Biotech Values

[DewDiligence]

Re: Handicapping the market for 40mg Copaxone (US only)

I would say there's an 80% chance MNTA has the only approved generic during the first year (Feb 2017 – Jan 2018); a 60% chance MNTA has the only approved generic during the second year (Feb 2018 – Jan 2019), and a 55% chance MNTA has the only approved generic during the third year (Feb 2019 – Jan 2020).

Discussion

• MNTA has the only FDA-approved generic for 20mg Copaxone, which is virtually identical to 40mg Copaxone. (The only difference is the concentration of drug in the pre-filled syringe.)

• The scientific hurdle for FDA approval of generic Copaxone is high (#msg-112848073).

• Unlike the way it handled generic Lovenox, the FDA did not disclose how MNTA reverse-engineered branded Copaxone (#msg-112812696).

• There are known differences between MYL’s 20mg Copaxone and MNTA’s 20mg product (#msg-90636221).