Sanofi Faces Generic Plavix Threat in Europe

Sanofi-Aventis, which briefly faced generic competition to its second-biggest product Plavix in the United States in 2006 and 2007, now faces a similar threat in Europe.

Schweizerhall, a generic drug company based in Basel, said on Friday it was close to winning approval for a generic version of the blood-thinning drug in Germany and Luxembourg.

It hopes to launch the cut-price generic medicine before the end of June.

The news sent shares in the French company -- the world's third-largest drugmaker by sales -- down by 5.9 percent, making them one of the biggest blue-chip losers in Europe, with trading volume matching the 30-day average.

"Obviously, generic competition would be a most unwelcome development," said Mike Ward, a pharmaceuticals analyst at Nomura Code Securities.

A spokesman for Sanofi said its blockbuster medicine was protected by patents until 2013.

But Schweizerhall said it was close to launching a generic version in association with partners.

"We expect shortly a positive ruling from the German authorisation agency for medicines and we plan to launch clopidogrel (generic Plavix) throughout the European Union in co-operation with marketing partners," Chairman Luzi von Bidder said in a statement on the company's website.

"A first license agreement with a major generics company has been concluded and the signing of a contract with another generics provider is imminent. We expect first sales in the current quarter," it said.

Generic clopidogrel may also obtain marketing authorisation in Luxembourg in the second quarter of 2008, the company added.

$3 Billion Market

Schweizerhall said the European market for clopidogrel was about 3.2 billion Swiss francs ($3.03 billion), of which Germany accounted for 600 million Swiss francs.

The generic form of Plavix was developed by Cimex, a specialty generics business of Schweizerhall.

WestLB analyst Oliver Kaemmerer said the move was unexpected, since Europe did not have a history of patent challenges in the same way as the United States.

"Usually in Europe, you don't have any patent challenges," he said.

"It is awkward to me that there is only one company, Schweizerhall, that would be able to launch a generic.

Usually, there are many rivals." Plavix, which is marketed in the United States in partnership with Bristol-Myers Squibb, suffered a dramatic sales decline after Apotex launched a generic form of the medicine in August 2006.

Although a New York federal judge blocked the sale of the generic weeks later, the huge supplies already on the market undermined sales of Plavix through early 2007.

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