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Posts | 120476 |
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Alias Born | 09/05/2002 |
Tuesday, October 10, 2017 2:03:50 PM
[Updated to indicate that M710 is probably Xolair.]
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 formally disclose what the compound is. M710 is likely Xolair (#msg-135286163).
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.
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