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News > Business
Sanofi hit by generic Plavix threat in Europe
2008-05-09 18:53:25
By Ben Hirschler
LONDON (Reuters) - French drugmaker Sanofi-Aventis
<SASY.PA>, which briefly encountered generic competition to its
second-biggest product Plavix in the United States in 2006 and
2007, now faces a similar threat in Europe.
Schweizerhall <SWHN.S>, a Swiss generic drug company, 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 Sanofi, the world's third-largest
drugmaker by sales, down 5.9 percent to 47.50 euros by 8:20
a.m. EDT, making them the biggest blue-chip loser in Europe,
with trading volume well above the stock's average.
Schweizerhall shares jumped 8.5 percent to 193 Swiss
francs.
"Obviously, generic competition would be a most unwelcome
development," said Mike Ward, a pharmaceuticals analyst at
Nomura Code Securities.
Sanofi's blockbuster medicine is protected by patents until
2013. But Schweizerhall said it was close to launching a
generic version despite this.
"We're not releasing any details on our patent strategy but
what I can tell you is we are not infringing any of Sanofi's
patents," Schweizerhall Chairman Luzi von Bidder told Reuters.
The Basel-based company expects approval shortly from
German regulators for its version of clopidogrel, as Plavix is
known generically, and it plans to launch the drug throughout
the European Union in cooperation with marketing partners.
"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 in a statement.
Generic clopidogrel could also win marketing authorization
in Luxembourg in the second quarter of 2008, it added.
Deutsche Bank analyst Michael Leuchten said Schweizerhall
may have got around the patent issue by developing a different
chemical salt of clopidogrel, which would mean its product was
not exactly the same as Plavix.
Von Bidder declined to confirm or deny this.
Sanofi said in a statement it was evaluating its legal and
regulatory options but would vigorously defend its intellectual
property rights, including patent protection, in Germany.
The new generic drug was developed by Cimex, a specialty
generics business of Schweizerhall.
$3 BILLION MARKET
Schweizerhall said the European market for clopidogrel was
about 2 billion euros ($3.09 billion), of which Germany --
Europe's biggest drugs market -- accounted for 18 percent.
Losing some of that business to generics could lop up to 4
percent off Sanofi's earnings per share, according to Morgan
Stanley analysts. But the impact may well be less if Sanofi
wins an injunction or there are regulatory delays in other
European countries.
Still, the threat will likely keep Sanofi stock trading at
depressed multiples. The shares fetch just 8.7 times forecast
2009 earnings, against 10.9 times for GlaxoSmithKline <GSK.L>
and 12.3 times for Novartis <NOVN.VX>, reflecting doubts about
Sanofi's existing medicines and recent pipeline setbacks.
Bristol-Myers Squibb <BMY.N> also markets clopidogrel in
Germany under the brand name Iscover.
Plavix, which is sold in the United States in partnership
with Bristol-Myers, 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.
(Additional reporting by Astrid Wendlandt in Paris; Editing
by Will Waterman and Quentin Bryar)
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