IHS Global Insight Perspective | |
Significance | Up to 12 generic competitors have reportedly filed for approval to market versions of Plavix (clopidogrel bisulphate) in Europe, despite Sanofi-Aventis's main patent on the drug being valid until 2013. |
Implications | Swiss firm Acino has been marketing a generic version of Plavix in Germany since last August, sidestepping patent laws by mixing its active ingredient with a different salt. Other companies are now trying to mimic this formula to gain a slice of this lucrative market. |
Outlook | Generic competition is inevitable for Plavix, but its potential early arrival in Europe will put more pressure on Multaq (dronedarone) and other new drugs to be successful in order to minimise losses. |
A dozen generic drug makers are seeking European marketing approval for copy versions of Plavix (clopidogrel bisulphate), the blockbuster anti-platelet treatment produced by French pharmaceutical giant Sanofi-Aventis. Among those awaiting a verdict from the European Medicines Agency (EMEA) are Biogaran (France), Mylan (U.S.), Ranbaxy (India) and Acino (Switzerland). European patent protection on Plavix is only set to expire in 2013, two years after the drug's U.S. patent protection ends in November 2011. Plavix was the second highest-selling drug in the world in 2008, bringing in some 2.6 billion euro (US$3.6 billion) in global turnover for Sanofi-Aventis.
According to French newspaper Les Echos, generics companies are hoping to sidestep the technicalities of Plavix's European patent protection by mixing the drug's active ingredient, clopidogrel, with a different salt, such as besylate or hydrobromide. Sanofi-Aventis has described these versions of clopidogrel as not offering as wide a range of therapeutic indications as the original Plavix, but has acknowledged that they do pose a threat to the company's existing patent protection. Acino, which has been selling its generic clopidogrel in Germany since August 2008, reported in January that the generic had captured a quarter of the German market for the drug by the end of last year (see Germany: 29 January 2009: Generic Clopidogrel Grabs 25% of German Market, Boosts Acino's 2008 Results).
In the United States, where Sanofi-Aventis co-markets Plavix with Bristol-Myers Squibb (U.S.), Plavix saw sales soar by 21% year-on-year (y/y) in 2008, bouncing back successfully from a protracted legal battle with Canadian generics company Apotex (see France: 20 June 2007: Early Relief for Sanofi-Aventis, BMS as U.S. Judge Rules in Favour of Plavix Patent).
Outlook and Implications
With 12 separate generic versions reportedly seeking European Union approval, Sanofi-Aventis runs the risk of seeing the European market share of its second top-selling product erode still further before the year is out. However, following the decision by Israeli firm Teva in April to withdraw the European application for its generic version of Plavix, other companies may begin to reassess their chances of approval (see Israel: 24 April 2009: Teva Withdraws EMEA Generic Plavix Marketing Application).
Following a full-year decline in net sales witnessed during 2008, Sanofi-Aventis relied mainly on favourable currency effects to boost its first-quarter turnover this year, meaning that its performance in terms of growth is still fragile and susceptible to risk (see France: 29 April 2009: Sanofi-Aventis Posts 2.5% Y/Y Sales Growth in Q1, Drops 14 R&D Projects). Plavix's global sales growth is also beginning to slow. Within its cardiovascular franchise, Sanofi-Aventis's biggest hope of a possible replacement for Plavix's revenue is Multaq, the atrial fibrillation treatment that is currently awaiting final approval from the U.S. FDA (see France: 5 May 2009: Sanofi-Aventis Reassures on Multaq Approval as FDA Action Date Slips By). Delays to Multaq's approval risk harming the company's top-line growth, as Plavix's massive sales revenue cannot be replaced overnight.
Elsewhere in the pipeline, Sanofi-Aventis is renewing investment in anti-viral vaccines through new projects for its Sanofi Pasteur division (see France: 13 May 2009: Sanofi Pasteur to House Production of Dengue Vaccine at Home in France and France: 8 May 2009: FDA Licenses Sanofi Pasteur's U.S. Production Base for Seasonal 'Flu Vaccines). It is also making long-term investments in its oncology pipeline, as recently evidenced by its acquisition of rights to chronic lymphocytic leukaemia (CLL) drug fludarabine from U.K. biotech Antisoma (see France: 12 May 2009: Sanofi-Aventis Buys U.S. Rights to Antisoma's Oral CLL Treatment Fludarabine for US$65 mil.).