FDA Is Asked to OK Diabetes Drug Made From Lizard Saliva

A lizard has certainly become a pet project for a tiny San Diego biotech company.

Amylin Pharmaceuticals Inc. and Indianapolis-based drug giant Eli Lilly & Co. said Wednesday that they had asked the Food and Drug Administration for permission to market a new treatment for Type 2 diabetes.

The drug is derived from the saliva of a lizard known as the Gila monster that lives in the Arizona desert and eats just four times a year, according to Amylin officials.

Called Exenatide, the treatment is the first in a new class of medicines known as incretin mimetics to treat Type 2, or adult-onset, diabetes, in which the body does not produce enough insulin and cells in the body do not respond normally to insulin.

“Exenatide can be very effective in controlling blood sugar, give patients a chance at losing weight and delay the need to take insulin,” said Leerink Swann analyst Robert Parente, who expects the drug to post eventual peak sales of $1 billion if it is approved.

Amylin and Lilly began collaborating on the development and commercialization of Exenatide in September 2002.

Type 2 diabetes is the most common form of diabetes, affecting an estimated 15 million Americans, and can lead to serious complications such as blindness and kidney disease. About 80% to 90% of people with the condition, which is becoming increasingly common among children, are obese.

Exenatide, given twice daily by injection, would be aimed at diabetics who are not using insulin and who have failed to adequately control their blood sugar levels with oral medications.

Many patients with Type 2 diabetes can control it with pills such as the widely used drug metformin and an older class of medicines called sulfonylureas -- but others need injections of insulin.

The Amylin drug would introduce another injectable treatment for the same group of patients, without the weight gains and risk of hypoglycemia -- potentially dangerous declines in blood sugar -- that are associated with insulin.

The average patient taking Exenatide for a year lost 8 pounds.

Exenatide, in three major trials, significantly reduced hemoglobin A1C, a measure of average blood glucose levels over a three- to four-month period. The average reduction in A1C in patients taking the highest dose of Exenatide was approximately 1%.

About 40% of the highest-dose patients in the trials got their A1C measurements down to or below 7%, a target level that many doctors believe reflects satisfactory glucose control.

The most common side effect of Exenatide was mild to moderate nausea. Few patients taking it developed serious cases of hypoglycemia, which can cause headaches, delirium or even coma or death, a main reason some patients stop taking insulin.

Lilly and Amylin would equally split profit from U.S. sales of the medicine should it be approved by the FDA.

Shares of Lilly fell 34 cents to $69.91 on the New York Stock Exchange.

Amylin rose 60 cents to $22.80 on Nasdaq.