Merck said on Friday that it would delay seeking approval for an experimental osteoporosis drug, an announcement that helped send the company’s shares down 3 percent on the same day it announced its fourth-quarter earnings for 2012.

Company executives told analysts in a conference call Friday morning that Merck was delaying its application for the drug, odanacatib, because it is seeking additional data from a clinical trial. But they said they remained confident in the drug’s ultimate chances for approval and would submit their application in 2014.

Separately, Merck reported that it earned $1.4 billion, or 46 cents a share, in the fourth quarter, compared with $1.51 billion, or 49 cents a share, a year earlier, when it took charges for acquisition and restructuring expenses.

Earnings excluding the special items were 83 cents a share in the fourth quarter, down from 97 cents a share the previous year. The company nevertheless beat analysts’ estimates of 81 cents a share for the quarter.

Sales for the quarter fell 5 percent, to $11.74 billion. The company said strong sales of drugs like the diabetes medicine Januvia and sales of animal health and consumer products helped offset a 67 percent dip in revenue from the asthma drug Singulair, which lost its patent protection last year.

The company suffered another setback in December when a combination drug, called Tredaptive, aimed at raising so-called good cholesterol, failed to protect against heart attacks and strokes in a large clinical trial. After the news, Merck announced it would not seek approval of Tredaptive, which contained the drug niacin, in the United States and withdrew it from the European market, where it had already been approved.

A clinical trial of odanacatib, a once-weekly pill to treat osteoporosis in postmenopausal women, last July appeared to show benefits to patients, but the company continued a follow-up trial of 8,000 women to keep monitoring potential safety issues.

Peter Kim, Merck’s head of research, told analysts that the company still did not have data from the continuing extension trial. The company had previously planned to submit it for approval in 2013.

“We continue to believe in the potential of odanacatib to address unmet medical needs for patients with osteoporosis,” Mr. Kim said.

Article source: http://www.nytimes.com/2013/02/02/business/merck-delays-osteoporosis-drug.html?partner=rss&emc=rss