Replies to post #143730 on Biotech Values

[biomaven0]

blood tests on liver function (as measured by mean ALT and AST levels) statistically significantly increased from baseline and were higher than with insulin glargine. The mean levels of both liver enzymes remained within the normal range during the study for glargine and LY2605541-treated patients.

Either everyone went up a bit, which would be worrying; or a few went up a lot, which would be worrying. :)

Peter

[DewDiligence]

Has fear of a hypoglycemic event—rather than hypoglycemic events per se—been previously used as an endpoint in a clinical study? It’s an endpoint in the phase-2 study of LY2605541 (jointly owned by LLY and B-I):

http://finance.yahoo.com/news/lilly-boehringer-ingelheim-present-health-101500746.html

Study results showed that in addition to clinical results showing a statistically significant 48 percent baseline adjusted reduction in nocturnal hypoglycaemia compared with insulin glargine [0.25 vs. 0.39 events/ 30 days/patient, after adjusting for baseline hypoglycaemia events (p=0.020)], patients treated with LY2605541 reported a statistically significant reduction in the anxiety and fear associated with experiencing a hypoglycaemic event based upon the Adult Low Blood Sugar Survey (ALBSS).

LY2605541 is yet another drug whose sponsors seek to chip away at the huge market for SNY’s Lantus.

[DewDiligence]

B-I dumps LY2605541—returns full rights to LLY:

http://finance.yahoo.com/news/lilly-reassumes-sole-worldwide-development-130000683.html

[jq1234]

Lilly's Basal Insulin Peglispro Shows Superiority in HbA1c Reduction Compared to Insulin Glargine in Three Phase III Trials in Patients with Type 2 Diabetes

[Peglispro is LY2605541 BI returned to LLY after ph2. Safety issues remain in ph3.]

In all three clinical trials, more patients taking BIL had an increase in the liver enzyme ALT (alanine aminotransferase) to greater than three times the upper limit of the normal range compared with those taking insulin glargine. No cases of severe drug-induced liver injury (Hy's Law) occurred in these studies.

http://boardvote.com/symbol/LLY/communique/643820