Amicus Therapeutics' CEO Presents at Fabry Monotherapy Strategic Update Conference (Transcript)

Jun.17.13 | About: Amicus Therapeutics, (FOLD)

Amicus Therapeutics, Inc. (NASDAQ:FOLD)

Fabry Monotherapy Strategic Update Conference Call

June 17, 2013 8:00 AM ET

Executives

Sara Pellegrino – Investor Relations

John F. Crowley – Chairman and Chief Executive Officer

William D. Baird – Chief Financial Officer

Analysts

Ritu Baral – Canaccord Adams

Edward Nash – Cowen and Company

Anupam Rama – JPMorgan

Kim Lee – Janney Capital

Joseph Schwartz – Leerink Swann

Operator

Good day ladies and gentleman and welcome to the Amicus Therapeutics Fabry Monotherapy Strategic Update. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions) As a reminder, today’s conference call is being recorded.

I would now like to turn the conference over to your host, Ms. Sara Pellegrino, please go ahead.

Sara Pellegrino

Good morning and thank you for joining Amicus Therapeutics conference call to discuss the regulatory strategy for migalastat hydrochloride for Fabry disease. On today’s call, John Crowley, our Chairman and Chief Executive Officer will provide a brief update following our recent Type C meeting with the U.S. Food and Drug Administration. Then we will open up the call for questions. Chip Baird, our Chief Financial Officer and Bradley Campbell, our Chief Business Officer are also here with us today and available to participate in the Q&A.

Today’s slide presentation is currently being webcasted live on our corporate website at www.amicusrx.com in the Investors section under Events and Presentations.

Turning to slide two, you will find a reference to our Safe Harbor statement. The presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, relating to business, operations and financial conditions of Amicus, including, but not limited to, preclinical and clinical development of Amicus candidate drug products, and the timing and reporting of results from clinical trials evaluating Amicus candidate drug products.

Words such as but not limited to, look forward, to, believe, expect, anticipate, estimate, intend, plan, would, should and could, and similar expressions or words identify forward-looking statements. Although Amicus believes the expectations reflected in such forward-looking statements are based upon reasonable assumptions, there can be no assurance that its expectations will be realized.

Actual results could differ materially from those projected in Amicus’ forward-looking statements, due to numerous known and unknown risks and uncertainties including the risk factors described in our annual report on Form 10-K for the year ended December 31, 2012. All forward-looking statements are qualified in their entirety by this cautionary statement and Amicus undertakes no obligation to revise or update this presentation to reflect events or circumstances after the date hereof.

It is now my pleasure to turn the call over to John Crowley, our Chairman and Chief Executive Officer.

John F. Crowley

Great, thank you Sara and good morning everybody. We’ve got number of items to go through here. So let me begin by referencing slide three and I’ll state at the outset here that we continue to remain completely committed to the further development of migalastat as a monotherapy for people living with Fabry disease who have amenable mutations, we also believe that the growing body of data from all clinical studies continue to support the potential for migalastat to be an important new treatment option for these Fabry patients with so much unmet medical needs still exist.

I’ll remind everybody that there are two ongoing Phase 3 studies evaluating the safety and efficacy of migalastat monotherapy. We have Study 011 and that is a study where 60 patients enrolled, again half originally enrolled in the placebo arm half enrolled in the migalastat arm. After six months, the 30 patients in the placebo arm then transitioned over to migalastat. At the end of the year of treatment total, patients were given the option to continue for another 12 months. So in-all it takes 24 months treatments and observation period including the extension study for Study 011.

Now, we have our second ongoing Phase 3, which is Study 012, again that’s a switch study from ERT, also 60 patients enrolled, 1.5 to 1 randomization, 36 patients completely stopping their enzyme replacement therapy and switching to migalastat, 24 patients remaining on enzyme replacement therapy that Study 012 is an 18-month study with a clinical endpoint of kidney function as measured by iohexol GFR.

Moving to Slide 4, I’ll get into the Type C feedback from the meeting recently held with the FDA. Of course, we began by presenting the FDA with six months data from Study 011, and again the six months study as we announced back in December of 2012, and this is the primary endpoint of Stage 1, and therefore as we have known, the data was not sufficient for conditional approval in itself.

In briefing documents, which we submitted to the FDA early in the second quarter, just a few months ago, we proposed revisions to add to, not take away from the statistical analysis plan for Stage 2 of this study or the 12 months data. Previous revision to the SAP of statistical analysis plan had been accepted by the FDA in the fall of 2012.

Let’s remind you, these prior revisions included statistical comparison of the six-month placebo group compared to the same group at six months once crossed over from placebo to migalastat as well as the migalastat treated group for 12-month period versus a six-month placebo group.

The briefing documents, which we submitted earlier this quarter, proposed additional statistical comparison for Stage 2 or the 12-month part of the analysis. These proposed analyses focus primarily on comparison involving the overall amounts of the substrate GL‐3, again that being the surrogate marker of disease in people with Fabry disease, the overall amounts of GL-3 in the interstitial capillaries of the kidney over the 12-month period of time, we have called this in many meetings with you and in some of our public pronouncements, the continuous variable analyses of the GL-3.

In the recently held Type C Guidance Meeting with the FDA, we discussed the updates to the SAP as well as the data from Stage 1 of this Study 011. Importantly, the agency acknowledged the trends toward improvement in kidney interstitial capillary GL‐3 in Stage 1, the six-month part of the study, although again these were not statistically significant.

The agency further recognized the merits of our proposed addition to the SAP for Study 011 Stage 2 to 12-month endpoint, and the FDA strongly encouraged us to conduct these additional comparisons. The agency further indicated that from a statistical perspective, these additional analyses would be considered pre‐specified. However, the agency indicated that these additional analyses would not be considered pre‐specified from a regulatory perspective given that the Study 011 six-month data had already been unblinded and reported.

So, in other words, while instructive and supportive of this concept of the entirety of the data, reaching statistical significance in any of these additional 12-month analyses, which we will perform and will submit to FDA would not in itself be deemed to be independently supportive of an NDA submission for approval.

Let me emphasize that neither we nor GSK has seen any of the Stage 2 12-month data, we remain completely blinded to this data. In fact given these ongoing regulatory discussions, we have not yet even locked the database for this Stage 2 analysis.

The FDA also agreed, and this is very important, the FDA also agreed that the assessment of the risk benefit relationship for Migalastat Monotherapy would be based on the entirety of the histological end clinical data from all studies for Migalastat Monotherapy, Phase 2 and Phase 3 studies.

The agency also agreed as do Amicus and GSK to a follow-up meeting after we have six and 12 months data from Study 011 as well as the top line data from our second Phase 3 study of our Study 012, the ERT switch study. In due of this advice from the FDA and in consultation with our partners at GSK, we plan to do the following to build the most robust NDA submission that will include long-term data from over 100 Fabry patients on migalastat.

First, we will continue all ongoing and extension studies as currently designed and executed. We have no plans and do not intend to run another Phase 3 monotherapy study. We will conduct these additional 12-month histological analyses as proposed in the revised statistical analysis plan for Stage 2 of Study 012 including the analyses of the overall levels of GL-3 in patient [cell] (ph) as a continuous variable.

These to line 12-month analyses will be reported in the fourth quarter of this year, and that is a slight delay, from our previous guidance in the third quarter and that’s due to having pushback the database lock to engage in these Type C discussions with the FDA and to digest this very recent feedback for the agency.

However, at this time, we do not plan to submit our NDA based solely on the data from Study 011 that we view and report upon in Q4 and again this is regardless of the potential strength of this 12-month data. We believe that the better regulatory strategy is to obtain all of the Phase 3 data sets and to combine and integrate these data into one NDA submission. Again, these complete Phase 3 data include all data for Study 011, and again the last patient out from the 12-month treatment extension or 24 months of this study is in December 2013 this year. We also expect to include all data from Study 012, and again the last patient out of this 18-month clinical study is in the second quarter of next year 2014.

And we also expect to include the integrated data from the long-term open label extension study in patients who rolled over from Phase 2 and Phase 3 studies that we believe will be highly supportive of an NDA filing in the United States. We believe that this U.S. regulatory strategy will provide the highest likelihood of a successful NDA with the U.S. FDA, all of these Phase 3 data sets from Study 012, and our extension studies will be completed, received, and announced in the second half of 2014 at which time we expect to engage in three NDA meetings with the U.S. FDA with this entirety of the data.

Again that’s data from the integrated Phase 2 studies and from both Phase 3 study. I will also note that through these discussions the FDA has been incredibly helpful and transparent; they clearly recognize the unmet medical needs that remains in Fabry disease and are committed to working with us to evaluate the complete data set to determine a path towards filing and approval. I’ll also note that FDA leadership including Dr. Woodcock and Dr. Jenkins have been evolved and Dr. Graybill and have been a tremendous help throughout this process and we expect to stay together with the reviewers in our division will remain so going forward.

Let me add to that we are in complete agreement with our partners at GSK on this revised strategy for regulatory approval in the United States for migalastat; this is a strategy that was developed jointly by Amicus and GSK. GSK has further assured us of their 100% commitment to the further development globally of Migalastat Monotherapy and Fabry disease in collaboration with Amicus and we fully expect this excellent partnership to continue.

I will close here on slide 7, by reiterating our plans and commitments toward advancing our other significant new products and program in Fabry disease and as the proprietary next generation ERT that combines a GSK/JCR developed new ERT with migalastat in the formulation.

This new ERT is on track and to patients with Fabry in early 2014 and is further evidence of the strength of the collaboration between GSK and Amicus in the rare diseases and our shared vision to bring a range of new therapies to everyone living with Fabry disease and potentially beyond. We think Migalastat Monotherapy remains a potentially strong treatment option for all patients with amenable mutation and for those people who patients who do not have amenable mutation we think that this new proprietary next generation ERT could also offer a potential treatment advantage.

So in sum then we believe that migalastat works and it works very well as a monotherapy in patients for whom it’s intended. We’ve seen these positive effects for many years now and we believe that our job is to build the best data set to support an approval. We look forward to the top line Stage 2 or 12 months data from Study 011 in the fourth quarter of this year based on our years of Phase 2 experience and the interim Stage 1 data from Study 011 we expect that the effect seen with the drug will be persistent and durable and we think based on all of our experience that this 12 months data together with the additional statistical analyses performed will be key elements of our submission package.

Together with the data from Study 012, which includes important clinical endpoints and again that is a study which continues to go exceedingly well with 34 of 36 patients will switch from ERT to migalastat remaining in this study and on migalastat as their only treatment for Fabry disease. Just to conclude we are trading a relatively small amount of time for what will be a much more robust data set and higher degree of certainty for approval.

And with those comments, I am happy to open it up to questions operator.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from Ritu Baral of Canaccord. Please go ahead.

Ritu Baral – Canaccord Adams

Thanks for taking the question guys. I guess if we could turn to the 012 trial, how many patients did you say were remaining on treatment; and as part of this Type C meeting, did you get any input from FDA on the adequacy of that trial design for registration?

John F. Crowley

Sure Ritu, so remember, it was 60 patients and 36 stopped ERT completely and went to migalastat. And of those patients, many for more than a year now off treatment all for at least six months, having switched; 34 of those 36 remain. In fact, I’ll note that it was actually only one person who came off of migalastat to go back to ERT, the other patient who withdrew it actually never began migalastat treatment.

And on the ERT arm, we had 24 people transfer, I’m sorry stay on the ERT, and 20 of those 24 remain in the study on ERT. So, we’re particularly encouraged by the compliance. We think it speaks certainly to the safety profile of the drug to those patients getting switched. We know from the Enzyme Replacement Therapy shortages that when Fabry patients come off of ERT, many times often they will complain of increased fatigue, GI symptoms, and obviously were blinded to this data as well. But we think in terms of at least building a significant data set, we think these patients who continue to remain on migalastat bode pretty well for the study.

The concept that we discussed with the FDA, was again this notion were two of the totality of the data, that’s what they’d indicated to us they would consider for approval in the Type C meeting held last summer. We wanted more clarity on that, and the FDA was clear that the totality of the data, they would look at the six-month endpoint from Study 011, the twelve-month end point, they would look at the complete 24-month data set from Study 011, the Phase 2 study and those many years of extension studies, and then also to our second Phase 3 study. We don’t think that the 012 study in itself would support approval in the United States, but we do think it will be an important part of this notion of the totality of the data.

Ritu Baral – Canaccord Adams

Is there any notion as to what might be more important, you know, the GFR from 013, it was a biopsy out of the 012?

John F. Crowley

No, I think we’ll have to get the data and discuss that. But I mean I think in general, it’s safe to say that the FDA feels more confident when they have clinical data. And again, it’s not just clinical data from Study 012. We will have kidney function data on all of the 011 patients at 24 months in last patient out at 24 months at end of this year. So, that data will be collective. It will be part of what we discussed with FDA in the second half of 2014.

Ritu Baral – Canaccord Adams

Got it, and actually that leads into my last question to sort of what conclusion could come out of this Q4 meeting? Would it be things like threshold of clinical importance towards GFR changes? And what if --?

John F. Crowley

I'm sorry, Ritu, I lost you, what...

Ritu Baral – Canaccord Adams

Oh, sorry, the conclusions that can come out of this Q4 meeting, would it be things like the minimally important difference in GFR and what else might come out?

John F. Crowley

Yeah, maybe I missed – maybe I misspoke. I don’t think there is going to be a Q4 meeting this year. We’ll have the top line 011 data, and we’ll report that to everybody in the fourth quarter of this year. But, we think the better strategy again is to take all of that data, then the 24-month data from the 011 study, and the complete clinical data from the Study 012, that will be quite a significant data set, put all of that together into an NDA submission, and in the second half of 2014 that’s what we take to the FDA.

Ritu Baral – Canaccord Adams

I think that will be next meeting? Great, thanks for taking the questions.

John F. Crowley

Sure, thanks Ritu.

Operator

Our next question comes from Edward Nash of Cowen and Company. Please go ahead.

Edward Nash – Cowen and Company

Hi, thanks for taking my call. Just wanted to find out, I noted that you were saying that you in this decision to wait for the 012 data and file after you have that in hands, was kind of a decision between you and GSK. But was the FDA in anyway hinted that is really what they wanted to see as well from your side and kind of urged you guys to maybe follow that path that was just purely on your own?

John F. Crowley

No this is on our own Edward. So this was also a very practical consideration that we thought about and underlining this was do we want a regulatory strategy where it’s a rate to the NDA filing or a rate to approval, and we chose the latter with GSK. We both felt very strongly.

So for instance if you look at the way the timing of the data was lining up, we would have the 011 data in the second half of this year potentially filing an NDA end of this year or early next year. We put it on an eight-month review cycle, which could take it into about the third quarter of 2014.

However, when you look at the timing of all of that very significant data for Study 012 as well as the 24-month data from 011, there you are looking at about the same time period in 2014, and we felt with GSK, that there would be a very high likelihood that that approval, the FDA would not approve, no matter how strong the 011, 12-month data including those biopsies were, but they would want to see a more complete clinical data set that would just be coming.

So we think the better strategy would be rather than just filing this piece meal to put it altogether as one filing, and again it also gives us the option to think about do we file for conditional approval based on that surrogate endpoint from Study 011 or could there be significant enough clinical data, especially on kidney function from both the 24-month period of Study 011 as well as that 18-month clinical end point that we could consider actually going in with an NDA seeking full approval rather than conditional.

So all of that underlined the division, but this was if certainly informed by the FDA feedback, and especially given their notion of the entirety of the data here. But this was a decision driven by Amicus and GSK. And again it was to try to figure out, what gives us the highest degree, the highest likelihood of success on this filing. So we’re willing to trade a couple of quarters of time in the NDA for what we strongly believe to be a higher likelihood of success in the filing with a much more robust data set.

Edward Nash – Cowen and Company

Okay, that’s helpful. And then my last question is just with regard to the one month, I mean sort of the one quarter delay now with regard to giving the 011 data and that you said that was head to do also the Type C meeting that was coming a bit.

I was curious because that mean that’s really kind of this co-processes kind of going on in the background, the matter what you are doing with the agency correct. I mean the pathologists are still marking the actual inclusion then there being sinuous for reading by the three different independent readers. So just kind of curious that is just that’s a slower process as well, it’s a taking a bit longer than expected or…?

John F. Crowley

Yeah, that’s about it is a long and tedious process. We knew that would many months to complete or they have just about completed it from my understanding. However we’ve not yet locked the database and locking the database of course would include all of these additional statistical analyses, again that the FDA encouraged us to do.

We waited to do that now several months, so that we can complete the FDA Type C meeting and also to digest the feedback over short period of time. We expect to lock that database very soon. So it may well be that data comes earlier in Q4, but we thought the better guidance would be to just say Q4 for now, but so far everything technically with the analyses as planned and on schedule.

Edward Nash – Cowen and Company

Perfect. Thanks, so much I appreciate it.

John F. Crowley

You bet, thank you.

Operator

Our next question comes from Anupam Rama of JPMorgan. Please go ahead.

Anupam Rama – JPMorgan

Hi, guys thanks for taking the question. Actually, a quick question for Chip, in light of the new regulatory strategy, how you are feeling about your cash runaway and how long will that go up to, I guess? Thanks.

William D. Baird

Yeah, sure. Hi, Anupam, I think we’re continuing to look at all of our options which include a number back of an ongoing business development conversations as well as more traditional lots of financing. The update today doesn’t really change our projected 2013 net cash spend, which remains in that $52 million to $58 million range. So I think that’s what we have to say on runway and financing plans at this time.

Anupam Rama – JPMorgan

Great. Thanks for taking my question.

Operator

Our next question comes from Kim Lee of Janney Capital. Please go ahead.

Kim Lee – Janney Capital

Good morning. Just the quick question on histological analysis that you will need to do, will additional histological analyses needs to be done with in Study 012 and if so can you specify exactly what those analyses would include? Thanks.

John F. Crowley

Sure, well again Kim in Study 012, there are no biopsies. So there is not any histological analysis to be performed. In Study 011, we’re going to conduct everything that was in the original statistical analysis plan to revise SAP for last fall that the FDA signed off and as well as everything that we proposed to do in this briefing document that we submitted a few months ago.

So and a lot of that focused on the notion of looking at the overall version of GL-3 on the cell and looking at this as the continuous variable over time, which we think is a very telling indicator from a surrogate endpoint of what’s actually happening at the biochemical level in the kidney.

So we’ll do all of that. It will be a very robust data set and again the FDA did considered, it does consider these because we’ve not seen any of the 12 months data to be pre-specified from a statistical perspective, but not from a regulatory perspective.

Kim Lee – Janney Capital

Okay. Great and kind of what should we expect from Study 012, what would you consider successful outcome there?

John F. Crowley

Sure. So again the goal was to show that we can take patients half of the ERT with amenable mutation and immediately switch them to migalastat as their only treatment for Fabry disease, but we can of course first do it safely. And secondly the way the study is designed is to look at over time compared to the ERT alone arm do those patients continue to maintain the same level of kidney functions.

So we want to show non-inferiority to the ERT arm. So that I think would be very successful to show from an efficacy standpoint that this new orally available small molecule is non-inferior to the ERT product. But as we know from our Phase 2 studies, given the mechanism of action here that many patients actually show stabilization or even improvement of kidney function. So we’ll look at that as well and certainly report on that data.

Kim Lee – Janney Capital

Great, thanks.

John F. Crowley

Sure.

Operator

Our next question comes from Joseph Schwartz of Leerink. Please go ahead.

Joseph Schwartz – Leerink Swann

Thanks a lot. I was wondering I know that you’ve said that the FDA will consider the totality of the data, but I was wondering are you able to garner any sense of how they viewed affect sizes and what would the sufficient for approval in terms of that? How much we’re able to tickling from your conversations at this meeting?

John F. Crowley

Yeah there was no concern whatsoever Joe, about the effect sizes and the number of patients studied. Again to remind everybody, Fabrazyme was approved on a surrogate endpoint to that same GL-3 clearance. It was a Phase 3 study of 58 patients, 29 on drug, 29 on placebo.

So we have a substantially more patients in all of our studies. We have 60 in Study 011, 60 In Study 012. Together with I think its 17 patients to continue on the extension, some for more than seven years now from our Phase 2 study. So we’ll have well more than 100 patients of data and certainly many hundreds of patient years of data when we submit, when we hope to be able to submit in 2014.

Joseph Schwartz – Leerink Swann

So did the FDA seem to be favorably impressed by the GL-3 reductions that you showed them and even though overall they were not statistically significant, there were subsets that did better than others? Can you talk about your sense of how they view the data today?

John F. Crowley

Yeah, I think they see at the same way that we do and referenced that second bullet point on I believe its slide 3 or 4, where we stated that the FDA acknowledged trends toward improvements in the kidney IC GL-3. I will say Joe that it wasn’t just in the subgroups.

I think you’re referring to the people who had 0.3 and above inclusion bodies at baseline where it was measurable and above the noise of the assay. The FDA acknowledged the significance of the changes there. But then also in terms of this whole concept of the overall level of GL-3 and itself that certainly resonated with FDA.

So the conversation certainly focused a lot on the histological analyses that revised SAP. But the conversation with FDA also included our years of experience and the FDA seem to be particularly interested in patient compliance in this study.

For instance that of the 59 people who completed to their primary one-year treatment, in Study 011 and that included half of the patients who are on migalastat for a year, half who are on for at least six months, 57 of those elected to continue with another year of treatment. The FDA seem to be very impressed with that and certainly I think let them to want to see what the 24 months data in those 57 patients look like.

So I think given our experience, I think we’ll have again a pretty rich data set to present to the FDA, which at the end of the day, we think will increase our likelihood of success.

Joseph Schwartz – Leerink Swann

Okay that’s helpful. And can I just ask the conversations with the FDA, does it seem like their likely path of approval is in the patients as you’ve defined them for enrollment previously in terms of having an amenable genotype or do you think that it’s probably at the FDA, might look at subsets of those patients who appear to benefit the most?

John F. Crowley

No, we didn’t get any identification that the FDA is going to par steps further by magnitude of benefit if you will that they would look all of these patients. We presented for instance in a revised briefing documents data on all patients, we’ve been out of our way to acknowledge that point three cut-off was instructive for understanding the unexpected placebo response of six months.

But that we actually think for all patients with amenable mutation that the drug is having a strong benefit and that’s what we focused on as well and that would certainly be our regulatory in labeling strategy to continue down that road with FDA that this drug if the data continue to support it should be considered for approval for all patients with amenable mutation is not any particular subset of those.

Joseph Schwartz – Leerink Swann

Okay, great. Thank you.

John F. Crowley

And that’s also to Joe I think that more robust data set including the clinical endpoints could be very precise that as well.

Operator

I am showing no further questions at this time. And I would like to turn the conference back over to Mr. John Crowley for any closing remarks.

John F. Crowley

Great, thank you operator. So again we’ve also been incredibly transparent with all of our constituencies including Wall Street investors and we and GSK want to always continue to do so in this program. We again remain completely committed to the further development of migalastat as a monotherapy for people with Fabry disease with these amenable mutation.

And again we continue to believe that the growing body of data from all clinical studies does continue to support the potential for migalastat to be an important new treatment option for these Fabry patients with so much unmet medical need still exists. So thank you, have a great day.

Operator

Ladies and gentlemen, this does conclude today’s conference. You may all disconnect and have a wonderful day.

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