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Fosamax has had generic competition for five years and efforts to come up with a replacement have dragged on. On Friday, Merck executives skirted analysts' questions about whether the completed odanacatib study found unexpected risks with the drug. They said the extension study includes about 8,200 women, and they will add those results to the application to approve odanacatib
-- apparently a strategy to improve chances of approval. Zocor has had generic competition for 6 1/2 years. Merck's successor drug, Vytorin, combines generic Zocor, known chemically as simvastatin, with Zetia, a Merck drug still under patent that reduces bad, or LDL cholesterol, in a different way. Vytorin and Zetia had combined sales of $4.2 billion last year, but since Vytorin was launched in 2004, it seems to have been jinxed. First, research released in January 2008, based on imaging of neck arteries, indicated pricey Vytorin was no more effective at limiting plaque buildup in arteries than inexpensive generic Zocor. Public release of the unfavorable data had been held up for so long that a congressional committee investigated. Vytorin sales began to slide once the unfavorable results were known. Merck later had to pay $41.5 million to settle lawsuits -- brought by consumers, insurers and others who paid for Vytorin and Zetia
-- claiming the company delayed the unfavorable results because they would hurt sales. In July 2008, preliminary results from another study indicated a possible increased risk of cancer in patients getting Vytorin, further reducing its sales. At the end of 2009, the Food and Drug Administration, after reviewing reams of data, said there was no evidence Vytorin causes cancer. Since then, Merck has been hoping the IMPROVE-IT results would show Vytorin's value and boost sales of both Vytorin and Zetia.
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