Biotech investing is known for having more than its fair share of equivocal, confusing, or hard-to-interupt data. That's just really the price for sitting down at the table. The case of Amylin Pharmaceuticals (AMLN) seems to be taking that to a new level, though, and investors can be forgiven for not knowing quite what to do with this one.
Bad News First – DURATION-6
Amylin, along with partners Lilly (LLY) and Alkermes (ALKS) dropped a bombshell on investors last week when they announced disappointing results from the companies' DURATION-6 study of Bydureon, a once-weekly version of Amylin's successful Byetta GLP-1 analog for Type 2 diabetes. The study, designed as a marketing study and not a pivotal clinical trial, was destined to show similar efficacy to Novo Nordisk's (NVO) once-daily Victoza; the idea being that similar efficacy from Bydureon along with a more convenient dosing schedule and softer side-effect profile would establish Bydureon as the market leader if and when it gets approval.
Unfortunately for the AMLN-LLY-ALKS triumverate, it didn't work out that way. This study showed the lowest-ever seen efficacy rate for Bydureon (as measured by HbA1c) at 1.3%, lower than the 1.5% seen for Victoza. While the side-effect profile did look better for Bydureon (less than half as much nausea, vomiting, and diarrhea), the drop-out rates were similar.
Please click here for the link to the Seeking Alpha article:
Confusing Cross-Currents With Amylin's Data
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