GlaxoSmithKline Plc (GSK) said darapladib drug for preventing plaque ruptures failed to meet the primary goal of a late-stage study of more than 15,000 patients with chronic coronary heart disease.
The medicine didn’t lower the risk of heart attack or stroke, according to a study that tracked participants since December 2008, London-based Glaxo said in a statement today. Patients took darapladib or a placebo in addition to a cholesterol-lowering statin. The drugmaker said it will review the data, which indicated that some subgroups benefited, and await the results of a second late-stage study in acute coronary syndrome before deciding what the next steps will be.
Darapladib was developed with Human Genome Sciences Inc., which Glaxo bought last year for $3 billion. The treatment failed in a mid-stage study to meet the primary goal of getting rid of plaque. Glaxo proceeded with the late-stage trial anyway on the basis that the drug showed promise in lowering the risk of plaque rupturing and causing a heart attack.
The drug was developed for patients who aren’t helped enough by statins, a class of cholesterol-lowering medicines that includes Pfizer Inc.’s Lipitor and AstraZeneca Plc’s Crestor. About 12 million people in the U.S. and 21 million worldwide don’t achieve the recommended reduction in LDL cholesterol with statins, according to a presentation last year by Sanofi, which is also developing a new drug to reduce cholesterol.
Glaxo fell as much as 1.3 percent, the steepest intraday decline since Oct. 23, and was trading down 1.1 percent at 1,632.5 pence at 8:28 a.m. in London. That pared the stock’s gain this year to 22 percent, valuing the drugmaker at 79.4 billion pounds ($127 billion).
The trial had 20 percent chance of success, according to Andrew Whitney, an analyst at UBS AG. He estimates that darapladib could generate 604 million pounds in sales by 2017, should it reach the market.
Heart disease and stroke are the two biggest causes of death worldwide, accounting for almost 22 percent of deaths in 2011, according to the Geneva-based World Health Organization. The low-density lipoprotein, or LDL, form of cholesterol only comes from eating animal products, and it raises the risk of the two illnesses by clogging arteries, according to the American Heart Association.
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