Pharma Flop: Story Behind Merck’s Failed Cholesterol Pill
Less than a month after a study showed its Tredaptive cholesterol pill failed to prevent heart attacks, strokes and deaths more than traditional statin drugs that lower LDL, or bad cholesterol, Merck (MRK) is withdrawing the drug from 40 countries around the world. Tredaptive was not approved in the US, however.
The move is not surprising. At the time, the drugmaker acknowledged the results were so disappointing that regulatory approval would not be sought in the US. The trial followed more than 25,000 patients for almost four years and also found that Tredaptive significantly raised the incidence of some types of non-fatal, but serious side effects (covered in earlier Pharma news).
As we noted, Tredaptive combines an extended release form of niacin, a nutrient that has been widely used to raise HDL cholesterol, with a drug called laropiprant, which is designed to reduce facial flushing, a side effect of using niacin. This was the second study in which a prescription form of niacin failed to prevent heart attacks and strokes.
Merck, like other big drug makers, is struggling to generate revenue growth as patents expire on existing drugs and the company's lab produces too few new drugs. Merck offers a tempting 4% dividend yield, but its shares trade a pricey PE ratio of about 19.
Whether this closes the door on raising HDL as a premise for further development remains to be seen, but these flops have caused doubt given the failure Pfizer (PFE) experienced several years ago and a failed Abbott (ABT) trial. This latest episode may also raise doubts about CETP inhibitors, which are designed to raise HDL cholesterol. Merck and Eli Lilly (LLY) is developing such a compound, although a different mechanism of action is involved.
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Ed Silverman, a contributing editor of YCharts, is the founder and editor of Pharmalot. He previously reported on the pharmaceutical industry and other business topics for the Star-Ledger of New Jersey, New York Newsday and Investor’s Business Daily. He can be reached at email@example.com.