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Sanofi Still To Receive Approval

Acomplia, the most important drug of Sanofi Aventis gets delayed again by the FDA for the third time.

The company also said that fourth- quarter profit fell, hurt by sales of generic copies of its blood thinner, Plavix. Net income dropped 4.2 percent to €1.38 billion, or $1.79 billion, in the fourth quarter. Fourth-quarter revenue rose 5.1 percent to €7.36 billion.

Sanofi, based in Paris, said late Monday that U.S. regulators wanted another three months to review Acomplia.

The company needs the new diet pill because its top three products are being challenged by generic-drug makers.

Profit from Plavix shrank in the quarter after cheaper copies entered the U.S. market. Sanofi lost a patent lawsuit last week on the Lovenox blood clot treatment, and its exclusivity on the Ambien sleeping pill ends in April. Investors are worried by the delay over Acomplia, which analysts say may bring in more than $3 billion a year.

"It looks pretty bad on the generics front," said Romain Pasche at Vontobel Asset Management in Zurich. "It's very important they come through on the pipeline," he said, referring to new drugs.

Sanofi and Bristol-Myers Squibb, which markets Plavix in the United States, are defending the medicine's patent in a New York court. Hanspeter Spek, who oversees Sanofi's drug unit, said Plavix copies made by Apotex should be sold out by the end of the second quarter. Apotex shipped at least a six-month supply last year before a U.S. judge halted sales.

Sanofi shares fell €1, or 1.5 percent, to close at €66.80 in Paris. They have dropped 4.5 percent this year.

Sanofi said Monday that the U.S. Food and Drug Administration would take until July 27 to complete analysis of human tests of Acomplia, the first in a new class of medicines to combat obesity. Sanofi has submitted data showing that the drug may also help patients with diabetes.
Marc Cluzel, who heads the company's research and development unit said, "Nobody has any doubts about its efficacy," He declined to comment on the reasons for the delay saying, "We hope to get FDA approval this year."

The chief executive, Gerard le Fur, presented the company's research progress Tuesday. Le Fur said that Sanofi planned to submit 18 new drug applications for approval this year and next. Cholesterol drugs lift Teva

Teva Pharmaceutical Industries, the world's largest maker of generic drugs, said Tuesday that fourth-quarter profit surged on U.S. sales of cholesterol treatments.

The revenue rose up to 63 percent to $2.3 billion, and the net income at the Israeli company went up to $460 millions climbing 51 percent.