Sanofi, Regeneron Capture a Shot at First-Mover Advantage in the PCSK9 Market

Thursday, January 29, 2015

Source: FierceBiotech

Amgen ($AMGN) just lost a key regulatory race. Armed with a handy FDA shortcut voucher, Regeneron ($REGN) and its Big Pharma partner Sanofi ($SNY) announced today that the agency has accepted their application for the powerful new PCSK9 cholesterol drug alirocumab and set a priority deadline of July 24 for their marketing decision. If they get a quick green light, as many analysts expect, their decision to buy the priority review voucher will be rewarded with first-mover advantage with U.S. payers as Amgen sits out an FDA game clock that ends August 27.

There are still plenty of 'ifs' to acknowledge. An approval is not assured, the FDA doesn't always abide by its deadlines and a few weeks head start won't necessarily translate into big market gains anyway. But Sanofi and Amgen both see these cholesterol drugs as major new product opportunity and proof positive that their pipeline strategies can deliver. Regeneron wants to demonstrate that it can build a portfolio of big products and both development teams recruited thousands of patients to provide a mountain of safety and efficacy data for the regulators.

Sanofi and Regeneron plan to market their new drug as Praluent.

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