Concerns About Byetta Deaths Lead Amylin to Cut Work Force
November 12th, 2008 • Filed Under: News • 4 Comments
Amylin Pharmaceuticals announced yesterday that they are cutting their work force by 25 percent following unexpectedly slumping sales for their once promising diabetes drug Byetta, which has recently been associated with 6 deaths caused by severe cases of pancreatitis.
Byetta (exenatide) is a synthetic incretin mimetic, which is sold in a pre-filled pen by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. The drug was approved by the FDA in 2005 as a twice-daily injection to help treat type 2 diabetes.
After it was introduced, Byetta sales grew consistently, reaching $636 million by 2007. Earlier this year, analysts had hoped for further sales increases with a new long-acting version of the drug that would be injected only once a week. However, a recent response from the FDA indicates that the new drug application for this longer-acting Byetta will likely be delayed from June 2009, until late 2010 or early 2011.
Over the past year, concerns have emerged about a potential connection between Byetta and deaths from pancreatitis among several users, causing sales for the drug to fall.
In October 2007, Amylin agreed to update the precautions section of the Byetta warning label with information about 30 post-marketing reports of individual who developed acute pancreatitis while on the drug.
In follow up to that warning, the FDA announced on August 18, 2008 that at least six cases of severe necrotizing pancreatitis and hemorrhagic pancreatitis had been associated with Byetta, including two deaths. During a telephone conference on August 25, 2008 in response to the FDA report, Eli Lilly and Amylin disclosed that they had notified the FDA of at least four additional Byetta deaths from pancreatitis among users of the drug.
Although Amylin and Lilly deny that there is any confirmed causal connection between the pancreatitis deaths and Byetta, several analysts have speculated that the FDA is considering adding a black box warning about the potential risk, which is the strongest warning that can be added to a prescription medication that remains on the market. This warning would likely deal a further set-back to Byetta sales.
“We’ve made a difficult, but necessary, decision as a result of factors affecting our business,” said Daniel M. Bradbury, president and CEO of Amylin in a statement released November 10, 2008 announcing the staff cut-backs. “Sales revenues have not met the expectations we had when we scaled up our organization.”
Amylin will be terminating 340 employees to reduce its work force by approximately 25 percent, and reduce projected 2009 cash expenditures by more than $80 million. This will leave about 900 employees for the drug maker in San Diego and 1800 employees worldwide.
Comment by Michael on 12 November 2008:
About 800 diabetics die daily and are on many different drugs. Byetta does not cause pancreatitis! If it did, more would get pancreatitis and more would dead. Duh!
Diabetics get pancreatitis while taking many different drugs such as metformin, januvia, pranding and others, and many people on byetta have failed other drugs and have had pancreatitis prior to using byetta, and probably got it again, while many got better while using byetta. It helps to lower blood sugar for many and help them to lose alot of weight. I know because I have seen the success and see alot of prescriptions, since I am a pharmacist at a very large mail order facility. Sure I also own the stock, but I bought it way before the drugs were approved and saw in the clinical trials that byetta was proven safe and relatively no serious side effects, which goes to show that those very ‘few’ cases had other issues such as cancer, severely obese or other! Do a little due diligence and you will know the truth!
Comment by Sarah on 12 November 2008:
As a diabetes educator, I am appalled at your transparent attempt to link the job restructuring at Amylin to reports of associations between Byetta and pancreatitis. Either your law firm understands little about science or you are irresponsibly promoting your firm’s frivolous litigation practices. When analyzed properly without intentional distortion, data show that the incidence of pancreatitis may be less with people taking Byetta than that occurring in the general population. That having been said, I would imagine that when Amylin opens its Ohio plant to produce the extended release version of its effective first in class drug (which, by the way, was endorsed as an important treatment for Diabetes by a recent panel of diabetes experts) you will find a way to publish a press release linking that event to something negative.
Comment by Ilena on 13 November 2008:
As a physician, trying to tie Byetta to pancreatitis is sheer folly. In fact patients on Byetta have LOWER incidents of pancreatitus.
Ever see the aspirin FDA event sheet where thousands die yearly? This is hype. the 6 SIX were alcoholics etc ,the drug is amazingly safe.Amylin cut backs are due to the “injectible”Byetta a great drug that diabetics resist because they have to pen inject twice a day.
Comment by Jon on 13 November 2008:
I couldn’t believe this headline…I think someone has an agenda here.
There is no causality between Byetta and pancreatitis. This article is irresponsible…I think the author should spend less time chasing ambulances and more time at journalism school.