Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Updates:
Lovenox
generic Lovenox has 47% script share;
additional musings on probability of a Teva Lovenox approval;
FDA requirements for Lovenox were essentially written by MNTA;

Copaxone
District Court’s Copaxone docket for Teva-Mylan (thanks mouton);
handicapping the Copaxone patent case (zipjet; Dew);
musings on likelihood of ‘at-risk’ Copaxone launch;
FDA requests more data from Teva on ‘low-volume’ Copaxone;

Financial and miscellaneous
$92M tax credit can be applied to Lovenox profits;
link to 3-Nov-2010 Oppenheimer webcast.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-25473104 Capsule summary of proprietary technology
3-Nov-2010 Oppenheimer webcast (highly recommended)
#msg-56166824 Transcript of 3Q10 conference call
#msg-28748329 MNTA helps FDA solve contaminated-heparin problem
#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
#msg-54327728 MNTA receives US patent on Lovenox characterization
#msg-55909862 Recent patent applications and overview of IP estate
#msg-56219013 FDA requirements for generic Lovenox essentially written by MNTA


News flow
#msg-56170798 2010-2011 possible/probable news flow


Valuation and finances
#msg-56133714 MNTA logs 3Q10 profit of $0.70/sh
#msg-56166824 Transcript of 3Q10 conference call
#msg-55020801 Cowen values Lovenox program alone at mid $20s/sh
#msg-56176508 $92M tax credit can be applied to Lovenox profits
#msg-54022252 Valuation of non-Lovenox assets (Dew)
#msg-54490305 Valuation based on buyout
#msg-44687884 Potential Lovenox/Copaxone milestones = $163M
#msg-56166173 $5M fm NVS for FDA Lovenox approval is separate fm above
#msg-55811231 Additional milestones at anniversaries of Lovenox launch
#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-54286333 Composition of Board of Directors
#msg-56169633 Outgoing COO exercises and holds 56K options (Nov 2010)
#msg-55907213 Musings on Steven Brugger’s departure
#msg-54286035 Ram Sasisekharan resigns from BoD (Sep 2010)
#msg-54532698 Musings on Ram’s decision
#msg-38633640 Bruce Downey, ex-CEO of Barr, joins BoD (Jun 2009)
#msg-33979910 James Sulat named Chairman of BoD (Dec 2008)
#msg-27338039 James Roach, CMO, joins MNTA (Feb 2008)
#msg-12824293 Craig Wheeler, CEO, joins MNTA from Chiron (Aug 2006)
#msg-49501257 How MNTA executed against 2009 internal goals
#msg-55908942 Insider shareholdings and options
#msg-53029172 Tax rationale for recent insider selling
#msg-54286676 Major shareholders
#msg-47147018 No legal impediments to an acquisition



LOVENOX PROGRAM

FDA approval and related litigation
#msg-53730236 Judge denies Sanofi’s request for preliminary injunction
#msg-53731775 Index to legal/regulatory documents
#msg-52582225 Why FDA approved generic Lovenox (simple version)
#msg-52581746 Why FDA approved generic Lovenox (technical version)
#msg-56219013 FDA requirements for generic Lovenox essentially written by MNTA
#msg-52620730 FDA approves NVS/MNTA’s generic Lovenox (NVS PR)
#msg-52578102 FDA approves NVS/MNTA’s generic Lovenox (MNTA PR)
#msg-53569996 Immunogenicity data is gauge of manufacturing purity
#msg-47460573 FDA label specs for dosing by indication
#msg-53625554 Proportion of Lovenox use by dose size
#msg-29282002 End of the line for Sanofi’s Lovenox patent (May 2008)


Economic rationale and profit split in US market
(See related section below on potential competition from other Lovenox generics.)
#msg-55774996 NVS sells $292M of generic Lovenox in 69 days!
#msg-55778832 Adjusting 3Q10 Lovenox sales for channel stocking
#msg-56253339 Generic Lovenox has 47% script share
#msg-55818120 How NVS/MNTA account for Lovenox on financial statements
#msg-56123442 Beware of SNY’s claims re Lovenox “volume” share
#msg-53835981 SNY’s EPS guidance precludes steep price cuts
#msg-33839164 MNTA’s economics depends on the number of generics
#msg-43761160 Lovenox royalty if multiple generics
#msg-44687884 Potential milestone payments of $163M
#msg-56166173 $5M fm NVS for FDA Lovenox approval is separate fm above
#msg-55811231 Additional milestones at anniversaries of Lovenox launch
#msg-44644009 Lovenox is essentially the entire LMWH market
#msg-54355727 60-70% of US Lovenox market is hospital-based
#msg-28936334 Proportion of Lovenox sales in various indications


Potential Lovenox US generics from other companies
#msg-54327728 MNTA receives US patent on Lovenox characterization
#msg-56096637 OSCS still contaminates US heparin supply (good for MNTA)
#msg-56000748 Lovenox knockoffs have varied potential for immunogenicity
#msg-56016886 Teva’s version of Lovenox comes from ItalFarmaco
#msg-55670004 Teva admits its version of Lovenox not developed in-house
#msg-54461652 Teva has no known expertise in Lovenox characterization
#msg-52999229 Sanford Bernstein’s dubious rumor causes sell-off
#msg-52589074 Teva’s sour grapes PR on losing out to MNTA
#msg-54978841 Teva’s credibility is suspect on multiple fronts
#msg-53070505 Musings on a Teva approval (ThomasS)
#msg-52985447 Musings on a Teva approval (tinker)(1)
#msg-53026617 Musings on a Teva approval (tinker)(2)
#msg-56047605 Musings on a Teva approval (tinker)(3)
#msg-56323662 Musings on a Teva approval (tinker)(4)
#msg-53053911 Musings on a Teva approval (RockRat)
#msg-52894756 Musings on a Teva approval (zipjet)
#msg-53090148 Musings on a Teva approval (oc631)
#msg-56267201 Musings on a Teva approval (Dew)(1)
#msg-56195372 Musings on a Teva approval (Dew)(2)
#msg-43206942 Possibility of a non-substitutable generic by Teva
#msg-55919812 The sorry state of Amphastar’s application (FDA lawsuit)
#msg-55920125 The sorry state of Amphastar’s application (amusing gaffe)
#msg-46348431 FDA dismisses Amphastar’s conflict-of-interest complaint
#msg-56123199 SNY rules out an ‘authorized generic’
#msg-46578876 (How MNTA would have been affected by an AG)
#msg-33857504 Why SNY opted not to launch an AG (zipjet)


Lovenox competition from other anticoagulants
#msg-56171420 What’s new in the anticoagulant market?
#msg-29698599 Competition from new oral anticoagulants
#msg-39151366 Xarelto has a long way to go in ACS
#msg-55569376 Generic Arixtra could be approved in 2011…
#msg-40342721 …but Arixtra is all but inconsequential to MNTA


Generic/biosimilar Lovenox outside the US
#msg-55882487 Musings on Lovenox development outside US
#msg-52625998 EU requirements for Lovenox biosimilars and patent info



COPAXONE PROGRAM

FDA application
#msg-30621490 FDA accepts NVS/MNTA ANDA for review
#msg-54201872 Wedbush is bullish on MNTA’s Copaxone (9/7/10)
#msg-48167251 Will Copaxone ANDA require clinical trials?
#msg-30649453 Notes on Copaxone ANDA from 7/11/08 conference call
#msg-50163309 Link to FDA rejection of Teva’s Citizen Petition
#msg-50113814 Leerink Swann on rejection of Teva’s Citizen Petition (1)
#msg-50149604 Leerink Swann on rejection of Teva’s Citizen Petition (2)
#msg-50185042 Musings on Teva’s CP rejection from BioWorld Today
#msg-30647865 “Controlled chaos” and reverse engineering
#msg-48166546 Teva’s disinformation campaign (10^28 permutations)
#msg-53260088 Musings on regulatory outlook (COO Steven Brugger)
#msg-48127583 Musings on regulatory outlook (dewophile)
#msg-48145473 Musings on regulatory outlook (genisi)
#msg-52577893 Musings on regulatory outlook (Dew)
#msg-52702351 FDA might grant bioequivalence waiver
#msg-52589866 Why Teva’s stock was hammered on 7/23/10
#msg-53728063 Prognostic value of FDA’s actions vis-à-vis Copaxone and FoB’s


Economic rationale and profit split
#msg-12222305 NVS/MNTA split profits 50/50 in all cases
#msg-55928450 US Copaxone sales are $2.1B per annum
#msg-44687884 Potential milestone payments are $163M
#msg-53081150 Ex-US market for generic Copaxone not especially attractive
#msg-55641123 5-year Copaxone data in CIS


Patent litigation
#msg-54113660 List of Copaxone patents in Teva-NVS/MNTA litigation
#msg-54150823 Index to legal documents in Teva-NVS/MNTA litigation
#msg-56222992 Docket for Teva-Mylan (now consolidated w Teva-NVS/MNTA)
#msg-55490818 Teva thinks it could lose patent case, evidently
#msg-56147443 NVS/MNTA will pursue four tacks in litigation
#msg-52735648 Handicapping the Copaxone case (Wall Street)
#msg-56320705 Handicapping the Copaxone case (Dew)
#msg-56326587 Handicapping the Copaxone case (zipjet)
#msg-54139320 Court denies summary judgment, no trial date yet
#msg-56215358 Musings on the likelihood of “at-risk” launch


Potential competition from other generic and branded drugs
#msg-29902618 FDA to review Mylan/Natco ANDA (1)
#msg-52598947 FDA to review Mylan/Natco ANDA (2)
#msg-56226773 FDA requests more data on Teva’s ‘low-volume’ Copaxone
#msg-50939364 Teva’s annotated PR on low-volume Copaxone
#msg-51123550 Musings on low-volume Copaxone from MNTA annual meeting
#msg-51168875 FDA approves NVS’ Gilenya
#msg-52553991 Copaxone should hold its own against Gilenya (haaretz.com)
#msg-54849106 Copaxone should hold its own against Gilenya (genisi)
#msg-54826950 FDA labels of approved MS drugs
#msg-54834214 Copaxone is only approved MS drug with pregnancy Category B
#msg-56125835 Worldwide market share in MS (2Q10)
#msg-39971611 US market share in MS (2Q09)
#msg-55928450 Copaxone is cleaning Tysabri’s clock in US market
#msg-55803073 Tysabri has 70 cases of PML, 20% fatal
#msg-55804866 PML info from Tysabri’s FDA label (Oct 2008)
#msg-37325525 MS drugs in phase-2 or phase-3 (4/09)
#msg-31553565 Musings on MS drugs in development (genisi, 8/08)
#msg-54812455 Merck KGaA’s Cladribine rejected in EU
#msg-55545333 Campath 5-year data from phase-2
#msg-34832939 Musings on Campath (with another table of MS drugs)
#msg-55641299 Sanofi’s Teriflunomide Cuts MS Relapse Rate by 31%
#msg-55927582 New Teriflunomide phase-3 trial with IFN
#msg-55116264 Peptimmune files Citizen Petition against generic Copaxone (1)
#msg-55134848 Peptimmune files Citizen Petition against generic Copaxone (2)



OTHER R&D PROGRAMS

M118 proprietary-anticoagulant program
#msg-39146357 M118 quick primer
#msg-51227061 How large is the anticoagulant market?
#msg-48837475 What are MNTA’s goals for M118?
#msg-41897705 Musings on M118 differentiation in the ACS market
#msg-29698599 Competition from new oral anticoagulants
#msg-53281197 Musings on partnership opportunities
#msg-53282238 Economics of ACS partnership deals

#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-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

#msg-56171420 What’s new in the anticoagulant market?
#msg-39151366 Xarelto has a long way to go in ACS
#msg-36668503 Integrilin whiffs in ‘upstream’ ACS
#msg-55348772 Phase-2a data for Regado’s RB006/RB007
#msg-55640856 Musings on Regado’s threat to MNTA’s M118
#msg-50887745 Musings on relevance of PolyMedix’s PMX-60056
#msg-39180621 M118 is not ‘Recothrom Part Deux’


M402 oncology program
#msg-37030489 Rationale for a heparin-derived cancer drug
#msg-56124256 Preclinical data from 2010 AACR
#msg-47769823 Description of program from 10K report
#msg-37152092 Presentation at 2009 AACR
#msg-55872859 Paper from Journal of Hematological Oncology
#msg-55517588 Paper from Methods in Molecular Biology


FoB program
#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-54287870 Table of patent expiries and FoB opportunities
#msg-53728063 Prognostic value of FDA’s actions vis-à-vis Copaxone and FoB’s
#msg-44688351 Why M178 was dropped
#msg-52853238 Speculation re Orencia FoB
#msg-54034992 Speculation re Integrilin FoB
#msg-33839321 Procognia is not a serious competitor
#msg-33597614 Also-ran companies in the FoB arena



INTELLECTUAL PROPERTY

#msg-54327728 US patent #7,790,466 re Lovenox characterization
#msg-55899246 US patent #7,816,144 (continuation of above)
#msg-56219013 FDA requirements for generic Lovenox essentially written by MNTA
#msg-55909862 Recent patent applications and overview of IP estate
#msg-55997916 Patent app re LMWH composition
#msg-55510863 Patent app re purity of heparin API
#msg-55355036 Patent app re copolymer (Copaxone) process
#msg-55355036 Patent app re non-anticoagulant compositions of heparin (M402)



PUBLICATIONS

#msg-48115945 Weizmann Institute re chemistry of Copaxone (date unknown)
#msg-52862494 Globes online (Israel) interview with Sandoz CEO (8/10)
#msg-52632000 Forbes re ‘The Golden Age of Biogenerics’ (7/10)
#msg-52606143 NY Times re FDA approval (7/10)
#msg-28748329 Nature Biotechnology re contaminated heparin (4/08)
#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)