Double-whammy dyslipidemia drug Certriad abandoned by Abbott and AstraZeneca
Companies determine that rosuvastatin/fenofibric acid combo drug is no longer commercially attractive
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ABBOTT PARK, Ill. and LONDON—Abbott and AstraZeneca have announced that they will discontinue the joint development of the experimental dyslipidemia drug Certriad as they no longer consider the effort to be "commercially attractive." The rosuvastatin/fenofibric acid delayed-release pill—essentially a combination of AstraZeneca's Crestor and Abbott's TriLipix—was under development for the treatment of mixed dyslipidemia.
Both companies have noted that there is no expected impact to their ongoing earnings per share in 2010 or 2011 resulting from this action.
The announcement follows the U.S. Food and Drug Administration's rejection of the drug in March, when it asked for more information about the therapy from the companies—a development that threatened to delay any possible approval for the U.S. market. In an official statement, both drugmakers said they made their decision to ditch Certriad after considering the FDA's verdict, "the resulting regulatory delay and the commercial attractiveness of the product in the U.S. market."
The drug had been viewed as an important product to extend both firms' cholesterol-lowering franchises, and consensus forecasts had pointed to sales of $564 million by 2013, according to Thomson Reuters data.
Neither company disclosed the FDA's reason for rejecting the therapy; however, earlier this year the FDA did note that it was reviewing whether results of the ACCORD trial would have any bearing on the approved uses for TriLipix. The study in question involved Abbott's TriCor, which is similar to TriLipix, and which had data showing that adding the therapy to a statin didn't reduce the risk of heart attacks and strokes among people with diabetes. Some analysts speculated that the trial would not only delay approval of Certriad, but would also limit the commercial potential of Certriad.
Other criticisms already existed for the drug, though in a more general sense, as consumer groups, health plans and employers sometimes criticize combination pills like this as merely a way to for Big Pharma to extend patents and continue charging high prices. Critics say the pills typically contain ingredients which are already in the market as cheaper generic copies or in the form of similar but less expensive rivals. In fact, the Certiad product included a combination of a statin and a fenofibrate—and there are indeed generic statins and fenofibrates already on the market.
Both companies have noted that there is no expected impact to their ongoing earnings per share in 2010 or 2011 resulting from this action.
The announcement follows the U.S. Food and Drug Administration's rejection of the drug in March, when it asked for more information about the therapy from the companies—a development that threatened to delay any possible approval for the U.S. market. In an official statement, both drugmakers said they made their decision to ditch Certriad after considering the FDA's verdict, "the resulting regulatory delay and the commercial attractiveness of the product in the U.S. market."
The drug had been viewed as an important product to extend both firms' cholesterol-lowering franchises, and consensus forecasts had pointed to sales of $564 million by 2013, according to Thomson Reuters data.
Neither company disclosed the FDA's reason for rejecting the therapy; however, earlier this year the FDA did note that it was reviewing whether results of the ACCORD trial would have any bearing on the approved uses for TriLipix. The study in question involved Abbott's TriCor, which is similar to TriLipix, and which had data showing that adding the therapy to a statin didn't reduce the risk of heart attacks and strokes among people with diabetes. Some analysts speculated that the trial would not only delay approval of Certriad, but would also limit the commercial potential of Certriad.
Other criticisms already existed for the drug, though in a more general sense, as consumer groups, health plans and employers sometimes criticize combination pills like this as merely a way to for Big Pharma to extend patents and continue charging high prices. Critics say the pills typically contain ingredients which are already in the market as cheaper generic copies or in the form of similar but less expensive rivals. In fact, the Certiad product included a combination of a statin and a fenofibrate—and there are indeed generic statins and fenofibrates already on the market.
