Novartis $NVS, through its Sandoz generics unit, is one of the leading biosimilars players worldwide. They also have collaborations with Momenta Pharma $MNTA around generic versions of LOVENOX (enoxaparin) and COPAXONE. Here are some highlights from their recent 1q-2013 conference call (c/o SeekingAlpha). Note there was no substantive discussion on either the enoxaparin program or their ALK inhibitor LDK378, which is covered extensively on our HSP90 Central site.
Second question is for Jeff on Sandoz. Following all the setbacks from your competitors on biosimilars projects, could you give us an update on your view, on your projects in this front, in terms of timing and different projects there?
We continue to see good progress in our biosimilars pipeline. We have six Phase III clinical trials across four molecules right now as well as several monoclonal antibody projects on route to the clinic. We have, as you alluded to, seen a shakeout in biosimilars. The most notable example is in rituximab where we have seen two of our competitors terminating their Phase III follicular lymphomas trials and two others putting their trials on hold....
Well, for competitive reasons, we don't provide specific timelines for our biosimilar development programs, because we have never given a timeline, for example, on rituximab, I can say that we continue to track according to our plan in terms of patient recruitment, both for that Phase III follicular lymphoma trial as well as our Phase II rheumatoid arthritis trial. I think a key advantage that Novartis has over the competition is our strong cross-divisional collaboration between Sandoz and Novartis Oncology where we are able to leverage our clinical experience and network to provide a similar patient recruitment in the clinics.
As we expected clinical trials with life-saving oncology medicines take longer to complete than trials for supportive care products. But I think, in summary, we believe we are very well positioned versus the competition, both in rituximab and (inaudible) and that frankly the shakeout that we are seeing shows both the development in this area is harder than some of the aspiring entrants had anticipated and its more rewarding for those who are successful in the end.
Secondly, just going back to biosimilars, obviously, with the rituximab, the competitive landscape is changing, but so is the regulatory landscape, so I just wondered if you could help us understand whether you are looking to do or start in the U.S. specific focused trials and also an update on what you are expecting mid-year on the Copaxone and the potential ANDA.
First on the regulatory landscape, we are pleased with both the EMA's final guidelines for the approval of biosimilar mAbs as well as the draft guidelines that FDA has put out which call for a stepwise approach and totality of evidence approach where we can use the analytical tools to minimize the size of clinical trials and it also allows for extrapolation across indications.
The key, for us, is how the FDA will interpret and then implement their guidelines, especially around the extent of clinical trial requirements and, for us, it's important that the agency recognize that the goal of a biosimilar trial is to prove similarity to the originator and not to confirm safety and efficacy all over again. But we are optimistic based on what we are seeing from them. I don’t want to comment on what specific trials we are doing in the U.S. or outside of U.S. for confidentiality and competitiveness reasons.
With respect to Copaxone, we have the first to file for Copaxone. As you know last June the District Court of Southern New York, it issued a decision in favor of Teva on those patents. We have appeal that decisions to the U.S. Federal Circuit Court of Appeals and the oral hearing is scheduled for May. So we will look forward to those hearings and to seeing how that progresses.
We continue to see good progress in our biosimilars pipeline. We have six Phase III clinical trials across four molecules right now as well as several monoclonal antibody projects on route to the clinic. We have, as you alluded to, seen a shakeout in biosimilars. The most notable example is in rituximab where we have seen two of our competitors terminating their Phase III follicular lymphomas trials and two others putting their trials on hold....
Well, for competitive reasons, we don't provide specific timelines for our biosimilar development programs, because we have never given a timeline, for example, on rituximab, I can say that we continue to track according to our plan in terms of patient recruitment, both for that Phase III follicular lymphoma trial as well as our Phase II rheumatoid arthritis trial. I think a key advantage that Novartis has over the competition is our strong cross-divisional collaboration between Sandoz and Novartis Oncology where we are able to leverage our clinical experience and network to provide a similar patient recruitment in the clinics.
As we expected clinical trials with life-saving oncology medicines take longer to complete than trials for supportive care products. But I think, in summary, we believe we are very well positioned versus the competition, both in rituximab and (inaudible) and that frankly the shakeout that we are seeing shows both the development in this area is harder than some of the aspiring entrants had anticipated and its more rewarding for those who are successful in the end.
Secondly, just going back to biosimilars, obviously, with the rituximab, the competitive landscape is changing, but so is the regulatory landscape, so I just wondered if you could help us understand whether you are looking to do or start in the U.S. specific focused trials and also an update on what you are expecting mid-year on the Copaxone and the potential ANDA.
First on the regulatory landscape, we are pleased with both the EMA's final guidelines for the approval of biosimilar mAbs as well as the draft guidelines that FDA has put out which call for a stepwise approach and totality of evidence approach where we can use the analytical tools to minimize the size of clinical trials and it also allows for extrapolation across indications.
The key, for us, is how the FDA will interpret and then implement their guidelines, especially around the extent of clinical trial requirements and, for us, it's important that the agency recognize that the goal of a biosimilar trial is to prove similarity to the originator and not to confirm safety and efficacy all over again. But we are optimistic based on what we are seeing from them. I don’t want to comment on what specific trials we are doing in the U.S. or outside of U.S. for confidentiality and competitiveness reasons.
With respect to Copaxone, we have the first to file for Copaxone. As you know last June the District Court of Southern New York, it issued a decision in favor of Teva on those patents. We have appeal that decisions to the U.S. Federal Circuit Court of Appeals and the oral hearing is scheduled for May. So we will look forward to those hearings and to seeing how that progresses.
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