Replies to post #17504 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

MNTA 2017-2018 News Flow

[Miscellaneous updates from disclosures on 2Q17 CC.]


Copaxone (Glatopa) 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.

(Although there are other companies with 40mg-Copaxone ANDAs under FDA review, only NVS/MNTA has received FDA approval for the original 20mg formulation. The 20mg and 40mg formulations are identical except for the concentration of drug in the syringe.)


FoB program

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

• Timing unknown—probably after 351(k) submission: Out-license or commercial partnership for M923.

• 2H17: Report phase-1 data for Orencia FoB, which is designated M934 is and the lead compound in the 50/50 FoB partnership between MNTA and MYL (#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 MNTTA-MYL partnership) and disclose what the compound is.


Proprietary autoimmune program

• 2H17: Report data from SAD and MAD portions of phase-1 trial of M281, an anti-FcRn mAb wholly owned by MNTA.

• 2H17: 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.