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Momenta (Nasdaq:MNTA) and Sandoz Score a Win in Generic Lovenox Battle

|Includes: Momenta Pharmaceuticals, Inc. (MNTA), NVS, SNY

Judge Emmet Sullivan refused to issue an injunction to block Momenta and partner Sandoz (a unit of Novartis, Nasdaq:NVS) from moving forward with a generic version of Lovenox as requested by Sanofi-Aventis (Nasdaq:SNY).  To be brief, this has been a long battle, dragging on for roughly 7 years, as the FDA has been constantly reviewing the generic to ensure efficacy and safety since the initial citizen's complaint was filed by Sanofi to stop the approval of any Abbreviated New Drug Application (ANDA) for a generic to Lovenox.

In the simplest terms, U.S. District Judge Sullivan countered all arguments of SNY and sided with the FDA citing that they had conducted proper diligence and not overused power in its evaluations of the generic drug.  An interesting side note to the argument was that SNY complained that the lack of an injunction will cause it to lose revenues to Sandoz, but the Judge countered by clarifying the situation as "a wash" because if a temporary injunction were put into effect, Sandoz would lose an equal amount of business.

Bottom Line:  Keep an eye on NVS and MNTA today.  Shorts went in heavy and the MNTA chart looks primed to try and turn.

The court's decision can be viewed at:  ecf.dcd.uscourts.gov/cgi-bin/show_public...

and the response by the FDA to the petition can be viewed at:  www.fda.gov/downloads/Drugs/DrugSafety/P...


Disclosure: No Positions