Followers | 829 |
Posts | 119621 |
Boards Moderated | 14 |
Alias Born | 09/05/2002 |
Tuesday, May 16, 2017 7:10:59 PM
[Delete entry for USPTO ruling on ABBV’s ‘135 Humira
patent—the ruling was issued today and is favorable for
MNTA (#msg-131412979).]
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
• 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.)
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM