ABT Seeks Simcor Label Expansion

Abbott (ABT - Analyst Report) recently submitted a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for two new dosage strengths of Simcor, a cholesterol medication. Simcor is a fixed-dose combination of Niaspan (niacin extended-release) and Merck’s (MRK - Analyst Report) Zocor (simvastatin), recommended for use in people who cannot control their cholesterol levels by diet and exercise alone.
 
Simcor was initially approved in February 2008 in three dosage strengths: 500/20 mg, 750/20 mg and 1000/20 mg (niacin extended-release/simvastatin). Abbott is now seeking approval for two additional dosage strengths of Simcor: 500/40 mg and 1000/40 mg (niacin extended-release/simvastatin).
 
Simcor is a part of Abbott’s cardiovascular franchise which contributes significantly to the company’s pharmaceutical division revenues. TriCor, a powerful triglyceride lowering agent often used in combination with statins, and its next-generation product, TriLipix are the main growth drivers of Abbot’s cardiovascular business. TriLipix was approved in December 2008 and should strengthen Abbott’s position in the fenofibrate market.
 
Abbott has been actively seeking to grow its cardiovascular business over the past few quarters. The company, in collaboration with AstraZeneca (AZN - Analyst Report), recently filed for FDA approval of Certriad, a fixed-dose, single pill formulation of TriLipix and AstraZeneca’s powerful statin drug, Crestor. This new combination fenofibrate-statin looks to offer the best high-density lipoprotein (HDL)-raising, low-density lipoprotein (LDL)/triglyceride-lowering efficacy available.
 
AstraZeneca is co-promoting TriLipix and will co-promote Certriad with Abbott once approved. Certriad could hit the market as early as the second quarter of 2010. We expect Abbott’s cholesterol franchise to contribute significantly to revenue growth over the next several years given the growing need for treatments that help patients achieve recommended lipid goals.
 
The approval of additional dosage strengths of Simcor should help expand the patient base for the product. We currently have a Neutral recommendation on Abbott.

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