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Amylin shares fell $6.76 to close at $20.48.That puts Amylin's total stock value at $2.81 billion, nearly $2 billion less than on the close of trading Friday, Aug. 15. The following Monday, Amylin and marketing partner Eli Lilly announced that two Byetta patients died from severe pancreatitis, which can cause nausea, vomiting and abdominal pain.
The tragic development underscores just how risky biotech can be, even when success seems assured.
Amylin is one of San Diego County's largest biotech companies. It reported that Byetta sales reached $178 million worldwide in the second quarter, compared with $152 million in the same quarter a year ago. Byetta, derived from Gila monster saliva, was approved for sale in April, 2005.
The four newly reported deaths were previously known to federal regulators, said James Malone, medical director of Eli Lilly, an Indianapolis-based pharmaceutical company. The deaths had not been announced as being possibly linked to Byetta because the patients had a milder form of pancreatitis. Lilly decided to report them out of caution, Malone said.
Biotech companies face formidable odds from the outset. It takes an estimated $800 million on average to take drugs through the lengthy clinical trial process of testing in humans. That high cost reflects the low success rate: Only about 20 percent of drugs that enter human testing succeed.
However, as the case with Byetta and many other popular drugs, even a successfully approved drug can run into disaster once it's introduced into the general population. When that happens, it's also a disaster for the company.
August begin with a similar debacle concerning Tysabri, a drug for multiple sclerosis. Tysabri was developed by Biogen Idec, a Cambridge, Mass.-based company with offices in San Diego. On Aug. 1, the company reported two cases of a potentially fatal brain disease, progressive multifocal leukoencephalopathy, or PML, in Tysabri patients.
Shares of Biogen Idec dropped 28 percent that day.
In 2005, the same disease occurred in a handful of Tysabri patients, causing one death. Biogen Idec and marketing partner Elan Corp. plc of Ireland suspended sales while the cases were investigated. Tysabri was reintroduced three months later with stronger label warnings.
One reason for post-approval drug problems is that clinical trials typically involve a fairly small fraction of potential users. Harmful effects that occur very infrequently may not be detected during testing.
Another possibility is that patient deaths or injuries are not related to the drug.The deaths could be within the range of statistical expectations for the thousands of people who have taken Byetta. Amylin says that patients with Type 2 diabetes, the kind treated with Byetta, are nearly three times more likely to develop pancreatitis than people without diabetes.
Byetta works with insulin to help control blood sugar levels. Control of blood sugar is important in diabetics, because serious health problems result when levels fall too low or rise too high.
Dr. George Bailey, medical director of the Scripps Whittier Institute for Diabetes, said he will continue prescribing Byetta. Bailey said he cautions patients who get symptoms of pancreatitis to take a blood test that can diagnose the disease.
The news of deaths among Byetta patients come from a medical reporting system that errs on the side of caution, Bailey said. In one case, Bailey said he has heard that the patient had stopped using Byetta four months before death. That long a delayed reaction to the drug is a remote possibility, but "conceivable," Bailey said.
The Associated Press contributed to this story.
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