Quotes c/o Morningstar transcript
"Sandoz has had a great run for the last six quarters or so, but has now reached the annualization of the launch of enoxaparin, with an exaggerated effect in this quarter resulted in heavy pipeline stocking in the third quarter of last year. Enoxaparin sales this quarter were $259 million [Important to keep in mind that this $1b annual run rate in the duopoly with SNY branded Lovenox is the baseline for any calculations that take into account the effects of the authorized generic launch or potential launch of Amphastar/Watson $WPI generic], down from $290 million in quarter three last year."
"So, for Q3 2011 our development spend in biosimilars did increase significantly over Q3 of last year as we are further along in our pipeline than we were last year, and as key programs advance closer and closer to moving into the clinic as we have recently with rituximab for Phase III onco trials in follicular lymphoma starting a couple of months ago, patient recruitment as well as on rituximab for rheumatoid arthritis, which began in January. We also have several programs moving into Phase III clinical trials in 2012. So, naturally our development spending will follow."
"But I can tell you that there is no better company positioned for biosimilars. We think this can be a potential multi-billion dollar business for us long-term because we have the technical capability of a pharmaceutical company in Pharma, but we also have the generic commercial capability through our Sandoz arm, and if you look at everybody else who is competing in biosimilars or who is claiming that they're going to be big in biosimilars, they only have one of those two capabilities that we think are going to be critical"
Question and answer session:
I was wondering how confident you are that you're current clinical strategy is going to match the FDA biosimilar guidelines we're going to be seeing later on this year?
"On our regulatory strategy, we expect that the FDA will issue direct guidelines by end of year, and on how to actually implement the biosimilar pathway that was signed into law by the Obama administration. I think it's interesting to look at Janet Woodcock's recent New England Journal of Medicine article which provided some thoughtful perspective on some of the key issues, and I think gives some clues as to the likely content of the final guidelines, and specifically she and her co-authors highlighted the likely overall FDA approach around totality of evidence, which supports our belief that demonstrating highly similar product attributes. So, fingerprinting of two products, for example, will allow for an appropriately focused or abbreviated clinical trial program, and this was the approach that was already used by FDA for our generic enoxaparin approval. Secondly, there is clearly, I would say, caveating that there is clearly uncertainty anytime a pathway is not completely spelled out" [This certainly doesn't sound like NVS is adament that the "European" biosimilars model is the only way to go- as has been suggested by MNTA in the past. I still think there is a reasonable possibility that NVS decides they want MNTA technology for US biosimilar market after the final guidance comes out. If so, a buyout seems the only logical outcome vs yet another partnership]
What the dynamics are for generic Lovenox right now, how are pricing and share changing from previous quarter, and what do you think the impact of authorized generic entering the market will be?
"With respect to enoxaparin, in terms of the situation there, as you know, Watson and Amphastar received approval on September 19; somewhat surprisingly from our point of view given that no Watson or an Amphastar product is on the market yet, Sanofi made the decision to launch and authorize generic under its Winthrop label with corresponding some impact on pricing and and share, but we feel very good about where we are on both of those. We do anticipate looking forward to 2012 that generic competition will result in a significant sales decline once there is added competitors, but we can't comment a lot farther because we don't disclose pricing or channel strategy on this. I also can say, as you know, there is pending litigation with the District Court, recently having granted TRO that's been extended until, I think a couple of days for now on the Watson Amphastar products, so we'll see how that (PI) hearing goes." [This PI was granted on 10/28]
Just a couple of questions on Sandoz just to follow-up. On the R&D spend, it is rising very quickly, and just going forward, potentially with a lot more Phase III studies required to basically get this product to market, should we be looking at that actually going up still quite a lot more over the next couple of years? Then on GP2, 2013 the Phase III study and first-line SL, what about for second-line and maintenance in SL, and then for (indiscernible) and CLL, are we expecting Phase III studies in each of these areas to basically get on to market?
"As we have a number of programs that are moving into Phase III clinical trials in 2012 development spend will certainly increase and we see that as a positive as we're moving along quite well with our programs, but clearly in the short-term that has an impact on development spending that's not as we've alluded to earlier, fully offset by end-market products. With respect to rituximab, we don't disclose a lot around our filing strategy; in fact, I don't disclose anything there, but what I can say is for, we generally file for all indications at the same time including the data that we have on extrapolating to other indications. The recruitment for both the rheumatoid arthritis and follicular lymphoma trial is underway. For competitive reasons, you can understand that we don't comment further, but we're targeting a little under 800 patients in those two studies, the Phase II RA and the Phase III follicular lymphoma trials. I can't comment on the U.S. trial that you referred to earlier for competitive reasons again"