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.
Not much to report from Isis Pharma (NASDAQ: ISIS) partners from 3q-2012 among major pharma/biotech companies:
Sanofi SNY (transcript via SeekingAlpha)
"You've seen the advisory committee, which voted in favor of KYNAMRO for Homozygous Familial Hypercholesterolemia just last week, PDUFA date in January and a European opinion in the fourth quarter of this year. "
Biogen BIIB - no comments about Isis partnerships
For archival purposes, even though it seems less and less likely that these trials will happen. Full background on Biosante Pharma BPAX and Libigel here.
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.
TopoTarget (partner of Spectrum Pharma $SPPI) conference call notes - belinostat in CUP trial results
TopoTarget is a European biotech company that licensed the histone deacetylase (HDAC) inhibitor belinostat to Spectrum Pharma $SPPI. In June 2012 Topo released top-line data for the clinical trial in cancer of unknown primary (CUP) - belinostat failed to achieve the primary endpoint of an increase in progression-free survival (PFS). A secondary endpoint of objective response rate (ORR) was positive and statistically significant.
The company then held a conference call to explain the results and justify to shareholders why they shouldn't view this as a failure. They even went so far as to release a further press release in August 2012 with some new data-mining. This sort of behavior is typical of small biotech companies heavily reliant on the fate of a single drug, and diligent biotech investors must recognize this and not invest in a company advancing a drug out of necessity or convenience vs. actual clinical and commercial potential.
My notes from the conference call continue below the jump.