BURLINGTON, Mass.--()--Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the discontinuation of Roche/Japan Tobacco’s dalcetrapib earlier this year leaves Merck’s anacetrapib as the front-runner in the novel CETP inhibitor drug class in the dyslipidemia drug market. However, dalcetrapib’s discontinuation has cast doubt upon the entire CETP inhibitor class and calls into question the high-density lipoprotein cholesterol (HDL-C) hypothesis, which previously came under fire when niacin (Abbott’s Niaspan) failed to show outcomes benefit in the AIM-HIGH clinical trial.
“We also expect the results of these trials will trigger changes in international guidelines for dyslipidemia management in the near term”
The Pharmacor advisory service entitled Dyslipidemia also finds that key agents that will lose market exclusivity worldwide through 2021 include the statins atorvastatin (Pfizer’s Lipitor; generically available in 2011 in the United States) and rosuvastatin (AstraZeneca/Shionogi’s Crestor), as well as ezetimibe (Merck’s Zetia), ezetimibe/simvastatin (Merck’s Vytorin), Merck’s pipeline agent ezetimibe/atorvastatin and ER niacin. Anticipated aggressive generic erosion will mean that these brands combined will lose approximately $15 billion in annual sales between 2011 and 2021 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
The arrival of CETP inhibitors is expected to begin in 2018 with the launch of anacetrapib. With morbidity/mortality data expected at launch, Decision Resources forecasts rapid uptake of anacetrapib and Eli Lilly’s evacetrapib as add-on therapies—particularly in coronary heart disease (CHD) and CHD risk-equivalent patients—and overall sales of CETP inhibitors is estimated to exceed $5 billion in 2021.
The findings also reveal that the results of several major outcomes trials, including HPS2-THRIVE (for niacin-based products) and IMPROVE-IT (for ezetimibe), should result in greater consensus regarding the choice of second- and third-line therapies among physicians.
“We also expect the results of these trials will trigger changes in international guidelines for dyslipidemia management in the near term,” said Decision Resources Analyst Pam Narang, M.Sc., Ph.D. “Interviewed experts believe these trials to be sufficiently powered to demonstrate outcomes benefit and expect them to validate the use of ezetimibe and niacin-based drugs.”
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