Acomplia delayed for the Third Time 13 February, 2007 Acomplia the company's most important new product for obesity has been delayed in the U.S. for the third time. Sanofi-Aventis SA said that that profit fell. The Paris-based company said today that: Net income dropped 4.2 percent to 1.38 billion euros ($1.79 billion), or 1.02 euros a share, in the fourth quarter from 1.44 billion euros, or 1.08 euros, a year earlier and is hurt by copies of its Plavix blood thinner. Sanofi said late yesterday that U.S. regulators want 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. Sanofi lost a patent lawsuit last week on the Lovenox clot treatment and its exclusivity on the Ambien sleeping pill ends in April. Investors are worried by the delay to Acomplia, which analysts say may bring in more than $3 billion a year. "It looks pretty bad on the generics front,'' said Romain Pasche, who manages about $800 million in drugs stock at Vontobel Asset Management. "It's very important they come through on the pipeline. The delay to Acomplia isn't good news. There's uncertainty with the generics and nothing really moving on with their new drugs." France's largest drugmaker and Bristol-Myers Squibb Co., which markets Plavix in the U.S., are defending the medicine's patent in a New York court. Hanspeter Spek, who oversees Sanofi's drug unit, said Plavix copies by Apotex Inc. should be sold out by the end of the second quarter. Apotex sent out at least a six- month supply last year before a U.S. judge halted sales. Shares Decline "The market has changed, it has slimmed down in terms of growth.'' Spek said at a press conference in Paris. "2006 has been a difficult year." Sanofi was expected to earn 1.34 billion euros, or 1 euro a share, according to the median estimate of 10 analysts Bloomberg News surveyed by telephone and e-mail. Fourth-quarter sales rose 5.1 percent to 7.36 billion euros, the company said. This year, Sanofi is targeting an increase in earnings per share similar to the 5.9 percent gain reported for 2006. Sanofi plans to increase the dividend payment by 15 percent to 1.75 euros a share for 2006. 'Questions' "Sanofi really has to answer a huge number of questions, and I don't know that they've got the answers," Chief Executive Officer Gerard le Fur, who took over from Chairman Jean-Francois Dehecq last month, presented the company's research progress today. Le Fur plans to submit 12 new drug applications for approval this year and next or 18 including vaccines. Marc Cluzel, who heads the research and development unit, said at a briefing in Paris; that "we feel that our portfolio is probably not well known." The company is working on drugs to treat depression and Alzheimer's disease as well as studies to expand the use of Eloxatin and Taxotere, its biggest cancer medicines. Sanofi also stopped developing a medicine for prostate cancer. Delay for Acomplia "We hope to get FDA approval this year." Cluzel said about Acomplia, "Nobody has any doubts about its efficacy," He declined to comment on the reasons for the U.S. delay. U.S. regulators first extended their review a year ago, saying the drug might be approved with the submission of more data. Sanofi completed its response last October and later said it didn't expect a decision until April. Newspaper reports last month said Sanofi may bid for Bristol-Myers to gain new products and revive growth. The partners couldn't come to an agreement, the Times of London reported Feb. 10. Le Fur wouldn't comment on any discussions. Sanofi would be interested in buying a biotechnology company as well as a transaction that would help boost its presence in Japan, Le Fur also said today. Credit-default swaps based on 10 million euros of Sanofi bonds fell 0.4 percent to 14,754 euros today from 14,813 euros yesterday, according to data complied by Bloomberg. A decrease in price indicates improvement in the perception of credit quality, while an increase suggests deterioration. Patent Disputes Last week, Sanofi lost a lawsuit over the patent of Lovenox, adding to its legal woes and increasing the pressure to get new drugs on the market. Today, Le Fur said the company will appeal the ruling and remained optimistic about the product. Sanofi is also set to lose patent protection for Ambien, its third-largest drug, in April. It has already lost market exclusivity for cancer drug Eloxatin in Europe. 'Tough Year' Fourth-quarter sales were helped by a 30 percent increase in revenue from vaccines, where Sanofi is the market leader. In November the company won a contract from the U.S. government to supply a vaccine that can help in the protection against avian influenza. By this year, the vaccine is expected to be shipped. |
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