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door Obelisk » 27 Feb 2015 06:14
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Question-and-Answer Session
Jan De Kerpel - KBC Securities
Hi, good afternoon. Thanks for taking my questions. I have three questions. First of all, on the RSV project you said that, there was a clear winter effect of mild winter on the recruitment what were actually other reasons for the slow recruitment, could you also share with us how many sites were open in the Northern Hemisphere at the start of this season versus how many were not yet open at this moment in time?
And could you share with us, how many sites you anticipate to open in Australia and Asia? The second question is on caplacizumab. Which kind of elements are you looking for in Phase III trial design which are different from the acute setting at the Phase II TITAN trial, was if you could elaborate on that? Will you go for an SBA in your discussions with the FDA? And what timing of read out and submission for the BLA are you anticipating?
The third question relates to Merck Serono, what areas I mean disease areas were the projects in that will be in worked on? And in what stage were they? I believe, Edwin that you also said during your presentation that they were going to use their resources elsewhere, maybe I misunderstood it, but if not could you elaborate a little bit on what you really mean by, that are you referring to the Pfizer deal? Thank you.
Edwin Moses - Chief Executive Officer
Okay, thanks very much, Jan. It's a lot of questions and we'll try and answer them more, but will start with your first question what you asked, first a little about RSV, what were the other reasons apart from the mild winter. The recruitment was challenging, you asked about how many sites were opened in beginning of the study in Europe and then you also asked about our intentions in terms of number sites in Australia and Asia. Dominique, do you want to deal?
Dominique Tersago - Chief Medical Officer
Yes, the things with the seasonal effect. We had about five sites opened towards the end of the year and at the beginning of this year that had increased to 12 sites that were able to recruit, but with it being a mild winter and the peak being not easy to predict and again the challenges of having parents’ consent to their infants be included in the clinical trial as an investigational product. Meant that possibly for some of the sites that were opened later, that the peak season was actually list [ph].
With regard to the number of sites that we plan to open in Australia, we are looking at opening six sites there, but we're looking at opening a higher number than that in the Asian countries that we are currently investigating and what is worth pointing out because it is a seasonal disease, expanding sort of geographic spread to the southern hemisphere and Asia, we are now going to cover sort of full year potential for recruiting patient. So that we don't lose any months of recruitment because we're in the wrong geographic reason for that season.
Edwin Moses - Chief Executive Officer
If I can just add to that as well, I think one very important criteria is, we have very strict inclusion, exclusion criteria. It's a very vulnerable patient population and so it's very important that we only attempt to treat the right patients. So for instance, we don't treat very young patients. Patients who are one-month or two months old in this trial. We will intend to do that in the future trials because they're very important part of these potential groups of patients that could benefit from this product, but they're not the people that we should start with from a safety perspective.
So there are reasons like that and we've also seen in the season that there seem to be a least [ph] in the sites that we were dealing with, a shift to other sites being younger patient group which will cement [ph] them more excluded. This varies from region-to-region as well as that we see where, for example Asia it appears that, the groups, the Asia, the groups admitted to hospital might be a little older. So that completes the question, try to answer now and caplacizumab.
Let me start on the USA Phase III design and about SBA and about timing submission of BLA. On the Phase III design, we're not going to go into details on this call on that simply because we're still interacting with the regulatory authorities and we don't want to prejudice those discussions at all. We will come back to that in the future as soon as that Phase III design is being concerned. Dominique, do you want say about the SBA and about those questions?
Dominique Tersago - Chief Medical Officer
I think with regard to the SBA, what I can say is that the interaction that we had is regulators both in Europe and the US were actually very positive. They were very constructive, engaged discussions that we have with them and part of that engagement is also to allow us to progress on a more informal basis with the agencies to actually ensure that the expectations about the Phase III trial and our regulatory process as the procedures that we'll be following that those expectations are fully aligned.
So we actually at this point prefer to continue with sort of informal discussions, as we feel that gives us the most flexibility and the needed feedbacks that we have. With regard to the read out for BLA submission. Clearly it's the Phase III trial, we're aiming to have that done. The size of that trial will be similar to the number of patient that we had included in the TITAN trial, with the positive results that we have in the feedback from the clinical experts and the design of the study that we're looking at the moment.
We anticipate that trial will read out potentially during the review of period of the MAA for Europe. So that the BLA could follow shortly on that.
Edwin Moses - Chief Executive Officer
Okay and if I can just then the pick up your last question for Merck Serono. You asked about the areas we're involved in. I think a key part of that, research agreement we signed in 2013 with Merck Serono was that, the aim was to have a research group here at Ablynx that was able to interact with all the therapeutic activity, all the therapeutic division. So there were a number of broad areas that were involved in and what I was referring to, I think the more, every company, every pharmaceutical company has to from time-to-time review the priorities of its activities that's what every company does and I think we respect the fact that, we've seen for example activity of Merck Serono in the very large deal with Pfizer in immuno-oncology which we were clearly taking a considerable resource and we interpret that, might well lead to reprioritization from their site.