[Updates: pricing of generic Lovenox (with musings by zipjet); 2010-2011 news flow; SNY’s ‘Hail Mary’ request for an injunction; 2Q10 Copaxone sales.]
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-49883723MNTA is a beneficiary of US FoB legislation
Lovenox program in US: regulatory decision #msg-52582225Why FDA approved generic Lovenox (simple version) #msg-52581746 Why FDA approved generic Lovenox (technical version in bottom link) #msg-52620730Novartis’ PR on FDA approval #msg-52578102 MNTA’s PR on FDA approval #msg-52672381Sanofi’s ‘Hail Mary’ request for injunction #msg-52589074 Teva’s sour grapes PR
Lovenox program in US: economics #msg-49567739Lovenox sells $4.1B/yr, 57% in US #msg-42166244Share-price upside in the best-case scenario #msg-52651605Generic priced at 14% discount—very bullish! #msg-52652888 Musings on pricing decision (zipjet) #msg-44687884Potential 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-33839164MNTA’s economics depends on the number of generics #msg-43761160 Lovenox royalty if multiple generics #msg-46578876How is MNTA affected by a Sanofi AG? #msg-38906603 Musings on likelihood of an ‘authorized’ generic #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-45522123Teva’s disinformation re Lovenox characterization #msg-52624120 How likely is FDA to approve Teva’s Lovenox ANDA? #msg-46578876How 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-52382839What’s new in the anticoagulant market? #msg-40342721Why 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-29698599Competition from new oral anticoagulants #msg-39151366Xarelto has a long way to go in ACS
Generic-Copaxone program (See separate section below on the competitive landscape in MS.) #msg-52673284US Copaxone sales are $2.1B per annum #msg-52577893Copaxone is easier to characterize than Lovenox (IMO) #msg-52589866Why Teva’s stock was hammered on 7/23/10 #msg-52599384When can FDA approve MNTA’s Copaxone? #msg-50163309FDA 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-36015642 FDA approves Copaxone for CIS #msg-12222305NVS/MNTA split Copaxone profits 50/50 #msg-44687884Potential milestone payments are $163M #msg-30621490FDA 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-36604466Weakness of Copaxone patents (last 2 paragraphs) #msg-44092062 Court bars Teva from adding patents to litigation #msg-33580867 MNTA/NVS allege inequitable conduct #msg-45789837Leerink 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-48166546Teva’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-39146357M118 quick primer #msg-51227061How 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-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-48837475What 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-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
M402 oncology program #msg-37030489Rationale 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-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-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-50939364Teva’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-52673284Copaxone 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-52632000Forbes re ‘The Golden Age of Biogenerics’ (7/10) #msg-52606143NY Times re FDA approval (7/10) #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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