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Generic Plavix challenge hits BMS and Sanofi forecasts

Published on 05/09/06 at 12:07pm

A US district court has granted an injunction to stop sales of the generic version of  blood-thinner Plavix,  the world's second best selling prescription drug.

Despite the court ruling, co-marketers Sanofi-Aventis and BMS have both slashed their full-year profit forecasts because of the damage already inflicted by generic challenger Apotex.

District court judge Sidney Stein ruled that Apotex was insufficiently persuasive when it argued that it could prove the drug's patents were invalid.

But crucially, the court has not ordered Apotex to recall products already sold or shipped, meaning its generic Plavix, which has flooded the market, can remain to seize a huge swathe of sales.

Meanwhile, the bitter court battle looks set to continue, with Apotex to appeal against the court ruling.

Speaking to the Toronto Globe and Mail, Barry Sherman, the founder and chief executive of Apotex, said: "He [the judge] went in favour of everything. None of it makes sense to us."

Mr Sherman told the Globe and Mail that Apotex has sought an emergency stay of the ruling so it can continue to sell its generic version of the drug until a civil case is heard. It is understood a trial hearing has been set for Monday, 22 January 2007.

Apotex launched a 75mg generic version of Plavix (also known as clopidogrel bisulfate) on 8 August, threatening the $3.3 billion sales co-marketers Sanofi-Aventis and BMS earn from the drug in the US every year.

On 14 August, the two drug companies sought an injunction against the Apotex product, arguing that it infringed their intellectual property rights.

Last March, the two drug companies struck a deal with Apotex to pay it not to market a generic version of Plavix until mid- 2011  about six months before its maximum patent expiry life - but this arrangement was rejected by US regulators, giving Apotex the chance to launch an at-risk generic.

The US court has ordered the co-marketers to post a bond worth $400 million to provide security to Apotex should next January's patent litigation rule that the injunction was imposed wrongly.

Plavix is used to prevent blood clots that can cause heart attacks or strokes, and sales reached $5.9 billion in 2005,  accounting for about 30% of BMSs annual earnings per share and 15% for Sanofi-Aventis.


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