Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Updates:
MNTA inks worldwide FoB partnership with BAX;
‘biobucks’ scorecard for the MNTA-BAX partnership;
BAX pays for post-IND development and commercialization of 1st two FoB’s;
timing of MNTA’s opt-in for FoB’s #3-#6;
first two FoB’s in BAX partnership could be Orencia and Humira;
link to MNTA’s Orencia paper in Nature Biotechnology;
Humira factoids;
an interchangeable Humira FoB has colossal upside;
musings on the terms of the BAX deal (rkrw);
musings on the terms of the BAX deal (Dew);
musings on BAX as the chosen partner;
2012-2014 news flow;
four bullish things that could happen at any time.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-69795106 Transcript of Deutsche Bank webcast (12/5/11)
#msg-68769696 Transcript of 3Q11 conference call (11/7/11)
#msg-62559655 FDA official cites MNTA in discussion of FoB pathways
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-26837144 Momenta’s mantra on biogenerics
#msg-28748329 MNTA helps FDA solve contaminated-heparin problem


News flow
#msg-70251049 2012-2013 possible/probable events
#msg-70251361 Four bullish things that could happen at any time


Valuation and finances
#msg-68735389 3Q11 net income = $1.18/sh
#msg-68810619 Calculation of MNTA’s 3Q11 Lovenox profit
#msg-68735389 Effective 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-65879687 Potential Copaxone/Lovenox milestones exceed $163M
#msg-68471951 Teva’s Lovenox program doesn’t matter much anymore
#msg-67293937 Dew’s valuation of MNTA’s non-Lovenox assets

#msg-47147018 No legal impediments to a buyout
#msg-62283456 Musings on buyout vig (rkrw)
#msg-67230635 Musings on buyout vig (Dew)


Management, BoD, and major shareholders
#msg-62461556 Composition of Board of Directors
#msg-62463569 How MNTA executed against 2010 internal goals
#msg-69174113 Insider shareholdings and options
#msg-60142538 Chairman exercises and holds 7K options (Feb 2011)
#msg-70171811 Chairman exercises and holds 3K options (Dec 2011)
#msg-61651527 Officers’ restricted stock vests on Copaxone approval
#msg-69174646 Major 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)



INTELLECTUAL PROPERTY

#msg-68479315 Court blocks launch of Amphastar’s generic Lovenox
#msg-57290171 MNTA sues Teva for patent infringement
#msg-69165740 ‘235 patent may be workaround to Teva’s “Gad” patents
#msg-54327728 ‘466 patent on Lovenox characterization
#msg-59682546 ‘187 patent on Copaxone manufacturing
#msg-69595597 MNTA acquires sialic switch IP from Virdante Pharmaceuticals
#msg-69681347 Musings on the Virdante deal
#msg-69919935 Recent patent applications and overview of IP estate



LOVENOX PROGRAM

FDA approvals and related litigation
#msg-68479315 Court blocks Amphastar’s generic Lovenox (MNTA PR)
#msg-68468217 Court blocks Amphastar’s generic Lovenox (Court Order)
#msg-68468114 Court blocks Amphastar’s generic Lovenox (Court Memorandum)
#msg-69012802 NVS, MNTA agree on split of $100M Court bond
#msg-69681599 Appeal of preliminary injunction scheduled for 1/24/12

#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-67230597 FDA 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 (syringe formulation)
#msg-69495753 FDA approves NVS/MNTA’s generic Lovenox (vial formulation)
#msg-52582225 FDA’s criteria for approval of generic Lovenox


Sales, market share, and pricing of generic Lovenox
#msg-69524363 Sanofi un-launches Lovenox authorized generic
#msg-69510335 Chronology of Lovenox pricing changes Sep 2011 to present
#msg-69394237 NVS-MNTA contract has no provision to revert to pre-AG mode
#msg-68293836 How SNY’s un-launched AG affects MNTA’s Lovenox economics (1)
#msg-68469857 How SNY’s un-launched AG affects MNTA’s Lovenox economics (2)

#msg-68710933 NVS/MNTA’s Lovenox had $259M and 58% share in 3Q11
#msg-69794414 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-59138957 FDA does not approve Teva’s ANDA
#msg-68471951 Teva’s Lovenox program doesn’t matter much anymore
#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-57290171 MNTA sues Teva for patent infringement
#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-69846401 What’s new in the anticoagulant arena?
#msg-69173426 How 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-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 activity can be measured (1)
#msg-62672351 Copaxone 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-69753179 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-62613681 Weizmann paper on chemistry of Copaxone
#msg-60150443 Copaxone paper in The Journal of Immunology


Economic rationale and profit split
#msg-57054326 Why Copaxone?
#msg-70158971 Copaxone has ~$2.8B annualized US sales (2012 forecast)
#msg-68583537 Copaxone has ~$2.8B annualized US sales (3Q11 actual)
#msg-12222305 NVS/MNTA split profits 50/50 in all cases
#msg-65879687 Estimated 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-66864421 Summary of NVS/MNTA arguments in patent trial
#msg-61953697 MNTA is indemnified against liabilities from patent litigation

#msg-66626914 Court rules in Teva’s favor on Markman hearing
#msg-66633018 Leerink 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-59682546 MNTA receives US patent on Copaxone characterization
#msg-61312284 Patent suit could be settled if FDA approves ANDA
#msg-62133298 Cowen agrees, evidently


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 patent could impede Mylan’s prospects

#msg-70039774 Synthon submits Copaxone ANDA
#msg-70049144 Synthon’s Copaxone trial for FoB approval in Europe

#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-58083875 FDA 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-65574194 How 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-68349126 BG-12 data from CONFIRM study
#msg-68377541 Musings on the BG-12 CONFIRM data (1)
#msg-68349501 Musings on the BG-12 CONFIRM data (2)
#msg-62320268 BG-12 data from DEFINE study
#msg-62384175 BG-12 is not the same drug as Fumaderm
#msg-68381070 Musings on BG-12 threat to Copaxone

#msg-70116979 Aubagio fails to show superiority to Rebif
#msg-55927582 SNY starts phase-3 trial of Aubagio+IFN

#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-70212854 MNTA inks worldwide FoB partnership with BAX
#msg-70258421 ‘Biobucks’ scorecard for the MNTA-BAX partnership
#msg-70261411 BAX pays for post-IND development and commercialization of 1st two FoB’s
#msg-70235751 Timing of MNTA’s opt-in on FoB’s #3-#6
#msg-70216712 First two FoB’s in BAX partnership could be Orencia and Humira

#msg-56429332 MNTA publishes Orencia paper in Nature Biotechnology (PR)
#msg-56456168 MNTA publishes Orencia paper in Nature Biotechnology (full text)
#msg-52853238 MNTA files patent application re Orencia
#msg-68403750 3Q11 Orencia sales were $233M, +27% YoY

#msg-70236725 Humira factoids
#msg-70237561 An interchangeable Humira FoB has colossal upside (1)
#msg-70238965 An interchangeable Humira FoB has colossal upside (2)

#msg-70249988 Musings on the terms of the BAX deal (rkrw)
#msg-70239632 Musings on the terms of the BAX deal (Dew)
#msg-70266174 Musings on BAX as the chosen partner

#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-62559655 FDA official cites MNTA in discussion of FoB pathways
#msg-62631138 Addendum to above discussion
#msg-66837147 NEJM article on FoB pathway
#msg-65845219 Musings on the NEJM article (by ‘MTB’)
#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-61414941 FoB’s will sell $3.7B in 2015, says Datamonitor
#msg-70191760 US patent-expiration dates of big-selling biologics
#msg-69265200 New AMGN patent takes Enbrel off list of MNTA’s likely candidates
#msg-57601389 Presentation by James Roach at FDA hearing on FoB’s
#msg-58469454 Musings on how an FoB applies to disparate indications
#msg-54034992 Speculation re Integrilin FoB
#msg-33839321 Procognia is not a serious competitor
#msg-33597614 Also-ran companies in the FoB arena



OTHER R&D PROGRAMS
(For info on M118, see prior version of ReadMeFirst at #msg-65636771.)

M402 oncology program
#msg-37030489 Rationale 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



PUBLICATIONS

#msg-63126386 BioCentury re prospects for US FoB’s (5/11)
#msg-59966324 Barron’s opines re MNTA’s business plan (2/11)
#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)