Teva Pharmaceutical (NASDAQ:TEVA) Files Third Citizen Petition

Needham & Company maintains a "Strong Buy" on Teva Pharma (NASDAQ:TEVA), citing the filing of a third Citizen Petition with the FDA.

Here's why they say it's different this time:

"Teva has filed a third Citizen Petition (CP) with the FDA requesting that the regulatory agency refuse to approve any ANDA applications related to Teva’s blockbuster MS drug Copaxone.

"Though we have not yet read the petition, Teva management insists the latest submission is not simply a regurgitation of disputed criterion contained in two prior petitions--both technically "denied" but more accurately simply not acted upon. The latest petition purportedly draws on many of the lessons learned and rationale proposed by FDA for the approval of Momenta's generic enoxaparin (Lovenox), essentially outlining the case that much of the rationale for supporting the enoxaparin approval is exactly why a generic Copaxone could not be approved by the agency using similar criteria. Most interesting about the petition is that Teva has gone the additional step of requesting a multidisciplinary FDA advisory committee to consider the approval of follow-on Copaxone products. Though this may seem like just another item on the Xmas wish list, we don't think the significance of this should be underappreciated. If Teva management were not 100% confident of their position, the best path to follow would be to simply rely on the vagaries of the generic drug approval process and the historical tendency of the Office of Generic Drugs to behave like a “deer in headlights” anytime complex issues are raised in a petition; at least this would buy time and potentially lots of it even if Teva's position wasn't ultimately supported. By essentially saying to the agency "we'll show you ours, if you show us yours", Teva is laying out all its cards on the table and taking a potentially huge gamble. Whether or not FDA will take the company up on their offer or how the agency responds to other requests in the petition remain to be seen, though obviously management would not do so unless they were supremely confident in their position."

Teva Pharmaceutical closed Monday at $53.42, down $0.38, or 0.71 percent. Needham has a price target of $65 on them.