Sanofi aims to show there's still life in Acomplia
PARIS, Sept 17 (Reuters) - Sanofi-Aventis (SASY.PA) suffered a body blow in June when its key anti-obesity drug Acomplia was rebuffed in the United States -- but the world's third biggest drugmaker announced ambitious plans on Monday to fight back.
The French group said it would begin new clinical trials of the medicine as a treatment for type 2 diabetes, which is closely linked with obesity.
"I'm confident in Acomplia because it is a unique product," research head Marc Cluzel told reporters at an R&D presentation.
U.S. experts had recommended against approving the product as a treatment for diabetes after linking it to suicidal thoughts and depression.
Sanofi is to broaden substantially its clinical trial programme for the drug in diabetes with more than 5,700 patients involved in tests.
The plans include a head-to-head trial of Acomplia against Merck & Co's (MRK.N) recently launched Januvia, which will begin in the first quarter of 2008.
Cluzel said tests showed Acomplia had a powerful effect on reducing HbA1c -- a common measure of blood sugar levels -- which was comparable to oral anti-diabetic drugs, while also having the advantage of helping diabetic patients lose weight.
Sanofi hopes to submit Acomplia worldwide as a treatment for diabetes in 2009, with a fixed combination of Acomplia plus the older diabetes drug metformin slated for filing 2010. There are also plans for submission of a combination of Acomplia and cholesterol-lowering statin drug in 2011.
All that should keep Acomplia on the radar screen in the coming years but it may still leave it lagging behind rivals, since Merck has a similar obesity treatment using the same mode of action that analysts believe could be filed for approval in 2008.
Acomplia -- also known by the brand name Zimulti in the United States and generically as rimonabant -- is the first in a new class of drugs that switch off the same brain circuits that make people hungry when they smoke cannabis.
Its unique biochemical effect and ability to reduce several risk factors for cardiovascular disease initially led to predictions it would become a multibillion-dollar-a-year blockbuster.
But, although available in Europe since last year, sales to date have been modest and analysts question whether it will ever become a big seller, given its troubled history and the risk of depression highlighted by U.S. medical experts.
