Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

MNTA ReadMeFirst

[Updates:
MNTA reports phase-1 data for M281;
M710 is an Eylea FoB;
musings on selection of Eylea;
MNTA guides to 2H18 FDA approval of 40mg Copaxone;
2018 news flow;
new corporate slide set (from JPM webcast).]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-119915120 MNTA’s drug portfolio and pipeline
#msg-137519448 Latest corporate slide set (from Jan2018 JPM webcast)
#msg-137725434 2018 news flow
#msg-135223471 Musings on the value of MNTA’s technology
#msg-135905077 Transcript of 3Q17 conference call (11/1/17)


Valuation and finances
#msg-135983998 MNTA had $389M pro forma cash at 9/30/17
#msg-135984375 Diluted share count for valuation purposes


Officers and directors
#msg-127373731 Composition of Board of Directors
#msg-135073055 Ganesh Kaundinya (co-founder) named COO/CSO (10/17)
#msg-131814122 Santiago Arroyo named CMO (6/17)
#msg-126247557 Scott Storer named CFO (11/16)
#msg-12824293 Craig Wheeler named CEO (8/06)



FOLLOW-ON BIOLOGICS (FoB) PROGRAM

FDA guidance and MNTA’s view on interchangeable FoBs
#msg-127909952 FDA issues (draft) guidance on interchangeable FoBs
#msg-130220988 Incoming FDA commissioner emphasizes interchangeable FoBs…
#msg-26837144 …which fits right in with Momenta’s mantra on interchangeable FoBs
#msg-127947222 FDA permits indication extrapolation for interchangeable FoBs


M923 (Humira FoB) program
#msg-134970085 ABBV-AMGN settle Humira-FoB litigation
#msg-135992347 MNTA’s M923 launch delayed until 2022+

#msg-125412687 MNTA regains full ownership of M923
#msg-130582027 Interchangeable Humira FoB for US is badly needed
#msg-126858164 Positive phase-3 data for M923
#msg-127945401 Phase-3 trial of M923 included switching to/from branded Humira (1)
#msg-130182027 Phase-3 trial of M923 meets FDA draft guidelines for interchangeable FoBs


MNTA/Mylan partnership for Orencia, Eylea and 4 other FoBs
#msg-135854040 Orencia FoB (M834) misses PK endpoint in phase-1 trial
#msg-137394042 M710 (2nd partnership FoB) is Eylea
#msg-137525788 Musings on selection of Eylea
#msg-137530324 Why M710 can go directly to phase-3 (no PK trial)

#msg-119689602 MNTA inks 50/50 partnership with MYL for 6 FoBs
#msg-119697433 Commentary on MNTA-Mylan partnership by FierceBiotech


Miscellaneous FoB info
#msg-123094763 FDA’s FoB guidance docs (other than for interchangeable status)
#msg-48581353 Text of BPCIA enabling US FoBs
#msg-70191760 US patent-expiration dates of big-selling biologics



PROPRIETARY AUTOIMMUNE PROGRAM

#msg-137491062 MNTA reports phase-1 data for M281
#msg-133024075 Scientific rationale for M281

#msg-127656306 MNTA inks M230/autoimmune collaboration with CSL
#msg-129436390 MNTA introduces M230 (press release)
#msg-128995744 Biocentury Innovations write-up on M230
#msg-134441274 MNTA opts in for 50% profit-sharing on M230

#msg-107107809 Structure/rationale of M281, M230, and M254 (slides 118-142)
#msg-128572827 Global IVIG market expected to reach $12.6B in 2022
#msg-111515491 What is IVIG? (short videos)



COPAXONE PROGRAM

#msg-137504857 MNTA guides to 2H18 FDA approval of 40mg Copaxone
#msg-128816545 PFE compliance issue delays FDA approval of 40mg Copaxone
#msg-129066912 Text of PFE’s warning letter from FDA

#msg-135115103 FDA approves Mylan’s 40mg/20mg Copaxone (10/17)
#msg-135223471 Musings on MNTA’s technology in light of MYL approval

#msg-112799454 FDA approves NVS/MNTA’s 20mg Copaxone (4/15)
#msg-135962750 Why MNTA isn’t seeking to market generic Copaxone in EU



INTELLECTUAL PROPERTY

#msg-126849411 Recent patent applications and overview of IP estate
#msg-89344512 USPTO issues sialylation patent licensed to MNTA