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

To: arnie h who wrote (1820)	4/29/2005 10:11:10 AM
From: richardred	Read Replies (1) \| Respond to of 2173

This seems the disappointment, but still a big hurtle-They have plenty of data to present for later. Besides IMO it's worth doing more studies now if needed for expansion. Time to watch how the new approvals do in the market and see what kind of share they can capture. Will Lilly pay out the milestone payment in cash or the AMLN option in stock. I think the later. >The FDA did not approve the drug as a stand-alone treatment, which would have represented a bigger market. The agency said any additional data the companies present in order to win approval as a stand-alone therapy would be reviewed within six months. UPDATE 2-FDA OKs Lilly-Amylin drug for type 2 diabetes Fri Apr 29, 2005 09:19 AM ET (Updates share price, changes dateline from CHICAGO) By Toni Clarke NEW YORK, April 29 (Reuters) - A drug derived from lizard saliva has been approved by U.S. regulators to treat diabetes in patients who have not responded to other treatments, the drug's developers, Eli Lilly and Co. (LLY.N: Quote, Profile, Research) and Amylin Pharmaceuticals Inc. (AMLN.O: Quote, Profile, Research) , said on Friday. The drug, exenatide, to be sold under the brand name Byetta, was approved by the U.S. Food and Drug Administration as a twice-a-day injectable add-on therapy for patients with type II diabetes -- the most common form -- whose blood sugar is not sufficiently controlled by two other treatments. The drug is made from the saliva of the Gila monster lizard, which lives in the Arizona desert and eats just four times a year. Exenatide is the first of a new class of drugs known as incretin mimetics. It mimics hormones, released in the human gut in response to food, that help regulate glucose levels. About 18 million people in the United States have diabetes, or 6.2 percent of the population. Diabetics are unable to produce enough insulin or cannot process their insulin properly, resulting in dangerously high blood-sugar levels, which can lead to heart disease, blindness and amputations if not treated. The FDA did not approve the drug as a stand-alone treatment, which would have represented a bigger market. The agency said any additional data the companies present in order to win approval as a stand-alone therapy would be reviewed within six months. Amylin shares fell 38 cents, or 2 percent, to $17.90 in pre-market trading on the Inet electronic brokerage network. Lilly's shares were unchanged at $58. (Additional reporting by Julie Steenhuysen in Chicago).