Dyslipidemia

Pharmacor -- March 2007

  Introduction:

The treatment of dyslipidemia is among the most lucrative markets. In 2005, sales of antidyslipidemic agents totaled nearly $27 billion. Nevertheless, the global burden of lipid risk factors on coronary heart disease (CHD) prevalence and mortality remains unacceptably high. Novel agents that can significantly reduce low-density lipoprotein (LDL) beyond the reduction already achieved by a statin will have a vital role in the future treatment of dyslipidemia. Innovative therapies that modulate high-density lipoprotein (HDL) will also be warmly received and should add substantial value by 2015.

  Questions Answered in This Report:

Thought-leading specialists tell us of their surprise and disappointment regarding the discontinuation of Pfizer’s torcetrapib, an agent that had the potential to fulfill a major unmet need, namely the treatment of suboptimal levels of HDL. What is the outlook for other CETP inhibitors in the pipeline, such as Roche’s R-1658, according to the experts? How will existing and emerging HDL-raising drugs, including Merck’s MK-0524A, fare in a future without torcetrapib?

The 2006 patent expiries of Pravachol and Zocor will prompt widespread adoption of generics at the expense of these and other leading statin brands through 2010. Will the influx of generic pravastatin and simvastatin products significantly erode sales of Pfizer’s atorvastatin (Lipitor)? If so, to what extent and in which patient populations? Will other antidyslipidemics, such as rosuvastatin (AstraZeneca’s Crestor), also suffer from generics erosion before their patent expiries?

One effect of stringent LDL goals in treatment guidelines and efforts by medical associations to encourage LDL control in the secondary prevention setting will be further uptake of the most potent antidyslipidemics and polypharmacy. How will this trend affect drug sales of ezetimibe (Merck/Schering-Plough’s Zetia/Ezetrol), simvastatin/ezetimibe (Merck/Schering-Plough’s Vytorin/Inegy), and rosuvastatin (AstraZeneca’s Crestor)? Will there be room in the marketplace for Takeda’s squalene synthase inhibitor lapaquistat or new cholesterol absorption inhibitors?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 39 country-specific interviews with thought leaders.

Epidemiology: Prevalence of hypercholesterolemia, prevalence of specific dyslipidemias including abnormal levels of LDL, HDL, and/or triglycerides, prevalence of dyslipidemia stratified by CHD risk according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).

Population segments in market forecast: Primary prevention patients, CHD or CHD-risk-equivalent patients.

Emerging therapies: Phase II: 17 drugs; Phase III: 6 drugs. Coverage of 13 select preclinical and Phase I products.

Market forecast features: Using a proprietary patient-flow model, we forecast drug sales for the treatment of dyslipidemia through 2015.

Alternative market scenario: CETP inhibitors in development demonstrate significant improvements in clinical outcomes in Phase III trials.