[Updates: 2013-2014 news flow; US Supreme Court denies certiorari in Lovenox patent case; Supreme Court denial presumably ends the Lovenox patent case; worst-case scenario for MNTA is probably forfeiture of $35M Court bond; analysis of judicial machinations in the Lovenox case (from ‘Patent Docs’ blog); USPTO issues sialylation patent licensed to MNTA; musings on Tecfidera’s effect on US sales of Copaxone; transcript of 5/29/13 DB webcast; summary of UBS report on MNTA’s valuation.]
CORPORATE AND FINANCIAL
What is MNTA’s business all about? #msg-88432052 Transcript of Deutsche bank webcast (5/29/13) #msg-87418114 Transcript of 1Q13 conference call (4/30/13) #msg-73905464The Deal interviews Craig Wheeler on FoB’s #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-893080882013-2014 possible/probable events #msg-87414106 Bullish things that could happen at almost any time
Valuation and finances #msg-87393720 1Q13 financial results #msg-873937203/31/13 cash=$344M; projected 2013 burn=$80-90M #msg-76922372 Diluted share count for valuation purposes #msg-88706198 Summary of UBS report on MNTA valuation (6/6/13) #msg-87412567Estimated NPV of MNTA’s Lovenox royalty stream #msg-81498217Timing of FoB payments from BAX #msg-72178468 Potential Copaxone milestones from NVS are ~$115M #msg-77977706 MNTA’s NOL’s are no longer a significant asset #msg-47147018 No legal impediments to a buyout #msg-83696645 Biotech partnerships often lead to buyout bids
Management, BoD, and major shareholders #msg-87125406 Composition of Board of Directors #msg-86824967Insider shareholdings and options #msg-61651527 Officers’ restricted stock vests on Copaxone approval #msg-85541345Major shareholders
#msg-58383722 Young Kwon named VP, Business Development (1/11) #msg-38633640 Bruce Downey, ex-CEO of Barr Labs, 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)
COPAXONE PROGRAM
FDA review #msg-89308088Even 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-82159882 FDA rejects Teva’s fourth Citizen Petition opposing generic Copaxone #msg-76420849 Background info on Teva’s prior Copaxone CPs (1) #msg-57629433 Background info on Teva’s prior Copaxone CPs (2)
#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-87482341Annualized US Copaxone sales=$3.3B, despite competition #msg-81090759 Copaxone has >40% US Rx share among MS drugs #msg-12222305NVS/MNTA split profits 50/50 in all cases #msg-72178468 Estimated potential milestones from NVS: $115M #msg-53081150 Ex-US market for generic Copaxone not attractive
Patent litigation #msg-76898031 MNTA loses Copaxone patent case in District Court… #msg-77983332 …but an appeal is filed to the Federal Circuit Court #msg-85870008‘De novo’ claims construction enables possible appellate reversal #msg-77877734 Full text of District Court Order in Copaxone patent case #msg-54113660 List of Copaxone patents being litigated #msg-81717993Timing of Copaxone patent expirations #msg-66864421 Summary of NVS/MNTA/MYL arguments in patent trial #msg-61953697 MNTA 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-62355790 Musings on a Copaxone ‘authorized generic’
#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-87520671 Teva submits sNDA for thrice-weekly Copaxone #msg-87522151 Musings on prospects for thrice-weekly Copaxone #msg-76611659 Teva’s phase-3 data on thrice-weekly Copaxone #msg-76644423 Thrice-weekly Copaxone can’t be substituted for regular Copaxone #msg-58083875 FDA rejects Teva’s “low-volume” Copaxone
#msg-70212854MNTA inks worldwide FoB partnership with BAX #msg-70258421‘Biobucks’ scorecard for the MNTA-BAX partnership #msg-81498217Timing of Fob Payments from BAX #msg-80359616 Slide on MNTA partnership from BAX Investor Day #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 #msg-78116738BAX-MNTA begin work of a third undisclosed FoB compound #msg-78126680 Fees earned by MNTA on third compound come when BAX licenses it #msg-70235751 Timing of MNTA’s opt-in on FoB’s #3-#6 #msg-78125123 Musings on identities of first three FoB compounds #msg-78163795 US patent expirations of Humira, Orencia, and Erbitux #msg-78195937 Why Rituxan is probably not one of the BAX-MNTA FoB’s
#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-79941294 Survey of rheumatologists is (paradoxically) bullish for MNTA
#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-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-78694285 Musings on NVS’ standing in FoB market #msg-54034992 Speculation re Integrilin FoB #msg-33839321 Procognia is not a serious competitor #msg-33597614 Also-ran companies in the FoB arena
LOVENOX PROGRAM
Patent-infringement lawsuit against generic competitors #msg-89307368US Supreme Court denies certiorari in Lovenox-patent case #msg-89309317 Supreme Court denial presumably ends the Lovenox patent case #msg-89317351 Worst-case scenario for MNTA is probably forfeiture of $35M Court bond #msg-89414428 Succinct analysis of the judicial machinations (Patent Docs blog) #msg-78175269Appellate Court lifts preliminary injunction against Amphastar #msg-78395974 Parties stay proceedings in District Court pending higher review
Sales, market share, and pricing of generic Lovenox #msg-87216520 NVS reports $47M of 1Q13 Lovenox sales #msg-71975717 MNTA’s royalty rate is 10-12% with two tiers #msg-87412567Estimated NPV of MNTA’s royalty stream #msg-54355727 60-70% of US Lovenox market is hospital-based #msg-59555188 Average price in hospital setting 35-40% lower than retail #msg-82279707 How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales? #msg-55882487 Musings on Lovenox development outside US
FDA actions and product launches #msg-71365074 Amphastar/ACT 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
OTHER R&D PROGRAMS
M402 oncology program #msg-87393720Phase-1/2 trial revised to include Abraxane #msg-87859870 Clinicaltrials.gov listing for revised M402 trial #msg-37030489Rationale for a heparin-derived cancer drug #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 #msg-89344512 USPTO issues sialylation patent licensed to MNTA
INTELLECTUAL PROPERTY
#msg-84501925Musings on trade secrets and FDA disclosure policy #msg-84865864 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 for Copaxone manufacturing #msg-89344512 USPTO issues sialylation patent licensed to MNTA
PUBLICATIONS
#msg-86139857FiercePharma re FoB manufacturing (3/13) #msg-85017663Boston Business Journal re FoB’s (2/13) #msg-73905464The Deal interviews Craig Wheeler re FoB’s (3/12) #msg-63126386BioCentury re prospects for US FoB’s (5/11) #msg-28748329Nature Biotechnology re contaminated heparin (4/08) #msg-23005127Nature re FoB’s (9/07) #msg-25803923The Pink Sheet interviews Wheeler re MNTA’s technology (3/07) #msg-25779774Boston Globe re MNTA’s IPO (11/04)
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