Replies to post #201107 on Biotech Values

[DewDiligence]

Based on MNTA’s CC today, I expect NVS/MNTA to launch 40mg Glatopa “at risk” (assuming they have FDA approval) when the Hatch-Waxman stay expires in Jan 2017, regardless of the status of the patent litigation with Teva. (The only exception would be if the court imposes a preliminary injunction against launching, which is highly unlikely, IMO.)

[DewDiligence]

MNTA 2016-2017 News Flow

[New item for potential “at risk” launch of 40mg Glatopa in Feb 2017.]


Glatopa (20mg & 40mg) programs

• 2H16: FDA GDUFA date for NVS/MNTA’s 40mg-Copaxone ANDA.

• Aug 2016: USPTO decision on inter partes review regarding three of Teva’s Orange Book patents on 40mg Copaxone. (The IPR itself occurs on 5/12/16.)

• 26-Sep-2016: US District Court trial on all four of Teva’s Orange Book patents on 40mg Copaxone.

• Feb 2017: Potential NVS/MNTA “at risk” launch of 40mg Glatopa (assuming FDA approval has been obtained)—see #msg-122479122.


FoB program

• Mid 2016: Start phase-1 trial for Orencia FoB.

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

• Late 2016/early 2017: 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).

• 2016: MNTA expects to earn $60M in milestone payments from MYL (out of the $200M total) for meeting undisclosed FoB milestones.

• 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/AGN 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 AMPH/AGN are not protected by the Hatch-Waxman Safe Harbor: #msg-118404904, #msg-115468100.)


Necuparanib program

• Jun 2016: Updated clinical data at ASCO.

• 2H17: Report final data from phase-2 data trial in pancreatic cancer. (Trial listing at: http://www.clinicaltrials.gov/ct2/show/NCT01621243 .)


Sialylated IVIG program

• Mid 2016: Start phase-1 trials for first two of three sialylated-IVIG candidates (of which two are recombinant and one is plasma-derived). The third candidate will start phase-1 in 2017.