Replies to post #164925 on Biotech Values

[vinmantoo]

{{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?}}

We would need to know what the batch to batch variation Teva had when they received FDA approval for Copaxone.

[DewDiligence]

MNTA/TEVA/MYL—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?

There is clearly some flexibility in the FDA’s standard of sameness or no generic for a complex molecule would ever be approved; however, the differences you cited in the court documents may be consequential.

As far as I know, MYL did no development work on its generic-Copaxone product, so MYL’s ANDA is based on the Copaxone knockoff that Natco sells in India and Ukraine (#msg-29902618). Still, I don't think MYL's Copaxone ANDA is a hoax in the sense that Teva's Lovenox ANDA was.

[DewDiligence]

(MNTA)—MYL needs to get generic Copaxone (and generic Advair) approved in the US to hit the very aggressive 2018 targets the company has given to investors for sales and EPS. If MYL fails to get these products approved, the shortfall would presumably have to be made up via one or more acquisitions that are accretive to EPS.

[DewDiligence]

Bullish for MNTA: MYL disclosed CRLs for 20mg/40mg Copaxone ANDAs on yesterday’s GS webcast.