Replies to post #116687 on Biotech Values

[investorgold2002]

Due - Question

For Lovenox , I am just wondering , if momenta has demonstrated the structural sameness by identifying a signature component of Lovenox that would assure sameness and quality and patented that "structural signature"(identification and characterization), how else would another company be able to demonstrate structural sameness without infringing on momenta's patent ?

For eg, for copaxone, momenta says
"The invention is based, at least in part, on the identification and characterization of L-pyroGlutamic Acid (pyro-Glu) as a structural signature of glatiramer acetate (GA). Analysis of this signature component of GA is useful to assess product and process quality in the manufacture of GA."

So another company(mylan) that would want to make copaxone has to come up with another criteria for proving structural sameness to FDA I would think? or else they would infringe of momenta's patent

Same for TEVA on generic LOVENOX

let me know your thoughts...I think momenta's analytical methods that helps them identify structure is on to something big and is here in opportune time with pathway for follow on biologics to be released any time. Question is how easy or hard it is to use momenta's analytical methods to identify signature of these compounds. Is this a 5 year deal for each drug ? lovenox took many years i think

[DewDiligence]

MNTA ReadMeFirst

[Updates:
FoB’s will sell $3.7B in 2015, says Datamonitor;
FDA replies to Peptimmune CP (neutral for MNTA);
Peptimmune (unsurprisingly) files for bankruptcy;
table of insider shareholdings and options;
new version of “What’s New in the Anticoagulant Arena?”]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-60510033 Webcast from 3/2/11 RBC conference (highly recommended)
#msg-59783582 Transcript of 4Q10 conference call (2/9/10)
#msg-28748329 MNTA helps FDA solve contaminated-heparin problem
#msg-28865474 Characterizing a compound by “ruling out” structures
#msg-52632000 ‘The Golden Age of Biogenerics’ (Forbes)
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-54327728 MNTA receives US patent on Lovenox characterization
#msg-59682546 MNTA receives US patent on Copaxone characterization
#msg-59684426 Recent patent applications and overview of IP estate


News flow
#msg-61149821 2011-2012 possible/probable events
#msg-59599399 Seven bullish things that could happen anytime


Valuation and finances
#msg-59748088 MNTA logs 4Q10 profit of $0.77/sh
#msg-59749024 Lovenox operating margin bodes well for future quarters
#msg-59789788 Operating expenses will average $15-18M/qtr (net of R&D rev)
#msg-60906809 Potential Copaxone/Lovenox milestones exceed $163M
#msg-56176508 $92M tax credit can be applied to Lovenox profits
#msg-59164333 Wedbush notes Teva’s disingenuous PR (1/25/11)
#msg-59201009 Canaccord reiterates $27 price target (1/26/11)
#msg-55020801 Cowen values Lovenox program alone at mid $20s/sh
#msg-54022252 Dew’s valuation of MNTA’s non-Lovenox assets
#msg-57621347 Adjustment to above for lack of progress on M118
#msg-58118280 Diluted share count for valuation purposes
#msg-58058451 Latest financing transaction
#msg-44367437 Shelf registration filed 12/9/09


Management, BoD, and major shareholders
#msg-54286333 Composition of Board of Directors
#msg-58383722 Former 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-12824293 Craig Wheeler, CEO, joins MNTA from Chiron (Aug 2006)
#msg-49501257 How MNTA executed against 2009 internal goals
#msg-61587279 Insider shareholdings and options
#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-59949123 Major shareholders
#msg-47147018 No legal impediments to an acquisition, but…
#msg-59693296 …Teva won’t buy MNTA (I guarantee it!)



LOVENOX PROGRAM

FDA approval and related litigation
#msg-52582225 Why FDA approved generic Lovenox (simple version)
#msg-52581746 Why FDA approved generic Lovenox (technical version)
#msg-58201819 FDA’s 5 criteria for Lovenox “sameness” are merely a starting point
#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-53730236 Judge 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-59225528 NVS’ 4Q10 Lovenox sales=$170M ($462M all told)
#msg-59749024 Lovenox operating margin bodes well for future quarters
#msg-59286675 Estimated run rate and channel inventory
#msg-55818120 How NVS/MNTA account for Lovenox on financial statements
#msg-33839164 MNTA’s economics depends on the number of generics
#msg-43761160 Lovenox royalty if multiple generics
#msg-60906809Milestone payments from NVS at anniversaries of US launch
#msg-44644009 Lovenox is essentially the entire LMWH market

#msg-61117334 Generic Lovenox has 71% retail-script share
#msg-59695921 SNY reports €233M of US Lovenox sales in 4Q10
#msg-56123442 Beware of SNY’s claims re Lovenox “volume” share
#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-59138957 FDA does not approve Teva’s ANDA (1/25/11)
#msg-59688528 Teva not commenting on ANDA (draw your own conclusions)
#msg-59151084 Example of minor-deficiency letter that led to ultimate rejection
#msg-59673351 Teva’s EPS guidance includes no contribution from Lovenox
#msg-59669784 Enox-o-what?
#msg-59172130 Musings on why Teva got an FDA response in Jan 2011

#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-54327728 MNTA receives US patent on Lovenox characterization
#msg-57290171 MNTA sues Teva for patent infringement (PR)
#msg-57302580 MNTA actual complaint filed with District Court
#msg-60638698 Pretrial timetable->Teva has no expectation of FDA approval
#msg-57319356 Teva’s PR response to MNTA lawsuit
#msg-57304268 Musings on the business rationale for MNTA’s lawsuit

#msg-54978841 Teva’s credibility is suspect on multiple fronts
#msg-59164333 Wedbush notes Teva’s disingenuous Lovenox statements
#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-56123199 SNY 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-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-61409888 What’s new in the anticoagulant arena?
#msg-29698599 Musings on competition from new oral anticoagulants (1)
#msg-58484489 Musings on competition from new oral anticoagulants (2)
#msg-55569376 Generic Arixtra could be approved in 2011…
#msg-40342721 …but Arixtra is all but inconsequential to MNTA
#msg-56880416 Apixaban program in ACS discontinued
#msg-39151366 Xarelto has a long way to go in ACS
#msg-57502712 What is Angiomax?
#msg-36668503 Integrilin whiffs in ‘upstream’ ACS
#msg-55348772 Phase-2a data for Regado’s RB006/RB007
#msg-55640856 Musings on Regado’s program
#msg-50887745 Musings on relevance of PolyMedix’s PMX-60056


Generic/biosimilar Lovenox outside the US
#msg-55882487 Musings on Lovenox development outside US
#msg-52625998 EU requirements for Lovenox biosimilars and patent info
#msg-60906809Estimated potential milestones from NVS: $48M



COPAXONE PROGRAM

FDA review
#msg-30621490 FDA 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-60838182 Copaxone PK/PD can be measured
#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-50113814 Leerink Swann on rejection of Teva’s 2nd CP (1)
#msg-50149604 Leerink 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-48166546 Teva’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-58119344 Weizmann monograph on chemistry of Copaxone
#msg-60150443 Copaxone paper in The Journal of Immunology


Economic rationale and profit split
#msg-57054326 Why Copaxone?
#msg-59647292 US Copaxone sales are $2.6B per annum
#msg-12222305 NVS/MNTA split profits 50/50 in all cases
#msg-60906809 Estimated potential milestones from NVS: $115M
#msg-53081150 Ex-US market for generic Copaxone not especially attractive
#msg-55641123 5-year Copaxone data in CIS


Patent litigation
#msg-60430638 Copaxone patent trial begins 9/7/11
#msg-54113660 List of Copaxone patents in Teva-NVS/MNTA litigation
#msg-54150823 Index to legal documents in Teva-NVS/MNTA litigation
#msg-56222992 Docket for Teva-Mylan (now consolidated w Teva-NVS/MNTA)
#msg-60899488 Markman ruling prior to trial is not assured
#msg-54139320 Court denies summary judgment on indefiniteness argument

#msg-59682546 MNTA receives US patent on Copaxone characterization
#msg-56147443 NVS/MNTA will pursue four tacks in litigation
#msg-33580867 Rationale for inequitable conduct argument against Teva
#msg-55490818 Teva thinks it could lose patent case, evidently
#msg-61312284 Patent suit could be settled if FDA approves ANDA

#msg-59368793 Branded Copaxone has weak IP protection (tinkershaw)
#msg-52735648 Handicapping the Copaxone case (Wall Street)
#msg-59693896 Handicapping the Copaxone case (exwannabe)
#msg-59688565 Handicapping the Copaxone case (Dew)
#msg-56326587 Handicapping the Copaxone case (zipjet)


Potential competition from other generic and branded drugs
#msg-29902618 Mylan 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-58083875 FDA 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-59919610 Musings on thrice-weekly Copaxone

#msg-54677007 FDA approves NVS’ Gilenya
#msg-59293907 How is Gilenya affecting Copaxone?
#msg-56524579 Copaxone will hold its own against Gilenya (Leerink Swann)
#msg-52553991 Copaxone will hold its own against Gilenya (haaretz.com)
#msg-54849106 Copaxone will hold its own against Gilenya (genisi)
#msg-59296554 Copaxone will hold its own against Gilenya (tinkershaw)

#msg-54826950 FDA labels of approved MS drugs
#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-59647292 Copaxone is cleaning Tysabri’s clock in US market
#msg-60115928 Tysabri has 95 cases of PML, 21% fatal
#msg-60144268 Musings on Tysabri’s PML rate
#msg-55805176 Black-box warning from Tysabri’s FDA label (Nov 2009)
#msg-60984424 Biogen halts Tysabri ‘switching’ study due to slow enrollment

#msg-60477805 FDA rejects Cladribine (again)
#msg-57981307 Campath slides from 12/20/10 Genzyme webcast
#msg-55545333 Campath 5-year data from phase-2
#msg-34832939 Musings on Campath
#msg-55641299 Sanofi’s Teriflunomide Cuts MS Relapse Rate by 31%
#msg-55927582 New Teriflunomide phase-3 trial with IFN
#msg-57549574 Phase-3 Laquinimod data from ALLEGRO study

#msg-55116264 Peptimmune files Citizen Petition re Copaxone
#msg-61504526 FDA denies Peptimmune’s CP…
#msg-61529230 …which is neutral for MNTA
#msg-60953425 Mylan responds to Peptimmune CP
#msg-61204770 Peptimmune (unsurprisingly) files for bankruptcy



OTHER R&D PROGRAMS

Follow-on Biologics (FoB) program(s)
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-48581353 What the new healthcare law says about FoB’s
#msg-26837144 Momenta’s mantra on biogenerics
#msg-61414941 FoB’s will sell $3.7B in 2015, says Datamonitor
#msg-60342122 FoB ‘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
#msg-56429332 MNTA publishes Orencia paper in Nature Biotechnology…
#msg-56433178 …which presumably means MNTA has an Orencia FoB
#msg-59020436 Why Orencia?
#msg-56471065 Orencia factoids
#msg-59857407 Notes on possible TNF-alpha FoB’s
#msg-53728063 Prognostic value of FDA’s actions vis-à-vis Copaxone and FoB’s
#msg-54034992 Speculation re Integrilin FoB
#msg-33839321 Procognia is not a serious competitor
#msg-33597614 Also-ran companies in the FoB arena


M118 program for acute coronary syndromes
(See Lovenox section for info on potential competition from oral anticoagulants.)
#msg-39146357 M118 quick primer
#msg-51227061 How large is the anticoagulant market?
#msg-57237257 Musings on the M118 phase-2b program (1)
#msg-57258943 Musings on the M118 phase-2b program (2)
#msg-56388251 Example of how large ACS trials must be (Cangrelor)
#msg-56881418 With failure of Apixaban, BMY/PFE are potential partners
#msg-56915307 M118 partnership musings

#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-41846746 Data 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-48705801 Apr 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


M402 oncology program
#msg-37030489 Rationale for a heparin-derived cancer drug
#msg-60373285 Upcoming presentation at 2011 AACR
#msg-56124256 Preclinical data from 2010 AACR
#msg-47769823 Description of program from 10K report
#msg-37152092 Presentation at 2009 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-57290171 MNTA sues Teva for patent infringement (PR)
#msg-54327728 US patent #7,790,466 re Lovenox characterization
#msg-55899246 US patent #7,816,144 (continuation of above)
#msg-59682546 MNTA receives US patent on Copaxone characterization
#msg-59684426 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-59966324 Barron’s opines re MNTA’s overall prospects (2/11)
#msg-48115945 Weizmann Institute re chemistry of Copaxone (date unknown)
#msg-52862494 Globes online (Israel) interview with Sandoz CEO (8/10)
#msg-52632000 Forbes re ‘The Golden Age of Biogenerics’ (7/10)
#msg-52606143 NY Times re FDA approval (7/10)
#msg-28748329 Nature Biotechnology re contaminated heparin (4/08)
#msg-25160571 WSJ re anticoagulant market (12/07)
#msg-23005127 Nature re FoB’s (9/07)
#msg-20308884 Lab Technologist re production process (6/07)
#msg-25803923 The Pink Sheet interview with C. Wheeler (3/07)
#msg-7370282 WSJ re MNTA’s raison d’etre (8/05)
#msg-25779774 Boston Globe re MNTA’s IPO (11/04)
#msg-33867074 Signals Magazine re glycobiology (9/03)