Abbott Labs (ABT) and partner AstraZeneca (AZN) faced a regulatory setback recently when the US Food and Drug Administration (FDA) issued a complete response letter for their experimental drug, Certriad.
Certriad is a fixed-dose, single pill formulation of Abbott’s next-generation triglycerides lowering pill, TriLipix and AstraZeneca’s powerful statin drug, Crestor. This new combination fenofibrate-statin looks to offer the best HDL-raising, LDL/triglyceride-lowering efficacy available.
In its complete response letter, the FDA has asked for additional information. However, the companies refrained from making public any information regarding the FDA’s request.
The delay in Certriad’s approval is a setback for both Abbott and AstraZeneca. Both companies were looking to drive sales of their cardiovascular franchises by launching Certriad.
The companies were initially planning to launch Certriad in the first half of 2010. AstraZeneca is currently co-promoting TriLipix and will co-promote Certriad with Abbott once approved. However, Certriad’s approval could now get delayed by anything ranging from 6 months to more than a year, depending on the FDA’s requirements.
The delay could be significant if the FDA asks them to conduct new studies. Abbott and AstraZeneca intend to discuss the requirements with the agency so that they can respond to the complete response letter.
We currently have a Neutral recommendation on Abbott. Growth in Abbott’s cardiovascular business is currently being driven by TriCor, a powerful triglyceride lowering agent often used in combination with statins, and its next-generation product, TriLipix.
Another product, Niaspan, should also benefit thanks to the presentation of favorable data from the Arbiter-6 HALTS at the American Heart Association in November 2009. These products should help drive revenue growth given the growing need for treatments that help patients achieve recommended lipid goals.
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