Generic Upstart Rattles Sanofi

LONDON -

Europe is not a traditional venue for patent battles in the pharmaceutical industry, but that is precisely where Sanofi-Aventis now faces a generic threat to its blood-thinning blockbuster Plavix.

The threat at the moment is limited to Germany, where Swiss generics manufacturer Schweizerhall shortly expects approval for its generic version of Plavix. But Basel-based Schweizerhall added on Friday that it could obtain marketing authorization in Luxembourg over the next two months, while applications for approval elsewhere in Europe were “in preparation.”

The chairman of Schweizerhall, Luzi Andreas von Bidder, told Forbes.com: “We are not infringing on any rights or patents, to the best of our knowledge, and the knowledge of our advisers.” He refused to comment on whether this announcement was designed to pressure Sanofi-Aventis (nyse: SNY - news - people ) into striking a deal.

Shares in Sanofi-Aventis dropped 2.43 euros ($3.76), or 4.8%, to 48.02 euros ($74.26), during midday trading in Paris. The company markets Plavix in partnership with Bristol-Myers Squibb (nyse: BMY - news - people ) and maintains that the drug is protected by a European patent in place until 2013.

“I think the share price reaction is somewhat overdone,” said Oliver Kammerer, analyst with WestLB Research. “If you put it into perspective, Sanofi-Aventis generates 200 million euros [$309.3 million] in revenue in Germany, and global sales of 2.7 billion euros [$4.2 billion]. We’re talking about 7.4%.”

Shares in Schweizerhall Holding jumped 9.1%, or 16.10 Swiss francs ($15.47), to 194 Swiss francs ($186.44), during midday trading in Zurich. The company said a first license agreement had already been signed with “a major generics company” and that another contract was imminent.

According to Kammerer, the threat of a Europe-wide assault on Plavix is far off at this stage. He said that, unlike in the United States, which has a nationwide pharmaceutical industry, generic drugs have to be launched and approved on a country-by-country basis in Europe.

A spokesman for Sanofi-Aventis declined to comment on Friday.

Although it is not clear just yet how significant this latest threat is, it comes at a time when Sanofi-Aventis was starting to put up resistance to pressure from other generic rivals. A long-running battle with Canada’s Apotex–which launched a generic version of Plavix in the United States in January 2006–ended last June, when a U.S. district court upheld the Plavix patent. (See: “Sanofi Shrugs Off Generic Pressure”)

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