Failure City: Pharma Eats Up R&D Budgets Trying to Make Drugs to Raise Good Cholesterol
For the second time this year, a closely watched drug designed to increase HDL, or goof cholesterol, has encountered a huge setback. The latest involves Tredaptive, a drug sold by Merck (MRK) in Europe, but a newly released study results found the pill failed to prevent heart attacks, strokes and deaths more than traditional statin drugs that lower LDL, or bad cholesterol.
Moreover, Tredaptive significantly raised the incidence of some types of non-fatal, but serious side effects. The results of the trial, which followed more than 25,000 patients for almost four years, prompted Merck to say that regulatory approval will not be sought in the U.S. Last spring, Roche abandoned a drug designed to raise HDL cholesterol (see earlier Pharma news).
Here is the significance. 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. And this is now the second study in which a prescription form of niacin has failed to prevent heart attacks and strokes.
Last year, a study run by the National Institutes of Health was ended 18 months early after finding that adding Niaspan to a statin in people with heart disease did not reduce the risk of cardiovascular events, including heart attacks and strokes. Moreover, Niaspan may have boosted the risk of ischemic events. The drug is sold by Abbott Laboratories (ABT) (see prior Pharma news).
Most of the Big Pharma companies are having a hard time generating revenue growth, as patents expire on old blockbuster drugs and company labs fail to develop enough new drugs.
The upshot is the notion of raising HDL cholesterol may, once again, be called into question, a debate that was raised when Pfizer (PFE) halted development of such a drug several years ago and was renewed last year after the Abbott trial flopped. Meanwhile, this latest failure may also raise doubts about CETP inhibitors, which are designed to raise HDL cholesterol. Both Merck and Eli Lilly (LLY) are developing such compounds, 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.