#87649
Re: Farmas USA
asi a bote pronto, lo que mas me ha gustado de la conference:
- We are also working with a CDC on RSV disease burden evidence generation, and we’re optimistic that this will lead to the creation of an ACIP RSV work group this summer. You may recall that ACIP, the Advisory Committee on Immunization Practices is the group that advises the CDC and major payors in the U.S. including Medicare on recommendations for vaccine use. All of these activities support our commercial strategy in preparation for the launch of our RSV vaccine in older adults, planned for 2018.
- We recently met with two European national regulatory agencies, The Paul-Ehrlich-Institut in Germany and the Medicines & Healthcare Products Regulatory Agency in the UK. And in that meeting, both the infant and maternal immunization, and older adult programs were discussed. Consistent with the FDA, both agents were supportive of each program including clinical trial designs, trial endpoints and the proposed clinical datasets to support future marketing authorization applications, the European equivalent of a U.S. BLA. Importantly, both agents also agreed that our clinical development plan could support an annual vaccination study [ph] within our label.
- We also are continuing to work on plans for conducting a clinical trial for the combination of respiratory vaccine that will combine a version of our seasonal flu vaccine with our RSV vaccine. Under ideal circumstances, we would plan to conduct a single clinical trial including arms of a combination product and our seasonal influenza nanoparticle vaccine in the first half of 2017. This trial would be the first of our seasonal influenza nanoparticle vaccine, which is a new approach that builds on advancements achieved with the RSV nanoparticle. We will provide additional details on this approach at the upcoming Keystone Symposia to be held on -- between May 22nd and 26th in Cape Town, South Africa.
- We’ve also begun to work on the zika vaccine, leveraging our unique experience in the rapid development of vaccine against emerging disease threats. As we discussed last quarter, we initiated efforts to develop the zika vaccine with a goal of rapidly progressing through animal studies and the early process development activities. At this point, the vaccine is being developed as an envelope protein nanoparticle, and we expect to benefit from the use of our Matrix-M adjuvant. This approach has been successfully used with 879 [ph] in Ebola and we have confidence that can be successfully used in other emerging diseases, including zika. We will continue to work with various government and non-government groups to determine the pathway forward to fund larger scale productions in clinical trials.
- You’re still close to your Phase 3 data, how do you weigh the decision to partner before that data versus afterwards? It seems like you may be able to capture a lot more value after the study reads out? - Someone could get aggressive and try to do something earlier but our expectation is that the deal will be post data .... I said no more details, but for you, so, yes, impressed in terms of -- by the quality. So, everybody knows the pharma world and the companies that are involved in developing vaccines. And I think I am impressed by the fact that we’re not just drinking our own kool-aid when we think that we’re leaders in the RSV vaccine world, everybody else thinks we are too. And that’s reflected in the quality of the meetings we’re having with these people. I think that’s about as much details I can give you, but we’re not having a difficult time attracting good conversations.
- Vaccines are very unique in the way that they are launched and unique in the way that they are recommended and then of course payor strategy. So, with vaccines differentiation in mind, the policy piece becomes critically important. So, the work that we have begun with the CDC, the work that we expect to continue with ACIP, is critical to the success of our product. So, a policy recommendation for the ACIP is a cornerstone event for us. And we’re putting therefore the right priority against that effort. With an anticipated initiation of a working group with ACIP, that will take place over the next -- an evaluation period pre-launch, pre-commercialization. They’ll get a very clear window into RSV for the disease and then the commercialization efforts around that in order to make their recommendation. But once we have that recommendation that really opens the door to executing a very clear definitive care strategy. So, we’re talking about older adults; it’s primarily in the Medicare space. There is a sequencing of events that has to happen, one is FDA approval; two is a presentation to ACIP for ACIP to make a recommendation. With ACIP recommendation, you then get recognition by the payor community. And that happens I think due to couple of comps in there. Look at Prevnar ACIP recommendation and the 3 to 6 months or so that it took to be properly covered by Medicare prior to that first season. So, with the right groundwork being done, all that’s going to happen pretty quickly.
- In the second quarter of this year we would provide guidance on the path of the clinical development path forward for our flu and combo program. And so, we’ll do that. And now we have told you today that we’ll do that at the end of this month. And so give me that time until we can do that, so we have -- we can talk about data and we can talk about clinical development timeline. But we’re very excited about the new flu program in combination with both the potential standalone product with the combination with RSV. And we’re working -- we’re tracking to BARDA. BARDA changes to programs require discussion. So, we’ll see where discussion is with that. But the ideal program would include this new combination strategy for commercial vaccine that would apply to all the changes that we make, would apply to the pandemic program. And the goal would be to take both of those programs in with BARDA partnership in hand. And so we’ll talk about that at the end of this month
NVAX
