Sanofi: Alirocumab (PCSK9) reports first positive phase III results

BUY, Fair Value EUR88 (+20%)

News published on October Wednesday 16, 2013
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We were expecting two sets of very significant clinical news for Sanofi by the end of the year, capable of offsetting fairly uninspiring quarterly results, namely the last two phase III results for U300 on the one hand and the first phase III results for alirocumab, usually known as PCSK9 inhibitor, on the other. The second set has been published today and headline results are positive with the drug achieving its primary endpoint in ODYSSEY MONO, in comparison with ezetimibe after 24 weeks of treatment. Although it is not the most relevant trial of the overall programme, it is the first time alirocumab has been able to show superiority over another approved cholesterol-lowering drug in a randomised trial. There was no safety signal. We expect alirocumab to be filed in Q4 2014 and launched late in 2015. So far, our probability-adjusted 2021 peak sales estimate stands at EUR750m with a big unknown about pricing. As with U300, we see nothing other than upside for these numbers.


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