[Corporate and miscellaneous updates: 1Q12 financial results; 3/31/12 effective cash balance was $422M; musings on NPV of MNTA’s royalty stream for Lovenox and overall valuation; guidance for quarterly cash operating expenses is $22-28M; Lovenox royalty rate is 10-12% with two tiers; Lovenox split between NVS-MNTA could be renegotiated, says SB; MNTA’s NOL’s no longer a significant asset; how MNTA executed against 2011 internal goals; UBS valuation report (7/20/12); diluted share count for valuation purposes; transcript of 6/7/12 Goldman Sachs webcast; transcript of 1Q12 CC table of insider shareholdings; recent patent applications and overview of IP estate; 2012-2014 news flow; bullish things that could happen at almost any time;
Lovenox updates: Appellate Court lifts preliminary injunction on Amphastar/WPI launch; WPI is taking a go-slow approach to Lovenox; WPI director might be worried about MNTA’s lawsuit; Markman (claims construction) ruling in Lovenox patent case; NVS reports $156M of 2Q12 Lovenox sales; new version of “How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales?”; new version of “What’s New in the Anticoagulant Arena?”;
Copaxone updated: MNTA loses Copaxone patent case in District Court…but an appeal is filed to the Federal Circuit Court; even with a delayed launch, FDA tentative approval of MNTA’s Copaxone ANDA is consequential; Copaxone will remain big seller despite competition (Teva’s 2012 forecast); Copaxone has 40% prescription share in US despite new oral competition; Teva’s PR on GALA study thrice-weekly Copaxone; approval of Teva’s thrice-weekly Copaxone unlikely before 2015; thrice-weekly Copaxone can’t be substituted for regular Copaxone; estimated market share for thrice-weekly Copaxone; US Copaxone market is “sticky”; US sales of Gilenya have hit a plateau; 2Q12 Tysabri sales; Tysabri label update re JCV testing; musings on BG-12 commercial uptake;
FoB updates: ‘The Deal’ interviews Craig Wheeler on FoB’s; redacted version of BAX-MNTA contract; transcript of 12/23/11 CC on BAX deal;
M402 updated: first patient dosed in M402 phase-1/2 trial; description of M402 trial from clinicaltrials.gov; flowchart of M402 trial design; M402 PR and poster from 2012 ASCO; musings on M402’s probability of regulatory success;
Enhanced-IVIG program (new section of RMF): how MNTA intends to differentiate its version of IVIG.]
CORPORATE AND FINANCIAL
What is MNTA’s business all about? #msg-73905464The Deal interviews Craig Wheeler on FoB’s #msg-76396957 Transcript of 6/7/12 Goldman Sachs webcast #msg-62559655 FDA 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-779821692012-2014 possible/probable events #msg-78079512 Bullish things that could happen at almost any time
Valuation and finances #msg-75150121 1Q12 financial results #msg-75182054 Transcript of 1Q12 CC (5/3/12) #msg-77997663Effective cash balance at 3/31/11 was $422M #msg-75185636Guidance for quarterly cash operating expenses is $22-28M #msg-76922372 Diluted share count for valuation purposes #msg-72178468Potential Copaxone milestones from NVS are ~$115M #msg-77977706 MNTA’s NOL’s are no longer a significant asset #msg-77726801 UBS has neutral rating, $15 price target, and 2012 EPS of (0.73) #msg-71982718 Musings on NPV of MNTA’s royalty stream for Lovenox #msg-73668882 Lovenox split between NVS-MNTA could be renegotiated, says SB #msg-76918548 Musings on MNTA’s overall valuation #msg-47147018 No legal impediments to a buyout
Management, BoD, and major shareholders #msg-62461556Composition of Board of Directors #msg-76922328Insider shareholdings and options #msg-61651527 Officers’ restricted stock vests on Copaxone approval #msg-69174646Major shareholders #msg-74739058 How MNTA executed against 2011 internal goals
#msg-58383722 Young Kwon named VP, Business Development (1/11) #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-77951712 Recent patent applications and overview of IP estate #msg-54327728 ‘466 patent issued on Lovenox characterization #msg-69165740 ‘235 patent is workaround to Teva’s “Gad” patents #msg-59682546 ‘187 patent issued on Copaxone manufacturing #msg-69595597 MNTA acquires sialic switch IP from Virdante Pharmaceuticals #msg-69681347 Musings on the Virdante deal
LOVENOX PROGRAM
FDA actions and product launches #msg-71365074 Amphastar/WPI launch generic Lovenox #msg-67230597 FDA approves generic Lovenox from Amphastar #msg-52620730 FDA approves NVS/MNTA’s generic Lovenox (syringe formulation) #msg-69495753 FDA approves NVS/MNTA’s generic Lovenox (vial formulation) #msg-59138957 FDA does not approve Teva’s Lovenox ANDA #msg-66767716 Teva’s ANDA might not ever be approvable #msg-52582225 FDA’s criteria for approval of generic Lovenox
Patent-infringement suit #msg-71346891Appellate Court lifts PI on Amphastar/WPI #msg-68468114District Court says NVS/MNTA likely to win patent trial #msg-67308386NVS/MNTA sue Amphastar/WPI for patent infringement #msg-67310706 NVS/MNTA Complaint vs Amphastar/WPI #msg-67313777 Descriptions of MNTA’s ‘886 and ‘466 patents #msg-68479105 ‘466 patent could still be in play #msg-67941277 Patent claims where NVS/MNTA allege infringement #msg-77266994 Markman (claims construction) ruling in Lovenox patent case #msg-68240669 Musings on the Bolar exemption safe harbor #msg-69012802 NVS/MNTA agree on 65/35 split of $100M Court bond #msg-69022234 Split of Court bond suggests potential split of judgment/settlement #msg-57290171 NVS/MNTA sue Teva for patent infringement #msg-57302580 NVS/MNTA complaint vs Teva
Sales, market share, and pricing of generic Lovenox #msg-77653314NVS reports $156M of 2Q12 Lovenox sales #msg-71975717 MNTA’s royalty rate is 10-12% with two tiers #msg-77884681 WPI is taking a go-slow approach to Lovenox (1) #msg-77974723 WPI is taking a go-slow approach to Lovenox (2) #msg-78075221 WPI director might be worried about MNTA’s lawsuit #msg-54355727 60-70% of US Lovenox market is hospital-based #msg-59555188 Average price in hospital setting 35-40% lower than retail #msg-44644009 Lovenox is essentially the entire LMWH market #msg-55882487 Musings on Lovenox development outside US
Lovenox competition from other anticoagulants #msg-77374539What’s new in the anticoagulant arena? #msg-76857091How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales? #msg-65132332 FDA approves generic Arixtra
COPAXONE PROGRAM
FDA review #msg-77978962Even with delayed launch, FDA tentative approval is consequential #msg-30621490 FDA accepts NVS/MNTA ANDA for review #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-76420849 Teva submits fourth Citizen Petition opposing generic Copaxone #msg-57629433 Teva submits third Citizen Petition #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-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-60686112 MNTA may be conducting a bioequivalence study (1) #msg-60741332 MNTA may be conducting a bioequivalence study (2) #msg-52702351 FDA might grant bioequivalence waiver
Economic rationale and profit split #msg-57054326Why Copaxone? #msg-75932085Copaxone will remain big seller despite competition (2012 forecast) #msg-76905526 Copaxone has 40% US prescription share among MS drugs #msg-12222305NVS/MNTA split profits 50/50 in all cases #msg-72178468Estimated potential milestones from NVS: $115M #msg-53081150 Ex-US market for generic Copaxone not especially attractive
Patent litigation #msg-76898031MNTA loses Copaxone patent case in District Court… #msg-77983332…but an appeal is filed to the Federal Circuit Court #msg-77877734 Full text of District Court Order in Copaxone patent case #msg-54113660 List of Copaxone patents being litigated (1) #msg-75185398 List of Copaxone patents being litigated (2) #msg-66864421 Summary of NVS/MNTA/MYL arguments in patent trial #msg-61953697MNTA is indemnified against liabilities from patent litigation
Potential competition from other generic and branded drugs #msg-29902618Mylan inks Copaxone deal with India’s Natco #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-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-76611659 Teva’s PR on thrice-weekly Copaxone #msg-63817727 Approval of thrice-weekly Copaxone unlikely before 2015 #msg-76644423 Thrice-weekly Copaxone can’t be substituted for regular Copaxone #msg-77016146 Estimated market share for thrice-weekly Copaxone
#msg-76905526 US Copaxone market is sticky (1) #msg-62810742 US Copaxone market is sticky (2) #msg-61960285 Efficacy data from FDA Copaxone label #msg-54834214 Copaxone is only approved MS drug with pregnancy Category B
#msg-77810032 US sales of Gilenya have hit a plateau
#msg-77808635 2Q12 US sales of Tysabri were $211M #msg-71134133 Tysabri label update for JCV testing (Feb 2012) #msg-61835910 Tysabri label update re PML incidence (Apr 2011) #msg-60984424 Biogen halts Tysabri ‘switching’ study due to slow enrollment
FOLLOW-ON BIOLOGICS (FoB) PROGRAM
#msg-70212854MNTA inks worldwide FoB partnership with BAX #msg-70258421‘Biobucks’ scorecard for the MNTA-BAX partnership #msg-70612914 Transcript of 12/23/11 CC to discuss BAX deal #msg-72624576 Redacted version of BAX-MNTA contract #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-78005361 Orencia sells at annualized rate of $1.2B
#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-73905464The Deal interviews Craig Wheeler on FoB’s (3/30/12) #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-63126386 BioCentury article spells out regulatory pathway for US FoB’s #msg-63127867 Crux of the issue for US FoB’s #msg-71919555 Limited clinical trials will be required, at least initially (1) #msg-62805964 Limited clinical trials will be required, at least initially (2)
#msg-61414941FoB’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
M402 oncology program #msg-37030489Rationale for a heparin-derived cancer drug #msg-77147254First patient dosed in M402 phase-1/2 trial #msg-77444006 Description of M402 trial from clinicaltrials.gov #msg-76536593 Flowchart of M402 trial design #msg-76229566 PR re ASCO 2012 data #msg-77188957 M402 poster from 2012 ASCO #msg-77165730 Musings on M402’s probability of regulatory success #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
Enhanced-IVIG program #msg-69595597 MNTA acquires sialic switch IP from Virdante Pharmaceuticals #msg-69681347 Musings on the Virdante deal #msg-77593979 How MNTA intends to differentiate its version of IVIG
PUBLICATIONS
#msg-73905464The Deal interviews Craig Wheeler on FoB’s (3/12) #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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