Replies to post #17888 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

MNTA 2018 News Flow

[Updated for disclosures concurrent with JPM conference.]


FoB program

• Timing unknown: M923 (Humira FoB) commercial partnership or out-license.

• 1H18: Start phase-3 trial for M710 (Eylea FoB).

• mid 2018: Report reason for inability of M834 (Orencia FoB) to meet its phase-1 pharmacokinetic endpoint; start phase-1 do-over, if necessary.


Proprietary autoimmune program

• 1H18: Start phase-1 trial of M230, which is partnered with CSL (#msg-127656306).

• 2018 Start phase-1 trial of M254, a hyper-sialylated IVIG.


Copaxone program

• 2H18: Anticipated FDA approval of NVS/MNTA’s 40mg-Copaxone ANDA. (On 2/17/17, MNTA reported that the ANDA approval was held up due to an FDA compliance issue at PFE’s fill/finish facility at McPherson, KS, which NVS/MNTA are using for Copaxone. Approval of the ANDA can’t happen until PFE fixes the compliance issue at this site.)