Replies to post #17547 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

MNTA 2017-2018 News Flow

[Miscellaneous updates.]


Copaxone program

• 2017(?): Expected 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, which NVS/MNTA are using for Glatopa (#msg-128816545). Approval probably can’t happen until PFE fixes all compliance issued at this site.


FoB program

• 4Q17: Submit 351(k) FDA application for M923 (Humira FoB), which is wholly owned by MNTA.

• Timing unknown: M923 commercial partnership or out-license.

• 2H17: Report phase-1 data for M934 (Orencia FoB), the lead FoB compound in the MYL-MNTA partnership (#msg-126247535). The phase-1 trial started in Nov 2016 (#msg-126247535).

• 4Q17: CAFC hearing on BMY’s Orencia patent. (MNTA appealed the USPTO’s IPR decision in favor of BMY to the CAFC, which granted expedited review.)

• Late 2017/early 2018: File IND for M710 (the second FoB compound in the MYL-MNTA partnership) and disclose what the compound is.


Proprietary autoimmune program

• 4Q17: Report data from SAD and MAD portions of phase-1 trial of M281, an anti-FcRn mAb wholly owned by MNTA.

• 4Q17: Start phase-1 trial of M230, an Fc-receptor compound partnered with CSL (#msg-127656306).

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