See below for recent comments from Teva Pharmaceuticals $TEVA and Baxter International $BAX relevant to Momenta Pharmaceuticals $MNTA - specifically their generic COPAXONE program for MS and their biosimilars partnership, respectively.
This post will summarize highlights from biopharma conference calls - including Novartis, Roche, Baxter, and Sanofi - that are relevant either to Momenta Pharma MNTA specifically, or to the biosimilars space in general.
2012 continues to be an eventful year for Momenta Pharma and their generic drug programs for Lovenox, Copaxone, and undisclosed biosimilars or follow-on biologics (FOBs). Continue reading below for a round up of updates from MNTA's partners and competitors in the space.
We are not likely to get much in the way of specifics anytime soon, but Momenta Pharma $MNTA partner Baxter BAX had this brief update about the status of their biosimilars/follow-on biologics (FOBs) collaboration on their recent earnings call (excerpt via SeekingAlpha):
"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 had the opportunity to develop up to 6 biosimilars through our partnership."
Ligand and GlaxoSmithKilne $GSK will present early stage data for the use of PROMACTA (eltrombopag) in chemotherapy-induced thrombocytopenia at ASCO 2012 in June. Also, partner Merck will present phase 2 melanoma data for SCH727965. Finally, there will be several presentations from Onyx Pharma $ONXX related to carfilzomib. Abstracts will be released May 16th so stay tuned.
First quarter 2012 Partner Updates:
Merck $MRK and Baxter $BAX have partnered programs with LGND that were not discussed on their respective 1q-2012 earnings calls.
Partner Onyx Pharma $ONXX also has the multiple myeloma drug (which utilizes Ligand Captisol formulation technology) up for a FDA panel review and PDUFA date this summer. I have not seen a 1q-2012 conference call transcript or listened to the webcast, but I don't think there have been any material updates while we wait for those fey FDA events.
I speculate that evacetrapib is the undisclosed Eli Lilly $LLY programs slated to enter phase 3 in 2012 that utilizes LGND Captisol technology. As this drug is a member of the troubled CETP inhibitor class, I will carefully monitor to see if this phase 3 program actually begins (and to verify if this is indeed the program partnered with Ligand). With that caveat, here are the relevant excerpts from the conference call:
"We anticipate beginning Phase III trial for evacetrapib, our CETP inhibitor"
Q: "anything to update us on the timing and design of the evacetrapib studies?"
A: "As you know, we communicated our very promising data then in the fall and we are doing extensive planning them for the Phase III trial including interaction with regulators, which we are close to completing. We have also been preparing the CMC material for the trial. So we feel very good about the options we have to start the trial before the end of this year as we have communicated."