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Associated Press
January 13, 2011
INDIANAPOLIS (AP) — Drugmaker Merck & Co. unexpectedly halted a late-stage trial for a potential blood-thinner and said Thursday it would stop giving the drug — seen as a key product in its development pipeline — to stroke victims in separate study.
The Whitehouse Station, N.J., company’s shares plunged in heavy trading, as analysts removed the potential treatment, vorapaxar, from projections for Merck’s future performance due to a lack of clarity behind the moves, said Barbara Ryan, who covers the drugmaker for Deutsche Bank Securities.
“At this juncture, all we can do is speculate as to why these actions have been taken,” she said.
Morningstar analyst Damien Conover thinks the likelihood of the drug’s approval has been reduced, and if it is approved, it may be for a smaller patient population than originally expected.
Merck is studying vorapaxar for the prevention of cardiac events and had planned to submit the anti-clotting medication this year to the Food and Drug Administration for approval. But Merck Research Laboratories President Peter Kim said in a conference call with analysts the company will set a new time frame after it analyzes information from the two studies.
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Wall Street Journal
BY RON WINSLOW AND JONATHAN D. ROCKOFF
January 14, 2011
Merck & Co. said Thursday that researchers halted one of two major studies of its experimental heart drug vorapaxar and curtailed patient participation in the other, casting a cloud over one of the most important medicines in its product pipeline.
Neither the company nor researchers leading the two clinical trials, involving a total of 39,000 patients, detailed specific reasons for the moves. But for the ongoing study, they said they immediately discontinued patients who had suffered a stroke before or during the trial.
The news sent Merck’s shares tumbling 6.6% to $34.69 in 4 p.m. trading on the New York …
The pharmaceutical industry has control over safety trials, this being an example of the fox guarding the hen house.
Protocols for trials are drawn up by the pharmaceutical companies and they only publish results which are in their favour.
If a protocol is stopped the regulatory authorites do not have to be informed.
Trials may be stopped because there are difficulties. One “difficulty” may be because patients die.
The whole issue of safety trials is a tragic farce.