[Updates: 3Q09 financial results and CC transcript; liquidity and cash usage; the Lovenox plot may have thickened (Teva CC); Copaxone continues to clean Tysabri’s clock in US market; patent application re reverse engineering Copaxone (thanks, floblu); 3Q09 sales of branded Lovenox; M118 paper from Nov09 issue of Thrombosis and Hemostasis; revised table of major shareholders; revised table of recent biotech buyouts; index to posts on anticoagulants.]
Management and BoD #msg-37687271How MNTA executed against its 2008 internal goals #msg-38645684Bruce Downey, ex-CEO of Barr, joins BoD #msg-42166392Composition of Board of Directors #msg-33979910 James Sulat appointed Chairman of Board #msg-12824293 CEO, Craig Wheeler, hired from Chiron (Aug 2006) #msg-27338039 CMO, James Roach, hired from Sepracor (Feb 2008) #msg-42490241 Major shareholders #msg-38645904 Insider shareholdings
Generic Lovenox program (See separate section below on competition from other Lovenox generics.) #msg-41323601FDA “ready to approve,” says Craig Wheeler #msg-41414776Handicapping 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-39720275FDA 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 #msg-37893451 FDA can’t keep the ANDA in limbo indefinitely #msg-43119870Lovenox sells $4.4B/yr, 60% in US #msg-35544866Single generic would be largest-selling of all time #msg-41482908 Lovenox is not at all like Omnitrope #msg-33862924Sandoz pays the freight #msg-33839164Profit split depends on # of generics #msg-42166244Share-price upside in the best-case scenario #msg-41326335 Approval of multiple generics is not the ticket #msg-41324486 Estimated royalty if multiple generics #msg-12685766 Royalty payable to MIT #msg-36972416Status 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
M118 (proprietary anticoagulant) program (See separate section below on the competitive landscape for anticoagulants.) #msg-41846746Phase-2 data from EMINENCE trial #msg-41820503Musings on the EMINENCE data #msg-39146357M118 ‘refresher course’ #msg-41897705 Musings on M118 differentiation #msg-39180621 Why M118 is not ‘Recothrom Part Deux’ #msg-39151654 Index to M118 clinical trials #msg-27272430 Meeting an unmet need #msg-31029674 Advantage vs Lovenox re drug interactions #msg-26898084 How M118 binds both FIIa and FXa (graphic) #msg-43301340 M118 paper from Thrombosis and Hemostasis
Generic Copaxone program (See separate section below on the competitive landscape in MS.) #msg-30621490FDA accepts Copaxone ANDA for review #msg-36604466 Leerink Swann report on Teva’s Citizen Petition (3/27/09) #msg-36600603 Will Copaxone be regulated as a biologic? #msg-30938608MNTA/Sandoz have first-filer status #msg-33580867 MNTA/Sandoz allege inequitable conduct #msg-36601428 Teva counters with claim of stolen IP #msg-30960930 List of Copaxone patents being challenged #msg-12222305 Copaxone falls under 2006 collaboration #msg-30649453 Notes from 7/11/08 Copaxone conference call #msg-30647865 “Controlled chaos” and reverse engineering #msg-36015642 FDA approves Copaxone for CIS
Follow-on Biologics (FoB) programs #msg-27114485US FoB’s are a question of when not if #msg-35824847 Update on the same topic #msg-26837144Momenta’s Mantra on FoB’s #msg-40156726 MNTA only marginally affected by terms of FoB legislation #msg-35607204 Biogenerics vs biosimilars #msg-12222305 2006 PR announcing FoB deal with Sandoz #msg-34383144 $178M in remaining potential milestones #msg-37325602What is M178? (table of biologic patent expirations) #msg-20699044 Largest-selling biologics by class #msg-33866262 Reference website for FoB’s
M402 oncology program #msg-37030489Rationale for a heparin-derived cancer drug #msg-37152092 Presentation at 2009 AACR
Competition from other Lovenox generics #msg-38044302What about ANDA’s from Teva and Amphastar? #msg-43206942 The Lovenox plot may have thickened (Teva CC) #msg-38906603Musings on likelihood of an ‘authorized’ generic #msg-35170055 Amphastar’s 180-day ‘exclusivity’ expired on 3/31/09 #msg-33960572 HSP filed an ANDA for vial formulation only
Competition from other anticoagulants #msg-40342721Why Arixtra is inconsequential to MNTA #msg-33630772 Lovenox more cost-effective than Arixtra, says SNY #msg-29698599Competition from new oral anticoagulants #msg-39151366Xarelto has a long way to go in ACS #msg-43348853Index to posts on anticoagulants
Competition: multiple sclerosis #msg-43348059Copaxone continues to clean Tysabri’s clock in US #msg-39971611 US market share of MS drugs (2Q09) #msg-35065247 Comparative efficacy of approved MS drugs #msg-41292688 Tysabri’s 3-year PML rate #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-42057827 Merck Serono submits Cladribine NDA #msg-42018880 FTY720 data from the FREEDOMS study #msg-34832939 Musings on Campath (with another table of MS drugs) #msg-39934109 Dirucotide from BioMS fails—program terminated #msg-41481687FDA to review Mylan’s Copaxone ANDA #msg-37567642 Teva begins work on “low volume” Copaxone
Competition: miscellaneous #msg-33839321 Procognia is not a serious competitor #msg-33597614 Also-ran companies in the FoB arena
Intellectual property #msg-41924957 Overview of MNTA’s patent estate #msg-42006364 MNTA’s EU patent applications #msg-42872766 Recent patent application re Copaxone
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