Additionally, we continue to seek ways to enhance patient experience with Copaxone and are pleased to announce that on March 29, Teva filed with the U.S. FDA the three times weekly dosing of Copaxone 40 milligrams per mil and we anticipate FDA action in the first quarter next year. We are excited about the possibility of providing an alternative therapeutic option for RRMS without compromising efficacy or safety. And in addition, we are assuming approval in Europe and we expect to submit that for approval this quarter
Then now that you have filed the tree times weekly, could you talk about your expectations for this product in the long-term? Do you think you might be able to transition a majority of the Copaxone, the existing Copaxone formulation to the three times weekly?
We have stated back in December during the strategy day that we are modeling right now about 30% to 35% of the patients currently on a daily Copaxone will find that three times a week, preference some of the market research that we have been doing in preparation of that and reduction show that that could go as high as 50%, but we continue to model right now about a third of the population are going to find interest in that, so certainly excited about bringing that forward. There is a strong interest in it, but there's also a strong interest in the ones a day as well.
Thank you, Jon, and also we are excited about brining that to patients and we also, the recent data that we published and expert opinion and therapeutic targets showing how the mechanism of action of Copaxone providing a lot more clarity and we compare that to portfolio of generics and to our surprise even though this is a generic comp rate of activation of these generics compared to Copaxone, a market leader and with the potential for also the changes with potential changes in inflammatory pathway, so what goes with Copaxone goes down and as this kind of significant implication, so the bottom line for us is that we strongly believe that any generic will need clinical trial really improve that.
It is a very complex molecule, so difficult to produce and I think we are seeing now more and more evidence around that in terms of the operator activated that it had to be remarkably different between Copaxone and portfolio generics.
I know there has been a lot of news in this area by a number of different organizations, a lot of discussion around the opportunities and otherwise. The potential to develop in manufacture market, affordable, efficacious and safe biosimilars is in my opinion and our opinion an area of significant opportunity.
One has to really be shake the opportunity, pick the opportunity and be very clear about what you are doing there. We both, Teva and Lonza both as partners and individual companies as you know our focus in refining the best roots to realize the benefits that safe biosimilars will bring to the community this large, but in the U.S. abroad and in the emerging market. But as we know, in some of these areas, there is significant regulatory uncertainty in the biosimilars area from that perspective, while the partnership continues to explore the field both companies are taking very measured approach.
Michael [is] very hard from the pipeline prospective and choosing really to evaluate fully both, the prevailing regulatory and commercial circumstance before sort of taking any and decisions of long-term investment, but it is an area that we both regard and certainly Teva regardless, speak to Teva's perspective of great retention and we will continue to look at it very carefully and selectively.
Comments from BAX at Deutsche Bank conference 5/29/2013 (c/o SeekingAlpha)
"Momenta is actually, given the timelines, no meaningful contribution by 2017, so it's not in our long-range plan. And, of course, we're focused with them on trying to accelerate the approval process, given their capabilities around molecule characterization and so on. So that deal is structured to pay significant milestones if we're able to accelerate time-to-market, but no contribution built in our long-range plan."