[Updates: FDA proposes dedicated unit to evaluate FoBs; FDA guidance documents wrt FoBs; preliminary ruling on Humira IPR filed by CHRS goes against ABBV; final data from phase-1 portion of Necuparanib trial in pancreatic cancer.]
CORPORATE AND FINANCIAL
What is MNTA’s business all about? #msg-119915120MNTA’s drug portfolio and pipeline #msg-1224791632016-2017 possible/probable events #msg-122478833Transcript of 1Q16 CC (5/3/16) #msg-119915029 Webcast on MNTA-MYL partnership for FoBs (1/8/16) #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-25803923The Pink Sheet interviews Craig Wheeler (dated, but still a good read)
Valuation and finances #msg-122476390MNTA is well financed (3/31/16 cash = $388M) #msg-122364058 1Q16 financial results and 2016 guidance #msg-114728853 Glatopa milestone payments from NVS #msg-116223816 Diluted share count for valuation purposes
Officers and directors #msg-121076217 Composition of Board of Directors #msg-118984568 Former Biogen executive, Matt Ottmer, named COO (12/15) #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)
#msg-119689602MNTA inks 50/50 partnership with Mylan for 6 FoBs #msg-119691929 Terms of partnership meet two of MNTA’s stated goals #msg-119697433 Commentary on MNTA-MYL partnership by FierceBiotech #msg-122395849 FDA PoV on interchangeable FoBs may have moved in MNTA’s favor
#msg-110925786MNTA still partnered with BXLT for Humira FoB #msg-122391552 Effect of SHPG-BXLT merger on Humira FoB program #msg-70237561 An interchangeable Humira FoB has colossal upside #msg-117482545MNTA/BXLT start phase-3 trial of Humira FoB #msg-119314596 MNTA/BXLT report phase-1 bioequivalence data for Humira FoB;
#msg-118781959Can Abbvie block US Humira FoBs until 2022? #msg-119852113 Abbvie wins USPTO ruling vs Amgen on Humira… #msg-122698047 …but loses (preliminary) USPTO action vs Coherus
#msg-48581353 Affordable Care Act (ObamaCare) enables US FoBs #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-70191760 US patent-expiration dates of big-selling biologics
GLATOPA (COPAXONE) PROGRAM
Economic rationale and profit split #msg-12222305NVS/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-112799454FDA approves 20mg Glatopa #msg-112799896 FDA’s rationale for approval of 20mg Glatopa
40mg Glatopa #msg-120661209NVS/MNTA’s 40mg ANDA has 2016 GDUFA date #msg-122479122“At risk” launch likely in early 2017 (if ANDA approved) #msg-116691993 USPTO IPR re Teva’s 40mg patents on 5/12/16 (decision Aug 2016) #msg-116704965 ~80% of patents subject to IPR are invalidated #msg-118423273Patent trial re 40mg Copaxone starts 9/26/16
Potential competition from other generic Copaxone products #msg-112812696No FDA roadmap for competing generics #msg-112887376 MNTA’s Copaxone IP may thwart other generics
#msg-112817624 Musings on likelihood of competition from other generics (MTB) #msg-112848073 Musings on likelihood of competition from other generics (indigokid)
#msg-115996641Mylan admits it has work to do on Copaxone ANDA #msg-90636221Mylan and MNTA products are not identical #msg-119705776 New inference that Mylan not close to FDA approval #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-118404904CAFC remands Lovenox patent case to District Court for trial (1) #msg-118397347 CAFC remands Lovenox patent case to District Court for trial (2) #msg-115493056 Preliminary injunction unlikely #msg-118462482 Amphastar changes its tune on Court bond #msg-117378149 Amphastar files desperation “antitrust” lawsuit against MNTA
#msg-37030489Rationale for a heparin-derived cancer drug #msg-123093925 Phase-1/2 trial in pancreatic cancer (scan to bottom) #msg-123093925 Final data from phase-1 portion (ASCO 2016) #msg-107073252 Phase-2 powered at 80% for 50% increase in OS #msg-107143382 Phase-2 trial has potential to be pivotal #msg-108636891 Necuparanib receives FDA Fast Track designation #msg-102765888 Necuparanib receives FDA Orphan Drug designation
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 thwart other generics #msg-89344512 USPTO issues sialylation patent licensed to MNTA