Replies to post #194807 on Biotech Values

[DewDiligence]

MNTA 2015-2017 News Flow

[Phase-3 trial for Humira FoB has already started.]


Glatopa program

• 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).

• 2-May-2016: USPTO inter partes review of Teva’s three Orange Book patents for 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.)


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: Phase-1 (PK) data for Humira FoB. (The phase-3 trial in psoriasis started on 10/5/15; 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.