The race to developed novel cholesterol-lowering monoclonal antbodies targeting PCSK9 is heating up as Regeneron REGN and Sanofi SNY are the first to embark on a massive phase 3 program. While this battle is the realm of the big pharmas, small-cap biotech investors should also track the progress of these hypercholesterolemia drugs which are competitors in the familial HoFH/severe HeFH arena to KYNAMRO/mipomersen (developed by Isis Pharma ISIS with SNY - note Isis abandoned their PCSK9 antisense program), lomitapide (Aegerion AEGR), and ALN-PCS (RNAi against PCSK9 from Alnylam ALNY, which is seeking a parter for phase 2 development). Continue reading below the jump for the latest updates from 3q-2012 earnings conference calls about these candidates.
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Quick notes from the Isis Pharma $ISIS conference call after tepid endorsement of KYNAMRO (mipomersen) by the FDA metabolic and endocrine products advisory committee. You can find more of my commentary on this event (as well as competitor Aegerion Pharma $AEGR and their drug lomitapide) on the Chimera Research Group blog.
Both Aegerion Pharma AEGR (lomitapide) and Isis Pharma ISIS (KYNAMRO/mipomersen with partner Sanofi SNY / Genzyme) will face FDA advisory committees for the homozygous familial hypercholesterolemia (HoFH) drugs this week:
I compiled a few key figures from the FDA briefing document for AEGR, highlighted my notes from the FDA reviewers, and added a few comments of my own that relate to the panel discussions for both AEGR and ISIS. Sorry it is a bit disorganized, but I will try to go back and clarify further - keep reading here for all the details. Continue reading below for a round-up of 2q-2012 earnings commentary from Momenta Pharma's $MNTA partners and competitors, as well as about biosimilars in general. Includes Sanofi $SNY, Mylan $MYL, Watson Pharma $WPI, Pfizer $PFE, and Teva Pharma $TEVA:
ASCO I did not locate any ISIS presentations coming up at ASCO in June 2012, but please let me know if I missed one. Note that partner Oncogenex $OGXI will be presenting and I will cover their data separately on the blog. 1q-2012 pharma partner updates Keep reading below for information from Biogen $BIIB, Bristol Myers Squibb $BMY, Eli Lilly $LLY, and Sanofi $SNY |
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