In 2004, the market for prescription dyslipidemia treatments reached approximately $26 billion worldwide. Much of this growth was driven by statins, which accounted for approximately 87% of sales. Non-statin therapies, including fibrates, niacin and cholesterol absorption inhibitors, have also seen an increase, in particular in combination with low dose statins.

Lowering LDL cholesterol remains the primary focus of current therapies for reducing cardiovascular risks in patients with high cholesterol. A significant gap remains, however, between the number of patients who would benefit from therapy and those actually achieving treatment goals. For example, a survey in the U.S. reported that 37% of patients at high risk of developing coronary heart disease and only 18% of patients with established coronary heart disease actually achieved the LDL cholesterol values recommended by the NCEP.

Among cholesterol lowering therapies, statins are the most widely used because they are considered to be the most effective. Troublesome or serious side effects may limit their utility in some patients. Statins are sometimes combined with other therapies to limit the statin dose in patients who cannot tolerate higher doses and to achieve LDL cholesterol target levels in patients for whom use of statins alone is not sufficient. Combining statin therapy with some other cholesterol lowering drugs may cause adverse side effects resulting from the interaction of the drugs. In addition, certain drugs used in combination with statins have adverse side effects themselves, including adverse liver and GI effects and facial flushing. Because of this, new treatments to use in combination with statins are sought.

While statin therapy has proven to be safe and effective in the majority of patients for lowering LDL cholesterol, it does not address all cardiovascular risk factors. Statins have only small effects on triglycerides and HDL-cholesterol and no effect on Lp(a). We believe a drug that reduces LDL and Lp(a) and that can be used either alone or in combination with statins would produce additional benefits over existing therapies.