Momenta Pharmaceuticals ( MNTA) 2012 Citi Global Health Care Conference Feb 28, 2012 11:00 AM ET Executives Analyst Presentation Unidentified Company Representative
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We are still working through the courts to enforce enoxaparin patents and I'll discuss that a little bit more as well. Our ANDA for generic Copaxone is and continues to be under review at the FDA and we did acquire the Sialic Switch assets of Virdante and exciting novel drug platform opportunity for the company.So our product pipeline is generic Lovenox, nox product that was approved in July of 2010 and Sandoz continues to market that product. M356 is our generic version of Copaxone to MS product and that NDA is under review at the FDA. We're working on multiple biologics and currently working on those in collaboration with Baxter with whom we recently signed a six product deal and we are working on a novel drug, M42 is our oncology candidate, heparin based oncology candidate which we are hoping can get into the clinic sometime in 2012. So I'll move directly to Follow-On Biologics and the Momenta approach to Follow-On Biologics we believe is different from our competitors. So what we're trying to do with our technology is, we are trying to use the analytical technology that we applied to generic Lovenox and that we have applied to generic Copaxone, now to biologics and what we are trying to do is through our analysis of the structure of branded biologic drugs, we then select a cell line using the same cell line system as the brand in order to create an equivalent product, really a true bio generic for these biologic products so using the same cell line and trying to engineer the same process conditions as the brand and again using our superior structural characterization technology to accomplish that. So with existing biosimilars there is our acknowledged differences between the biosimilar and the brand and there are portions of the product that are unknown. So we're using our technology first to substantially reduce the portions of the product that are unknown and then over time to reduce the differences between our products and the branded product and so we're using the FDA's the same approach that we applied in generic Lovenox to this process. So the FDA has come out in several ways with their discussion of how they are approaching regulatory review of this biologics and initially their guidance came through an article in the New England journal.
More recently their guidance came through the biosimilar user fee pathway and discussion of that approach and more recently now they have come out with specific guidelines on the 351K biosimilar pathway and would like to point out that they emphasized that they would start with understanding the structure of the product that is being filed under the IND. That is the first step. The structural characterization and its only by understanding the differences or similarity of the product with the branded product that the clinical pathway can be determined and this is going to be done on a case-by-case approach. The language that the FDA used in describing their process contained language that suspiciously looked like the language that we use in describing our approach to characterization and talking about identifying fingerprint like structures as ways to demonstrate structural similarly and structural equivalence. So again we believe that this demonstrates that we will have differentiation in this market that we will have an approach that the FDA will differentiate and that by showing that we have more equivalent structural characteristics to the brand that there will be an offset within the clinical pathway and ultimately with the interchangeability of the product and we would point out that the guidelines indicated that the first interchangeable product could be granted a period of exclusivity.So again the entire market approach here is to reduce clinical studies, thereby reducing costs, reducing time, its product launch and then once the product is approved, obtaining interchangeability which we think is going to be a game changer in the market. So the collaboration agreement we signed with Baxter really capitalized on our strengths and our differentiation. So under the collaboration we have, two products that have been named in development for additional products which will be named, we have responsibility for the product development through IND, Baxter has monetary responsibility for clinical study as well as the commercialization of the product and Baxter has made an upfront payment of $33 million and has a potential for over $400 million of milestone payments and these really breakdown into two types of milestone. One site is the milestone's true IND and so the milestone's true IND will offset substantially our cost to develop these fixed products through IND and as Baxter opts in to the remaining four products as we demonstrate technical aspects of the product to Baxter and they expect the products and as we file INDs and have INDs accepted, we'll be earning milestones that will be offsetting our cost. Read the rest of this transcript for free on seekingalpha.com