Replies to post #16250 on Momenta Pharmaceuticals, Inc. (MNTA)

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MNTA 2017-2018 News Flow

[Updated for delay in FDA approval of 40mg
Glatopa, as noted in first bullet item below.]


Copaxone (Glatopa) program

• 2Q17(?): 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). As a result, MNTA no longer expects FDA approval in 1Q17.

• 2Q17(?): 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

• 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).

• Timing unknown: Disclosures re the five FoB compounds other than M934 to be developed by the MNTA-MYL 50/50 partnership. The second compound in the collaboration, which has not been identified, is designated M710. For each FoB compound in the collaboration, disclosure of the identity will likely be made when the phase-1 trial begins.


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

• 10-Jul-2017: US District Court trial 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.)