Sanofi-Aventis has put back the anticipated launch date for its obesity drug Acomplia, but still believes it should be on the market by the end of 2006.
The Franco-German company was sent an approvable letter for Acomplia (rimonabant) by the US Food and Drug Administration (FDA) last week, making a delay in approval inevitable. Sanofi-Aventis had originally scheduled a launch in the first half of this year, but said yesterday this has slipped to the second half.
Crucially, Sanofi-Aventis confirmed that the FDA has not asked for an additional clinical trial to support approval of Acomplia in obesity, but another will be needed to support its approval in smoking cessation, an indication rejected by the agency outright.
The firm said it was committed to developing Acomplia for both indications.
Meanwhile, Sanofi Aventis reported net earnings up over 20% in the fourth quarter of 2005 to 1.44 billion euros ($1.71bn), helped by cost-savings from the merger of Sanofi and Aventis in 2004. The company posted its sales figures for 2005 at the end of January.
The company said earnings per share rose 26% to 4.74 euros in 2005, but added EPS growth would slow to 10% this year, held back by the onset of generic competition to four products, the antihistamine Allegra (fexofenadine), diabetes drug Amaryl (glimepiride), Arava (leflunomide) for arthritis and DDAVP (desmopressin).
Acomplia is an important element in Sanofi-Aventis’ strategy to overcome the loss of sales of these products, along with additional cost-cutting measures valued at 1.6 billion euros this year.
The company is also facing the threat of generic competition to its two top-selling drugs, Plavix (clopidogrel) and Lovenox (enoxaparin), while other big sellers such as the cancer drugs Taxotere (docetaxel) and Eloxatin (oxaliplatin) and Avapro (irbesartan) for high blood pressure could also come up against copycat rivals over the next few years.