[Updates: Teva says its Lovenox ANDA is “stuck in bureaucratic limbo”; why Teva is behaving like a baseball manager; political considerations do not favor Teva, Amphastar; link to GAO report alleging FDA bias; MNTA publishes paper in Nature Biotechnology pertaining to Orencia; Orencia factoids; example of how large ACS trials must be (Cangrelor).]
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-28748329MNTA helps FDA solve contaminated-heparin problem #msg-52632000‘The Golden Age of Biogenerics’ (Forbes) #msg-28865474 Characterizing a compound by “ruling out” structures #msg-49883723MNTA 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
Valuation and finances #msg-56133714MNTA logs 3Q10 profit of $0.70/sh #msg-56166824 Transcript of 3Q10 conference call #msg-52999229 Sanford Bernstein’s dubious rumor causes sell-off (Aug 2010) #msg-55020801 Cowen values Lovenox program alone at mid $20s/sh #msg-56176508 $92M tax credit can be applied to Lovenox profits #msg-54022252Valuation of non-Lovenox assets (Dew) #msg-54490305 Valuation based on buyout #msg-44687884Potential 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-54286333Composition 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-55908942Insider shareholdings and options #msg-53029172 Tax rationale for recent insider selling #msg-54286676Major 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-52582225Why FDA approved generic Lovenox (simple version) #msg-52581746Why 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-53569996Immunogenicity 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-55774996NVS sells $292M of generic Lovenox in 69 days! #msg-55778832Adjusting 3Q10 Lovenox sales for channel stocking #msg-56253339Generic 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-44687884Potential 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-54327728MNTA 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-56448408Teva says Lovenox ANDA is “stuck in bureaucratic limbo” #msg-56487255Why Teva is behaving like a baseball manager #msg-55670004 Teva admits its version of Lovenox not developed in-house… #msg-56016886…and my sources say it comes from ItalFarmaco #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-56323662Musings 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-56450420Political considerations do not favor Teva, Amphastar #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-56496573 Link to GAO report alleging FDA bias (Nov 2010) #msg-56123199SNY 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-56171420What’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-55882487Musings on Lovenox development outside US #msg-52625998 EU requirements for Lovenox biosimilars and patent info
COPAXONE PROGRAM
FDA application #msg-30621490FDA 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-50113814Leerink Swann on rejection of Teva’s Citizen Petition (1) #msg-50149604Leerink 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-48166546Teva’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-12222305NVS/MNTA split profits 50/50 in all cases #msg-55928450US Copaxone sales are $2.1B per annum #msg-44687884Potential 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-55490818Teva thinks it could lose patent case, evidently #msg-56147443NVS/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-52553991Copaxone should hold its own against Gilenya (haaretz.com) #msg-54849106Copaxone should hold its own against Gilenya (genisi) #msg-54826950 FDA labels of approved MS drugs #msg-54834214Copaxone 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-55928450Copaxone 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-39146357M118 quick primer #msg-51227061How large is the anticoagulant market? #msg-48837475What are MNTA’s goals for M118? #msg-41897705 Musings on M118 differentiation in the ACS market #msg-29698599Competition from new oral anticoagulants #msg-56388251 Example of how large ACS trials must be (Cangrelor) #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-41846746Data 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-48705801Apr 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-37030489Rationale 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-49883723MNTA is a beneficiary of US FoB legislation #msg-48581353What the new healthcare law says about FoB’s #msg-26837144 Momenta’s mantra on biogenerics #msg-56429332MNTA publishes Orencia paper in Nature Biotechnology #msg-56471065 Orencia factoids #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-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-54327728US 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-48115945Weizmann Institute re chemistry of Copaxone (date unknown) #msg-52862494Globes online (Israel) interview with Sandoz CEO (8/10) #msg-52632000Forbes re ‘The Golden Age of Biogenerics’ (7/10) #msg-52606143NY Times re FDA approval (7/10) #msg-28748329Nature Biotechnology re contaminated heparin (4/08) #msg-25160571WSJ re anticoagulant market (12/07) #msg-23005127Nature re FoB’s (9/07) #msg-20308884Lab Technologist re production process (6/07) #msg-25803923The Pink Sheet interview with C. Wheeler (3/07) #msg-7370282WSJ re MNTA’s raison d’etre (8/05) #msg-25779774Boston Globe re MNTA’s IPO (11/04) #msg-33867074Signals Magazine re glycobiology (9/03)
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