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Plavix faces generic challenge in Germany

Published on 16/05/08 at 01:06pm

Sanofi-Aventis and Bristol-Myers Squibb are feeling the heat from a Swiss drugs company which intends to market a generic version of the their blood-thinning blockbuster Plavix (clopidogrel).

Generics company Schweizerhall Holding says it will launch its own version of clopidogrel in the £300 million German market and suggests that approval, which had been thought unlikely, could also follow in Luxemburg by the summer.

The company is preparing applications for approval in other European countries and its strategy could have a significant impact on the £1.6 billion European market for clopidogrel.

It is not the first time Plavix's manufacturer Sanofi: the company suffered a dent in its $3.3 billion sales in the US in 2006, where it co-markets the drug with BMS, because of competition from Canadian generics manufacturer Apotex.

Used to prevent or treat cerebrovascular disease, coronary artery disease and peripheral vascular disease, clopidogrel works by stopping blood platelets massing together, thus inhibiting the formation of blood clots.

The drug, marketed in Germany as Plavix by Sanofi and Iscover by BMS, still has EU regulatory data protection and Sanofi said it was "currently evaluating its legal and regulatory options and will vigorously defend intellectual property rights, including patent protection, in Germany".

Although European patents on Plavix do not expire until 2013, Sanofi shares fell more than 5% after Schweizerhall's announcement.

Schweizerhall claims that a first licence agreement with 'a major generics company' has been concluded and the signing of a contract with another generics provider is imminent. It said the first sales of its cheaper version would come in this quarter.

"We expect shortly a positive ruling from the German authorisation agency for medicines and we plan to launch clopidogrel throughout the European Union in cooperation with marketing partners," said Schweizerhall's chairman Luzi von Bidder.

The clopidogrel business is being done through Schweizerhall's subsidiary Cimex, which specialises in solid slow-release forms. Based in Basel, the £88 million turnover company employs 320 staff.

Plavix was recently approved in a 300mg dose in Europe, a move which the marketers say may help increase appropriate early use of the drug. But the Plavix generics debate has not been a happy one for Sanofi and BMS in recent years.

The Apotex issue claimed a high profile scalp when BMS chief executive Peter Dolan was forced to resign after the company's legal advisor called for his dismissal in connection with his part in the affair. BMS and Sanofi were investigated by US government anti-competition watchdogs over an aborted deal to pay Apotex to delay the generic version. The Canadian company had five days to market the drug before a court order forced it to stop, by which time it had flooded the US market.

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