Sanofi-Aventis reportedly told a conference call on Friday that it has filed for European and US approval of its novel anti-obesity drug, Acomplia (rimonabant), which also doubles up as a smoking cessation pill. Acomplia has been touted as the company’s next star turn in a pipeline currently headed by the clotbusting agent Lovenox (enoxaparin), with peak sales forecast at between $2 and $3 billion [[07/09/04g]].
A launch could come as early as the fourth quarter, but depends on whether Sanofi-Aventis will try and secure fast-track approval in the USA – a facility that permits a quicker path to market for drugs of great medical need. However, the timing is particularly important as Sanofi-Aventis is currently facing a generic challenge to its super-aspirin Plavix (clopidogrel), its second best selling drug in the first quarter, reaping 468 million euros [[10/05/05d]], [[13/05/05a]].
Acomplia would enter a market already occupied by the likes of Roche’s Xenical (orlistat) and Abbott’s Meridia (sibutramine). However, sales of some of these compounds have been hampered by concerns over side effects [[13/04/05b]], [[04/09/03d]], leaving the door wide open to new offerings in the marketplace. According to research published in The Lancet earlier this year, patients given Acomplia 20mg saw three times as much weight loss compared to placebo receivers. The drug also produced significantly greater improvements than placebo in waist circumference, HDL-cholesterol (the so-called “good” cholesterol), triglycerides, and insulin resistance, with only mild side effects [[18/04/05f]].