Replies to post #9164 on Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

The legal ruling and FDA approval do NOT mix. If & when we get mC FDA approval, as Dew states, there will be a settlement.

BTW - CW at GS GLOBAL - June 7

I get a sense that at least a certain portion of our investors are looking at the district court decision as the big milestone for Momenta and what’s going to happen. And I actually – we don’t view at that way. Because we basically view it as a 100% probability of an appeal here. 100%. It’s going to get appealed.

http://seekingalpha.com/article/645271-momenta-pharmaceuticals-ceo-presents-at-goldman-sachs-33rd-annual-global-healthcare-conference-transcript


Regards,

Flo

[alertmeipp]

>>Not so fast....I don't believe the FDA takes into consideration legal issues when considering approval of a drug....

I believe they can get a tentative one which may or may not trigger a settlement talk with Teva...


See this:

http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm296039


When will the generic version of my medicine be available?
The availability of generic drug depends on many factors, including patent expiration and FDA approval of the generic drug application.

Each drug may hold several patents. The availability of generic versions depends on the court ruling of the validity of any pertinent patents and the expiration dates. FDA publishes the Orange Book. The Orange Book lists the patent number and expiration date of each patent that claims the drug or method of using the drug.

Each drug may have multiple patents, and not all patents are listed in the Orange Book. For example, drugs may have patents that are listed with the U.S. Patent and Trademark Office, but are not required to be listed in the Orange Book.

The availability of generic versions also depends on whether generic applications for approval are submitted to FDA, and whether these applications contain sufficient information for approval. If a generic drug product is ready for approval before the expiration of any patents, FDA issues a tentative approval letter to the applicant. A tentative approval does not allow the applicant to market the generic drug product.

FDA delays final approval of the generic drug product until all patent issues are resolved.

[DewDiligence]

The FDA can approve NVS/MNTA’s Copaxone ANDA irrespective of the patent litigation. Pursuant to Hatch-Waxman, there’s a 30-month stay on FDA approval following a Paragraph-IV challenge, but this 30-month stay for NVS/MNTA’s Copaxone ANDA expired on 1/11/11. (The clock on the 30-month stay started when the FDA accepted NVS/MNTA’s Copaxone ANDA for review on 7/11/08 [#msg-30621490] and NVS/MNTA notified Teva of their Paragraph-IV challenge, triggering the patent lawsuit by Teva.)

NVS/MNTA have clearly decided not to launch Copaxone “at risk” unless the Appellate Court reverses the District Court’s ruling. Hence, even following FDA approval of NVS/MNTA’s ANDA, there will no actual launch of generic Copaxone prior to the conclusion of the appeal unless there is a settlement between the parties.

Nevertheless, from the standpoint of MNTA’s shareholders, FDA approval of the Copaxone ANDA is consequential insofar as it can be expected to boost the share price substantially by re-validating MNTA’s technical prowess in replicating complex drugs and by guaranteeing that a generic-Copaxone launch is possible following the expiration (or settlement) of Teva’s patents.