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Diabetes Drug Injected Weekly Wins F.D.A. Approval

Sunday, January 29, 2012

David Maxwell/Bloomberg News
Amylin Pharmaceuticals won federal approval on Friday for its new, more convenient drug for Type 2 diabetes, ending years of setbacks.
The drug, Bydureon, is injected once a week. Its main competitor is expected to be Novo Nordisk’s Victoza, a similar drug that is injected once a day.

Novo Nordisk, apparently girding for competition, has hired Paula Deen, the celebrity chef, to promote Victoza. Ms. Deen revealed earlier this month, to much criticism, that she has had Type 2 diabetes for three years, all the while promoting recipes laden with fat and sugar.

The Food and Drug Administration twice declined to approve Bydureon in 2010, with its most serious concern being that the drug might contribute to heart rhythm abnormalities.

A study by Amylin, which is based in San Diego and led by Daniel M. Bradbury, suggested this was not the case. Analysts expected approval, so Amylin’s stock rose only modestly Friday, closing up 1.7 percent at $12.14.

Analysts expect annual sales of Bydureon to eventually exceed $1 billion. But they are less enthusiastic than they once were, in part because of safety concerns involving thyroid cancer and pancreatitis.

David Kliff, publisher of Diabetic Investor, an electronic newsletter following the diabetes industry, said a once-weekly self-injection could make Bydureon an alternative for many patients to multiple insulin injections or even to multiple pills every day.

The failure of people to consistently take their medicines is “one of the biggest obstacles to better patient outcomes,” Mr. Kliff, who has Type 1 diabetes, wrote in a note to clients Friday. “Think for a moment how much easier their lives would be by taking a drug just once a week, a drug that offers solid glucose control, does not require glucose monitoring and comes with added benefit of weight loss.”

Bydureon is a longer-lasting version of Amylin’s existing drug Byetta, which is injected twice a day. Alkermes, which supplied the technology that slowly releases Bydureon inside the body, is entitled to royalties on sales of the drug.

Bydureon, Byetta and Victoza are drugs called GLP-1 receptor agonists, which mimic the effect of glucagonlike peptide- 1, a hormone that increases insulin production when blood sugar is high.

The main ingredient in both Bydureon and Byetta is exenatide, a hormone derived from the saliva of the Gila monster, a poisonous lizard found in the Southwestern United States and Mexico.

Despite the less frequent injections, Bydureon will not automatically be preferred over Victoza.

That is in part because there is some data from one of Amylin’s own trials suggesting Bydureon is slightly less effective in controlling blood sugar than Victoza. Also, it is more cumbersome for a patient to prepare Bydureon for each injection and the needle used is larger than for Victoza.

Amylin said the wholesale price of Bydureon would be $323.44 for four doses, or about $4,200 a year. That is between the roughly $3,400 for the low dose of Victoza and $5,000 for the high dose, said Mark Schoenebaum, an analyst at the ISI Group.

The F.D.A. is requiring Amylin to conduct a clinical trial, which has begun, to assess whether Bydureon increases the risk of heart attacks and other cardiovascular problems. The same trial will also look at whether the drug increases the risk for thyroid cancer, pancreatitis and other health problems.

Amylin, founded in 1987, has never been profitable from drug sales and it still faces hurdles. It must pay Lilly $1.2 billion over time from sales of Bydureon.

Robyn Karnauskas, an analyst at Deutsche Bank, said Amylin might be a takeover candidate for a big company.

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