Merck & Co. Inc (NYSE: MRK) decided to wrap up an advanced study of its osteoporosis drug, since the initial examination confirmed the effectiveness of the drug.
The pharmaceutical company said that it will submit applications for regulatory approvals of the drug called odanacatib in the U.S., Europe and Japan by the end of 2013.
The third phase trial- where company conducted placebo-controlled randomized study on 1600 patients- was intended to review the safety and effectiveness of odanacatib in lowering risk of fracture in post-menopausal women with osteoporosis.
The experiment begun in 2007; and, it was scheduled to continue to the point where hip fractures were reported in total of 237 patients. At the time of data-monitoring committee’s analysis, almost 70% of that targeted number had been attained.
Commenting over data-monitoring committee’s suggestion, Peter S. Kim, president of Merck Research Laboratories, said “We are encouraged by the data-monitoring committee’s recommendation to close the trial early; and look forward to reviewing the data with the scientific community to bring forward this innovation.”
According to the company, closing of the study will take several months.
The monitoring committee pointed out that safety concerns linger in few areas, and suggested that Merck follow up on them.
As a result, Merck has decided to monitor the issues in a separate extension trial, which was unveiled in the past.
Last month, analysts at Credit Suisse said that the market did not pay any close attention towards the potential of this drug, and pointed out a favorable data could lead to upward revisions in the company’s outlook from 2015.
Following the announcement MRK shares rose sharply in trading on Thursday. The stock ended the day 4.13% higher at $42.91 on above average volume of 45.91 million.
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