Merck MRK (transcript via SeekingAlpha)
"Question on biosimilars. From what I understand, REMICADE does not have patent protection in a reasonable number of smaller European markets. In these markets, can you talk about when you think biosimilars might arrive? And then also, a number of years ago, Merck made quite a splash about its presence in biosimilars and what that would be going forward, but the company seems to have kind of gone quiet in this area for a while. And I know that earlier this year, you lost your head of biosimilars. I'm wondering if you can update us on your efforts there?
And Tim, with respect to your general question about MBV, I would say that we have a number of biosimilar molecules in early development. They include Rituxan and Enbrel, which we're prioritizing. We're also prioritizing other candidates across our portfolio, So what we are trying to do is to continually -- continue to look at our investments to select the molecules that have the highest potential relative to development costs, the ones where we think we have the highest probability of technical success and, of course, the molecules where we also think we have the highest probability of being one of the early first movers at the time of patent expiry."
Watson Pharma WPI (transcript via SA)
"In July, we licensed in the biosimilar to Herceptin from Synthon and contributed it to our Amgen collaboration. This transaction demonstrates the flexibility of this partnership to capitalize on opportunities to develop quality assets for introduction at market formation.
We are definitely committed to a long-term brand strategy. We are committed to women's health. We're committed to urology, and we're committed to a biosimilar franchise. So we will continue to look for business development opportunities. I would expect that you'll see some from us over the next few months, as we can bring home some of the deals we're currently working on. But we have not wavered in our commitment to our brand franchise
On the biogeneric opportunity, I think both Watson and Amgen will be speaking a bit more about these opportunities over the next few months. It turns out that Watson and Amgen both have investor days very close to one another in January and February, and we would expect that both of us will talk about that, and you'll be able to get a lot more clarity around kind of what we're working on and the timing of those products. But that's just the Watson-Amgen collaboration. As to FSH, we continue to believe that, that will be our first biosimilar that comes to market. As you know, it fits very nicely with our ability to sell products in the U.S. because of the woman's health care franchise. So I think we're well positioned to deal with that. Although we wouldn't expect to see any major contribution from any of these products truly until late 2015 and early 2016. And then finally, the R&D commitment, it is a significant commitment. Nothing comes without a price, and biosimilars are going to come with a big price. And that's why I think the assets are so valuable. Many people have talked about biosimilars. Many people have talked about wanting to be in this space, but when it comes down to spending the money, there's very few companies who are willing to take the P&L hit or willing able to do -- to spend the P&L money to invest in these products. And they are -- it is an extraordinary investment, $50 million to $100 million per product. If you're partnered with somebody, you can obviously -- you can defer some of that or offset some of that cost. But to believe that there's going to be 12 competitors on monoclonal antibodies in the U.S. is just mind boggling to me. I just don't see that. There's just not enough people who can spend that kind of money to get to that point. There's going to be a handful of players. I think that makes these products extremely valuable. And we're committed to them for the future."
Novartis NVS -Sandoz (transcript via Morningstar)
"The significant part of the [generic Lovenox] price erosion comes from Sandoz and the recent acceleration of price competition through enoxaparin.
For sales, the biggest impact is a decline in enoxaparin from $259 million in quarter three 2011to $34 million this quarter. Recent price declines have been very severe and the quarter result includes the impact resulting inventory and revenue adjustments. We now expect enoxaparin run rate to be at relatively low levels from now on.
Then finally on generic Rituxan, as you suggested in your opening comments, very many players in biosimilars have highlighted that they are rethinking their strategy in light of regulatory commentary recently. What give Sandoz the confidence that you've interpreted the regulations such that you are confident of moving forward in a near term timeframe?
Sure, Matthew on rituximab we've seen the emergence of what I would call a potential shakeout in biosimilars looking forward as we've seen several of our competitors putting their Phase III clinical trials on hold for rituximab. What I can say is that we've designed our clinical programs and we have several Phase III programs in addition to rituximab in closed consultation with regulatory authorities and we continue enroll patients and make progress on both our follicular lymphoma Phase III clinical trial as well as our Phase II rheumatoid arthritis trial. I think two advantages that Sandoz and Novartis have versus competition one is a learning curve factor. We started our development work on human growth hormone in 1996 and on EPO in 1997 and that gives a bit of a first mover advantage. I think secondly we have a strong cross functional – excuse me cross divisional team that's working on rituximab along with Novartis oncology that's really working diligently to drive enrollment in these clinical trials. We are firmly committed to our biosimilar rituximab program as well as our overall portfolio biosimilars.
Second question on the generic front, can you tell us what you think will be first biosimilar monoclonal to launches and when this might occur? Could be Merck's Remicade assuming something like 2014?
Tim, I'd be purely speculating at this point if I was to say which (mab) and from whom I think would get approve first. So I think I'll leave it that and let's see how the market plays out, but as kind of said earlier I think this is going to be more difficult than some players realized when they first got into it.
Baxter BAX (transcript via Morningstar)
"In addition under the terms of our agreement with Momenta Pharmaceuticals, we recently selected a third biosimilar for development, a monoclonal antibody for oncology designated as M511. This is in addition to the selection of M923 and M834 targeted for the treatment of autoimmune and other inflammatory disorders. As you know, Baxter and Momenta have the opportunity to develop up to six biosimilars through our partnership"
Roche ROG/RHHBY (transcript via Morningstar)
"Then lastly on Rituxan, last quarter you said that generic versions of Rituxan would likely be delayed until 2015 in Europe, that seem to be corroborated by news from Teva a few weeks ago. Can you please provide us with more detail on why there seems to be a delay with biosimilar programs and does that make you feel any less threatened that maybe monoclonal antibodies in particular have a long uncertain regulatory road ahead of them?
Relative to the generics on Rituxan, I would just say we are cautiously – we are cautiously optimistic about that. We don’t want to in any way forecast exactly what's going to happen with the generic manufacturers out there but we do see some struggles in them being able to bring their products to market place on their stated time lines. But as far as we are concerned we continue to see them entering the market place within a reasonable timeframe and that's why we want to continue to differentiate our pipeline program."