Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

MNTA 2017-2018 News Flow

[Update re M923 program (phase-3 data already reported).]


Glatopa (20mg & 40mg) programs

• Late 2016/early 2017: Expected FDA approval of NVS/MNTA’s 40mg-Copaxone ANDA.

• 1Q17: Ruling from US District Court trial on Teva’s 40mg-Copaxone patents. (The trial has completed; the Court’s ruling is independent of the USPTO IPR that invalidated Teva’s ‘250, ‘302, and ‘413 patents.)

• Feb 2017: Potential NVS/MNTA “at risk” launch of 40mg Glatopa. (See #msg-124820193.)


FoB program

• 1H17: Submit 351(k) application for Humira FoB, M923. (Projected US launch in 2018, subject to patent litigation—see #msg-118781959.)

• Timing unknown: Commercial partnership for Humira FoB.

• 15-Jan-2017: USPTO decision on Orencia IPR.

• 2H17: Report phase-1 data for Orencia FoB. (The phase-1 trial started in Oct 2016.)

• Timing unknown: Disclosures re five FoB compounds other than Orencia in MYL-MNTA partnership. (For each FoB program, disclosure will be made when the phase-1 trial begins.)


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.)


Proprietary autoimmune program

• 2H17: Report data from phase-1 trial of M281 (anti-FcRn mAb).

• 2017: Start phase-1 trial of M230 (Fc receptor).