After a review of lackluster efficacy data, Roche has thrown in the towel on developing one of the most promising drug candidates in the company's vast pipeline, dalcetrapib. And the Swiss drug giant's ($RHHBY) failure brings negative attention to similar drugs in development at Merck ($MRK) and Eli Lilly ($LLY) that raise "good" cholesterol to combat cardiovascular disease.
Dalcetrapib has gone down in flames after an interim assessment of a major Phase III trial, called dal-OUTCOMES, indicated that the HDL-raising drug lacked efficacy, Roche announced this morning. The company had hoped to show that adding the drug to the standard of care would benefit patients with coronary heart disease. The dal-OUTCOMES trial and all studies related to the program have been terminated.
Roche's fresh setback could trigger more angst about the prospects of drugs that raise good cholesterol, and analysts expect Merck and Lilly to feel the repercussions from this latest collapse. Pfizer ($PFE) previously ditched its own program in this field because a study showed that more patients on its drug, torcetrapib, died, Bloomberg reported. And Abbott ($ABT) raised doubts last year after reporting lackluster data on the company's own drug to boost good cholesterol.
"We anticipate a negative reaction driven by bad sentiment and we see other programs at risk as this is the second failure in this class following Pfizer's Torcetrapib," wrote Exane BNP Paribas analysts in a note, as quoted by Reuters.
Roche, the world's largest cancer drug provider, had banked on dalcetrapib to provide the company with a grand entrance into the cardio drug arena, and rosy projections of the drug's sales potential were in the neighborhood of $10 billion. The failure of the dalcetrapib program highlights the major challenge of improving on the standard-of-care statin therapies with new cardio drugs.
"Lowering cardiovascular risk beyond that which is achieved with intensive statin treatment is a very challenging goal and while we have always stated that dalcetrapib is a high-risk project, we are disappointed by the fact that this drug didn't provide benefit to the patients in our study," Roche medical chief Dr. Hal Barron stated. The company is dropping dalcetrapib, but it remains "fully committed" to the cardiovascular disease field, he added.
- here's Roche's statement
- see Bloomberg's article
- check out the Reuters story
- and the Wall Street Journal's report