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Momenta Pharmaceuticals, Inc. (MNTA)
2013 Barclays Global Healthcare Conference Call
March 14, 2013 09:00 AM ET
Richard Shea - SVP and CFO
Previous Statements by MNTA
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Momenta Technologies was founded on the basis of technology for de-convoluting complex mixtures and we use our sophisticated and leading edge analytics in order to uncover both the structure and the function of complex products and these include heparin-based products, complex polypeptides as well as biologics.
We have a diversified pipeline of products including two complex generics. We have a marketed generic version of Lovenox and we have an ANDA for generic Copaxone under review with FDA. With biosimilars, we have a global collaboration with Baxter for up to six biosimilars products, and we have two novel drug programs M402, a novel heparin-based oncology drug candidate in Phase I and sialylation technology that we’re applying to IVIG.
Enoxaparin sodium injection, our version was approved by the FDA in July of 2010 at the time of first generic Lovenox to be approved by the FDA after period of five years of review and under our collaboration with Sandoz generics division of Novartis; initially we received the profit share on sales of the product. Currently, we’re receiving a royalty of 10% to 12% on sales of generic Lovenox. Sandoz reported Q4 sales of $85 million.
In connection with our Enoxaparin program, we initiated litigation against Amphastar Pharmaceuticals and their partner Activist and against Teva for an infringement of two Momenta patents. Recently in 2012, the court of appeals found that our patents were not enforceable because of the Safe Harbor provisions of Hatch-Waxman. It’s a ruling and which we disagree despite that interpretation Hatch-Waxman. So, we requested that this case be taken to the Supreme Court.
Now, case that’s been taken to the Supreme Court was really only the request for an injunction and the granting of an injunction at the district court level. The underling patents themselves have never been litigated. So, this is the situation that we think it’s important, it’s important to our underling IP not only for this product but for other products. So we’ll continue to pursue this but certainly would caution investors that we don’t see a near-term resolution to this case. This will take some time to play out.
M356 is our generic version of Copaxone and since this was filed this an NDA drug, we filed an ANDA which was accepted for review by the FDA in July of 2008. Capaxone is a complex synthetic polypeptide and it is clearly not a biologic, therefore we believe that the ANDA pathway 505(j) pathway is an appropriate pathway for generic version and we also have partnered this product with Sandoz. The terms of this collaboration upon commercialization will receive 50% of the profits globally and that would be under all competitive circumstances.
We’ve recently said that the ANDA review is going well and we continue to be in dialog with the FDA about their review of the ANDA. We’re encouraged by the progress that has been made and we’re certainly looking forward to and expecting that the FDA will approve our ANDA under this pathway for an interchangeable version of Copaxone.
As far as the timing of any such action, we think it’s hazardous to make any predictions about the timetable of any FDA action but certainly possible that an approval could occur in 2013, but again I think it’s more important that we continue to make good progress and we certainly see the FDA having a bias towards approving a generic version of Copaxone as an interchangeable generic version.
We are also litigating Teva patents on Copaxone. There are nine patents, orange book patents one, non-orange book process patents. Orange book patents run to June of 2014, process patents September 2015. Most recently, upon a ruling in a District Court that the patents were valid and infringed, we are pursuing an appeal and the grief’s have been filed in the appeal and we are anticipating a second quarter; all arguments most probably in June. So ruling by the Court of Appeal in 2013 is certainly possible.
We’re also working on biosimilars, they are potentially interchangeable biologics. We like to add that because our goal in working on biosimilars is to make products that are substantially more similar than we believe our competitors will be creating; with a goal towards interchangeability which we think will be important for two reasons; one is the potential reduction of clinical studies and then secondarily upon commercialization, we believe a designation of interchangeability would carry weight with physicians and patients as well as with payers and give it a distinct commercial advantage.
So, we use our propriety analytic analysis in order to deconvolute these biosimilars. We believe it's important to select the right cell line, if you don’t know what the right cell line; you can't make a product that is highly similar to if not equivalent to the branded product. And then you need to essentially reverse engineer the process conditions in order to hit the product quality attributes that we have defined for the product in order to make the product that is highly similar if not essentially equivalent to the branded product.