Replies to post #17013 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

MNTA ReadMeFirst

[Updates:
2017-2018 news flow;
reasons to be optimistic;
1Q17 financial results, liquidity, and diluted share count;
transcript of 1Q17 CC;
phase-3 trial of M923 meets FDA draft guidelines for interchange FoBs;
incoming FDA commissioner (Scott Gottlieb) emphasizes interchangeable FoBs;
an interchangeable Humira FoB for US market is badly needed (chart).]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-119915120 MNTA’s drug portfolio and pipeline
#msg-129335529 Slide set from 3/7/17 Cowen webcast
#msg-131335423 2017-2018 news flow
#msg-130999575 Reasons to be optimistic
#msg-131070872 Transcript of 1Q17 conference call (5/2/17)
#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-131335614 MNTA had $471M pro forma cash at 3/31/17
#msg-131335265 Diluted share count for valuation purposes
#msg-130987220 1Q17 press release
#msg-114728853 Potential Glatopa milestone payments from NVS


Officers and directors
#msg-127373731 Composition of Board of Directors
#msg-126247557 Former Baxter executive, Scott Storer, named CFO (11/16)
#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 Potential Glatopa milestone payments from NVS


40mg Glatopa
#msg-128816545 Compliance issue at PFE plant delays approval of 40mg Glatopa
#msg-129066912 Text of PFE’s warning letter from FDA
#msg-124820193 “At risk” launch likely upon FDA approval

#msg-129439764 Teva loses patent trial on 40mg-Copaxone patents
#msg-125465255 Issue in 40mg patent litigation was (and is) obviousness


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


Potential competition from other generic-Copaxone products
#msg-124749893 Handicapping the competitive landscape for 40mg Copaxone
#msg-90636221 Mylan and MNTA products are not identical
#msg-129230239 More discussion on Mylan’s (20mg and 40mg) ANDAs
#msg-129225380 RDY, Biocon not close to FDA approval for either 20mg or 40mg
#msg-115896634 PFE licenses Synthon’s Copaxone ANDA
#msg-70039774 Synthon submits Copaxone ANDA…
#msg-99675480 …but acknowledges receiving CRL

#msg-59682546 MNTA’s ‘187 patent may thwart other generics (1)
#msg-112887376 H-W Safe Harbor probably doesn’t apply to MNTA’s ‘187 patent



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-127945927 Possible single-step FDA approval for interchangeable FoB…
#msg-26837144 …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-127962983 …and has colossal upside for MNTA

#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-118781959 Can Abbvie block US Humira FoBs until 2022?
#msg-126869318 Abbvie’s Humira-formulation patents not an impediment, says CW
#msg-129261201 UK Court rejects Humira “method of use” patents

#msg-125359509 FDA approves Amgen’s Humira FoB (Amjevita)
#msg-126114458 Amgen not launching Humira FoB until 2018 (or later) due to IP


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



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-127780821 CSL collaboration has dual opt-on options for MNTA
#msg-129436390 MNTA introduces M230 (press release)
#msg-128995744 Biocentury Innovations write-up on M230

#msg-123192434 MNTA starts phase-1 trial of M281 (FcRn antagonist)

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



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



INTELLECTUAL PROPERTY

#msg-126849411 Recent patent applications and overview of IP estate
#msg-59682546 USPTO issues ‘187 patent re Copaxone manufacturing
#msg-89344512 USPTO issues sialylation patent licensed to MNTA