Replies to post #17215 on Momenta Pharmaceuticals, Inc. (MNTA)

[jbog]

Pfizer last week talked about their "Hospira" plant solutions (all Plants) and did say the McPhearson problems happened very early in their ownership and are being resolved.

[DewDiligence]

MNTA 2017-2018 News Flow

[New entries for M710 phase-1 trial, USPTO ruling
on ABBV’s ‘135 Humira patent, and CAFC ruling on
BMY’s Orencia patent; correction re date of Lovenox
patent retrial in US District Court.]


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 apparently can’t happen until PFE fixes all compliance issued at this site.

• 2017(?): Commercial launch of 40mg Glatopa. Having won the 40mg-Copaxone patent case in the US Court of Appeals, NVS/MNTA will almost certainly launch 40mg Glatopa as soon as they have FDA approval (#msg-124820193).

(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

• May 2017: USPTO ruling on ABBV’s ‘135 Humira dosing patent. (The IPR was brought by CHRS, but it affects all companies seeking to commercialize Humira FoBs in the US market.)

• Mid 2017: Submit 351(k) FDA application for Humira FoB, which is designated M923 and is wholly owned by MNTA. (Projected US launch of M923 is in 2018, subject to patent litigation—see #msg-118781959.)

• 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).

• Late 2017/early 2018: Disclosure of identity of M710 (the second FoB compound in the MNTTA-MYL partnership) and start of phase-1 trial.

• Apr 2018: CAFC ruling on BMY’s Orencia patent, which MNTA attempted to challenge via an IPR.


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).


Lovenox program

• 2H17: US District Court retrial of NVS/MNTA vs AMPH on infringement of MNTA’s Lovenox patents, which could result in substantial damages payable to NVS/MNTA. (The Appellate Court remanded the case to the District Court on 11/10/15, finding that the defendant, Amphastar, is not protected by the Hatch-Waxman Safe Harbor: #msg-118404904, #msg-115468100.)