[NPInfo] Byetta

[David Mittman]

If you read the headline below you think the drug has some serious  
side effects.
Then you read the article and see that of the last 4 people,all died  
of really non related things.
Dave

More Business news
Amylin reports four more deaths tied to diabetes drug



By Terri Somers
UNION-TRIBUNE STAFF WRITER

7:19 p.m. August 26, 2008

SAN DIEGO – Amylin Pharmaceuticals on Tuesday reported an additional  
four deaths among patients taking its diabetes drug, Byetta, although  
the deaths could be attributed to other causes.
Two of the patients died after complications from gallbladder surgery,  
while a third died after a relapse of leukemia, company officials  
said. The San Diego company still has not gotten additional  
information on the fourth death.

It was the second round of negative news in a week for Amylin and its  
Byetta development partner, Eli Lilly. On Aug. 18, the Food and Drug  
Administration announced that six people taking the drug had developed  
acute pancreatitis, and two of them died.

The company had reported the death of all six Byetta patients to the  
FDA prior to its announcement last week. The regulatory agency did not  
mention the four cases revealed Tuesday, because it was focusing on  
the acute cases of pancreatitis, which can cause scarring of the  
pancreas or bleeding and lead to death, the companies said.

Byetta, the top-seller of Amylin's two marketable products, has not  
been found to be the cause of any of the deaths or pancreatitis.  
However, the companies said they are pursuing a review of all the  
cases, as well as clinical and epidemiological studies to determine  
whether there is an association.

The additional deaths were revealed on a day the companies held a  
conference call to try to boost the reputation of its drug for type 2,  
or adult onset, diabetes, which is responsible for 90 percent of its  
product revenue.

Amylin's shares have dropped about 20 percent in the past week. The  
shares fell 53 cents to close at $27.24 Tuesday, then dropped an  
additional $2.44 to $24.80 in after-hours trading.

Lilly shares fell 52 cents to $46.50.

Prescriptions for the twice-daily Byetta fell 2.1 percent last week,  
according to pharmaceutical data firm IMS Health.

Byetta has been used by more than one million people and the incidence  
of people taking it who developed pancreatitis, a painful swelling of  
the pancreas, is no higher than the incidence of the ailment in the  
general population, said Orville Kolterman, Amylin's senior vice  
president of development.

About one in 3,000 people with diabetes develops pancreatitis, and  
about one in 3,000 people using Byetta developed pancreatitis,  
Kolterman said.

People with type 2 diabetes have nearly three times as much risk of  
developing pancreatitis as people without diabetes, Kolterman said.  
Other known risk factors are a previous history of pancreatitis,  
gallstone disease, alcohol abuse and high triglycerides, he said.

The companies have a once-weekly version of Byetta under development.  
In the conference call Tuesday, analysts questioned company executives  
about whether they thought it now would be harder to get regulatory  
approval for the long acting version of the drug. The company hopes to  
file for regulatory approval of that drug in mid-2009.

“We haven't seen a case of pancreatitis in the (long acting version)  
with over 600 patients exposed now,” Kolterman said.

The companies and the FDA are working together to “ensure thatour  
Byetta product label continues to provide physicians and patients  
withinformation about the risk of pancreatitis,” Amylin officials said  
last week.

The Byetta label was updated in October to include the risk of  
pancreatitis. The FDA cited 30 reports of pancreatitis in Byetta  
patients and said the drug was suspected in some cases. Amylin alerted  
doctors.

Canaccord Adams analyst Adam Cutler said the company was trying to  
make a case for why pancreatitis is unlikely to be caused by Byetta,  
“yet the FDA is concerned.”

Given the FDA's concerns, Cutler said: “I'm wondering whether they  
will have to do longer, larger, safety trials” of the version that is  
designed to stay in the body for a full week. Such a decision could  
significantly delay the drug reaching the market.