By ANDREW POLLACK
http://www.nytimes.com/2005/04/30/bu...tml?oref=login
Published: April 30, 2005
diabetes drug derived from a poisonous lizard has been approved by the Food and Drug Administration, its developers, Amylin Pharmaceuticals and Eli Lilly, said yesterday.
The drug, called Byetta, will be the first in a new class of drugs to reach the market for Type 2 diabetes, the form that usually occurs in adults. Studies have shown it can help control blood sugar and also help people lose a few pounds. The drawback for patients is that the drug must be injected twice a day and nearly half the people who use it suffer nausea, at least initially.
Analysts have said Byetta could achieve sales of hundreds of millions of dollars a year, or even more than $1 billion. Those sales could propel money-losing Amylin, a biotechnology company in San Diego, to profitability. Lilly, a drug giant that is already a leading producer of insulin, could further bolster its presence in the diabetes drug market.
Still, Amylin's stock sank $1.18, to close at $17 yesterday, after the approval was announced. That was in part because the F.D.A. did not approve Byetta for use as a stand-alone treatment, but only in combination with older drugs when those older drugs by themselves do not provide adequate control of blood glucose.
Amylin executives, however, said they had never expected stand-alone approval so soon and would continue to pursue it.
Lilly's stock rose 47 cents, to $58.47. Dr. Nathaniel Clark, the national vice president for clinical affairs at the American Diabetes Association, said having a new class of drugs was important because diabetics are increasingly being treated with combinations of drugs.
But he said Byetta's efficacy in reducing blood sugar levels was similar to that of other drugs. "This is not going to change the treatment of diabetes in the sense someone is going to go on this medication and that's it, that's all they need," he said.
About 18 million Americans have diabetes, the vast majority Type 2. Amylin executives said six million of them take either sulfonylureas, an old class of generic diabetes drugs, or metformin, sold as Glucophage by Bristol-Myers Squibb and also available generically. Some 60 percent of those people do not achieve recommended blood glucose levels, and they are the candidates for Byetta.
Still, many of those people might first opt for a relatively new oral drug, like Avandia or Actos, rather than injections of Byetta, Dr. Clark said. Others might opt for insulin, which at least initially might require only one injection a day and would be more powerful and cheaper than Byetta, which is being sold to wholesalers for $145 or $172.50, depending on dosage, for a 30-day supply.
Ginger Graham, chief executive of Amylin, said Byetta would be easier to use than insulin. It spurs insulin production only when blood glucose levels are high, so there is less risk of blood sugar levels dropping dangerously low than with insulin injections, she said. Users of Byetta do not have to increase the monitoring of their blood sugar or adjust their doses as users of insulin do, she said.
Ms. Graham also said the company was testing a version of Byetta that would require only once-a-week injections.
The approval of Byetta comes only a month after Amylin won approval of its first drug, Symlin, also for diabetes. The company, which has lost more than $800 million since its founding in 1987, nearly ran out of money in 1999 but was rescued by a cash infusion from a wealthy software entrepreneur whose daughter had diabetes.
Byetta is the first approved drug of a class called incretin mimetics. Incretins are hormones released by the gut that help spur insulin production after meals.
Byetta is a synthetic version of a peptide, or small protein, found in what has been variously described as the saliva or the venom of the Gila monster, a poisonous lizard that lives in the Southwest and Mexico.
The discovery was made in the early 1990's by Dr. John Eng, a researcher at the Veterans Affairs Medical Center in the Bronx, who was working on a way to discover new hormones. He realized the Gila monster hormone was similar to glucagon-like peptide 1, an incretin hormone produced in the human digestive tract.
The Department of Veterans Affairs declined to patent the substance, saying it was not directly relevant to veterans, so Dr. Eng patented it by himself. He then tried in vain to license it to a drug company before finding Amylin. Amylin in turn licensed rights to Lilly in 2002 for payments that could eventually reach $325 million. Both companies plan to sell the drug in the United States and split the profits evenly.
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