Replies to post #16090 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

MNTA ReadMeFirst

[Updates:
MNTA reports positive phase-3 on (wholly-owned) Humira FoB;
MNTA introduces M230;
2017-2018 news flow;
RDY acknowledges CRL for 20mg-Copaxone ANDA;
MNTA patent applications & IP overview.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-119915120 MNTA’s drug portfolio and pipeline
#msg-126861896 2017-2018 news flow
#msg-126349837 Transcript of 3Q16 conference call (11/2/16)

#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-26837144 Momenta’s mantra on interchangeable FoBs
#msg-122395849 FDA PoV on interchangeable FoBs may have moved in MNTA’s favor
#msg-25803923 The Pink Sheet interviews Craig Wheeler (dated, but still a good read)


Valuation and finances
#msg-126330809 MNTA has very strong liquidity
#msg-126247520 3Q16 press release
#msg-114728853 Glatopa milestone payments from NVS
#msg-124349021 Diluted share count for valuation purposes
#msg-124870976 NVS’ equity stake


Officers and directors
#msg-125530546 Composition of Board of Directors
#msg-126247557 Former Baxter executive, Scott Storer, named CFO (11/16)
#msg-118984568 Former Biogen executive, Matt Ottmer, named COO (12/15)
#msg-33979910 James Sulat named Chairman of BoD (12/08)
#msg-12824293 Craig Wheeler named CEO (8/06)



GLATOPA (COPAXONE) PROGRAM

Economic rationale and profit split
#msg-12222305 NVS/MNTA split Glatopa profits 50/50
#msg-113300123 MNTA guides to $35K revenue per Glatopa patient-year
#msg-114728853 Glatopa milestone payments from NVS


20mg Glatopa
#msg-112799454 FDA approves 20mg Glatopa
#msg-112799896 FDA’s rationale for approval of 20mg Glatopa


40mg Glatopa
#msg-120661209 NVS/MNTA’s 40mg ANDA has 2016 GDUFA date
#msg-124820193 “At risk” launch likely in early 2017 (if ANDA approved)
#msg-124918501 USPTO invalidates three of Teva’s 40mg Copaxone patents
#msg-124628031 Five 40mg-Copaxone patents will be litigated in US District Court
#msg-125465255 Main issue in patent litigation is obviousness
#msg-124749893 Handicapping the 40mg-Copaxone market



Potential competition from other generic-Copaxone products
#msg-112812696 No FDA roadmap for competing generics
#msg-84501925 Musings on trade secrets and FDA disclosure policy (Dew)
#msg-112848073 Musings on trade secrets and FDA disclosure policy (indigokid)

#msg-112817624 Mylan and MNTA products are not identical
#msg-41441618 Mylan’s Copaxone ANDA has been under FDA review for >7 years

#msg-112887376 MNTA’s Copaxone IP may thwart other generics
#msg-59682546 USPTO issues ‘187 patent re Copaxone manufacturing

#msg-115896634 PFE licenses Synthon’s Copaxone ANDA
#msg-70039774 Synthon submits Copaxone ANDA…
#msg-99675480 …but acknowledges receiving CRL
#msg-126518291 RDY acknowledges receiving CRL



FOLLOW-ON BIOLOGICS (FoB) PROGRAM

#msg-125412687 MNTA regains control of Humira-FoB program
#msg-126858164 Positive phase-3 data for Humira FoB (PR)
#msg-126805014 Positive phase-3 data for Humira FoB (AACR poster)
#msg-70237561 An interchangeable Humira FoB has colossal upside
#msg-122395849 FDA PoV on interchangeable FoBs may have moved in MNTA’s favor

#msg-118781959 Can Abbvie block US Humira FoBs until 2022?
#msg-126869318 CW says ABBV’s formulation patents not an impediment

#msg-125359509 FDA approves AMGN’s Humira FoB (Amjeta)
#msg-124960991 ABBV sues AMGN for Humira-patent infringement
#msg-126114458 AMGN not launching Humira FoB until 2018 or later
#msg-126120856 AMGN’s delay is probably positive for MNTA


#msg-119689602 MNTA inks 50/50 partnership with Mylan for 6 FoBs
#msg-119691929 Terms of partnership meet two of MNTA’s stated goals
#msg-126247535 MNTA/MYL start phase-1 trial of Orencia FoB
#msg-126388090 Orencia has US annualized sales of $1.5B
#msg-119697433 Commentary on MNTA-MYL partnership by FierceBiotech


#msg-104534644 FoB market expected to reach $35B by 2020
#msg-26837144 Momenta’s mantra on interchangeable FoBs
#msg-122623720 FDA proposes dedicated unit to evaluate FoBs
#msg-123094763 FDA guidance documents wrt FoBs
#msg-122395849 FDA PoV on interchangeable FoBs may have moved in MNTA’s favor
#msg-48581353 Text of BPCIA enabling US FoBs
#msg-70191760 US patent-expiration dates of big-selling biologics



LOVENOX PROGRAM

#msg-118404904 CAFC remands Lovenox patent case to District Court for trial (1)
#msg-118397347 CAFC remands Lovenox patent case to District Court for trial (2)
#msg-123721732 New patent trial to begin in late 2017 or 2018
#msg-118462482 Amphastar changes its tune on Court bond
#msg-114749299 NVS/MNTA split Lovenox profits/damage awards 50/50



PROPRIETARY AUTOIMMUNE PROGRAM

#msg-107107809 Structure/rationale of MNTA’s autoimmune compounds (slides 118-142)
#msg-123192434 MNTA starts phase-1 trial of M281 (FcRn antagonist)
#msg-126627330 MNTA introduces M230 (press release )
#msg-126805141 MNTA introduces M230 (Science Translational Medicine)
#msg-106041077 MNTA acquires antibody technology from Anaptys
#msg-111515491 What is IVIG? (short videos)



INTELLECTUAL PROPERTY

#msg-126849411 Recent patent applications and overview of IP estate
#msg-84501925 Musings on trade secrets and FDA disclosure policy
#msg-59682546 USPTO issues ‘187 patent re Copaxone manufacturing
#msg-112887376 MNTA’s Copaxone IP may thwart other generics
#msg-89344512 USPTO issues sialylation patent licensed to MNTA