Abbott Gets TriLipix Approval, Ensuring Lipid Lowering Franchise Beyond TriCor
This article was originally published in The Pink Sheet Daily
Executive Summary
Approval bodes positively for Abbott/AstraZeneca’s joint development of a TriLipix/Crestor combination.
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FDA approved Abbott's next-generation fenofibrate TriLipix, a delayed-release capsule to help lower triglycerides and LDL cholesterol and raise HDL cholesterol in patients with lipid problems, the company announced Dec. 15. The drug can be used alone or with statins and is the first fenofibrate approved for use in combination with a statin to improve lipid levels. Abbott will begin shipping the drug before the end of the year, the firm said. The approval effectively extends Abbott's foothold in the lipid-lowering market beyond TriCor (fenofibrate), which is expected to face generic competition in 2011. TriCor is a blockbuster brand for Abbott; the drug generated $886 million in the first nine months of 2008. The company declined to provide pricing for TriLipix, but said the drug will be priced comparably to TriCor. The approval also bodes positively for Abbott's plans to develop a fixed-dose combination of TriLipix with AstraZeneca's statin Crestor (rosuvastatin), a partnership formed in 2006. The companies announced an expansion of their collaboration earlier this year to include Abbott's joint marketing of Crestor (1 (Also see "Abbott, AstraZeneca Riding Crestor Wave With Expanded Partnership" - Pink Sheet, 18 Aug, 2008.), p. 7). Abbott and AstraZeneca aim to submit a regulatory filing for the combination to FDA in second half 2009. "Abbott is well positioned in our opinion to handle the transition from TriCor to TriLipix, and remains ahead of the curve versus statin patent cliffs, with the franchise likely to grow 10 percent or above through 2012," Morgan Stanley analyst David Lewis had said in a Nov. 6 research note on Abbott. The approval was based on a clinical studies involving 2,698 patients with mixed dyslipidemia. The studies evaluated TriLipix in combination with Crestor and two other commonly prescribed statins, Pfizer's Lipitor (atorvastatin) and simvastatin ( Zocor and generics). Combination therapy significantly improved HDL and triglycerides compared to statin therapy alone, and significantly improved LDL compared to TriLipix alone, Abbott reported. -Jessica Merrill ([email protected]) |