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Lilly draws flak after touting PhIII diabetes success for Lantus rival

In all three of the trials of the once-daily BLI (LY2605541), investigators reported "a small but statistically significant increase in triglycerides"--a type of blood fat. Also, more patients taking BIL had an increase in the liver enzyme ALT, though there were no reports of severe liver damage.

"Watch liver safety on new $LLY basal insulin," tweeted ISI analyst Mark Schoenebaum Monday morning. "Unclear this will be competitive with $SNY's Lantus or not ... need more info."

In a quick note to investors, Schoenebaum highlighted the liver safety issues and added: "In addition, HDL (good cholesterol) declines and triglycerides (bad) increase. These factors, in my humble (and often incorrect) opinion, will give this drug a difficult commercial profile. In addition, it's conceivable (likely?) that the FDA will want a full blown outcomes trial prior to approval, as it did for Novo's Tresiba."

Read more: Lilly draws flak after touting PhIII diabetes success for Lantus rival - FierceBiotech http://www.fiercebiotech.com/story/lilly-draws-flak-after-touting-phiii-diabetes-success-lantus-rival/2014-05-12#ixzz31XZmw8Ol
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