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Biotech / Medical : AMLN (DIABETES DRUGS) -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (1765)	11/10/2003 6:24:41 PM
From: Miljenko Zuanic	Respond to of 2173

F**** SI, they are cutting long post. Part II Key Study Details Of the 377 randomized subjects, approximately two-thirds received exenatide and one-third received placebo. Those on active drug received an introductory 5-microgram dose of exenatide for one month, given by subcutaneous injection twice a day at breakfast and dinner. This was followed by six months of exposure to doses of either 5 micrograms or 10 micrograms given twice a day at breakfast and dinner. Overall, no severe hypoglycemia was observed. As glucose control improved in the exenatide arms of the study, the rate of mild to moderate, sulfonylurea-induced hypoglycemia increased. Patients in the study were instructed to maintain their maximally effective dose of sulfonylurea unless hypoglycemia occurred, at which point they were instructed to reduce their dose of sulfonylurea. Patients treated with the highest dose of exenatide showed the greatest improvement in A1C and a 36% incidence of mild to moderate hypoglycemia. In contrast, the placebo arm, with no improvement in A1C, had an incidence of hypoglycemia of 3%. Only one subject receiving exenatide withdrew from the study due to mild to moderate hypoglycemia. Although nausea was the most frequent adverse event, it was transient in nature and only eight patients receiving exenatide discontinued as a result. Antibody formation observed in this study is consistent with previous exenatide data reported to date. The data do not demonstrate a relationship between antibody formation and exenatide's sustained effect on A1C.

To: Miljenko Zuanic who wrote (1765)	11/12/2003 12:21:21 AM
From: mopgcw	Respond to of 2173

GS NOTE: Amylin Pharmaceuticals, Inc. EPS (FY Dec) 2003E ($1.58), 2004E ($0.58) Outperform/Neutral (AMLN) $25.96 Amylin reported top line data from its 2nd phase III trial with exenatide, in development with Eli Lilly. Results appear consistent with top line data from the 1st Phase III study: there was a statistically significant, dose dependent reduction in blood sugar (HbA1c), weight reduction, and no major adverse events, including severe hypoglycemia. Not unexpectedly, there was an increase in mild to moderate hypoglycemia in patients on both sulfonylureas and exenatide, which we believe will likely be manageable. While we were hoping to see more detail on HbA1c reduction, we regard the consistency of the data as a positive. We expect that the stock could be volatile given lack of some details of the results, and as the results from the final Phase III study are expected later this quarter. We maintain our Outperform rating and Neutral coverage view. Key risks include potential for negative clinical trial data and or regulatory failures or delays on Symlin, which we think could be approved in the U.S. around mid-December.