Biotech/Pharmaceuticals
The European Union is expected to act on Acomplia a few months later. Amusa predicts the drug could reach $5.3 billion in worldwide sales by 2010.
"We seen an 80% chance of approval for Acomplia by mid-2006 and a 55% chance the label goes beyond weight management and smoking cessation to include claims on diabetes and/or [cholesterol]," Amusa says. The drug has met efficacy goals in clinical trials, offers "good safety and tolerability," and has "survived scrutiny" by two major medical journals, The Lancet and The New England Journal of Medicine, Amusa says. The only delay, he adds, could be caused by "slow label discussions" between the company and the agency. Amusa, who doesn't own shares, has an outperform rating on the stock. His firm doesn't have an investment banking relationship. Prudential's Anderson is a bit less enthusiastic, predicting that the FDA may grant conditional approval for Acomplia, pushing the launch back several months to the late second quarter. He speculates the FDA might require Sanofi-Aventis to employ "some form of risk management program" to monitor patients for potential safety issues. This "could temper the drug's initial uptake and launch," says Anderson, who is neutral on Sanofi-Aventis. He doesn't own shares, and his firm doesn't have an investment banking relationship. Anderson says Sanofi-Aventis' fourth-quarter revenue of $8.46 billion was slightly below his estimate because of generic competition for some drugs and lower-than-expected sales for several others. Still, the company ended the year with 10 drugs each producing more than $1 billion in sales. Eight of those drugs posted gains ranging from 10.6% to 47.5% between 2004 and 2005. Generic competition pounded the allergy drug Allegra, whose full-year sales dropped 9% to $1.62 billion. The real damage took place in the fourth quarter as sales plunged 59% to $193 million. The generically-challenged diabetes drug Amaryl was up 1% to $818 million for the year, but fourth quarter sales sank by 29% to $163 million.TheStreet Premium Services
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| Dow Jones | S&P 500 | NASDAQ | 10-Year Note |
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