What is MNTA’s business all about? #msg-38561800Notes from Goldman Sachs webcast (6/10/09) #msg-25473104 Capsule summary of proprietary technology #msg-37645908Transcript of 1Q09 conference call (5/8/09) #msg-35477216Webcast from BIO-CEO conference (2/10/09) #msg-28748329MNTA helps FDA with contaminated heparin #msg-33978205 Post-mortem on above story #msg-338670742003 article from Signals (still a good read) #msg-28865474 Characterizing a compound by “ruling out” structures #msg-26837144Salient FoB quote from MNTA’s CEO #msg-35477216Momenta’s Mantra on FoB’s
Management and BoD #msg-37687271How MNTA executed against its 2008 internal goals #msg-38645684Bruce Downey, ex-CEO of Barr, joins BoD #msg-38638129Composition of Board of Directors #msg-33979910 James Sulat appointed Chairman of Board #msg-12824293 CEO, Craig Wheeler, hired from Chiron (Aug 2006) #msg-27338039 CMO, James Roach, hired from Sepracor (Feb 2008) #msg-37695353 Major shareholders #msg-38645904 Insider shareholdings
Generic Lovenox program (See separate section below on potential competition from other Lovenox generics.) #msg-32449872Sandoz submits response to FDA #msg-37892516FDA request for new clinical trial is unlikely #msg-38682430Data on immunogenicity is a measure of product purity #msg-35090820 Why the Lovenox ANDA has taken so long to process #msg-38585972 Musings on Sanofi’s Citizen Petition #msg-37893451 FDA can’t keep the ANDA in limbo indefinitely #msg-37390328Lovenox sells $4B/yr, 61% in US #msg-35544866Single generic would be largest-selling of all time #msg-33862924Sandoz pays the freight #msg-33839164Profit split depends on # of generics #msg-33839413 Estimated royalty if multiple generics #msg-12685766 Royalty payable to MIT #msg-36972416Status of generic Lovenox program in the EU #msg-38113820 EMEA guidelines for biosimilar heparin-based drugs #msg-29728035 How generic Rx’s are written in EU
M118 (proprietary anticoagulant) program (See separate section below on the competitive landscape for anticoagulants.) #msg-39142514Phase-2 data from EMINENCE trial #msg-39143771 Brief comment on the relevance of the data #msg-39146357M118 ‘refresher course’ #msg-39180621Why M118 is not ‘Recothrom Part Deux’ #msg-39151654 Index to M118 clinical trials #msg-37693105 Rationale for phase-2 course correction #msg-27272430 Meeting an unmet need #msg-31029674 Advantage vs Lovenox re drug interactions #msg-26898084 How M118 binds both FIIa and FXa (graphic) #msg-38990466 Preclinical abstract from J of Thrombosis and Thrombolysis (1) #msg-37419500 Preclinical abstract from J of Thrombosis and Thrombolysis (2)
Generic Copaxone program (See separate section below on the competitive landscape in MS.) #msg-30621490FDA accepts Copaxone ANDA for review #msg-36600603 Will Copaxone be regulated as a biologic? #msg-30938608MNTA/Sandoz have first-filer status #msg-33580867 MNTA/Sandoz allege inequitable conduct #msg-36601428 Teva counters with claim of stolen IP #msg-30960930 List of Copaxone patents being challenged #msg-12222305 Copaxone falls under 2006 collaboration #msg-30649453 Notes from 7/11/08 Copaxone conference call #msg-30647865 “Controlled chaos” and reverse engineering #msg-36015642 FDA approves Copaxone for CIS
Follow-on Biologics (FoB) programs #msg-27114485US FoB’s are a question of when not if #msg-35824847Things sure ain’t getting any better #msg-36611433US Senators introduce bipartisan FoB bill #msg-26837144Salient FoB quote from MNTA’s CEO #msg-35477216Momenta’s Mantra on FoB’s #msg-35607204 Biogenerics vs biosimilars #msg-12222305 2006 PR announcing FoB deal with Sandoz #msg-34383144 $178M in remaining potential milestones #msg-37325602What is M178? (table of biologic patent expirations) #msg-20699044 Largest-selling biologics by class #msg-33866262 Reference website for FoB’s
M402 oncology program #msg-37030489Rationale for a heparin-derived cancer drug #msg-37152092 Presentation at 2009 AACR
Competition from other Lovenox generics #msg-38044302What about ANDA’s from Teva and Amphastar? #msg-38906603Musings on likelihood of an ‘authorized’ generic #msg-35170055 Amphastar’s 180-day ‘exclusivity’ expired on 3/31/09 #msg-33960572 HSP filed an ANDA for vial formulation only
Competition from other anticoagulants #msg-29698599Competition from new oral anticoagulants #msg-39151366Xarelto has a long way to go in ACS #msg-26739674 Lovenox’s Rx share of US anticoagulant market #msg-28936334 What indications do Lovenox sales come from? #msg-33630772 CHEST 2008 study on Lovenox vs Arixtra #msg-39422011Anticoagulant index #msg-28934131 Musings on Arixtra
Competition: multiple sclerosis #msg-37567414Copaxone continues to “clean Tysabri’s clock” in US #msg-37325488Worldwide market shares 2004-mid 2008 (with chart) #msg-35065247 Comparative efficacy of approved MS drugs #msg-37325525 MS drugs in phase-2 or phase-3 #msg-31553565 Musings on MS drugs in development (genisi) #msg-37060245 New orals to be used mostly in the second line #msg-35023606 Merck Serono’s phase-3 Cladribine data #msg-31515145 FTY720 runs into a safety setback… #msg-34138665 …but shows good results, all told, in first phase-3 trial #msg-34832939 Musings on Campath (with another table of MS drugs) #msg-29902618 Mylan enters the Copaxone fray—sort of. #msg-37567642 Teva begins work on “low volume” Copaxone
Competition: miscellaneous #msg-33839321 Procognia is not a serious competitor #msg-33597614 Also-ran companies in the FoB arena
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