June 24, 2006
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DOW JONES
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Reprints tool at the bottom of any article or visit:http://www.djreprints.com/. • See a sample reprint in PDF format. • Order a reprint of this article now. FDA Approves By HEATHER
WON TESORIERO and JANE ZHANG
June 24, 2006; Page A4 The Food and Drug Administration approved generic versions of Merck & Co.'s blockbuster cholesterol-fighting drug, Zocor, cooling a firestorm that had ensued over the lucrative medicine. Teva Pharmaceuticals Industries Ltd. won approval to market the pill in 5-, 10-, 20-, and 40-milligram versions, while Ranbaxy Pharmaceuticals Inc. will sell an 80-milligram tablet. In addition, Dr. Reddy's Laboratories Ltd., under an agreement it struck with Merck this year, will be the so-called authorized generic maker of the pill and will sell it in all five doses. Teva and Ranbaxy will sell the drug exclusively for 180 days, an incentive given to generics companies who are the first to file patent challenges to branded drug-company products. The long-anticipated move means versions of one of the biggest-selling drugs are now available at a price about 30% less than brand-name Zocor, which accounted for $4.4 billion in sales for Merck last year. Friday, one online drugstore, RxUSA.com, was selling 60 10-milligram generic simvastatin pills for $122, which was 31% cheaper than Zocor, which it sells for $177.39. The FDA announced its decision about two hours after a federal judge denied a motion from Novartis AG to temporarily block the agency from approving Teva's and Ranbaxy's versions of the drug and affirmed their six-month marketing exclusivity. Novartis's generic unit, Sandoz, said that delaying the final approval could help it and other drug makers in trying to market their own generic versions of Zocor. But Ranbaxy's attorney argued that the company, anticipating FDA approval, had already signed agreements to sell its generic and stood to lose money if the judge allowed Sandoz's motion to go forward. Judge Royce C. Lamberth of the U.S District Court for the District of Columbia agreed, saying the delay could harm Teva and Ranbaxy and the public's access to less expensive, generic drugs. Earlier in the week, in an unusual move, Merck entered into an agreement with health insurer UnitedHealth Group Inc. to slash the price of branded Zocor to less than that of the generic versions. Merck also struck a deal with health insurer WellPoint Inc., which will only sell Merck's Zocor, and not generic versions, through its mail-order pharmacy program. Write to Heather Won Tesoriero at heather.tesoriero@wsj.com1 and Jane Zhang at Jane.Zhang@wsj.com2
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