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Replies to post #177839 on Biotech Values
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."
09/04/14 8:03 PM
Eli Lilly and Company's basal insulin peglispro (BIL) demonstrated a statistically significant lower hemoglobin A1c (HbA1c) compared with insulin glargine (Lantus) at 26 weeks and 52 weeks, respectively, in the IMAGINE-1 and IMAGINE-3 Phase III clinical trials in patients with type 1 diabetes. Patients in these trials were also taking mealtime insulin. Notably, patients in IMAGINE-1 continued treatment beyond 26 weeks, and the HbA1c superiority for BIL was maintained at 52 and 78 weeks.
The Phase III trials needed for submission are now complete. The trials, in both type 1 and type 2 diabetes, showed consistent superiority of HbA1c for BIL against comparators. Lilly is on track to file a submission with regulators by the end of the first quarter in 2015.
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