Biotech Values

[DewDiligence]

MNTA 2015-2016 News Flow

[Updated for 2Q15 CC.]


Glatopa program

• Aug/Sep 2015: USPTO inter partes review of Teva’s patent for 40mg (thrice-weekly) formulation of Copaxone.

• 27-Oct-2015: NVS’ 3Q15 CC will provide additional info about the strength of the Glatopa launch (and at least a rough estimate of 3Q15 Glatopa sales).


Lovenox program

• 2015: Ruling from Appellate Court on Safe Harbor issue. The U.S. Solicitor General recently sided with NVS/MNTA by asserting that Amphastar’s (and Teva’s) invoking the Safe Harbor in their defense was inappropriate (https://www.dropbox.com/s/zxz9pfu2kfh3t7w/document.pdf ); if the CAFC sides with the SG, the Lovenox patent case will finally be tried on the merits and NVS/MNTA may be able to claim damages for patent infringement—see #msg-115468100.


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.. 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

• Timing unknown: New disclosures re recombinant IVIG program and other early-stage development programs.