Oxford BioMedica PLC (OXBDF)

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In April we announced an agreement to acquire AveXis, which gives us a platform now in gene therapy and builds out our neuroscience portfolio. So, as you can see, we continue to progress on this strategy and look for bolt-on opportunities in line with our capital allocation priorities.


Kymriah and DLBCL remains on track for U.S. approval in Q2 of this year as is Aimovig our first-in-class CGRP monoclonal antibody. We also filed ACZ885 for CV risk reduction in both U.S. and Europe, that filing was completed in December. And we're on track to complete our rolling submission of BAF312 in Secondary Progressive MS in Q2 and RTH258 in Q4 of this year. So, you can see taken together, 13 potential blockbuster launches assuming the closure of the AveXis transaction. So very strong profile that we believe can drive the growth for the next 5 years and beyond.


And of course, we have continued to expand our efforts in CAR-T cell therapies and related therapeutics and impact cancer care.


On the last topic, on the bispecific versus CAR-T therapy. I think the clinical thing here is durability. I mean we know that with Kymriah and pediatric ALL we seen durability of up to 5 years in many of the patients. In DLBCL, we're following where we know patients to get the 6-months usually stay in response up to 12 months and then longer term. I think the open question with bispecific and some of the other technologies as they can lead to durable response, because with these patients what you’re looking for, is a durable response to give them back their lives. So that’s going to be the open question. I don’t know the answer, but we do know that CAR-T cells because of the ability for the T-cell clones to expand again when the cancer recurs, when you do have patients that have at that long-term response they tend to stay in a positive state. So that’s how we think about the threat of bispecific and other technologies versus CAR-T cells.

We have the 13-potential blockbuster launches coming. We have a world-class R&D engine. Second, strong and growing dividend that does not change and third to use our capital defined strong bolt-ons that continue to build up our business in our core therapeutic areas and also bring new platforms like gene therapy or like radio nuclei therapy into the company or even digital therapeutics.

Second, we are a leader CAR-T, we have Kymriah we have a broad portfolio of CAR-Ts coming behind that. So, we have that as platform. We have immuno oncology, we have the 20 or so assets that are in the clinic evaluating them, but we'll take a stronger look at them. And then we brought in regular nuclide therapy, transformative in neuroendocrine tumors. We'll see how it unfolds in prostate cancer also looking at gastric cancers. So, we are strategically trying to take a broad position. So, we're not overexposed to IO per se. And it's not a binary event for us whether IO pans out for the company.

And the last one on priority review vouchers, you are correct we have multiple priority reviewed vouchers given the strength of our pipeline. We think it's prudent to have multiple priority review vouchers to enable us to accelerate programs. We'll comment on which priority vouchers we have used and which programs when we've received acceptance of the file from FDA and their confirmation on the priority review. So, you'll be hearing more from us over the course of this year.

Vasant Narasimhan
Great and on Kymriah.
Elizabeth Doherty
Yeah, sure. Love to give a little bit more color on that. As we've talked about before, their revenue in Q1 was actually in line with our expectations. We have been focused on exactly what you're talking about expanding the sites, we now have 35 sites up and running. Just keep in mind the new therapy is the new therapy for us it's also new therapy for the hospitals and centers. So, we spent a lot of time making sure that the experience that they're having is a positive one and that we are getting the logistics down properly. And we feel very good about where we are in preparation for the DLBCL hope for anticipation of expansion soon. So, I think we saw the reimbursement, we have not had any issues as reimbursement that's going very smoothly. The sites are up and running, we feel very good about that and in anticipation again of the expansion of the label soon. So, I think so far so good, yes, we expect that we'll see the trajectory improve overtime. But again, keeping in mind, not only with ALL but also with DLBCL outlook starts to launch that these patients need to be referred to the centers. And so, I think you'll see a continuous improvement quarter-over-quarter. But you will see it, it will take time for these centers to get up and running and used to use in this new therapy.

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