Wasn't there a thread about a month ago that since mnta could fully categorize their product they could get a fully substitutable anda, whereas Teva may get a approval but it wouldn't be able to be substituted for the brand. Hence they would need a sales force which would be tantamount to having an approval that wouldn't be worth very much.
[Updates: 2010-2011 news flow; index to legal/regulatory documents re generic Lovenox; reimbursement obligation will be satisfied in <=3 quarters; projecting Lovenox cash flow from the reimbursement offset; Teva’s Lovenox facilities presumably not inspected; musings on Copaxone regulatory outlook from COO Steven Brugger; musings on M118 partnership opportunities; economics of ACS partnership deals; new version of “What’s New in the Anticoagulant Market?”]
CORPORATE AND FINANCIAL
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 #msg-52891502Transcript from 2Q10 conference call #msg-53076761 Recent patent applications and overview of IP estate
Management, BoD, and major shareholders #msg-51595947Composition of Board of Directors #msg-38645684Bruce Downey, ex-CEO of Barr, joins BoD #msg-12824293 Craig Wheeler named CEO (Aug 2006) #msg-33979910 James Sulat named Chairman (Dec 2008) #msg-27338039 James Roach named CMO (Feb 2008) #msg-49501257 How MNTA executed against 2009 goals #msg-53211790Insider shareholdings and options #msg-53029172 Tax rationale for recent insider selling #msg-51596206Major shareholders #msg-47147018 No legal impediments to an acquisition
LOVENOX PROGRAM
FDA approval and related litigation #msg-53334693Index to legal/regulatory documents #msg-52582225Why FDA approved generic Lovenox (simple version) #msg-52581746Why FDA approved generic Lovenox (technical version) #msg-52620730 FDA approves NVS/MNTA’s generic Lovenox (NVS PR) #msg-52578102 FDA approves NVS/MNTA’s generic Lovenox (MNTA PR) #msg-52672381 Sanofi’s ‘Hail Mary’ lawsuit against FDA #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-52759766Lovenox sells $4.5B/yr, 60% in US #msg-52869916 NVS was supplying 35-40% of Lovenox market at launch #msg-33839164MNTA’s economics depends on the number of generics #msg-52868377 Reimbursement obligation will be satisfied in <=3 quarters #msg-53185820Projecting Lovenox cash flow from the reimbursement offset #msg-53349063 Reimbursement obligation to NVS effectively proportional to profit split #msg-52651605Generic priced at small discount to branded product #msg-52652888 Musings on pricing decision (zipjet) #msg-52936910 Musings on gross margin of generic Lovenox #msg-44687884Potential milestone payments of $163M #msg-52863951 $5M fm NVS for FDA Lovenox approval is separate fm above #msg-43761160 Lovenox royalty if multiple generics #msg-46578876 How would MNTA be affected by a Sanofi AG? #msg-52792105 MNTA royalty payable to MIT #msg-44644009 Lovenox is essentially the entire LMWH market #msg-52871590 60-70% of US Lovenox market is hospital-based #msg-28936334 Proportion of Lovenox sales in various indications #msg-41482908 Lovenox is not at all like Omnitrope
Potential Lovenox US generics from other companies #msg-52999229Sanford Bernstein’s dubious rumor causes MNTA sell-off #msg-52761665SNY appears to rule out Lovenox AG in near future #msg-38906603 Musings on likelihood of an AG #msg-45522123Teva’s disinformation re Lovenox characterization #msg-53314997 Teva’s Lovenox facilities presumably not inspected #msg-52589074 Teva’s sour grapes PR on losing out to MNTA #msg-53070505 Musings on a Teva approval (ThomasS) #msg-53090148 Musings on a Teva approval (oc631) #msg-52985447 Musings on a Teva approval (tinkershaw)(1) #msg-53026617 Musings on a Teva approval (tinkershaw)(2) #msg-52974802 Musings on a Teva approval (biomaven) #msg-53053911 Musings on a Teva approval (RockRat) #msg-52894756 Musings on a Teva approval (zipjet)(1) #msg-52842458 Musings on a Teva approval (zipjet)(2) #msg-43206942 Possibility of a non-substitutable generic by Teva #msg-46994189The sorry state of Amphastar’s application (1) #msg-52924781 The sorry state of Amphastar’s application (2) #msg-46348431 FDA dismisses Amphastar’s conflict-of-interest complaint
Lovenox competition from other anticoagulants #msg-53376343What’s new in the anticoagulant market? #msg-40342721 Why Arixtra is inconsequential to MNTA #msg-29698599Competition from new oral anticoagulants #msg-39151366 Xarelto has a long way to go in ACS
Lovenox biosimilar program in EU #msg-12222305 Lovenox in EU falls under 2006 NVS-MNTA agreement #msg-52625998EU requirements for Lovenox biosimilar and related musings #msg-44644009 Lovenox is essentially the entire LMWH market #msg-28936334 Proportion of Lovenox sales in various indications
COPAXONE PROGRAM
FDA application #msg-30621490FDA accepts NVS/MNTA ANDA for review #msg-48167251 Will Copaxone ANDA require clinical trials? #msg-30649453 Notes on Copaxone ANDA from 7/11/08 conference call #msg-52599384When can FDA approve MNTA’s Copaxone? #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
Economic rationale and profit split #msg-12222305NVS/MNTA split profits 50/50 in all cases #msg-52673284US Copaxone sales are $2.1B per annum #msg-44687884Potential milestone payments are $163M #msg-52863951 $5M fm NVS for FDA Lovenox approval is separate fm above #msg-53081150 Ex-US market for generic Copaxone not especially attractive
Patent litigation #msg-52735648Teva’s patents can be attacked on multiple fronts #msg-30960930 List of Copaxone Orange Book patents being challenged #msg-44092062 Court bars Teva from adding patents to litigation
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-52553991 Copaxone should hold its own against new entrants #msg-36015642 FDA approves Copaxone for CIS #msg-50939364 Teva’s ‘low-volume’ Copaxone (PR and comments) #msg-51123550 Musings on low-volume Copaxone from MNTA annual meeting #msg-52673284 Copaxone 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-52714348 FDA grants priority review for Cladribine #msg-39934109 Dirucotide from BioMS fails—program terminated
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-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-53376343 What’s new in the anticoagulant market? #msg-39151366 Xarelto has a long way to go in ACS #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-49143958 Preclinical data from 2010 AACR #msg-47769823 Description of program from 10K report #msg-37152092 Presentation at 2009 AACR
#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-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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