Your Best Source of Healthcare Business & Economic News
Since 1991
Hot Topics In This Week's Issue ...
SANOFI SHARES FALL AFTER FDA PANEL REJECTS WEIGHT-LOSS DRUG -- Shares of French pharmaceutical company Sanofi-Aventis SA sank last week as investors reacted to U.S. federal health advisers' rejection of the company's Accomplia weight-loss drug. The Food and Drug Administration's advisory panel turned down the drug, also known as rimonabant and Ziumlti, after hearing testimony that it increases the risk of suicidal thoughts, even in patients without a history of depression. Sanofi failed to show the drug is safe, the FDA panel said. The unanimous vote by the 14-member panel made it unlikely the FDA will approve the drug, which blocks certain brain receptors that regulate appetite. The agency usually follows its panel's advice, but it is not required to do so. In a statement, Sanofi said it would "continue to work closely with the FDA to address the committee's recommendations.
With Accomplia's future in the U.S. looking doubtful, analysts also raised concerns over possible repercussions in Europe, where the anti-obesity drug was approved last year. Sanofi reported sales of US$20 million in the first quarter of 2007 for the drug. More than 130,000 people have used the treatment since it was launched. Sanofi's American depositary shares closed the week down $3.68, or 8%, to $41.82 as the decision by the FDA panel triggered a wave of broker downgrades for Sanofi earnings and the group's share price.J&J SAYS FDA SANCTION OVER HEART STENTS RESOLVED -- Johnson & Johnson (New Brunswick NJ) said U.S. regulators ended almost three years of sanctions over manufacturing quality that limited the company's ability to sell new drug-coated stents. The FDA lifted a warning letter that had been issued in October 2004, J&J said in a statement. The letter dealt with quality assurance at seven manufacturing plants. J&J competes with Boston Scientific Corp. (Natick MA) in a global market worth $5.4 billion for the stents, which hold open arteries after they have been unclogged. The drug coating keep excess scar tissue from forming and creating new blockages. The restrictions made it harder for J&J to defend its leading position. The eight-page letter to J&J detailed flaws in paperwork and testing at plants that make the Cypher stent, the chief product. In September, the company said the FDA had inspected all but one plant and was likely to ease the sanctions before the end of 2007. The remaining plant was in Puerto Rico. J&J and Boston Scientific are the only companies with drug-coated heart stents approved in the U.S. J&J shares closed the week up 64 cents at $62.77.
MEDICAL STOCK SPOTLIGHT
-- Lipid Sciences Inc. (Nasdaq) led advancing issues, tacking on 40 cents, or 31% on the week, to $1.70. The company said it developed a synthetic form of the kind of cholesterol thought to help protect against heart attacks. The company said its substitute for high-density lipoprotein, the "good" cholesterol, was found in laboratory tests to carry cholesterol away from arteries. Elsewhere, Neurochem Inc. (Nasdaq) jumped $1.51, or 26%, to $7.26. The company said preliminary data on the Alzheimer's drug, Alzhemed, show "numerical differences in favor of" meeting the main goal in an advanced clinical study. The company said it is still adjusting the statistical model and the results aren't conclusive. And Medivation Inc. (Nasdaq) rose $2.57, or 16%, to $18.75. The company said its experimental drug Dimebon for Alzheimer's disease helped stop mental decline for as much as a year, the longest benefit observed for any drug in clinical trials.