Abbott and AstraZeneca drop Certriad
This article was originally published in Scrip
Abbott and AstraZeneca are to discontinue their joint collaboration for the development of Certriad (rosuvastatin/fenofibric acid delayed release) for the treatment of mixed dyslipidaemia.
The move comes after "careful consideration" of the complete response letter received from the US FDA on 30 March 2010 and the resulting regulatory delay, with the outcome that the development of Certriad is "no longer commercially attractive", said the companies.
The NDA for Certriad was submitted in June 2009 to treat mixed dyslipidaemia, a combination of two or more lipid abnormalities including high LDL cholesterol, high triglycerides and low HDL-cholesterol.
Certriad contained the active ingredients of the cholesterol treatment Crestor (rosuvastatin calcium) and Trilipix (fenofibric acid) for lipid management.
Abbott noted that there would be no financial impact to its ongoing earnings per share in 2010 or 2011 resulting from the decision.
Crestor patent
A US district court upheld the patent for Crestor earlier this year (scripintelligence.com, 30 June 2010). AstraZeneca and partner Shionogi (which owns the patent) launched a lawsuit in 2007 against eight generics drug makers (Apotex, Aurobindo, Cobnalt, Mylan, Par Pharmaceuticals, Sandoz, Sun and Teva Pharmaceutical Industries) to block generic versions of Crestor in the US before the expiration of the '314 patent in 2016.
Despite the positive Crestor patent news, the failure of Certriad is a blow for AstraZeneca. It faces major patent expiries ahead, including Seroquel (quetiapine fumarate) in 2012 and Nexium (esomeprazole) in 2014.