From Australia comes word that San Diego-based Amylin Pharmaceuticals’ biggest drug, exenatide (Byetta), has been caught up in a controversy over a diabetes report co-sponsored by Amylin’s marketing partner, Eli Lilly & Co.
The study, compiled by researchers at the University of Canberra’s National Centre for Social and Economic Modelling (NATSEM), warned that 1.6 million Australians would be diagnosed with diabetes by 2050, according to an account in The Australian. Over the next 40 years, according to the study, people with type 2 diabetes would have 270,000 heart bypass operations, 250,000 strokes, and 750,000 cases of kidney complications.
Although the study mentioned exenatide, the generic name for Byetta, only in a footnote, it asserted that drugs in the same class as exenatide could produce greater health improvements for diabetic patients than exercise or existing drugs. And that seems to have sparked a bit of a controversy Down Under.
The newspaper reports that some experts were concerned that the report was part of a marketing push to win public subsidies for the medication. Australia’s Public Benefits Scheme recommended the drug for inclusion last year, but the federal government has yet to respond. This means exenatide is available only on private prescription at a relatively high cost. Consequently, it is not widely used.
NATSEM defended the integrity of the research, saying the projected increase in type 2 diabetes was a legitimate concern. Lilly was one of seven organizations to support the research. “As an independent research organization, the last thing we want to do is compromise our position, and for people to regard the position we are taking as biased towards the funding body,” NATSEM research director (health) Laurie Brown told the newspaper. The account came to my attention through the Pharmalot blog.
Lilly is responsible for developing and commercializing Amylin’s diabetes drug outside the U.S. The partnership agreement calls for Lilly to pay Amylin a royalty on non-U.S. sales after a one-time cumulative gross margin threshold amount is met. Amylin told investors in June that it expected to begin receiving royalty payments in 2010. Operating profits from exenatide sales in the U.S. are shared equally by the two companies. Amylin reported exenatide sales of $503.9 million for the first nine months of 2009, compared to $515.9 million during the same period a year earlier.