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Momenta Pharmaceuticals Inc. (MNTA)
Lazard Capital Markets 9th Annual Healthcare Conference Call
November 14, 2012 2:30 pm ET
Richard Shea –Senior Vice President and Chief Financial Officer
James Cole – Lazard Capital Markets
Previous Statements by MNTA
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Thank you very much. Before I commence my presentation, I’d like to draw your attention to our Safe Harbor statement and the risk factors included in our SEC filings. Momenta Pharmaceuticals was founded on the principles of applying sophisticated analytical capabilities to understanding the physiochemical structure of complex mixture products.
And early in the history of the company we decided as a business model to initially apply that technology to developing generic versions of complex mixture products like Lovenox, like Copaxone and since that time, we moved towards biologics working with Janet Woodcock in the biosimilar field, but it always has been the long term vision of the company to also apply these capabilities to discovering and developing novel therapeutics.
So we have a pipeline that includes complex mixture drugs, generic versions of Lovenox and Copaxone. We are working on six biosimilar products in a collaboration with Baxter and we have two novel drug programs, M402 a novel oncology agent and we are working on a sialylated IVIG program.
So just to quickly cover our Q3 highlights, we have a market edge generic Lovenox and this Enoxaparin sodium product. We tried to implement an IP strategy whereby we could develop IP around our manufacturing methods with respect to these complex generics.
So, the sub-position of the company with respect to complex generics was one that we could use the analytics to develop and exact copy of the branded product and get that product approved with our clinical studies. The second proposition was that we could get approved before anybody else that essentially set the standard for what would constitute approvability for these types of products.
The third proposition was that we could protect the methods that we used to develop and manufacture these products with IP and enforce that IP. So, in the case of enforcing the IP around Enoxaparin, we sued competitors Amphastar, Watson as well as Teva and obtained an injunction that kept Amphastar and Watson after market for several months. When that temporary injunction was appealed by Amphastar and Watson, the injunction was lifted by the Appeals Court, it was lifted by the Appeals Court on the basis that these patents were not enforceable because they sell under the Hatch-Waxman Safe Harbor provision.
Now we strongly disagreed with this opinion and in fact in another case Classen versus Biogen, the appeals court found the exact opposite to be there ruling that in fact Hatch-Waxman doesn’t cover a commercial product. So this is something that it has to be worked out at the Appeals Court level.
And so we’ve filed for what’s called an unbank hearing which is a hearing of all of the nine Appeals Court judges. And we filed that in September, we believe that over the next several weeks or next couple of months, we will hear whether the Appeals Court is going to take that on as an hearing and we expect that sometime mid-year they will have the hearing and we’ll hear the results of that hearing shortly thereafter. So sometime in 2013, this would resolve itself and the importance of this is two-fold.
One is, if we can enforce these patents, we can go back and reinforce that these patents are valid and enforceable. We can potentially collect damages against Amphastar and Watson for their entry into the market. But equally importantly, we can illustrate the concept that this type of approach could also hold true for our other products in development like Copaxone, like biosimilar, we are actively accumulating IP relating to manufacturing methods for Copaxone and for biosimilar. So, this is something that’s important strategy for us. So this will be an important area for investors who watch during the year if this breaks in our favor, I think it will be very important for the company.
Follow-on biologics program, just briefly we have three products in development and we are working to get the lead product targeted towards an IND filing in 2014. On the novel drug program M402, we are enrolling patients in a Phase 1 dose escalation trial and we hope to complete that trial in 2013, move into the second phase of that Phase 1/2 study.
And with respect to some Sialylation technology, we are applying to IVIG. We did announced this quarter that we had successfully replicated the academic work that proves the concept that Sialylation of IVIG does in fact increase the potency, increases the immune response of that drug and so that’s an important proof-of-concept, In that program we are moving forward on that, I’ll talk a little bit more about it.
So, Q3 was not a good quarter for Enoxaparin sales. So Enoxaparin sales by Sandoz our partner where $176 million in the first quarter, $156 million in the second quarter, dropped to $34 million in the third quarter and part of that was, that there was intense pricing pressure from our competitors in the third quarter caused Sandoz to have to react with lower prices, that lower prices ripples through stock that’s at distributed and wholesalers and so you kind of get a double hit during the quarter.