"Well the timeline is first the court of appeals needs to issue a ruling on why they lifted the temporary injunction. They lifted the injunction following a hearing on January 24 and January 25 now into listing off to the PI. And we expect within the next month or so to get the ruling on why they lifted that PI. Now if that’s a narrow ruling simply addressing a higher hurdle than the district court has or injunctions such as theoretical higher standard that would be fine.
If it’s a broader ruling addressing the enforceability of our patent that’s something we will have to take into consideration in our arguments in the file that’s coming up in October defending those patents. But clearly the district court judge spent fair amount of time looking at the patents, hearing some arguments from Amphastar and Watson regarding the validity of those patents. The issue is actually fairly narrow in that case so that judge found pretty emphatically and definitively that our patents were valid and warranted preliminary injunction. So we will just have to see how that case develops as we go forward we have a trial scheduled in October and a ruling following the trial could be two to six months following the trial."
Q: Impact of potential TEVA generic Lovenox on MNTA's share/market performance?
"Well it’s clear that this is now really a three way generic market with Amphastar Watson competing against the Momenta Sandoz product. And it’s pretty likely that Sanofi Winthrop AG will re-launch so you really have three generic players. Whether Teva gets approved or not taking it from three to four players is much less significant I think from a market point of view and the kind of royalties that we will be getting back. So I mean Sandoz has been in this business the long time, I think they understand the customer dynamics. And so we are optimistic that we can maintain a reasonable market share. I think the real question is what kind of pricing results from this kind of competition."
Q: When could you achieve FDA Copaxone approval, if the patent legal situation is resolved in the near term as expected?
"Well I don’t think it’s a question of if the legal pathway gets resolved. I mean the legal pathway will get resolved the patent will all be overturned and that would have to hold up an appeal, an alternative would be that some of the patents are overturned and some of the patents hold. And depending on which of those patents and there is one process patent that runs till September 15, I mean ideally if that one gets knocked out and we are facing a June 14 that’s preferable in waiting an additional year.
With respect to the FDA that’s a completely separate process and we are very confident in the quality of our A&DA and quality of our science. We have a very good working relationship with the FDA. We’ve had a lot of give and take. We’ve had a very robust dialogue with the FDA. And we feel pretty confident that we can get a generic Copaxone approved as an interchangeable Copaxone without clinical studies, without full safety and efficacy study. So we continue to believe that....But as well as are also looking at the biology in the same way that we did extensive studies comparative studies to lay the FDA’s concerns about the potential for immunogenicity for Lovenox. We are doing very similar work with respect to Copaxone to look at the biology of products and to work that will get the FDA comfortable and not only have we demonstrated the cultures the structural, chemical structure of the product is equivalent to the brand but that’s the biology of the product also equivalent to that brand."
Q: Comment on FDA biosimilar guidance that was published recently?
"I would say the FDA guidelines exactly met our expectations...So companies that have been taking the European approach of spending relatively little time and effort and money on designing an equivalent product, that have been just developing similar products meeting say European standards to similarity. We think are going to run into significantly more questions and more hurdles with the FDA. Because the FDA is going to be looking at structure and this is something that’s been a theme both in looking at complex generic drugs and also looking at new drugs."
Q: Comment on selecting Baxter vs other prospective FOB partners?
"Well, part of it was the financial terms. I mean we like the fact that Baxter is very competitive globally, commercially and products that have relatively low margins. So in that respect they are different from other big pharma companies that we may have considered talking with. As far as big biotech you saw that the two big biotech players went after partners with deep pocket Novartis not necessarily have deep pockets but they put up $400 million we weren’t ready to put $400 million necessarily to work with Amgen and Biogen went with Samsung again they are going to be pointing above for the cost. The players like Sandoz, Teva, Aspira, Watson really pursuing a different strategy then we were and so we really found an ideal partner and collaborator in Baxter...[others] are focusing more on differentiating their products through the clinic rather than through the structural design and process development of the product."
"we have two novel products that we are very excited about. One is an oncology product it’s a heparin based product and we see that going into the clinic very soon. I mean it’s very different than other cancer therapies I mean heparin are known to have anti-metastatic, anti-coagulant properties. They are multi functional, multi targeted. They are really very different than the single target therapies out there right now. So we think this is a very interesting treatment modality and excited to get that into the clinic.
The second product is dilated IVIG. We acquired the technology around this product from a start-up company and this was technology developed in Rockefeller University we think with our background, with our scientific expertise of knowhow, we have a good chance of understanding how this sialylation mechanism works and apply it to a product like IVIG where there is real need. If this product is successful it will increase the potency thereby allowing a decreased dose now with plasma and a constrain apply this could be a usually valuable product."