Biotech Values

[DewDiligence]

MNTA—Am I the only who thinks [today’s MYL-MNTA announcement] probably means MYL has given up on Gx Copaxone?

This question was broached tangentially on today’s CC, and Craig Wheeler emphasized that the MYL partnership pertains to FoBs only. Hence, my guess is that MYL is nominally still seeking FDA approval for generic Copaxone, but they may not have the technical knowhow to satisfy the concerns in the FDA’s CRL, which includes demonstrating sameness to branded Copaxone on 1,000 distinct product characteristics.

So, MYL probably isn’t getting FDA approval for generic Copaxone anytime soon, but such an approval is not less likely because of MYL’s FoB partnership with MNTA.

On the other hand, MYL’s inability to get FDA approval for generic Copaxone to date may have gone a long way toward convincing MYL that MNTA has strong FoB technology and is a worthy FoB partner.