Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Updates:
Bruce Downey joins BoD;
notes from Goldman Sachs webcast;
musings on Sanofi’s Citizen Petition;
revised table of insider shareholdings;
musings on Lovenox ANDA’s from Teva and Amphastar;
EMEA guidelines for biosimilar heparin-based drugs;
revised anticoagulant index;
revised table of recent biotech buyouts.]


What is MNTA’s business all about?
#msg-38561800 Notes from Goldman Sachs webcast (6/10/09)
#msg-25473104 Capsule summary of proprietary technology
#msg-37645908 Transcript of 1Q09 conference call (5/8/09)
#msg-35477216 Webcast from BIO-CEO conference (2/10/09)
#msg-28748329 MNTA helps FDA with contaminated heparin
#msg-33978205 Post-mortem on above story
#msg-33867074 2003 article from Signals (still a good read)
#msg-28865474 Characterizing a compound by “ruling out” structures
#msg-26837144 Salient FoB quote from MNTA’s CEO
#msg-35477216 Momenta’s Mantra on FoB’s


News flow
#msg-35478959 2009-2010 news flow


Valuation and finances
#msg-37875396 Upside in the best-case scenario
#msg-37882435 Adjustments for less than best cases
#msg-37645888 1Q09 financial results
#msg-37646032 Liquidity and cash usage
#msg-34156708 Most recent financing transaction (Dec 2008)
#msg-36604466 3/27/09 report from Leerink Swann
#msg-3397119 2004 IPO at 6.50/sh
#msg-8410708 Poison pill adopted (11/8/05)
#msg-25377212 Standstill agreement with NVS expired on 7/25/08
#msg-38263007 Table of recent biotech buyouts


Management and BoD
#msg-37687271 How MNTA executed against its 2008 internal goals
#msg-38645684 Bruce Downey, ex-CEO of Barr, joins BoD
#msg-38638129 Composition 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-32449872 Sandoz submits response to FDA
#msg-37892516 FDA request for new clinical trial is unlikely
#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-37390328 Lovenox sells $4B/yr, 61% in US
#msg-35544866 Single generic would be largest-selling of all time
#msg-33862924 Sandoz pays the freight
#msg-33839164 Profit split depends on # of generics
#msg-33839413 Estimated royalty if multiple generics
#msg-12685766 Royalty payable to MIT
#msg-36972416 Status 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-26897124 “Checklist” rationale for M118 program
#msg-26900300 M118 has blockbuster potential
#msg-27272430 Meeting an unmet need
#msg-31029674 No drug interactions with Plavix or aspirin
#msg-26898084 How M118 binds both FIIa and FXa (graphic)
#msg-37693126 Index of M118 clinical trials
#msg-37693105 Rationale for phase-2 course correction
#msg-37419500 Preclinical abstract from J of Thrombosis and Thrombolysis


Generic Copaxone program
(See separate section below on the competitive landscape in MS.)
#msg-30621490 FDA accepts Copaxone ANDA for review
#msg-36600603 Will Copaxone be regulated as a biologic?
#msg-30938608 MNTA/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-27114485 US FoB’s are a question of when not if
#msg-35824847 Things sure ain’t getting any better
#msg-36611433 US Senators introduce bipartisan FoB bill
#msg-26837144 Salient FoB quote from MNTA’s CEO
#msg-35477216 Momenta’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-37325602 What 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-37030489 Rationale for a heparin-derived cancer drug
#msg-37152092 Presentation at 2009 AACR


Competition from other Lovenox generics
#msg-38044302 What about ANDA’s from Teva and Amphastar?
#msg-35170055 Amphastar’s 180-day ‘exclusivity’ expired on 3/31/09
#msg-33857504 Musings on an AG launch by Sanofi (zipjet, bullish)
#msg-34006751 Musings on an AG launch by Sanofi (BI, bearish)
#msg-33960572 HSP filed an ANDA for vial formulation only


Competition from other anticoagulants
#msg-37569276 Anticoagulant index
#msg-29698599 Competition from new oral anticoagulants
#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-28934131 Musings on Arixtra


Competition: multiple sclerosis
#msg-37567414 Copaxone continues to “clean Tysabri’s clock” in US
#msg-37325488 Worldwide 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


Feature stories on MNTA and related topics
#msg-27286206 Boston Globe (3/08)
#msg-25160571 WSJ (12/07)
#msg-25933221 Bioworld (11/07)
#msg-23005127 Nature (9/07)
#msg-20308884 Lab Technologist (6/07)
#msg-25803923 The Pink Sheet (3/07)
#msg-13119848 Chemical & Engineering News (9/06)
#msg-12686142 Boston Globe (8/06)
#msg-7370282 WSJ (8/05)
#msg-25779774 Boston Globe re IPO (11/04)
#msg-2220442 Boston Globe (1/04)
#msg-33867074 Signals (9/03)