There's blood in the water - again. Delaying the new osteo submission for an unspecified reason is bad in the near term and may be worse in the long...
http://www.nj.com/business/index.ssf/2013/02/merck_lowers_forecast_for_2013.html
With competition from generic brand drugs digging into its revenues, and facing a delay in its experimental medication to combat bone disease, Whitehouse Station-based Merck & Co. forecast lower profits for 2013 at its year-end earnings announcement today.
The world’s third-largest drugmaker said it would hold back on submitting its promising osteoporosis medicine called odanacatib. Without elaborating, officials said they want results of a second study on the drug because the first showed potential safety issues.
The announcement follows Merck’s decision last month to suspend worldwide sales of the cholesterol medicine Tredaptive — the drug isn’t available in the United States — after a major study raised health concerns. And in June, the company failed to win clearance for a therapy aimed at slowing the growth of sarcoma.
Merck chief executive Kenneth Frazier told industry analysts today he remained confident in the osteoporosis medicine, saying, "We continue to believe in the potential of this drug, and look forward to filing it in 2014." It had been scheduled for filing this year.
Meanwhile, on Wednesday, a federal judge in Newark allowed Merck shareholders to move forward with a class action lawsuit alleging it had misrepresented its pain medicine, Vioxx. The drug was pulled from shelves in 2004, sending the company’s stock down. In 2011, Merck agreed to pay nearly $1 billion to resolve criminal charges and civil claims related to how it marketed Vioxx, after having promoted the drug as a treatment for rheumatoid arthritis before regulators approved it for that use.
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As late as last summer, Frazier said Merck would begin selling six new drugs by 2014, including the now-delayed osteoporosis medication and a novel treatment for insomnia, which was filed with the Food and Drug Administration in November.
That pipeline was meant to overcome expected revenue loss from its top-selling asthma and allergies treatment Singulair, whose patent protection expired in August.
Sales of Singulair dropped 67 percent in the last quarter of 2012 to $480 million. That hit contributed to the company’s fourth quarter decline in income of 7.3 percent. Net income for the year was up, $6.66 billion from $6.27 billion, though overall sales dropped slightly, ending at $47.27 billion.
Patent expirations like the one for Singulair have long been expected, said Ira Loss, senior health care analyst at Washington Analysts. "The issue is how well the company will be able to overcome them."
Part of Merck’s approach, he said, included its 2009 acquisition of Schering-Plough, along with major reductions in expenses and workforce, and the closing of facilities. In October, Merck announced its headquarters will move to Summit.
Now, Loss said, "the future will depend on how successful these products in the pipeline will be."
Star-Ledger wire services contributed to this report.
http://www.nj.com/business/index.ssf/2013/02/merck_lowers_forecast_for_2013.html
With competition from generic brand drugs digging into its revenues, and facing a delay in its experimental medication to combat bone disease, Whitehouse Station-based Merck & Co. forecast lower profits for 2013 at its year-end earnings announcement today.
The world’s third-largest drugmaker said it would hold back on submitting its promising osteoporosis medicine called odanacatib. Without elaborating, officials said they want results of a second study on the drug because the first showed potential safety issues.
The announcement follows Merck’s decision last month to suspend worldwide sales of the cholesterol medicine Tredaptive — the drug isn’t available in the United States — after a major study raised health concerns. And in June, the company failed to win clearance for a therapy aimed at slowing the growth of sarcoma.
Merck chief executive Kenneth Frazier told industry analysts today he remained confident in the osteoporosis medicine, saying, "We continue to believe in the potential of this drug, and look forward to filing it in 2014." It had been scheduled for filing this year.
Meanwhile, on Wednesday, a federal judge in Newark allowed Merck shareholders to move forward with a class action lawsuit alleging it had misrepresented its pain medicine, Vioxx. The drug was pulled from shelves in 2004, sending the company’s stock down. In 2011, Merck agreed to pay nearly $1 billion to resolve criminal charges and civil claims related to how it marketed Vioxx, after having promoted the drug as a treatment for rheumatoid arthritis before regulators approved it for that use.
STAY CONNECTED 24/7 Download our free NJ.com mobile and tablet apps to keep up with the latest New Jersey news, sports and entertainment.
As late as last summer, Frazier said Merck would begin selling six new drugs by 2014, including the now-delayed osteoporosis medication and a novel treatment for insomnia, which was filed with the Food and Drug Administration in November.
That pipeline was meant to overcome expected revenue loss from its top-selling asthma and allergies treatment Singulair, whose patent protection expired in August.
Sales of Singulair dropped 67 percent in the last quarter of 2012 to $480 million. That hit contributed to the company’s fourth quarter decline in income of 7.3 percent. Net income for the year was up, $6.66 billion from $6.27 billion, though overall sales dropped slightly, ending at $47.27 billion.
Patent expirations like the one for Singulair have long been expected, said Ira Loss, senior health care analyst at Washington Analysts. "The issue is how well the company will be able to overcome them."
Part of Merck’s approach, he said, included its 2009 acquisition of Schering-Plough, along with major reductions in expenses and workforce, and the closing of facilities. In October, Merck announced its headquarters will move to Summit.
Now, Loss said, "the future will depend on how successful these products in the pipeline will be."
Star-Ledger wire services contributed to this report.