See message
Message 30045839
for the AdComm meeting dates. Here is a quote from a REGN PR on the PDUFA date:
"TARRYTOWN, N.Y. and PARIS, Jan. 26, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for PraluentTM (alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of July 24, 2015. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is intended for the treatment of patients with hypercholesterolemia."
files.shareholder.com
Also quoting from a PiperJaffray note published on Dec 12 2014 on "Potential "Surprise" Events in 2015", one of 15 such events. Further, they state: "Some are higher probability than others; high conviction was not a requisite for making the list."
#9. AMGN blocks REGN/SNY’s PCSK9
Few investors seemed to care much when AMGN filed a preliminary injunction to prevent
REGN/SNY from launching alirocumab based on infringement of AMGN’s patents. Most
were pretty dismissive of any chance of success, feeling that these injunction requests rarely
prove successful. But based on filing and development history, it appears to us that AMGN
does indeed have the position of strength in time-to-filing. Additionally, the inhibition of
PCSK9 to reduce cholesterol has a reasonable basis for non-obviousness, since not all
inhibition approaches led to lower LDL levels and the literature regarding the association of
PCSK9 mutations to LDL lowering was mixed. Lastly, there is a basis to claim ‘irreparable
harm’ from a concurrent launch of alirocumab, namely the lost opportunity to price the
product as a monopoly. As such, having alirocumab on the market will lead to lost pricing power
that could impact the long-term outlook of the class to such an extent that even
SNY/REGN may not be able to make AMGN whole for the damages
.
While obtaining a preliminary injunction may be a low probability event, its impact on
large market cap companies would definitely be a big ‘surprise’ event for next year. |
