[Updates: 2015-2016 news flow; 2Q15 sales of Glatopa estimated at $70M… …of which MNTA’s take is roughly $19M; pro forma cash balance ~$386M; Glatopa milestone payments from NVS; US Solicitor General sides with NVS/MNTA in Lovenox patent case; NVS/MNTA now split Lovenox profits 50/50; table of insider shareholdings and options; heavy insider selling Apr-Jun 2015.]
CORPORATE AND FINANCIAL
What is MNTA’s business all about? #msg-113297958Transcript and notes from 1Q15 CC #msg-107107809Transcript /slide set from 10/10/14 R&D Day #msg-49883723 MNTA is a beneficiary of US FoB legislation #msg-26837144 Momenta’s mantra on biogenerics
Management, BoD, and major shareholders #msg-113006744 Composition of Board of Directors #msg-114981124Insider shareholdings and options #msg-114980910 Heavy insider selling Apr-Jun 2015 (following Glatopa approval) #msg-113147094Major shareholders
#msg-94898356 Michael Franken named head of FoB program (12/13) #msg-58383722 Young Kwon named VP, Business Development (1/11) #msg-33979910 James Sulat named Chairman of BoD (12/08) #msg-27338039 James Roach, CMO, joins MNTA (2/08) #msg-12824293 Craig Wheeler, CEO, joins MNTA from Chiron (8/06)
COPAXONE PROGRAM
Economic rationale and profit split #msg-113297958MNTA’s model of Glatopa’s addressable market #msg-113300123 MNTA guides to $35K revenue per Glatopa patient-year #msg-12222305NVS/MNTA split Glatopa profits 50/50 #msg-115576637 2Q15 sales of Glatopa estimated at $70M… #msg-115577517 …of which MNTA’s take is roughly $19M #msg-114728853Glatopa milestone payments from NVS #msg-112813558 Future of 40mg Copaxone formulation key to MNTA’s valuation
FDA approval of Glatopa #msg-112799454FDA approves Glatopa (generic Copaxone) #msg-112799896 FDA’s rationale for approval #msg-112812696FDA not providing roadmap for other would-be generics #msg-105740021 FDA accepts MNTA’s ANDA for 40mg Copaxone formulation
Potential competition from other generic Copaxone products #msg-112887376MNTA’s Copaxone IP may hold up against Safe Harbor challenge #msg-112817624 Musings on likelihood of competition from other generics (MTB) #msg-112848073 Musings on likelihood of competition from other generics (indigokid)
#msg-29902618 Mylan inks Copaxone deal with India’s Natco (Jun 2008) #msg-41441618 FDA accepts Mylan’s Copaxone ANDA for review (Sep 2009) #msg-90636221Mylan and MNTA products are not identical #msg-95940872 Musings on Mylan’s Copaxone ANDA from JPM 2014 #msg-70039774 Synthon submits Copaxone ANDA (Dec 2011)… #msg-99675480 …but acknowledges receiving an unresolved CRL
LOVENOX PROGRAM
Patent-infringement lawsuit against Amphastar and Teva #msg-115466389 US Solicitor General sides with MNTA on Safe Harbor issue (chase the dropbox link) #msg-115468100What happens next? #msg-115493056 Preliminary injunction unlikely
Terms of NVS/MNTA partnership #msg-114749299 NVS/MNTA split Lovenox profits 50/50
FOLLOW-ON BIOLOGICS (FoB) PROGRAM
#msg-104501563FoBs will be $35B market by 2020, says market consultant #msg-104534644 More color on $35B forecast for 2020
#msg-70212854 MNTA inks FoB partnership with BXLT #msg-72624576 Redacted version of BXLT-MNTA contract #msg-110925786 BXLT terminates collaboration for compounds other than Humira #msg-111045283 Rationale for BXLT decision
#msg-107076513Lead FoB compound confirmed to be Humira #msg-108636687 Humira FoB begins phase-1 in Europe. #msg-97088208 Rationale for starting Humira Fob in Europe #msg-70237561 An interchangeable Humira FoB has colossal upside #msg-79941294 Survey of rheumatologists is (paradoxically) bullish for MNTA #msg-107107809MNTA’s FoB pipeline includes Orencia & several other compounds
#msg-48581353 Affordable Care Act (ObamaCare) enables US FoBs #msg-113503321 FDA guidance documents pertaining to FoBs. #msg-26837144 Momenta’s mantra on biogenerics #msg-70191760 US patent-expiration dates of big-selling biologics
NECUPARANIB PROGRAM
#msg-37030489Rationale for a heparin-derived cancer drug #msg-108636891 Necuparanib receives FDA Fast Track designation #msg-102765888 Necuparanib receives FDA Orphan Drug designation #msg-113635463 Necuparanib abstract from ASCO 2015 #msg-87859870 Clinicaltrials.gov listing for Necuparanib phase-1/2 trial #msg-107107809Necuparanib phase-1 data (slides 31-35) #msg-107107809Necuparanib phase-2 design (slides 41-42) #msg-107073252 Phase-2 powered at 80% for 50% increase in OS #msg-107143382 Phase-2 trial has potential to be pivotal
ENHANCED-IVIG PROGRAM
#msg-111515491 What is IVIG? (short videos) #msg-107107809Structure & rationale for MNTA’s compound (slides 118-131) #msg-101443478 MNTA reports preclinical data on IVIG program #msg-69595597 MNTA acquires sialic switch IP from Virdante Pharmaceuticals #msg-69681347 Musings on the Virdante deal #msg-106041077 MNTA exercises Anaptys option
INTELLECTUAL PROPERTY
#msg-84501925Musings on trade secrets and FDA disclosure policy #msg-111389703 Recent patent applications and overview of IP estate #msg-59682546USPTO issues ‘187 patent re Copaxone manufacturing #msg-112887376MNTA’s Copaxone IP may hold up against Safe Harbor challenge #msg-89344512 USPTO issues sialylation patent licensed to MNTA
PUBLICATIONS
#msg-86139857FiercePharma re FoB manufacturing (3/13) #msg-85017663Boston Business Journal re FoB’s (2/13) #msg-73905464The Deal interviews Craig Wheeler re FoB’ (3/12) #msg-66837147 NEJM on FoB pathway (9/11) #msg-63126386BioCentury re prospects for US FoB’s (5/11) #msg-28748329Nature Biotechnology re contaminated heparin (4/08) #msg-23005127Nature re FoB’s (9/07) #msg-25803923The Pink Sheet interviews Wheeler re MNTA’s technology (3/07) #msg-25779774Boston Globe re MNTA’s IPO (11/04)
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