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Amylin Releases Questionable Byetta Study in Attempt to Take Focus From Pancreatitis Risk

Sep 10, 2008 | Parker Waichman LLP

Byetta maker, Amylin Pharmaceuticals, is trying to save the diabetes drug's reputation by touting a new study that shows it to be more effective than a rival medication.  But at least one drug industry analyst has characterized the research - which compares Byetta to Januvia - as a "marketing study" meant to focus attention away from Byetta's association with pancreatitis.

Byetta was approved by the Food & Drug Administration (FDA) in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels.

On August 18, the FDA said that Byetta had been linked to 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.  Then, on August 26, Amylin announced that four additional fatalities had been confirmed in Byetta patients suffering from milder forms of pancreatitis.

Obviously, the news surrounding Byetta and pancreatitis does not bode well for sales of the drug, which is taken by 700,00 Americans.  The side effects reports also have endangered prospects for a once-weekly, long-acting form of Byetta that Amylin had hoped would be approved by 2010.  Most drug industry analysts expect that the  FDA will now want more information on the new version's side effects before it makes a decision.

The bad Byetta news is taking a toll on Amylin.  According to a report on Forbes.com, the company's shares have fallen 44.2% since the pancreatitis news broke in mid-August.

In an attempt to mitigate the damage done to Byetta's reputation, Amylin released a study at European Association for the Study of Diabetes in Rome on Tuesday that compared Byetta with Merck's diabetes treatment Januvia. According to Forbes.com, the study appears to show that Byetta is more potent than Januvia, which is made by Merck & Co.

One analyst told Forbes.com that the study is an attempt by Amylin to salvage its once-promising Byetta.  "This is clearly a marketing study to give their reps more stuff to talk about," said Natixis Bleichroeder analyst Jon LeCroy. "You wouldn't do this study unless you knew your drug was better."

Other sources told Forbes that there are also some problems with the study.  For one thing, Byetta and Januvia are very different drugs.  According to Forbes.com, Januvia is a once-daily pill in the DPP-IV inhibitor class of drugs that is normally prescribed by primary care physicians to patients experiencing the earlier signs of type 2 diabetes. Byetta, a twice daily injectable of the GLP-1 class of drugs, is usually prescribed by a specialist for people with advanced cases of type 2 diabetes that need the added effects of weight loss and appetite suppression.

It also does not appear that Januvia carries the same risk of pancreatitis found with Byetta.  According to Forbes.com, in a client note published late last week, Yaron Werber of Citi Investment Research said that of every 100,000 patients who took Byetta, about 6.49 developed acute pancreatitis.  The rate of pancreatitis in Januvia patients was only 1.61 out of 100,000, he said.  The Forbes report said Werber based this information on the total number of prescriptions written for the drugs.


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