Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Updates:
musings on M118 differentiation;
new section on MNTA’s IP (thanks, floblu).]


What is MNTA’s business all about?
#msg-38561800 Notes from 6/10/09 GS webcast (w webcast link)
Rodman & Renshaw webcast (9/9/09)
d#msg-25473104 Capsule summary of proprietary technology
#msg-40346234 Transcript of 2Q09 conference call (8/6/09)
#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 Momenta’s Mantra on FoB’s


News flow
#msg-41848714 Possible/probable 2009-2010 news flow


Valuation and finances
#msg-41810407 Liquidity and cash usage
#msg-41777300 Latest financing transaction
#msg-41817975 Financing deal was not a PIPE
#msg-40259357 2Q09 financial results
#msg-41479560 Share-price upside in the best-case scenario
#msg-41326335 Approval of multiple Lovenox generics is not the ticket
#msg-41293614 Table of recent biotech buyouts
#msg-25377212 Standstill agreement with NVS expired on 7/25/08
#msg-8410708 Poison pill adopted (11/8/05)


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 competition from other Lovenox generics.)
#msg-41323601 FDA “ready to approve,” says Craig Wheeler
#msg-41414776 Handicapping the Lovenox ANDA’s
#msg-32449872 Sandoz submits response to FDA (9/08)
#msg-37892516 FDA request for new clinical trial is unlikely
#msg-38682430 Immunogenicity data is measure of product purity
#msg-39720275 FDA completes inspections of manufacturing facilities
#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-40073523 Lovenox sells $4B/yr, 61% in US
#msg-35544866 Single generic would be largest-selling of all time
#msg-41482908 Lovenox is not at all like Omnitrope
#msg-33862924 Sandoz pays the freight
#msg-33839164 Profit split depends on # of generics
#msg-41479560 Share-price upside in the best-case scenario
#msg-41326335 Approval of multiple generics is not the ticket
#msg-41324486 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-41846746 Phase-2 data from EMINENCE trial
#msg-41820503 Musings on the EMINENCE data
#msg-39146357 M118 ‘refresher course’
#msg-41897705 Musings on M118 differentiation
#msg-39180621 Why M118 is not ‘Recothrom Part Deux’
#msg-39151654 Index to M118 clinical trials
#msg-27272430 Meeting an unmet need
#msg-31029674 Advantage vs Lovenox re drug interactions
#msg-26898084 How M118 binds both FIIa and FXa (graphic)


Generic Copaxone program
(See separate section below on the competitive landscape in MS.)
#msg-30621490 FDA accepts Copaxone ANDA for review
#msg-36604466 Leerink Swann report on Teva’s Citizen Petition (3/27/09)
#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 Update on the same topic
#msg-26837144 Momenta’s Mantra on FoB’s
#msg-40156726 MNTA only marginally affected by terms of FoB legislation
#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-38906603 Musings 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-40342721 Why Arixtra is inconsequential to MNTA
#msg-33630772 Lovenox more cost-effective than Arixtra, says SNY
#msg-29698599 Competition from new oral anticoagulants
#msg-39151366 Xarelto has a long way to go in ACS
#msg-41177613 Index to posts on anticoagulants


Competition: multiple sclerosis
#msg-39971611 Copaxone US sales and market share (2Q09)
#msg-37325488 Worldwide market share of MS drugs (2004-mid 2008)
#msg-35065247 Comparative efficacy of approved MS drugs
#msg-41292688 Tysabri’s 3-year PML rate
#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-39934109 Dirucotide from BioMS fails—program terminated
#msg-41481687 FDA to review Mylan’s Copaxone ANDA
#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


Intellectual property
#msg-41924957 Overview of MNTA’s patent estate
#msg-41924125 MNTA’s EU patent applications


Feature stories on MNTA and related topics
#msg-39860561 Mass High Tech (7/09)
#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)