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Recent drug trials, and marketing efforts in Europe, for Acomplia indicate that Sanofi-Aventis may be seeking a life-threatening indication for its much-hyped weight-loss drug.
Could Acomplia be the next diabetes drug?
Sanofi-Aventis appears to be saying "yes"--at least in Europe, where it has been approved since June as a weight-loss agent. The company also seems to be building an arsenal of data to promote the drug's anti-diabetic benefits if and when the drug gets approved in the United States.
Sanofi-Aventis' recently completed Serenade trial--the second to look at Acomplia's (rimonabant) effect on blood-sugar levels--showed that the drug not only helped patients with weight loss, but also lowered blood sugar. Type 2 diabetics taking the cannabinoid type 1 receptor blocker had better blood sugar and weight control, higher HDL levels, and lower triglycerides than patients taking a placebo.
Spokeswoman Julissa Viana would not comment on whether the company would seek to market Acomplia as a treatment for diabetes or pre-diabetes. But company officials have been positioning Sanofi-Aventis as a growing player in the $20 billion global diabetes market. In a presentation at last month's Credit-Suisse conference in London, two executives from marketing and medical affairs outlined studies on how Acomplia reduces heart risks.
There are big bucks at stake. While some European countries are reimbursing Acomplia, other major markets--Germany, most notably--are not. If Sanofi-Aventis wants to get the drug on Europe's publicly funded formularies, it needs to position the drug as more than a lifestyle treatment. A diabetes indication would likely do the trick.
Viana noted that reimbursement considerations were not the reason the company undertook the study. "The purpose of the program was to add to our knowledge," she said. "There's value in pursuing additional trials."
The blood-sugar data has also been used to win over physicians, and diabetes specialists and cardiologists have been core audiences for professional promotion efforts. Marketing messages have focused on how obese patients with heart risks will have a greater benefit from Acomplia than those who take the drug only for cosmetic reasons.
Marketers are also trying to reinforce those messages to European patients. Through the company's "It's What You Gain" program, patients have access to a Web site and phone number, motivational tools, and educational information about Acomplia.
Sanofi-Aventis, which works with a number of Publicis agencies across many of its brands, including Acomplia, in February received an approvable letter from FDA for Acomplia's weight-loss indication; additional information was submitted in late October. The user fee goal is April 26, 2007, according to the company.