Replies to post #198462 on Biotech Values

[DewDiligence]

MNTA—Wild speculation re delay in announcing new FoB partnership:

Nary a peep about Humira-FoB prgm w $MNTA on 50-min $BXLT GS webcast today. @biosimilarz

— Roy Friedman (@DewDiligence) January 5, 2016

[DewDiligence]

MNTA 2016-2017 News Flow

[Various changes re FoB program pursuant to
MYL-MNTA partnership announced today.]


FoB program

• Jan 2016: USPTO inter partes review against BMY on US Orencia patent.

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

• Throughout 2016: MNTA expects to earn $60M in milestone payments from MYL (out of the $200M potential total) during 2016 for meeting undisclosed FoB milestones. (The $60M is in addition to the $45M up-front amount in the MYL-MNTA partnership.)

• 2017: Completion of phase-3 trial of Humira FoB in psoriasis. (Trial started on 10/5/15.) 351(k) submission to FDA in 2017 with projected US launch in 2018 (subject to patent litigation—see #msg-118781959).

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


Glatopa & 40mg-Copaxone programs

• 2-May-2016: USPTO inter partes review of Teva’s three Orange Book patents on the 40mg formulation of Copaxone. (Approximately 80% of patents where the USPTO grants an IPR are ultimately invalidated; if Teva’s 40mg Copaxone patents are invalidated, MNTA could launch a generic version of 40mg Copaxone, with FDA approval, as soon as Jan 2017, when Teva’s Hatch-Waxman exclusivity on the 40mg formulation expires.)

• 26-Sep-2016: US District Court trial on Teva’s 40mg Copaxone patents. (This trial may be mooted if the May 2016 IPR [above] invalidates Teva’s patents.)


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

• 2H17: Report data from phase-2 data trial in pancreatic cancer. (The trial resumed enrolling patients on 12/21/15: #msg-119316006.) Trial listing at: http://www.clinicaltrials.gov/ct2/show/NCT01621243


Sialylated IVIG program

• Late 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.