Biotech Values

[DewDiligence]

MNTA 2015-2016 News Flow

[New guidance on phase-3 start for Humira
FoB; update re Lovenox patent case.]


Copaxone program

• Soon: Ruling from Appellate Court on Teva’s ‘808 patent, which probably affects NVS/MNTA decision whether to launch Glatopa prior to 9/1/15.

• 1-Sep-2015: Expiration of Teva’s ‘808 patent (and hence the latest launch date for Glatopa).


FoB program

• 2H15: Partnership deal for FoB compounds other than Humira (which is partnered with BXLT).

• Late 2015: Results of phase-1 trial and start of phase-3 trial for Humira FoB, which is partnered with BXLT (the BAX spin-off). Regulatory submissions expected in 2017 if no hitch.

• 2016: Orencia FoB starts phase-1.

• Timing unknown: New pipeline disclosures re M597, M615, M282, M706, M730, or M740. (See slide 53 at link in #msg-107107809.)


Necuparanib program

• 2016: Results of phase-2 trial in pancreatic cancer. Primary endpoint is overall survival. (The trial is listed at http://www.clinicaltrials.gov/ct2/show/NCT01621243 .)


Miscellaneous

• Summer 2015: Appellate Court ruling on Lovenox patent case. (A hearing with oral arguments took place on 5/4/15; MNTA still hopes to overturn the 2012 Safe Harbor ruling in favor of Amphastar and win damages for patent infringement.)

• Timing unknown: New disclosures re recombinant IVIG program.