Replies to post #106923 on Biotech Values

[turtlepower]

However, there is no pressing reason to approve Bydureon immediately.

I think the once weekly is a big advantage in terms of cost when compared to the other two drugs, given the info below about diabetes patients in the US. Victoza also has a black box cancer warning so there will be patients leery about taking it.

Diabetes to double or triple in U.S. by 2050: government

WASHINGTON | Fri Oct 22, 2010 7:48am EDT
(Reuters Life!) - Up to a third of U.S. adults could have diabetes by 2050 if Americans continue to gain weight and avoid exercise, the Centers for Disease Control and Prevention projected on Friday.

The numbers are certain to go up as the population gets older, but they will accelerate even more unless Americans change their behavior, the CDC said.

"We project that, over the next 40 years, the prevalence of total diabetes (diagnosed and undiagnosed) in the United States will increase from its current level of about one in 10 adults to between one in five and one in three adults in 2050," the CDC's James Boyle and colleagues wrote in their report.

"These are alarming numbers that show how critical it is to change the course of type-2 diabetes," CDC diabetes expert Ann Albright said in a statement.

"Successful programs to improve lifestyle choices on healthy eating and physical activity must be made more widely available because the stakes are too high and the personal toll too devastating to fail."

The CDC says about 24 million U.S. adults have diabetes now, most of them type-2 diabetes linked strongly with poor diet and lack of exercise.

Boyle's team took census numbers and data on current diabetes cases to make models projecting a trend. No matter what, diabetes will become more common, they said.

"These projected increases are largely attributable to the aging of the U.S. population, increasing numbers of members of higher-risk minority groups in the population, and people with diabetes living longer," they wrote.

Diabetes was the seventh-leading cause of death in the United States in 2007, and is the leading cause of new cases of blindness among adults under age 75, as well as kidney failure, and leg and foot amputations not caused by injury.

"Diabetes, costing the United States more than $174 billion per year in 2007, is expected to take an increasingly large financial toll in subsequent years," Boyle's team wrote.

http://www.reuters.com/article/idUSTRE69L21Y20101022

[DewDiligence]

Re: Bydureon debacle

…there is no pressing reason to approve Bydureon immediately. There are Byetta, Victoza already on the market. It's not going to be approved unless the question is resolved. As one FDA official said, the 3rd and 4th drug in the same class are tougher to get approved.

The commercial relevance of Bydureon just got even slimmer insofar as Bydureon failed show non-inferiority to NVO’s Victoza in AMLN’s own head-to-head study:

http://finance.yahoo.com/news/DURATION6-TopLine-Study-prnews-1873207569.html?x=0&.v=1

The mean reduction HbA1C was 1.5% for Victoza and 1.3% for Bydureon.