Tricor/Statin Combo Could Have Edge Over Pfizer's Lipitor/Torcetrapib, Abbott Says
This article was originally published in The Pink Sheet Daily
Fenofibrate/statin combination also has advantage of known safety profile for both components, the company maintains.
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Company expects the lipid-lowering agent to eventually reach $1 bil. in revenue, almost double the U.S. sales level in 2003. Abbott points to "four strong formulation patents" on the fenofibrate tablet formulation which, it believes, will help keep generics at bay.
Combination therapy trial reveals HDL-C increases of 61% for the drugs used together and 46% for torcetrapib alone. Pfizer is understood to be investing $800 mil. in the drug's development, including a $90 mil. manufacturing facility.
DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter