Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Major rewrite of section pertaining to M118.]


What is MNTA’s business all about?
#msg-46564147 Transcript of 4Q09 CC (2/11/10)
#msg-25473104 Capsule summary of proprietary technology
#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 biogenerics


News flow
#msg-46537561 2010-2011 possible/probable news flow


Valuation and finances
#msg-46530544 Liquidity and cash usage
#msg-42166244 Share-price upside in the best-case scenario
#msg-44687884 Potential Lovenox/Copaxone milestones are $163M
#msg-45710295 Opinion by Oppenheimer (1/20/09)
#msg-45712150 Musings on Oppenheimer report
#msg-46555149 Opinion by Wedbush (2/11/10)
#msg-44100212 Opinion by Leerink Swann (12/2/09)
#msg-43757292 Opinion by Canaccord Adams (11/18/09)
#msg-46530217 4Q09 financial results
#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-48535369 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-37687271 How MNTA executed against internal goals (May 2009)
#msg-47787672 Insider shareholdings
#msg-47902304 Major shareholders
#msg-47147018 No legal impediments to an acquisition


Generic-Lovenox program
(See separate section below on competition from other Lovenox generics.)
#msg-41323601 FDA “ready to approve,” says Craig Wheeler
#msg-46038154 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 (1)
#msg-43983774 Musings on Sanofi’s Citizen Petition (2)
#msg-37893451 FDA can’t keep the ANDA in limbo indefinitely
#msg-46480161 Lovenox sells $4.2B/yr, 60% in US
#msg-44644009 Lovenox is essentially the entire LMWH market
#msg-28936334 Proportion of Lovenox sales in various indications
#msg-35544866 Single generic would be largest-selling of all time
#msg-44687884 Potential Lovenox/Copaxone milestones are $163M
#msg-41482908 Lovenox is not at all like Omnitrope
#msg-33862924 NVS pays all expenses (2003 partnership PR)
#msg-33839164 MNTA’s economics depends on the number of generics
#msg-46578876 How is MNTA affected by a Sanofi AG?
#msg-42166244 Share-price upside in the best-case scenario
#msg-43761160 Lovenox royalty if multiple generics
#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


Generic-Copaxone program
(See separate section below on the competitive landscape in MS.)
#msg-46709942 Annualized US Copaxone sales are >$2B
#msg-36015642 FDA approves Copaxone for CIS
#msg-30621490 FDA accepts Copaxone ANDA for review
#msg-30938608 MNTA/NVS have Hatch-Waxman first-filer status
#msg-30960930 List of Copaxone patents being challenged
#msg-36604466 Weakness of Copaxone patents (second item from bottom)
#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-45730917 Barclays notes on Markman hearing
#msg-43947610 Teva resubmits Citizen Petition
#msg-12222305 NVS/MNTA split Copaxone profits (2006 agreement)
#msg-44687884 Potential milestones are $163M
#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)
#msg-48112893 Musings on regulatory outlook (Dew)


M118 proprietary-anticoagulant program
(See separate section below on the competitive landscape for anticoagulants.)
#msg-39146357 M118 quick primer
#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-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-47769823 Description of program from 10K report
#msg-37152092 Presentation at 2009 AACR


Follow-on Biologics
#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-45721919 Summary MNTA’s EU patent applications
#msg-47622557 Latest EU patent application


Competition from other Lovenox generics
#msg-45522123 Teva’s disinformation re Lovenox characterization
#msg-46578876 How is MNTA affected by a Sanofi AG?
#msg-38906603 Musings on likelihood of an ‘authorized’ generic
#msg-43206942 The Lovenox plot may have thickened (Teva CC)
#msg-46994189 The sorry state of Amphastar’s application
#msg-46348431 FDA dismisses Amphastar’s CoI complaint
#msg-33960572 HSP filed an ANDA for vial formulation only


Competition from other anticoagulants
#msg-48669262 Index to posts on competing anticoagulants
#msg-44644009 Lovenox is essentially the entire LMWH 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 UNH
#msg-29698599 Competition from new oral anticoagulants
#msg-39151366 Xarelto has a long way to go in ACS


Competition in multiple sclerosis
#msg-41481687 FDA to review Mylan’s Copaxone ANDA
#msg-46709942 Copaxone continues cleaning Tysabri’s clock—maybe
#msg-39971611 US market share of MS drugs (2Q09)
#msg-35060588 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-44040202 FDA issues RTF letter for Cladribine
#msg-42018880 FTY720 data from the FREEDOMS study
#msg-34832939 Musings on Campath (with another table of MS drugs)
#msg-39934109 Dirucotide from BioMS fails—program terminated
#msg-34865448 NVS takes option on Peptimmune’s PI-2301
#msg-43470309 Teva’s planned “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-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)