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DewDiligence

07/26/13 1:24 PM

#164546 RE: DewDiligence #164542

MNTA’s own PR on today’s Copaxone ruling:

http://finance.yahoo.com/news/momenta-pharmaceuticals-announces-potential-2014-171852956.html

"We are extremely pleased with today's ruling," said Craig Wheeler, President and Chief Executive Officer of Momenta. "Given the decision, we and Sandoz will continue to work with FDA to advance review of the ANDA for generic Copaxone in order for this product to be approved and available to patients as soon as possible."

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rwdm

08/03/13 3:19 PM

#164925 RE: DewDiligence #164542

In the Copaxone appellate court document the amino acid content of generic glatiramer acetate of both Momenta and Mylan are mentioned on Page 18. The numbers are quite different, especially in the case of Tyrosine (8.3% vs. 9.2% respectively which is a ~10% deviation). Does this mean that the similarity required by the FDA has some flexibilities?