[Updates: index to legal documents in Copaxone patent case (including summary of NVS/MNTA defense arguments); Teva’s credibility is suspect on multiple fronts; musings on most likely FoB partners; Lovenox scripts through Aug 2011; table of major shareholders; recent patent applications and overview of IP estate; new version of “What’s New in the Anticoagulant Arena?”]
CORPORATE AND FINANCIAL
What is MNTA’s business all about? #msg-65922169 Transcript of 2Q11 conference call #msg-64030605 Goldman Sachs webcast is a must-listen (6/8/11) #msg-62559655FDA official cites MNTA in discussion of FoB pathways #msg-49883723 MNTA is a beneficiary of US FoB legislation #msg-26837144Momenta’s mantra on biogenerics #msg-28748329MNTA helps FDA solve contaminated-heparin problem #msg-54327728 MNTA receives US patent on Lovenox characterization #msg-59682546 MNTA receives US patent on Copaxone characterization #msg-28865474 Characterizing a compound by “ruling out” structures #msg-66953616 Recent patent applications and overview of IP estate
News flow #msg-666349552011-2013 possible/probable events #msg-64630031 Five bullish things that could happen at any time
Valuation and finances #msg-658575642Q11 net income=$1.26/sh #msg-65857564Effective cash balance at 6/30/11 was $331M #msg-65880685 Qtrly expenses will average $19-22M (GAAP), $15-18M (cash) #msg-62215094 ‘Cheat sheet’ on MNTA’s income taxes and NOLs #msg-66016386 MNTA’s likely tax rate in 2012 #msg-65636329 Diluted share count for valuation purposes #msg-65879687Potential Copaxone/Lovenox milestones exceed $163M #msg-62296467 Valuation musings (tinkershaw) #msg-63912789 Dew’s valuation of MNTA’s non-Lovenox assets #msg-47147018 No legal impediments to a buyout #msg-62283456 Musings on possibility of NVS buyout #msg-59693296 Teva won’t acquire MNTA
Management, BoD, and major shareholders #msg-62461556Composition of Board of Directors #msg-58383722Former Biogen executive appointed VP, Business Development #msg-55907213 Musings on Steven Brugger’s departure #msg-54286035 Ram Sasisekharan resigns from BoD (Sep 2010) #msg-54532698 Musings on Ram’s decision #msg-38633640 Bruce Downey, ex-CEO of Barr, joins BoD (Jun 2009) #msg-33979910 James Sulat named Chairman of BoD (Dec 2008) #msg-27338039 James Roach, CMO, joins MNTA (Feb 2008) #msg-12824293Craig Wheeler, CEO, joins MNTA from Chiron (Aug 2006) #msg-62463569 How MNTA executed against 2010 internal goals #msg-66636158Insider shareholdings and options #msg-61651527 Officers’ restricted stock vests on Copaxone approval #msg-60142538 Chairman exercises and holds 7K options (Feb 2011) #msg-56169633 Outgoing COO exercises and holds 56K options (Nov 2010) #msg-53029172 Tax rationale for 2H10 insider selling #msg-66991985Major shareholders
LOVENOX PROGRAM
FDA approval and related litigation #msg-52582225Why FDA approved generic Lovenox (simple version) #msg-52581746Why FDA approved generic Lovenox (technical version) #msg-58201819Five criteria for “sameness” are necessary but not sufficient (1) #msg-66390512 Five criteria for “sameness” are necessary but not sufficient (2) #msg-52620730 FDA approves NVS/MNTA’s generic Lovenox (NVS PR) #msg-29282002 End of the line for Sanofi’s Lovenox patent (May 2008)
#msg-53730236Judge denies Sanofi’s request for preliminary injunction #msg-57781462 Sanofi seeks summary judgment #msg-53731775 Index to legal/regulatory documents in SNY lawsuit
Economic rationale and profit split in US market (See related section below on potential competition from other Lovenox generics.) #msg-65315981NVS reports $284M of 2Q11 Lovenox sales #msg-65334145$993M—largest 12-month sales ever by a generic drug #msg-55818120 How NVS/MNTA account for Lovenox on financial statements #msg-65881687 MNTA’s Lovenox income depends on the number of generics #msg-65879687 Milestone payments from NVS at anniversaries of US launch #msg-44644009 Lovenox is essentially the entire LMWH market
#msg-65635956Generic’s 2Q11 market share = 55% #msg-659346042Q11 US Lovenox sales by product and market segment #msg-65934586 Table of quarterly branded and generic scripts #msg-66940914 Table of monthly branded and generic scripts #msg-62838164 NVS/MNTA’s capacity constraint is deliberate
#msg-54355727 60-70% of US Lovenox market is hospital-based #msg-59555188 Average price in hospital setting 35-40% lower than retail #msg-60467081 Estimated profit margin of generic Lovenox in hospital setting #msg-47460573 FDA label specs for dosing by indication #msg-53625554 Proportion of Lovenox use by dose size
Potential Lovenox generics from other companies #msg-59138957FDA does not approve Teva’s ANDA (1/25/11) #msg-59688528Teva not commenting on ANDA (draw your own conclusions) #msg-59164333Wedbush notes Teva’s disingenuous Lovenox statements #msg-59151084 Example of minor-deficiency letter that led to ultimate rejection #msg-59673351 Teva’s EPS guidance includes no contribution from Lovenox #msg-59172130 Musings on why Teva got an FDA response in Jan 2011
#msg-66991985 Teva’s ANDA might not be approved ever #msg-55670004 Teva admits its version of Lovenox not developed in-house… #msg-56016886 …and my sources say it comes from ItalFarmaco #msg-59485489 Court document confirms Teva’s Italian connection
#msg-54327728MNTA receives US patent on Lovenox characterization #msg-57290171MNTA sues Teva for patent infringement (PR) #msg-57302580 MNTA actual complaint filed with District Court #msg-57304268 Musings on the business rationale for MNTA’s lawsuit #msg-61591240Feb 2013 trial date->Teva has no expectation of FDA approval #msg-66603178 Cases where a PI has blocked launch of a generic drug #msg-57319356 Teva’s PR response to MNTA lawsuit
#msg-66755361Teva’s credibility is suspect on multiple fronts #msg-62133298 Cowen doubts credibility of Teva’s Lovenox ANDA #msg-61589357 Enox-o-what? #msg-56487255 Why Teva is behaving like a baseball manager (1) #msg-56956538 Why Teva is behaving like a baseball manager (2) #msg-53070505 Musings on a Teva approval (ThomasS) #msg-52985447 Musings on a Teva approval (tinker)(1) #msg-53026617 Musings on a Teva approval (tinker)(2) #msg-56047605 Musings on a Teva approval (tinker)(3) #msg-56323662 Musings on a Teva approval (tinker)(4) #msg-53053911 Musings on a Teva approval (RockRat) #msg-52894756 Musings on a Teva approval (zipjet) #msg-53090148 Musings on a Teva approval (oc631) #msg-56267201 Musings on a Teva approval (Dew)(1) #msg-56195372 Musings on a Teva approval (Dew)(2)
#msg-56531176 The sorry state of Amphastar’s application (1) #msg-55920125 The sorry state of Amphastar’s application (2) #msg-60610139 Amphastar responds to FDA’s motion to dismiss lawsuit #msg-46348431 FDA dismisses Amphastar’s conflict-of-interest complaint #msg-56496573 Link to GAO report alleging FDA bias (Nov 2010) #msg-56450420 Political considerations do not favor Teva, Amphastar
#msg-64340400 HSP’s Lovenox ANDA is for vial formulation only #msg-33961609 Vial formulation is considered a distinct product #msg-64319647 Musings on HSP’s ANDA
#msg-56123199SNY rules out an ‘authorized generic’ #msg-46578876 How MNTA would have been affected by an AG #msg-33857504 Why SNY opted not to launch an AG (zipjet) #msg-62838164 NVS/MNTA’s capacity constraint is deliberate
#msg-56096637 OSCS still contaminates US heparin supply (good for MNTA) #msg-56000748 Lovenox knockoffs have varied potential for immunogenicity #msg-58119661 Lovenox knockoffs may be unsafe in ACS #msg-58254369 Antibodies to heparin-PF4 complex associated with poor survival
Lovenox competition from other anticoagulants #msg-66945561What’s new in the anticoagulant arena? #msg-64862315How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales? #msg-65788631 Eliquis update from PFE’s 2Q11 CC #msg-65132332 FDA approves generic Arixtra #msg-57502712 Angiomax backgrounder #msg-55640856 Musings on Regado’s RB006/RB007 #msg-50887745 Musings on relevance of PolyMedix’s PMX-60056
Generic/biosimilar Lovenox outside the US #msg-55882487Musings on Lovenox development outside US #msg-52625998 EU requirements for Lovenox biosimilars and patent info #msg-65879687 Estimated potential milestones from NVS: $48M
COPAXONE PROGRAM
FDA review #msg-30621490FDA accepts NVS/MNTA ANDA for review #msg-59964880 FDA review is not taking unduly long #msg-60686112 MNTA may be conducting a bioequivalence study (1) #msg-60741332 MNTA may be conducting a bioequivalence study (2) #msg-60838182Copaxone activity can be measured (1) #msg-62672351Copaxone activity can be measured (2) #msg-48167251 Safety and efficacy trials will not be needed #msg-60518523 MNTA has submitted workaround for ‘Gad’ patents #msg-58062330 Hatch-Waxman 30-month clock has expired #msg-57427318 Copaxone FUD from Sanford Bernstein #msg-54201872 Wedbush is bullish on MNTA’s Copaxone (9/7/10) #msg-60836359 Handicapping the Copaxone ANDA #msg-30649453 Notes on Copaxone ANDA from 7/11/08 conference call #msg-57629433 Teva submits a third Citizen Petition (LOL) #msg-50163309 Link to FDA rejection of Teva’s 2nd Citizen Petition #msg-50113814Leerink Swann on rejection of Teva’s 2nd CP (1) #msg-50149604Leerink Swann on rejection of Teva’s 2nd CP (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-57072104 Copaxone does not have any “junk” (1) #msg-58881765 Copaxone does not have any “junk” (2) #msg-52702351 FDA might grant bioequivalence waiver #msg-62613681 Weizmann paper on chemistry of Copaxone #msg-60150443 Copaxone paper in The Journal of Immunology
Economic rationale and profit split #msg-57054326Why Copaxone? #msg-65594032Copaxone has $2.7B annualized US sales #msg-12222305NVS/MNTA split profits 50/50 in all cases #msg-65879687Estimated potential milestones from NVS: $115M #msg-62969588 Copaxone has 40% US prescription share among MS drugs #msg-53081150 Ex-US market for generic Copaxone not especially attractive
Patent litigation #msg-54113660 List of Copaxone patents being litigated #msg-66991580 Index to legal documents in Copaxone case #msg-66864421Summary of NVS/MNTA arguments in patent trial #msg-61953697 MNTA is indemnified against liabilities from patent litigation
#msg-66626914Court rules in Teva’s favor on Markman hearing #msg-66633018Leerink Swann re Markman hearing and patent trial #msg-36604466 Musings by Joseph Schwartz re (see last two bullets) #msg-59368793 Branded Copaxone has weak IP protection (tinkershaw) #msg-64430231 Handicapping the Copaxone case (various iHub posters)
#msg-33580867 Rationale for inequitable conduct argument against Teva #msg-63573604 Showing inequitable conduct just got harder #msg-65627476 Mylan CEO’s comment re inequitable conduct
#msg-59682546MNTA receives US patent on Copaxone characterization #msg-61312284Patent suit could be settled if FDA approves ANDA #msg-62133298 Cowen agrees, evidently
Potential competition from other generic and branded drugs #msg-29902618Mylan inks Copaxone deal with India’s Natco #msg-60289240 Mylan’s 30-month Hatch-Waxman stay expires Mar 2012 #msg-59685034 MNTA’s new patent reduces MYL’s prospects
#msg-62810742 Musings on MS market from 1Q11 CC #msg-62346151 Teva might continue detailing Copaxone after generic launch #msg-62355790 Musings on a Copaxone ‘authorized generic’
#msg-58083875FDA rejects Teva’s ‘low-volume’ Copaxone #msg-50939364 Clinical data for low-volume Copaxone was weak #msg-59788384 Low-volume Copaxone is presumably dead #msg-63817727 Musings on Teva’s thrice-weekly Copaxone (1) #msg-63836262 Musings on Teva’s thrice-weekly Copaxone (2)
#msg-54677007 FDA approves NVS’ Gilenya #msg-65574194How does Gilenya affect Copaxone? #msg-56524579 Copaxone will hold its own against Gilenya (Leerink Swann) #msg-59296554 Copaxone will hold its own against Gilenya (tinkershaw)
#msg-65594032 Copaxone outsells Tysabri 4:1 in US market #msg-61835910 Apr 2011 Tysabri label update (102 cases of PML, 21% fatal) #msg-60144268 Musings on Tysabri’s PML rate #msg-60984424 Biogen halts Tysabri ‘switching’ study due to slow enrollment
#msg-54826950 FDA labels of approved MS drugs #msg-61960285 Efficacy data from FDA Copaxone label #msg-54834214 Copaxone is only approved MS drug with pregnancy Category B #msg-56125835 Worldwide market share in MS (2Q10) #msg-39971611 US market share in MS (2Q09) #msg-58131215 MS drugs in late-stage development (Oct 2010) #msg-31553565 Musings on MS drugs in development (genisi) #msg-57586166 Chart of comparative efficacy of MS drugs #msg-61959592 Musings on the crop of oral MS drugs
#msg-65742416 Laquinimod fails in phase-3 BRAVO study #msg-62320268 BG-12 data from DEFINE study are impressive #msg-62375616 BG-12 data from CONFIRM study due Sep 2011 #msg-62384175 BG-12 is not the same drug as Fumaderm #msg-62332894Musings on BG-12 threat to Copaxone #msg-55641299 Phase-3 Teriflunomide data from TESMO study #msg-55927582 SNY starts phase-3 trial of Teriflunomide+IFN #msg-64489232 Merck KGaA terminates Cladribine program
#msg-61504526 FDA denies Peptimmune’s Citizen Petition (3/11) #msg-62661879 Updated link to Peptimmune’s CP #msg-55116264 Peptimmune’s PR announcing CP filing (10/10) #msg-60953425 Mylan’s response to Peptimmune’s CP #msg-61204770 Peptimmune (unsurprisingly) files for bankruptcy
FOLLOW-ON BIOLOGICS (FoB) PROGRAM
#msg-49883723MNTA is a beneficiary of US FoB legislation #msg-48581353 What the new healthcare law says about FoB’s #msg-26837144Momenta’s mantra on biogenerics #msg-62559655FDA official cites MNTA in discussion of FoB pathways #msg-62631138 Addendum to above discussion #msg-66837147 NEJM article on FoB pathway #msg-65845219Musings on the NEJM article (by ‘MTB’) #msg-62941793FDA reiterates commitment to issue FoB guidance in 2011 #msg-63126386 BioCentury article spells out regulatory pathway for US FoB’s #msg-63127867 Crux of the issue for US FoB’s #msg-62805964 Limited clinical trials will be required, at least initially (1) #msg-62958889 Limited clinical trials will be required, at least initially (2) #msg-66670134 Musings on most likely FoB partners #msg-64278731 Musings on MNTA’s FoB technology and partnership prospects
#msg-61414941 FoB’s will sell $3.7B in 2015, says Datamonitor #msg-60342122FoB ‘cheat sheet’ #msg-59828805 Musings on terms of an FoB collaboration #msg-57601389 Presentation by James Roach at FDA hearing on FoB’s #msg-58469454 Musings on how an FoB applies to disparate indications
OTHER R&D PROGRAMS (For info on M118, see prior version of ReadMeFirst at #msg-65636771.)
M402 oncology program #msg-37030489Rationale for a heparin-derived cancer drug #msg-47769823 Description of program from 10K report #msg-64437243 M402 paper in PLoS ONE #msg-60373285 Presentation at 2011 AACR #msg-56822655 Paper from Investigational New Drugs #msg-55872859 Paper from Journal of Hematological Oncology #msg-55517588 Paper from Methods in Molecular Biology
INTELLECTUAL PROPERTY
#msg-57290171MNTA sues Teva for patent infringement (PR) #msg-54327728US patent #7,790,466 re Lovenox characterization #msg-55899246 US patent #7,816,144 (continuation of above) #msg-59682546MNTA receives US patent on Copaxone characterization #msg-66953616 Recent patent applications and overview of IP estate #msg-55997916 Patent app re LMWH composition #msg-55510863 Patent app re purity of heparin API
PUBLICATIONS
#msg-63126386BioCentury re prospects for US FoB’s (5/11) #msg-59966324Barron’s opines re MNTA’s business plan (2/11) #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-28748329Nature Biotechnology re contaminated heparin (4/08) #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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