Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

MNTA 2016-2017 News Flow

[Miscellaneous updates including discontinuation of Necuparanib program.]


Glatopa (20mg & 40mg) programs

• 2H16: FDA GDUFA date for NVS/MNTA’s 40mg-Copaxone ANDA. (See #msg-122479122 for background.)

• 25-Aug 2016 (or sooner): USPTO IPR decision on 40mg Copaxone. (The IPR concerns three of TEVA’s five Orange Book patents on 40mg Copaxone.)

• 26-Sep-2016: US District Court trial on 40mg Copaxone. (A ruling from the Court is expected in 1Q17 and is independent of the USPTO ruling on the IPR.)

• Feb 2017: Potential NVS/MNTA “at risk” launch of 40mg Glatopa. (See #msg-122479122 for background.)


FoB program

• Sep 2016: Oral arguments in USPTO IPR on BMY’s US Orencia patent.

• 2H16: Start phase-1 trial for Orencia FoB.

• 2H16: Report phase-3 data for Humira FoB in psoriasis. 351(k) submission to FDA in 2017 with projected US launch in 2018 (subject to patent litigation—see #msg-118781959).

• Jan 2017: USPTO decision on Orencia IPR.

• Timing unknown: Disclosures re five FoB compounds other than Orencia in MYL-MNTA partnership.


Lovenox program

• 2016: 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.)


Sialylated IVIG program

• 2H17: Report data from phase-1 trial of M281.

• 2017: Start phase-1 trial of M230.