think that the full explanation of the differentiation between the Novartis to Array BRAF melanoma combination and other options will become more apparent at the meeting specifically in the abstract you’ll note that LGX818 and MEK162 didn’t appear to have any or very little pyrexia or fever and rash or photosensitivity and these are side-effects that have plagued other combinations that are being developed in or available in the marketplace. So very excited to see that, look forward to that at ASCO. So as I mentioned Array is initiating Phase 3 and low grade serous ovarian cancer quite common cancer for women and ninth most common fifth leading cause of death amongst women, as serous cancer - serous ovarian certainly the largest subset and its broken down into low grade which is what we’re studying initially in high grade as well.
Patients with low grade serous tend to be diagnosed at a younger age and live longer but certainly after relapsing on chemotherapy there is a very low likelihood of future response to chemotherapy as low as 4% and at that point a median PFS of only about seven months and OS unfortunately not much longer, so very, very high unmet need population that we’re happy to test MEK162 in. Data here published actually in Lancet just a little bit earlier this year. Lancet Oncology regarding a MEK inhibitor in low grade serous ovarian cancer as you can see quite substantial improvement in median PFS versus historic data on chemotherapy and hormonal therapy, response rates also and clinical benefit also substantially improved. So we look forward to making this drug available in the future. The study design 300 patients randomized two to 1 to either MEK162 or physician’s choice of chemotherapy primary endpoint being PFS but a number of other endpoints would be collected.
Turning to NRAS melanoma and we expect this to be one of our first approvals and first sources of significant commercial revenue. Here is the data shown at ASCO last year where MEK162 is tested in both NRAS and BRAF patients and BRAF had responded historically to MEK’s – NRAS really hadn’t responded to anything and here you see not only strong disease control rates and certainly response rates for NRAS but you see them being comparable to BRAF. So very exciting first data of this kind and Novartis is certainly alone here and a way ahead of anyone else. What’s important about this is that this study called NEMO is expected to readout data in October 2014 and it was rapid filing and review it is released theoretically possible for us to see revenue at those high royalty rates in 2015 certainly in 2016 so we’re excited to see that study begin dosing in the very near future.
Turning to AstraZeneca selumetinib, Astra results are proven to be an outstanding partner. Our economics here assuming success would be in the double-digits, we – but Astra is actually responsible for development and commercialization although we have an excellent relationship with them great communication both way. The drug selumetinib has been very widely studied now, currently advancing in 48 trials, 31 of which are in Phase 2 across many tumor types. Well we’re looking forward to at this point is the KRAS non-small cell lung cancer Phase 3 and this is a – of course a very large population NRAS and – I’m sorry KRAS non-small cell lung cancer at 20% of non-small cell lung which is one of the larger cancer population as well as a pivotal trial beginning in thyroid cancer that is recently posted at clinicaltrials.gov.
And then there is some very exciting data that we expect with selumetinib to emerge at ASCO it’s currently embargoed it’s in uveal ocular melanoma. There is some historic data here from Lancet in 2011 was published with an old and very imperfect version of the selumetinib formulation but it directionally even here you see a greater than doubling of PFS in small trial, the trial that is going to be published at ASCO much larger almost a 160 patients also looking at Gnaq patients primary endpoint was PFS but embargoed until June 1st I will say that it is been selected to appear also at an ASCO Press Conference, it’s been selected as a – already as an to the best of ASCO one of the best of ASCO and we are aware that AstraZeneca will also be presenting information on this in selumetinib in general at a press conference following ASCO so could be very exciting and mainly to additional add pivotal trials.
The lung cancer data that was shown initially at ASCO 12 just as a reminder a statistical significance greater than doubling in PFS also statistical significance in ORR and alive & progression free at six months. Couple of months later it has no very impressive data on patient reported outcomes also very strong statistically significant results patients feeling good on drug. Also we have shown data in the past where selumetinib enhances or resensitized patients to radioactive iodine where high response rate here from the study at ASCO 12 this is 71% response rate and valuable patients mean percent reduction in tumor growth at 91% and this is what has inspired AstraZeneca to a Astra study which is a 228 patient study looking at essentially enhancing the effect of radioactive iodine in thyroid patients with an endpoint of a complete remission in other secondary endpoints to be studied.
So, Astra is been talking lot about selumetinib, recently at the Investor Day calling at greater than $1 billion peak sale product and championing its combinability so the KRAS lung study was run as a double it with docetaxel, selumetinib combining well at full doses whereas other MEK inhibitors have struggled to combine with other agents in this case selumetinib is what AstraZeneca is pointing to requiring substantial down dosing in most combination. So certainly this MEK inhibitor and we would argue a MEK162 is well highly combinable which is likely to be the way that MEK that used broadly in the treatment of cancer.
Just a reminder at ASCO the look for the uveal melanoma data there will also be some results on a DTIC combination trial with selumetinib in melanoma we don’t believe Astra is focused on this going forward but another example of the efficacy of MEKs in melanoma and then finally the full data on the LGX1 MEK162 data including the differentiation which would include differentiation on combinability and safety so excited about ASCO this year right around the corner.
Turning to our wholly-owned programs are KSP inhibitor for multiple myeloma acts preferentially of hematopoietic cells over epithelial cells based on MCL-1 survival dependence. And what this has led to is a consistent story now for our single agent combination with Dex combination with carfilzomib and combination with bortezomib that we are seeing first of all little I know non-hematoxicities in the neuropathy, no alopecia, minimum GI and any hematologic effects are tend to be transient non-cumulative and predominantly asymptomatic even if you have neutropenia patients are well managed with supportive care and tend not to progress to more serious condition. So very excited that the combinability and safety has now been consistent in a number of settings.
Regarding clinical data, we completed our Single Agent trial this was published at IMW just a couple I guess month and a half ago pointing to robust Single Agent efficacy in the ballpark of carfilzomib and pomalidomide with impressive survival results and load this continuation rates which we think is consistent with message of tolerability. When we combine with text and this is only the first cohort we’d expect about two- thirds more patients over time. We see a substantial – a improved outcome here as with Pom when they combine with Dex they saw an improvement we’re now up in this cohort 2 about a 22% response rate four months duration but it’s important to note that these patients were much more heavily pretreated than the population selected by Pom-Dex for their registration namely 10 prior therapies 100% refractory compared to a Pom-Dex at five priors and only about 70% to refractory.
But as you know we’ve identified a Patient Selection Marker called AAG or Alpha-1 Acid Glycoprotein which binds tightly to free 520 reducing the probability that patients will respond or benefit from the drug it doesn’t bind to any other multiple myeloma drugs so it’s quite a unique property to us. If we use AAG as a selection criteria selecting the bulk of patients 75% to 80% of patients who have load in normal AAG we would predict from that first cohort now response rates in the 30s with extended duration and even Single Agent you would predict based on the data for valuable patients that we had AAG data on up there at about 24 so we’re excited about potentially using AAG in our forward plan.
As I mentioned we’ve now shown data on carfilzomib and bortezomib both at ASH and more recently in IMW seeing clinical response in highly pretreated patients but most importantly at this point their continued result of transient non-cumulative predominantly asymptomatic hematologic effects and little to know little to know non-hematologic effect. So we are engaging FDA in discussions about forward path including the use of AAG and look forward to considering both accelerated path in multi-refractory patients as well as potential combination with PIs consistent with our plans as described in the past. So with ARRY-614 for MDS you recall we’ve updated our data from the prior formulation so these at ASH at in December this past December. Very impressive response rates using IWG 2006 which is composite measure looking at three lineages in fact patients who had multi-lineages often especially the highest dose showed multi-lineage response.
And what we – this is a patient example I think characterizes the opportunity for 614 here is a patient now been on drug for three years data here presented analyzed abstract two and a half years, patient came on trial with Grade 3 Anemia, Grade 4 Thrombocytopenia almost immediately became went from transfusion to independent on red blood cells platelets took a little bit longer to be transfusion independent and this patient has essentially practically have been cured although with this chronic therapy so to go with 614 is to find the right dose the dose which is both effective and well tolerated because we would like patients to be able to benefit from it long term so we did complete we hit MTD we’re in a substantial expansion at this point looking for data to inform how to move forward by the end of the year.
Met with the FDA to get guidance on endpoints and looking forward to marrying the data we’re collecting with that feedback to design of the best path forward. So by the end of the year ASH around that time we should be in a position to describe where we are. So coming up to the overview once again and we will be in a position to take questions in the next room in a moment. Both of our wholly-owned programs again on track for decisions by the end of the year with data emerging important data emerging during that time, multiple Phase 3 starts visibility net of five pivotal trials starts with the MEK inhibitors at both 162 and selumetinib. And then potential sources of additional non-dilutive financing through the asthma pain programs and other both clinical and preclinical opportunities which we are looking forward to help fund the company. And so with that looking forward to a very exciting 2013, we’re going to reconvene at the room down the hall which is Liberty 1 - Liberty 3 and I’d be joined there by Andy Robbins as well who is our Head of Commercial and Strategy and manages our programs through our program managers. Thank you very much.
[No Q&A Session for this event]
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