[Updates: FDA denies Teva’s ‘Citizen Petition’ re generic Copaxone; musings on the FDA denial of Teva’s CP from various sources; text from recent report by Leerink Swann; MNTA’s European patent estate (thanks, floblu).]
What is MNTA’s business all about? #msg-25473104 Capsule summary of proprietary technology #msg-28748329MNTA helps FDA with contaminated heparin #msg-33978205 Post-mortem on above story #msg-28865474 Characterizing a compound by “ruling out” structures #msg-49883723MNTA 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)
Generic-Lovenox program: FDA review (See separate sections below on Lovenox economics and competition.) #msg-41323601FDA “ready to approve,” says Craig Wheeler #msg-46038154Handicapping the Lovenox ANDA’s #msg-32449872 Sandoz submits response to FDA (9/08) #msg-37892516FDA request for new clinical trial is unlikely #msg-38682430Immunogenicity 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-38585972Musings 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-49567739Lovenox sells $4.1B/yr, 57% in US #msg-33862924 NVS pays all development and commercialization costs #msg-44687884Potential milestone payments of $163M #msg-33839164 MNTA’s economics depends on the number of generics #msg-42166244Share-price upside in the best-case scenario #msg-43761160 Lovenox royalty if multiple generics #msg-46578876How 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-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-49741817Annualized US Copaxone sales are ~$2B #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 (2nd item from bottom) #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-45730917 Barclays 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-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-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-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-50737002 Summary MNTA’s EU patent applications
Competition from other Lovenox generics #msg-45522123Teva’s disinformation re Lovenox characterization #msg-46578876How 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-46994189The 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-50005264Index to posts on competing anticoagulants #msg-44644009 Lovenox is essentially the entire LMWH 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 UNH #msg-29698599Competition from new oral anticoagulants #msg-39151366Xarelto has a long way to go in ACS
Competition in multiple sclerosis #msg-41481687FDA to review Mylan’s Copaxone ANDA #msg-49741817Copaxone continues cleaning Tysabri’s clock—maybe #msg-41292688 Tysabri’s 3-year PML rate #msg-43470309 Teva’s “low volume” Copaxone (1) #msg-49746622 Teva’s “low volume” Copaxone (2) #msg-39971611US 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-37060245 New orals to be used mostly in the second line #msg-42018880 FTY720 data from the FREEDOMS study #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-44040202 FDA issues RTF letter for Cladribine #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
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