Abbott gained FDA approval Feb. 15 for lipid-lowering Simcor , a fixed-dose combination of the company's own extended-release niacin product Niaspan with simvastatin (Merck's Zocor and generics).

Simcor will be used with dietary changes to lower levels of LDL cholesterol and raise HDL in patients with complex lipid disease when treatment with neither of its two active ingredients is considered adequate alone.

Abbott Park, Ill.-based Abbott plans to launch Simcor before the end of the first quarter of this year. An FDA decision is due around mid-2008 for the next lipid competitor in line: Merck's Cordaptive , which contains Merck's niacin as well as laropiprant, a novel flushing pathway inhibitor (¹ Also see "Merck’s Lipid-Lowering Combo Cordaptive Could Clear FDA In Mid-2008" - Pink Sheet, 29 August, 2007.).

Unlike the commonly used statins, Simcor has effects on HDL and triglycerides as well as LDL. The indication sought for Cordaptive, used alone or with a statin, also includes both forms of cholesterol as well as triglycerides.

Simcor enters a therapeutic space in which Schering-Plough's declining Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe, a cholesterol absorption inhibitor) - partnered with Merck - have faced investor dismay. At the start of the year, a study showed Vytorin failed to lower plaque in carotid arteries, though it did knock down LDL cholesterol by comparison to simvastatin alone (² Also see "Vytorin Fails To Show ENHANCEd Benefit Over Simvastatin In Plaque Reduction" - Pink Sheet, 14 January, 2008.).

Work goes on with the niacin/simvastatin combo. Abbott has sponsored the National Heart Lung and Blood Institute's AIM-HIGH outcomes study, trying the pair as a therapy to reduce cardiovascular events in patients with existing heart disease. AIM-HIGH began enrolling patients in 2005 and results are due in 2011.

- Randall Osborne (r.osborne@elsevier.com)

Abbott’s Simcor Wins FDA Nod

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