Sanofi and Regeneron's alirocumab tops Zetia, fueling PCSK9's blockbuster bluster

Sanofi ($SNY) and Regeneron's ($REGN) alirocumab resoundingly beat out Merck's Zetia in helping statin-intolerant patients lower their bad cholesterol in a study, data that bolster the case for a new class of highly anticipated cardio drugs.

As Reuters reports, among the 360 patients in a Phase III study, those in the alirocumab arm reported a 45% LDL cholesterol reduction compared to just 14.6% for subjects taking Zetia. Furthermore, Sanofi and Regeneron's drug helped 42% of patients get lower their LDL to target levels while only 4% hit the mark in the Zetia group.

The results, presented at the American Heart Association congress in Chicago, mirror a similar victory for Amgen's ($AMGN) competing evolocumab, which roughly halved bad cholesterol in statin-intolerant patients in a late-stage study disclosed earlier this year. Both treatments are antibodies designed to block the protein PCSK9, thereby helping the body clear LDL cholesterol from the blood, and analysts expect the market for such therapies to reach above $10 billion a year. Their broad success in patients who can't handle tried and cheap statins affirms what many figure will be a natural first population for the injectables once they hit the market.

And, thanks to Zetia, the approval and eventual adoption of PCSK9 blockers looks all the more likely. In results from a nearly decade-long study unveiled Monday, Merck's drug demonstrated a real, if modest, improvement in rates of heart attack, stroke and other cardiac events. That supports the premise that cutting cholesterol can extend lives, a hypothesis at the heart of the case for PCSK9 inhibition.

However, just which company will be first to test whether payers and physicians are on board remains to be seen.

Amgen, long the leader in a race that also includes Pfizer ($PFE), is expecting to win FDA approval for evolocumab no later than Aug. 27. That would have given it months of market exclusivity, but, over the summer, Sanofi and Regeneron paid $67.5 million for an FDA voucher that will cut alirocumab's review time down from 10 months to 6 months. Assuming the pair files its drug by year's end as planned, alirocumab will likely be up for approval at the same time if not before Amgen's contender. Further complicating matters, Amgen last month sued the makers of alirocumab, contending that the drug infringes its patents and seeking to block its eventual launch.

Analysts see few notable differences in efficacy between the leading PCSK9 contenders, figuring each will bring in peak sales of around $3 billion.

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Special Report: Tomorrow's cardio blockbusters: Inside 'the next big leap' in controlling cholesterol

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