Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Updates:
2010-2011 news flow;
handicapping the Lovenox ANDA’s during next six months;
new version of “Copaxone is Cleaning Tysabri’s Clock in US Market”;
musings on NVS’ Gilenia (from ‘neuroinv’);
new version of “What’s New in the Anticoagulant Market?”]


What is MNTA’s business all about?
#msg-25473104 Capsule summary of proprietary technology
#msg-28748329 MNTA helps FDA with contaminated heparin
#msg-33978205 Post-mortem on above story
#msg-28865474 Characterizing a compound by “ruling out” structures
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-46564147 Transcript of 4Q09 CC (2/11/10)
#msg-33867074 2003 article from Signals (still a good read)


News flow
#msg-52464278 2010-2011 possible/probable news flow


Valuation and finances
#msg-49928065 Liquidity and cash usage
#msg-42166244 Share-price upside in the best-case scenario
#msg-49454111 Musings on recent developments
#msg-50113814 Opinion by Leerink Swann 5/13/10 (1)
#msg-50149604 Opinion by Leerink Swann 5/13/10 (2)
#msg-49423686 Opinion by Canaccord Adams (4/26/10)
#msg-46555149 Opinion by Wedbush (2/11/10)
#msg-45710295 Opinion by Oppenheimer (1/20/09)
#msg-45712150 Musings on 1/20/09 Oppenheimer report
#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


Generic-Lovenox program: FDA review
(See separate sections below on Lovenox economics and competition.)
#msg-41323601 FDA “ready to approve,” says Craig Wheeler
#msg-52460245 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-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-Lovenox program: economics
(See separate section below on Lovenox competition.)
#msg-49567739 Lovenox sells $4.1B/yr, 57% in US
#msg-33862924 NVS pays all development and commercialization costs
#msg-44687884 Potential milestone payments of $163M
#msg-33839164 MNTA’s economics depends on the number of generics
#msg-42166244 Share-price upside in the best-case scenario
#msg-43761160 Lovenox royalty if multiple generics
#msg-46578876 How is MNTA affected by a Sanofi AG?
#msg-44644009 Lovenox is essentially the entire LMWH market
#msg-28936334 Proportion of Lovenox sales in various indications
#msg-41482908 Lovenox is not at all like Omnitrope


Generic-Copaxone program
(See separate section below on the competitive landscape in MS.)
#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-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 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-52382839 What’s new in the anticoagulant market?
#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-50939364 Teva’s ‘low-volume’ Copaxone (PR and comments)
#msg-51123550 Musings on low-volume Copaxone from MNTA annual meeting
#msg-41481687 FDA to review Mylan’s Copaxone ANDA
#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-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)