[Updates: Judge denies Amphastar’s motion to stay PI pending appeal; NVS, MNTA agree on split of $100M Court bond; MNTA’s new ‘235 patent may be workaround to Teva’s “Gad” patents; 2012-2013 news flow; musings on Lovenox pricing since launch of SNY’s AG; phase-3 Lemtrada data in second-line RRMS; table of major shareholders; table of insider shareholdings and options; new version of “How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales?”; new version of “What’s New in the Anticoagulant Arena?”]
CORPORATE AND FINANCIAL
What is MNTA’s business all about? #msg-68769696 Transcript of 2Q11 conference call (11/7/11) #msg-68456380 Transcript of BioCentury webcast (10/21/11) #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-28748329 MNTA helps FDA solve contaminated-heparin problem
News flow #msg-691754602012-2013 possible/probable events #msg-64630031 Five bullish things that could happen at any time
Valuation and finances #msg-687353893Q11 net income = $1.18/sh #msg-68810619 Calculation of MNTA’s 3Q11 Lovenox profit #msg-68735389Effective cash balance at 9/30/11 was $393M #msg-68768844 3Q11 cash operating expenses within prior guidance range #msg-62215094 ‘Cheat sheet’ on MNTA’s income taxes and NOLs #msg-65636329 Diluted share count for valuation purposes #msg-65879687Potential Copaxone/Lovenox milestones exceed $163M #msg-68471951Teva’s Lovenox program doesn’t matter much anymore (if it ever did) #msg-67293937 Dew’s valuation of MNTA’s non-Lovenox assets
Management, BoD, and major shareholders #msg-62461556Composition of Board of Directors #msg-62463569 How MNTA executed against 2010 internal goals #msg-69174113Insider shareholdings and options #msg-61651527 Officers’ restricted stock vests on Copaxone approval #msg-60142538 Chairman exercises and holds 7K options (Feb 2011) #msg-53029172 Tax rationale for 2H10 insider selling #msg-69174646Major shareholders
#msg-58383722 Young Kwon named VP, Business Development (1/11) #msg-54286035 Ram Sasisekharan resigns from BoD (9/10) #msg-54532698 Musings on Ram’s decision #msg-38633640 Bruce Downey, ex-CEO of Barr, joins BoD (6/09) #msg-33979910 James Sulat named Chairman of BoD (12/08) #msg-27338039 James Roach, CMO, joins MNTA (2/08) #msg-12824293 Craig Wheeler, CEO, joins MNTA from Chiron (8/06)
LOVENOX PROGRAM
FDA approvals and related litigation #msg-68479315Court blocks launch of Amphastar’s generic Lovenox (MNTA’s PR) #msg-68468217 Court blocks launch of Amphastar’s generic Lovenox (Court Order) #msg-68468114 Court blocks launch of Amphastar’s generic Lovenox (Memorandum) #msg-69012802 NVS, MNTA agree on split of $100M Court bond #msg-68470614 Amphastar files for appeal of preliminary injunction (as expected) #msg-69102634 Judge denies Amphastar’s motion to stay PI pending appeal
#msg-67308386 MNTA sues Amphastar and WPI for patent infringement #msg-67310706 Link to MNTA’s Complaint filed with the Court #msg-67313777 MNTA alleges infringement of ‘886 and ‘466 patents… #msg-68481332 …however, the ‘466 patent is presumably out of play #msg-68245484 Specific patent claims where MNTA alleges infringement #msg-68240669 Musings on the Bolar exemption safe harbor
#msg-67801477 Musings on a MNTA-Amphastar settlement (hypothetical terms) #msg-67891472 Musings on a MNTA-Amphastar settlement (Tercica/Insmed example) #msg-68019389 Musings on a MNTA-Amphastar settlement (“horizon” effect) #msg-68155650 Musings on a MNTA-Amphastar settlement (FTC impact) #msg-68498287 Musings on a MNTA-Amphastar settlement (NVS-MNTA cooperation)
#msg-67230597FDA approves generic Lovenox from Amphastar #msg-67345284 Link to FDA webpage for generic Lovenox #msg-67352849 Story of how Amphastar stalked FDA officials #msg-52620730 FDA approves NVS/MNTA’s generic Lovenox #msg-52582225 FDA’s criteria for approval of generic Lovenox
Sales, market share, and pricing of generic Lovenox #msg-68293836Sanofi launches a Lovenox authorized generic #msg-68341563 How SNY’s AG affects the MNTA’s Lovenox economics (1) #msg-68469857 How SNY’s AG affects the MNTA’s Lovenox economics (2) #msg-68742103 Market-share ramifications of SNY’s AG #msg-68646218 Profit-margin ramifications of SNY’s AG #msg-68983935 Musings on Lovenox pricing since launch of SNY’s AG
#msg-68710933NVS/MNTA’s Lovenox had $259M and 58% share in 3Q11 #msg-68906510 Table of monthly branded and generic Lovenox scripts #msg-68906536 Table of quarterly branded and generic Lovenox scripts
#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 #msg-44644009 Lovenox is essentially the entire LMWH market #msg-55882487 Musings on Lovenox development outside US
Potential Lovenox competition from Teva #msg-59138957FDA does not approve Teva’s ANDA (1/11) #msg-68471951Teva’s Lovenox program doesn’t matter much anymore (if it ever did) #msg-59164333 Wedbush notes Teva’s disingenuous Lovenox statements #msg-66755361 Teva’s credibility is suspect on multiple fronts #msg-66767716 Teva’s ANDA might not ever be approvable #msg-57290171MNTA sues Teva for patent infringement (12/10) #msg-57302580 NVS/MNTA complaint filed with District Court #msg-61591240 2013 trial date suggests Teva has no expectation of FDA approval
Lovenox competition from other anticoagulants #msg-69173505What’s new in the anticoagulant arena? #msg-69173426How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales? #msg-65788631 Eliquis update from PFE’s 2Q11 CC #msg-65132332 FDA approves generic Arixtra
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-68583537Copaxone has $3B 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 patent could impede Mylan’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-67094037 Teva to conduct new trial for low-volume Copaxone #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-68583537 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-67882457 5-year Copaxone data on brain volume #msg-54834214 Copaxone is only approved MS drug with pregnancy Category B #msg-68302787 Leerink Swann overview of MS market (Oct 2011) #msg-61959592 BioWorld musings on the crop of oral MS drugs (Apr 2011) #msg-58131215 MS drugs in late-stage development (Oct 2010) #msg-56125835 Worldwide market share in MS (2Q10) #msg-39971611 US market share in MS (2Q09) #msg-57586166 Chart of comparative efficacy of MS drugs #msg-68245312 Phase-2b Daclizumab data
#msg-65048827 Phase-3 Lemtrada data in first-line RRMS #msg-69008941 Phase-3 Lemtrada data in second-line RRMS #msg-62085679 Lemtrada 5-year data from phase-2
#msg-65742416 Laquinimod fails in phase-3 BRAVO study… #msg-68619257 …and isn’t ready for prime time by Teva’s own admission #msg-64489232 Merck KGaA terminates Cladribine program
#msg-67208700 Merck KGaA acquires Peptimmune’s PI-2301 program #msg-61504526 FDA denies Peptimmune’s Citizen Petition (3/11) #msg-60953425 Mylan’s response to Peptimmune’s CP #msg-62661879 Link to full text of Peptimmune’s CP #msg-55116264 Peptimmune’s PR announcing CP filing (10/10)
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-68756223 Musings on the timing of an FoB partnership #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-68479315Court blocks launch of Amphastar’s generic Lovenox #msg-57290171 MNTA sues Teva for patent infringement #msg-69165740 New ‘235 Copaxone patent may be workaround to Teva’s “Gad” patents #msg-54327728 PR re ‘466 patent on Lovenox characterization #msg-59682546 PR re ‘187 patent on Copaxone manufacturing #msg-68671077 Recent patent applications and overview of IP estate
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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