Sanofi's Patent Problems Are Still Potent

"Our model assumes no generic competition prior to patent expiry," says Beadle, who doesn't own shares and whose firm has had an investment-banking relationship with the drugmaker within the past three years. Without generic competition, Beadle predicts that Lovenox could produce worldwide sales of $3.8 billion in 2010.

Still, the last thing analysts want to see is another patent-related jolt to a company, whose near-term R&D pipeline isn't considered very strong.

"Beyond Acomplia, we see little in the way of positive catalysts," says Parry. "We remain concerned about the lack of late-stage pipeline progression in recent years."

Acomplia is a weight-loss drug still under review by the FDA. Although Acomplia has been approved by the European Union, the U.S. is the largest sales opportunity for the company. Acomplia officials have predicted that the FDA would approve the drug by year-end.

Sanofi also suffered a setback on Aug. 31 when the FDA rejected its application for Multaq, a drug for the erratic heartbeat called atrial fibrillation. The company expects to file a new application during the first half of 2008, pending the completion of an ongoing clinical trial.

On Sept. 7, Sanofi withdrew its Multaq application from the FDA's counterpart at the European Union. It plans to resubmit its application during the first half of 2008.

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