Biotech Values

[DewDiligence]

FDA Approves Abbott's Simcor

http://online.wsj.com/article/SB120310996279972229.html

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By SHIRLEY S. WANG
February 15, 2008 4:21 p.m.

The Food and Drug Administration granted Abbott Laboratories approval Friday for Simcor, an anticipated top-selling drug that both raises "good" cholesterol and lowers the "bad" the form and triglycerides.

Simcor is a combination of existing, approved treatments: simvastatin, a so-called statin, and Abbott's Niaspan, an extended-release version of niacin.

Simcor's approval is the first for a cholesterol drug since questions cropped up about the effectiveness of another treatment, Merck & Co. and Schering-Plough Corp.'s Vytorin, and could augur well for Merck's Cordaptive drug, which is also based on niacin.

Popular statin treatments lower LDL cholesterol but don't treat HDL or triglycerides, two other types of lipids that are believed to be important for cardiac health.

"Simcor is really the first product that allows physicians to treat all three of the lipids at the same time," says Jim Stolzenbach, head of Clinical Development for Dyslipidemia at Abbott. Abbott says it expects peak sales of Simcor to top out at $500 million.

In the data presented to the FDA, 640 patients were started on simvastatin, then added Niaspan to their regimen. After 24 weeks, patients experienced a 12% decrease above the 7% that they experienced on simvastatin alone, a 21% increase in HDL or good cholesterol compared to 8% on simvastatin alone and a 27% decrease in triglycerides compared to 15% in simvastatin alone.

The question with Simcor is whether the combination treatment will be any better at preventing heart attacks or death than the components of the medication alone, the same question that still faces Merck and Schering Plough's Vytorin. The two components of Simcor have separately demonstrated an ability to reduce heart attacks and death. It also remains to be seen how many patients will actually make the switch to a combination treatment.

Abbott says it is currently conducting a study investigating whether Simcor is better than simvastatin or Niaspan alone, but results won't be available until 2011. It also has a study underway to investigate whether Simcor slows down or even reverses clogging in the arteries using an imaging technology similar that that which was used in the Enhance trial that compared Vytonin to its two component drugs, Zetia and Zocor.
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