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Friday May 9, 07:25 PM

Sanofi hit by talk of Plavix generic

By Andrew Jack in London

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Shares in Sanofi (Paris: FR0000120578 - news) -Aventis, the French pharmaceutical group, fell nearly 6 per cent on unexpected indications that
Germany and Luxembourg may authorise the launch of generic equivalents of its blockbuster blood-thinning treatment Plavix in the next few months.

Schweizerhall, a small Swiss-based speciality drugs business, said it expected the German medicines agency to give a positive opinion "shortly" on a version of the drug known generically as clopidogrel, and the decision could be followed by a similar authorisation in Luxembourg during the second quarter of the year.

If successful, the launch would sharply cut into Sanofi-Aventis' sales up to five years ahead of the company's patent expires in Europe on Plavix, which generates annual revenues from Germany alone in excess of $500m.

Sanofi-Aventis said in a statement that it was "evaluating its legal and regulatory options" and would "vigorously defend" its intellectual property rights. It stressed that Plavix still enjoys data exclusivity within the EU, which provides additional protection on the launch of generic rivals.

However, analysts said that although the European patents on Plavix did not expire until 2013, Sanofi-Aventis did not hold patents on a different version of clopidogrel based on an alternative salt form of the compound which is more difficult to convert into a tablet which releases the active ingredient of the medicine at the right rate. They added that its data exclusivity also ran out shortly.

Schweizerhall said it had already agreed a license with one generics company and another was under discussion.

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