singulair

Merck Delays Osteoporosis Drug

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

Merck’s Quarterly Profit Surges on Sales and Cost Savings

The results beat Wall Street expectations and suggest drug sales and cost savings from acquiring Schering-Plough were starting to pay off.

Merck shares rose 18 cents Friday to close at $35.95. Net income in the quarter was $1.04 billion, or 34 cents a share, up from $299 million, or 9 cents a share, in 2010’s first quarter.

Revenue edged up 1 percent to $11.58 billion. That includes several billion dollars from products added in the Schering-Plough acquisition in November 2009. Excluding numerous one-time items, net income was $2.86 billion, or 92 cents a share.

On that basis, analysts had forecast earnings of 84 cents a share and revenue of $11.38 billion. Analysts typically exclude one-time items in their estimates.

The $1.82 billion in net charges included $1.58 billion in merger-related write-downs on the value of assets and research, $126 million in restructuring costs and a $500 million payment to settle arbitration with Johnson Johnson over the rights to two drugs. A year ago, Merck had charges totaling $2.31 billion.

Merck, based in Whitehouse Station, N.J., raised the bottom end of its 2011 profit forecast by 2 cents, predicting $3.66 to $3.76 a share, or $2.04 to $2.39 including one-time charges.

Production costs fell 22 percent to $4.06 billion, partly because Merck has sold some factories.

A Jeffries Company analyst, Ian Hilliker, wrote to investors that the higher revenue and lower-than-expected costs gave Merck a strong “earnings beat.”

Top-performing drugs included Singulair and Januvia, plus some drugs acquired with Schering: the allergy spray Nasonex and Remicade for immune disorders. Their growth was partly offset by a $356 million drop in revenue from two former blockbuster heart drugs, Cozaar and Hyzaar, caused by generic competition.

Januvia and Janumet, a pill that combines Januvia with the generic diabetes drug metformin, had combined quarterly sales that topped $1 billion for the first time, up 47 percent.

Total pharmaceutical revenue rose 2 percent to $9.82 billion. Two units Merck acquired with Schering, animal health and consumer health, also performed well. Animal health revenue rose 7 percent and consumer health 6 percent, on strong sales of Claritin allergy pills and Coppertone sun care products.

Article source: http://feeds.nytimes.com/click.phdo?i=09eac9cc0ab8e507763c4b10818d1f30

Merck Delays Osteoporosis Drug

Merck’s Quarterly Profit Surges on Sales and Cost Savings

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