Followers | 827 |
Posts | 119469 |
Boards Moderated | 15 |
Alias Born | 09/05/2002 |
Friday, August 04, 2017 5:45:12 PM
[Updates:
MNTA loses Lovenox patent case;
2017-2018 news flow;
rationale for M281;
transcript of 2Q17 CC;
6/30/17 pro forma cash balance = $464M;
diluted share count for valuation purposes.]
CORPORATE AND FINANCIAL
What is MNTA’s business all about?
#msg-119915120 MNTA’s drug portfolio and pipeline
#msg-133517488 2017-2018 news flow
#msg-133532612 Transcript of 2Q17 conference call (8/2/17)
#msg-130999575 Reasons to be optimistic
#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-131814122 Santiago Arroyo named CMO (6/17)
#msg-126247557 Scott Storer named CFO (11/16)
#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
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-132347810 Mylan receives CRL for generic 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-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-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-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
#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-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?
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
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
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