Replies to post #17555 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

MNTA ReadMeFirst

[Updates:
MYL receives FDA approval for 40mg/20mg Copaxone;
Hatch-Waxman 180-day exclusivity on 40mg Copaxone still undecided;
MNTA probably can’t sue MYL for patent infringement;
ABBV-AMGN settle litigation pertaining to AMGN’s Humira FoB;
ABBV-AMGN settlement implications for MNTA;
AMGN made no attempt to work around ABBV’s formulation patents;
status of CHRS’ Humira-FoB program;
MNTA opts in for 50% profit-sharing on M230;
2017-2018 news flow;
musings on the value of MNTA’s technology.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-119915120 MNTA’s drug portfolio and pipeline
#msg-135232489 2017-2018 news flow
#msg-135223471 Musings on the value of MNTA’s technology

#msg-133532612 Transcript of 2Q17 conference call (8/2/17)
#msg-26837144 Momenta’s mantra on interchangeable FoBs
#msg-130220988 Incoming FDA commissioner emphasizes interchangeable FoBs
#msg-25803923 The Pink Sheet interviews Craig Wheeler (dated, but still a good read)


Valuation and finances
#msg-133589207 MNTA had $464M pro forma cash at 6/30/17
#msg-133589478 Diluted share count for valuation purposes
#msg-133492994 2Q17 press release


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-125412687 MNTA regains full ownership of M923…
#msg-127579499 …while monetizing Shire’s contractual obligations to the program
#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

#msg-134970085 ABBV-AMGN settle Humira-FoB litigation
#msg-134976468 ABBV-AMGN settlement—implications for MNTA
#msg-134996849 AMGN made no attempt to workaround ABBV’s formulation patents
#msg-134989206 Status of CHRS’ Humira-FoB program

#msg-131412374 ABBV’s ‘135 Humira-dosing patent invalidated (actual ruling)
#msg-131412917 ABBV’s ‘135 Humira-dosing patent invalidated (what it means)
#msg-129261201 UK Court rejects Humira “method of use” patents


MNTA/Mylan partnership for Orencia and 5 other FoBs
#msg-119689602 MNTA inks 50/50 partnership with Mylan for 6 FoBs
#msg-119697433 Commentary on MNTA-Mylan partnership by FierceBiotech

#msg-126247535 MNTA/Mylan start phase-1 trial of Orencia FoB
#msg-129440984 Orencia has annualized global sales of $2.5B
#msg-128079578 Speculation re identities of other 5 FoBs in partnership
#msg-128904877 Why Avastin is not one of the FoBs in the partnership


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



COPAXONE PROGRAM

#msg-112799454 FDA approves NVS/MNTA’s 20mg Copaxone (4/15)
#msg-128816545 PFE compliance issue delays approval of NVS/MNTA’s 40mg Copaxone
#msg-129066912 Text of PFE’s warning letter from FDA
#msg-12222305 NVS/MNTA split Copaxone profits 50/50

#msg-135115103 FDA approves MYL’s 40mg/20mg Copaxone (10/17)
#msg-135143169 180-day exclusivity on 40mg Copaxone still undecided
#msg-135223457 MNTA probably can’t sue MYL for patent infringement
#msg-135223471 Musings on MNTA’s technology in light of MYL approval



PROPRIETARY AUTOIMMUNE PROGRAM

#msg-107107809 Structure/rationale of M281, M230, and M254 (slides 118-142)

#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-123192434 MNTA starts phase-1 trial of M281 (FcRn antagonist)
#msg-133024075 Scientific rationale for M281

#msg-132953972 Musings on M254 (hsIVIG)

#msg-128572827 Global IVIG market expected to reach $12.6B in 2022
#msg-111515491 What is IVIG? (short videos)



LOVENOX PROGRAM

#msg-133197956 MNTA loses Lovenox patent case
#msg-133216485 What happens to MNTA’s $35M Court bond?
#msg-134420952 Settlement with Amphastar possible on Court bond


INTELLECTUAL PROPERTY

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