Amylin Shares Drop after FDA Requests New Studies

This press release is an announcement submitted by Reuters Health, and was not written by Diabetes Health.

FDA wants more clarity on risks vs benefits of Byetta

Dec 28, 2009

BOSTON/NEW YORK, Dec 23 (Reuters) - The shares of Amylin Pharmaceuticals Inc (AMLN.O) fell nearly 10 percent on Wednesday after the U.S. Food and Drug Administration requested that the company conduct additional safety studies on its diabetes drug, Byetta.

A letter posted on the FDA's website requested the additional studies to ensure the benefits of Byetta, known generically as exenatide, outweigh the risk of inflammation of the pancreas and acute renal failure.

"We have determined that postmarketing requirements are needed to assess the risk of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, and the risk of thyroid neoplasms," the agency said in a letter to the company.

Thyroid neoplasms usually refer to cancer of the thyroid.

"This is all new information to us," said Yaron Werber, an analyst at Citigroup.

Werber noted the FDA is requiring Amylin to conduct an epidemiological study on acute pancreatitis in Byetta versus non-Byetta patients; epidemiologic queries on pancreatic cancer and thyroid neoplasm in Byetta versus patients taking certain alternative therapies; a clinical trial to see whether Byetta may increase the risk of gall bladder gallstones and therefore pancreatitis.

Epidemiological studies are designed to assess the prevalence of disease in different groups of people.

Amylin said in a statment on Wednesday afternoon that a study has shown "no increased risk of pancreatitis in patients taking Byetta compared to patients taking other antidiabetic medications."

Amylin also said a pre-clinical program demonstrated "no increased risk of pancreatitis with Byetta" and that it is studying Byetta and gall bladder gallstones.

Byetta, which Amylin makes together with Eli Lilly & Co (LLY.N) is a member of the GLP-1 class of drugs designed to stimulate the release of insulin in diabetics when glucose levels become too high.

Amylin's shares fell 9.6 percent to close on Wednesday at $13.97 on Nasdaq. (Reporting by Toni Clarke and Ernest Scheyder; editing by Andre Grenon)

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Posted by Anonymous on 28 December 2009

The problem with today's digital technology is that it is too easy to pass along news that is either incomplete or misleading. The Reuters story quoted an analyst at Citibank, who for some unknown reason, made a big deal out of old news (possibly to spin a story and influence the direction of the market for short sale advantage). The relevant facts are these; The FDA requested additional epidemiological studies and monitoring of safety issues with Byetta, a drug that has been on the market since 2005 with millions of prescriptions filled. There have been cases of acute pancreatitis ASSOCIATED with Byetta, just as there have been pancreatitis cases associated with other diabetes drugs. No proven cause and effect relationship has been found between Byetta and pancreatitis. In fact, follow up studies of large numbers of Byetta users have shown that there is less incidence of pancreatitis in Byetta users than among Diabetics in general.

That said, this mysterious and "important" revelation of the FDA requests for studies released by Citi neglected to put things in perspective. If the FDA truly thought there was a problem, it is highly unlikely they would not have approved Byetta for EXPANDED use, which is what they communicated in the very same letter in which they asked Amylin and Lilly to continue to monitor events associated with Byetta use and to conduct additional safety studies. These requests seem quite prudent for an agency entrusted to protect the public and were seen as out of the ordinary only by the Citi analyst. (Note that there are 30 other investment analysts who cover Amylin who were not the least concerned about those provisions in the letter which, again, communicated APPROVAL for EXPANDED

In fact, it is routine for the FDA to request additional study and monitoring whenever there is a POSSIBLE safety issue associated with an approved drug. That's why FDA has an extensive watch and alert system. Some of the studies requested in the FDA letter have already been completed, and others were well underway when the letter was received. It was irresponsible for Citibank analysts to provide only a part of the story...and one must wonder why???

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