[Updates: major rewrite of section on generic Copaxone, including several new entries; index to posts on competing anticoagulants.]
What is MNTA’s business all about? #msg-46564147Transcript of 4Q09 CC (2/11/10) #msg-25473104 Capsule summary of proprietary technology #msg-28748329MNTA helps FDA with contaminated heparin #msg-33978205 Post-mortem on above story #msg-338670742003 article from Signals (still a good read) #msg-28865474 Characterizing a compound by “ruling out” structures
Management, BoD, and major shareholders #msg-38645684Bruce Downey, ex-CEO of Barr, joins BoD #msg-42166392Composition of Board of Directors #msg-33979910 James Sulat appointed Chairman of Board (Dec 2008) #msg-12824293 CEO, Craig Wheeler, hired from Chiron (Aug 2006) #msg-27338039 CMO, James Roach, hired from Sepracor (Feb 2008) #msg-37687271 How MNTA executed against internal goals (May 2009) #msg-47787672 Insider shareholdings #msg-47902304Major shareholders #msg-47147018 No legal impediments to an acquisition
Generic Lovenox program (See separate section below on competition from other Lovenox generics.) #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-46480161Lovenox sells $4.2B/yr, 60% in US #msg-44644009 Lovenox is essentially the entire LMWH market #msg-28936334 Proportion of Lovenox sales in various indications #msg-35544866Single generic would be largest-selling of all time #msg-44687884 Potential Lovenox/Copaxone milestones are $163M #msg-41482908 Lovenox is not at all like Omnitrope #msg-33862924 NVS pays all expenses (2003 partnership PR) #msg-33839164MNTA’s economics depends on the number of generics #msg-46578876How is MNTA affected by a Sanofi AG? #msg-42166244Share-price upside in the best-case scenario #msg-43761160 Lovenox royalty if multiple generics #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-39146357M118 ‘refresher course’ #msg-41846746 Phase-2 data from EMINENCE trial #msg-41820503Musings on the EMINENCE data #msg-44374211 Why MNTA will partner the M118 program #msg-47474349 Why an M118 partnership has taken so long #msg-41897705Musings on M118 differentiation in the ACS market #msg-39180621 M118 is not ‘Recothrom Part Deux’ #msg-39151654 Past and future 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-46709942Annualized US Copaxone sales are >$2B #msg-36015642 FDA approves Copaxone for CIS #msg-30621490FDA accepts Copaxone ANDA for review #msg-30938608 MNTA/NVS have Hatch-Waxman first-filer status #msg-30960930 List of Copaxone patents being challenged #msg-36604466Weakness of Copaxone patents (second 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-43947610 Teva resubmits Citizen Petition #msg-12222305NVS/MNTA split Copaxone profits (2006 agreement) #msg-44687884Potential milestones are $163M #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) #msg-48112893 Musings on regulatory outlook (Dew)
M402 oncology program #msg-37030489Rationale for a heparin-derived cancer drug #msg-47769823 Description of program from 10K report #msg-37152092 Presentation at 2009 AACR
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-48042991Index 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-46709942Copaxone continues cleaning Tysabri’s clock—maybe #msg-39971611US market share of MS drugs (2Q09) #msg-35060588 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-44040202 FDA issues RTF letter for Cladribine #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-34865448 NVS takes option on Peptimmune’s PI-2301 #msg-43470309 Teva’s planned “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-45721919 Overview of IP estate (scan to bottom) #msg-45721919 Summary MNTA’s EU patent applications #msg-47622557 Latest EU patent application
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