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rwdm

05/28/14 2:40 PM

#178489 RE: biopearl #178485

Teva might know if phenol is used in Mylan/MNTA production by analyzing the generic copaxone on the market for levels of bromotyrosine.
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DewDiligence

05/28/14 3:25 PM

#178490 RE: biopearl #178485

Re: Generic Copaxone

Just curious as to how TEVA might know what process Mylan/MNTA is using for production.

Teva knows only a smidgen about MNTA’s Copaxone process, based on what was revealed in the Court pleadings for the patent litigation (#msg-90636221).

For MYL’s process, Teva may know a little more because Teva analyzed Natco’s Copaxone product, which was the starter material for MYL’s Copaxone ANDA. The differences between Natco’s product and Teva’s branded Copaxone was the subject an article Teva published in the journal PlosOne (#msg-95859421).

The PLosOne article was ridiculed by MYL in such a way that it made me think MYL was “protesting too much” and had a bona fide reason to be concerned about the lack of sameness to branded Copaxone (#msg-95940059).
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DewDiligence

06/30/14 4:30 PM

#179942 RE: biopearl #178485

US DoJ’s amicus brief in Copaxone patent case is bullish for MNTA, IMO:

#msg-103869690