Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Major rewrite for FDA approval of generic Lovenox. The material
has been reorganized and several new sections of the ReadMeFirst
have been added. Feedback is welcome!]


What is MNTA’s business all about?
#msg-25473104 Capsule summary of proprietary technology
#msg-52632000 ‘The Golden Age of Biogenerics’ (Forbes)
#msg-28865474 Characterizing a compound by “ruling out” structures
#msg-49883723 MNTA is a beneficiary of US FoB legislation


News flow
#msg-52622960 2010-2011 possible/probable news flow


Valuation and finances
#msg-52621637 Liquidity and cash usage
#msg-42166244 Share-price upside in the best-case scenario
#msg-52613313 Valuation musings by ThomasS
#msg-49840238 1Q10 financial results
#msg-44687884 Potential Lovenox/Copaxone milestones = $163M
#msg-42163809 Diluted share count for valuation purposes
#msg-44367437 Shelf registration filed 12/9/09
#msg-41777300 Latest financing transaction


Management, BoD, and major shareholders
#msg-51595947 Composition of Board of Directors
#msg-38645684 Bruce Downey, ex-CEO of Barr, joins BoD
#msg-12824293 Craig Wheeler named CEO (Aug 2006)
#msg-33979910 James Sulat named Chairman (Dec 2008)
#msg-27338039 James Roach named CMO (Feb 2008)
#msg-49501257 How MNTA executed against 2009 goals
#msg-51596139 Insider shareholdings
#msg-51596206 Major shareholders
#msg-47147018 No legal impediments to an acquisition


Lovenox program in US: regulatory decision
#msg-52582225 Why FDA approved generic Lovenox (simple version)
#msg-52581746 Why FDA approved generic Lovenox (technical version in bottom link)
#msg-52620730 Novartis’ PR on FDA approval
#msg-52578102 MNTA’s PR on FDA approval
#msg-52599789 Sanofi’s sour grapes PR
#msg-52589074 Teva’s sour grapes PR


Lovenox program in US: economics
#msg-49567739 Lovenox sells $4.1B/yr, 57% in US
#msg-42166244 Share-price upside in the best-case scenario
#msg-44687884 Potential milestone payments of $163M
#msg-41482908 Lovenox is not at all like Omnitrope
#msg-52588560 MNTA to repay NVS development costs fm its Lovenox profits
#msg-33839164 MNTA’s economics depends on the number of generics
#msg-46578876 How is MNTA affected by a Sanofi AG?
#msg-38906603 Musings on likelihood of an ‘authorized’ generic
#msg-43761160 Lovenox royalty if multiple generics
#msg-44644009 Lovenox is essentially the entire LMWH market
#msg-28936334 Proportion of Lovenox sales in various indications


Lovenox program in US: generics from other companies
#msg-45522123 Teva’s disinformation re Lovenox characterization
#msg-52624120 How likely is FDA to approve Teva’s Lovenox ANDA?
#msg-46578876 How is MNTA affected by a Sanofi AG?
#msg-38906603 Musings on likelihood of an ‘authorized’ generic
#msg-46994189 The sorry state of Amphastar’s application
#msg-46348431 FDA dismisses Amphastar’s CoI complaint


Lovenox biosimilar program in EU
#msg-52625998 Musings on generic Lovenox in the EU
#msg-44644009 Lovenox is essentially the entire LMWH market
#msg-28936334 Proportion of Lovenox sales in various indications


Lovenox US/EU programs: competition from other anticoagulants
#msg-52382839 What’s new in the anticoagulant market?
#msg-40342721 Why Arixtra is inconsequential to MNTA
#msg-33630772 Lovenox more cost-effective than Arixtra, says SNY
#msg-11669012 Lovenox more cost-effective than ordinary heparin
#msg-29698599 Competition from new oral anticoagulants
#msg-39151366 Xarelto has a long way to go in ACS


Generic-Copaxone program
(See separate section below on the competitive landscape in MS.)
#msg-52577893 Copaxone is easier to characterize than Lovenox (IMO)
#msg-52589866 Why Teva’s stock was hammered on 7/23/10
#msg-52599384 When can FDA approve MNTA’s Copaxone?
#msg-50163309 FDA denies Teva’s ‘Citizen Petition’
#msg-50113814 Musings on above by Leerink Swann (1)
#msg-50149604 Musings on above by Leerink Swann (2)
#msg-50111467 Musings on above by Oppenheimer
#msg-50151784 Musings on above by Dew
#msg-50185042 Musings on the above from BioWorld Today
#msg-49741817 Annualized US Copaxone sales are ~$2B
#msg-36015642 FDA approves Copaxone for CIS
#msg-12222305 NVS/MNTA split Copaxone profits 50/50
#msg-44687884 Potential milestone payments are $163M
#msg-30621490 FDA accepts Copaxone ANDA for review
#msg-30938608 MNTA/NVS have Hatch-Waxman first-filer status
#msg-30960930 Copaxone’s Orange Book patents being challenged
#msg-36604466 Weakness of Copaxone patents (last 2 paragraphs)
#msg-44092062 Court bars Teva from adding patents to litigation
#msg-33580867 MNTA/NVS allege inequitable conduct
#msg-45789837 Leerink Swann notes on Markman hearing
#msg-45808367 Musings on Leerink Swann’s notes
#msg-45710295 Oppenheimer notes on Markman hearing
#msg-45712150 Musings on Oppenheimer opinion
#msg-30649453 Notes from 7/11/08 Copaxone conference call
#msg-48167251 Will the Copaxone ANDA require clinical trials?
#msg-30647865 “Controlled chaos” and reverse engineering
#msg-48166546 Teva’s disinformation campaign (10^28 permutations)
#msg-48127583 Musings on regulatory outlook (dewophile)
#msg-48145473 Musings on regulatory outlook (genisi)


M118 proprietary-anticoagulant program
(See separate section below on the competitive landscape for anticoagulants.)
#msg-39146357 M118 quick primer
#msg-51227061 How large is the anticoagulant market?
#msg-26898084 Cartoon: How M118 binds to FIIa and FXa
#msg-31027378 M118 has no drug interaction with aspirin or Plavix…
#msg-31029674 …but Lovenox does (i.e. advantage: M118)
#msg-41846746 Data from phase-2a EMINENCE study
#msg-48837450 Non-inferiority analysis from EMINENCE study
#msg-48837695 Kaplan-Meier curves from EMINENCE study
#msg-31057367 Phase-1 results with subcutaneous formulation
#msg-48837475 What are MNTA’s goals for M118?
#msg-50887745 Musings on the relevance of PolyMedix’s PMX-60056
#msg-41897705 Musings on M118 differentiation in the ACS market
#msg-47474349 Why an M118 partnership has taken so long
#msg-39180621 M118 is not ‘Recothrom Part Deux’
#msg-48705801 Apr 2010 paper in Circulation
#msg-48815510 Review of Circulation paper by TCTMD
#msg-43301340 Nov 2009 paper in Thrombosis and Hemostasis
#msg-27272430 Feb 2008 paper in Blood


M402 oncology program
#msg-37030489 Rationale for a heparin-derived cancer drug
#msg-49143958 Preclinical data from 2010 AACR
#msg-47769823 Description of program from 10K report
#msg-37152092 Presentation at 2009 AACR


Follow-on Biologics
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-48581353 What the new healthcare law says about FoB’s
#msg-26837144 Momenta’s mantra on biogenerics
#msg-44688351 Why M178 was dropped


Intellectual property
#msg-45721919 Overview of IP estate (scan to bottom)
#msg-51229844 Summary of MNTA’s EU patent applications



Competition in multiple sclerosis
#msg-52553991 Copaxone should hold its own against new entrants
#msg-50939364 Teva’s ‘low-volume’ Copaxone (PR and comments)
#msg-51123550 Musings on low-volume Copaxone from MNTA annual meeting
#msg-29902618 FDA to review Mylan/Natco’s ANDA (1)
#msg-52598947 FDA to review Mylan/Natco’s ANDA (2)
#msg-52447790 Copaxone is cleaning Tysabri’s clock in US market
#msg-41292688 Tysabri’s 3-year PML rate
#msg-39971611 US market share of MS drugs (2Q09)
#msg-35060588 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-52012641 Musings on Gilenia by ‘neuroinv’
#msg-51168875 FDA panel unanimously backs Gilenia
#msg-48971681 Campath 4-year phase-2 data from 2010 AAN
#msg-34832939 Musings on Campath (with another table of MS drugs)
#msg-34865448 NVS takes option on Peptimmune’s PI-2301
#msg-51012919 Merck KGaA resubmits Cladribine NDA
#msg-39934109 Dirucotide from BioMS fails—program terminated


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-52632000 Forbes re ‘The Golden Age of Biogenerics’ (7/10)
#msg-52606143 NY Times re FDA approval (7/10)
#msg-25160571 WSJ re anticoagulant market (12/07)
#msg-23005127 Nature re FoB’s (9/07)
#msg-20308884 Lab Technologist re production process (6/07)
#msg-25803923 The Pink Sheet interview with C. Wheeler (3/07)
#msg-7370282 WSJ re MNTA’s raison d’etre (8/05)
#msg-25779774 Boston Globe re MNTA’s IPO (11/04)
#msg-33867074 Signals Magazine re glycobiology (9/03)