Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

MNTA ReadMeFirst

[Updates:
M281 phase-1 trial starts on schedule;
District Court in Lovenox patent case allows MNTA/NVS to augment claims;
2016-2017 news flow.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-119915120 MNTA’s drug portfolio and pipeline
#msg-123678808 2016-2017 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-25803923 The Pink Sheet interviews Craig Wheeler (dated, but still a good read)


Valuation and finances
#msg-122476390 MNTA 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-123485297 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)



FOLLOW-ON BIOLOGICS (FoB) PROGRAM

#msg-104534644 FoBs will be $35B market by 2020

#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-119697433 Commentary on MNTA-MYL partnership by FierceBiotech
#msg-122395849 FDA PoV on interchangeable FoBs may have moved in MNTA’s favor

#msg-110925786 MNTA’s partner is SHPG (formerly Baxter) for Humira FoB
#msg-122391552 Effect of SHPG-BXLT merger on Humira FoB program
#msg-70237561 An interchangeable Humira FoB has colossal upside
#msg-117482545 MNTA/SHPG start phase-3 trial of Humira FoB
#msg-123165310 Final phase-1 bioequivalence data for Humira FoB

#msg-118781959 Can 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-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-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-118423273 Patent trial re 40mg Copaxone starts 9/26/16


Potential competition from other generic Copaxone products
#msg-112812696 No 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-115996641 Mylan admits it has work to do on Copaxone ANDA
#msg-90636221 Mylan 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-115896634 PFE licenses Synthon’s Copaxone ANDA
#msg-70039774 Synthon submits Copaxone ANDA…
#msg-99675480 …but acknowledges receiving an unresolved CRL



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-118462482 Amphastar changes its tune on Court bond
#msg-117378149 Amphastar files desperation “antitrust” lawsuit against MNTA
#msg-114749299 NVS/MNTA split Lovenox profits/damage awards 50/50



NECUPARANIB PROGRAM

#msg-37030489 Rationale 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 of trial (PR)
#msg-123102084 Final data from phase-1 portion of trial (ASCO poster)

#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-107107809 Structure & rationale for MNTA’s compounds (slides 118-131)
#msg-123192434 MNTA starts phase-1 trial of M281 (FcRn antagonist)

#msg-101443478 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-84501925 Musings on trade secrets and FDA disclosure policy
#msg-111389703 Recent patent applications and overview of IP estate
#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