GZG 2011
`
`Martin Duddy
`
`Royal Victoria Infirmary
`
`Newcastle upon Tyne
`
`Page 1 of 62
`
`NHS Foundation Trust
`
`The Newcastle upon Tyne Hospitals m
`
`Biogen Exhibit 2125
`
`Mylan v. Biogen
`IPR 2018—01403
`
`
`
`Martin Duddy
`
`Royal Victoria Infirmary
`
`Newcastle upon Tyne
`
`Page 1 of 62
`
`NHS Foundation Trust
`
`The Newcastle upon Tyne Hospitals m
`
`Biogen Exhibit 2125
`
`Mylan v. Biogen
`IPR 2018—01403
`
`
`
`topics
`•what is MS?
`•why me?
`•treatment
`–DMTs
`–new symptomatic drugs
`• CCSVI
`
`Page 2 of 62
`
`Page 2 of 62
`
`
`
`Statistics
`•
`commonest cause of
`acquired neurological
`disability in young
`people
`• prevalence in UK
`– NI
`– 168/100 000 (1998)
`– 230/ 100 000 (2006)
`• F:M 4:1
`
`Page 3 of 62
`
`Page 3 of 62
`
`
`
`What is MS?
`
`inflammation
`
`degeneration
`
`Page 4 of 62
`
`Page 4 of 62
`
`
`
`What is MS?
`
`inflammation
`
`degeneration
`
`Page 5 of 62
`
`Page 5 of 62
`
`
`
`Almqosm
`
`Inflammation vs degeneration
`
`clinically apparent
`
`CDMS
`
`RRMS
`
`(ii/S ikA AA
`
`
`
`Page 6 of 62
`
`Time
`
`
`
`clinically opporen’r
`
`9-.
`
`Inflammation vs degeneration
`
`2*
`
`(I)
`
`Q Q
`
`.
`
`
`
`clinically opporen’r
`
`9.
`
`Inflammation vs degeneration
`
`2*
`
`U)
`
`Q Q
`
`.
`
`
`
`clinically opporen’r
`
`9-.
`
`Inflammation vs degeneration
`
`2*
`
`(I)
`
`Q Q
`
`.
`
`
`
`Inflammation vs degeneration
`
`2* Page 10 of 62
`
`0 C
`
`I.
`
`clinically opporen’r
`
`9-.
`
`(I)
`
`
`
`What is MS?
`Something you’re born with or
`something you catch?
`•genetic
`–1 in 6 cases have affected relative
`–1 in 650 general population
`–1 in 50 chance if one affected parent
`– butonly 30% concordance in identical twins
`
`Page 11 of 62
`
`Page 11 of 62
`
`
`
`Geographical variation
`
`Page 12 of 62
`
`Page 12 of 62
`
`
`
`Why me?
`•genes
`•vit D–place of birth
`–month of birth
`–ethnicity
`–adolescent sun exposure
`•Epstein Barr
`•smoking
`
`Page 13 of 62
`
`Page 13 of 62
`
`
`
`Patterns of MS
`
`85% Rm 2%
`
`relapsing/ remitting
`
`primary progressive
`
`PRMS
`
`
`
`l
`
`
`
`(benign)
`
`secondary progressive
`
`
`
`Management of relapses
`•nothing
`•steroids
`–oral
`–IV
`
`Page 15 of 62
`
`Page 15 of 62
`
`
`
`When should steroids be used?
`
`+no steroids
`
`only good for fresh
`inflammatory activity
`
`not good for slowly
`accumulated problems
`
`do not affect disease
`
`progression
`
`do not affect long term
`outcome of relapse
`
`Page 16 of 62
`
`1
`
`2
`
`3
`
`7
`
`4
`
`5
`
`6
`
`
`
`Disease modifying therapy
`First line
`•Five licensed therapies
`–Interferon-β
`•Avonex
`•Betaferon
`•Extavia
`•Rebif
`–Copaxone
`•Prescribed under ABN
`guidelines
`
`Page 17 of 62
`
`Page 17 of 62
`
`
`
`First line DMTs
`Summary of results from pivotal phase 3 trials
`
`Agent
`
`Dosage
`
`Reduction in
`relapses, % †
`
`Interferon beta-1b
`(Betaferon/
`Extavia)
`
`8 mIU (250 µg)
`SC every other
`day
`
`Interferon beta-1a
`(Avonex)
`
`30 µg
`IM once weekly
`
`Interferon beta-1a
`(Rebif)
`
`22 µg
`SC 3 times
`weekly
`
`44 µg
`SC 3 times
`weekly
`
`Glatiramer acetate
`(Copaxone)
`
`20 mg
`SC once daily
`
`34
`
`32
`
`29
`
`32
`
`29
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Adapted from Galetta S, et al. Arch Int Med 2002; 162; 2161-2169
`
`Relapse-free
`patients, % †
`
`31
`
`38
`
`27
`
`32
`
`34
`
`Page 18 of 62
`
`Page 18 of 62
`
`
`
`ABN 2009: RRMS/CIS
`
`• All eligible patients will normally be ambulant (maximum EDSS 6.5) and aged 18 or
`more years. No treatments are licensed for use during pregnancy.
`• RRMS two clinically significant relapses in the previous two years.
`• Neurologists may, in certain other circumstances where the evidence for efficacy is
`less secure, also consider advising treatment after discussion with the patient
`concerning the risks and benefits. For example;
`•
`(i)
`syndromewhen MRI evidence predicts a high likelihood of recurrent episodes (i.e.
`development of multiple sclerosis).
`patients with only a single major relapse in the preceding two years, but
`•
`(ii)
`combined with MRI evidence of continuing disease activity (i.e meet the revised
`McDonald criteria for MS)
`individuals aged less than 18 with relapsing remitting multiple sclerosis
`•
`(iii)
`
`patients within 12 months of a clinically significant clinically isolated
`
`Page 19 of 62
`
`Page 19 of 62
`
`
`
`ABN 2009 SPMS
`•treatment is not recommended in non-
`relapsing secondary progressive multiple
`sclerosis
`•only in relapsing secondary progressive
`multiple sclerosis when relapses are the
`
`predominant cause of increasing
`disability
`
`Page 20 of 62
`
`Page 20 of 62
`
`
`
`DMT: stopping
`1.
`It is almost impossible to conclude in individual patients
`that treatment is providing no benefit and the problem of
`discontinuation is compounded by the fact that there are
`few alternative options for disease modification.
`2. The development of non-relapsing secondary progressive
`multiple sclerosis with loss of ability to ambulate
`3. Positive tests for neutralising antibodies to beta
`interferon (NAB),
`
`Page 21 of 62
`
`Page 21 of 62
`
`
`
`Mitoxantrone
`
`Hartung HP et al. Lancet 2002; 360: 2018–25
`
`Page 22 of 62
`
`Page 22 of 62
`
`
`
`Natalizumab
`
`Natalizumab
`
`Page 23 0f 62
`
`Page 23 of 62
`
`Page 23 of 62
`
`
`
`Agent
`
`Interferon beta-1b
`(Betaferon)
`
`Interferon beta-1a
`(Avonex)
`
`Interferon beta-1a
`(Rebif)
`
`Reduction in
`relapses, % †
`
`1. relapse rate reduction
`Natalizumab:
`68%reduction in annualised
`relapse rate vs. placebo
`over 2 years (p < 0.001)
`81%in highly active group
`
`34
`
`32
`
`29
`
`32
`
`29
`
`Glatiramer acetate
`(Copaxone)
`
`Adapted from Galetta S, et al. Arch Int Med 2002; 162; 2161-2169
`
`Page 24 of 62
`
`Page 24 of 62
`
`
`
`Reduction in
`disease
`progression, % †‡
`
`29
`
`37
`
`23
`
`2. disability reduction
`Natalizumab:
`54%reduction in the risk of
`disability progression,
`sustained for 24 weeks,
`as assessed over 2 years
`(p< 0.001)
`64%in highly active group
`
`31
`
`12
`
`Agent
`
`Interferon beta-1b
`(Betaferon)
`
`Interferon beta-1a
`(Avonex)
`
`Interferon beta-1a
`(Rebif)
`
`Glatiramer acetate
`(Copaxone)
`
`Page 25 of 62
`
`Page 25 of 62
`
`
`
`disease freedom: highly active group
`
`—-
`
`no disease
`
`19%
`
`[Gd/ NETZ]
`
`activity
`[relapse] TEDSS]
`
`no radiology
`
`4%
`
`Page 26 0f 62
`
`1 . Havrdova et al. Lancet Neurol 2009; 8:254
`
`
`
`disease freedom: highly active group
`
`___—
`
`no disease
`
`19%
`
`67%
`
`activity
`[relapse/ TEDSS]
`
`no radiology
`
`4%
`
`38%
`
`[Gd/ NETZ]
`
`48.5%
`
`[36.0610]
`
`34.7%
`
`[23444.0]
`
`[17.7337]
`
`no combined
`
`2%
`
`27%
`
`25.7%
`
`Page 27 0f 62
`
`1 . Havrdova et al. Lancet Neurol 2009; 8:254
`
`
`
`disease freedom: highly active group
`
`_- mtafizumb
`
`no disease
`
`19%
`
`67%
`
`activity
`[relapse/ TEDSS]
`
`no radiology
`
`4%
`
`38%
`
`[Gd/ NETZ]
`
`70
`
`89/137
`
`El Placebo
`- Natalizumab
`
`48.5%
`
`[360/610]
`
`34.7%
`
`[23444.0]
`
`(9’0)
`Patientswithoutdiseaseactivity
`
`
`
`
`no combined
`
`2%
`
`27%
`
`25.7%
`
`[17733.7]
`
`Page 23 0f 62
`
`1 . Havrdova et al. Lancet Neurol 2009; 8:254
`
`
`
`4. disease improvement
`
`1. Munscauer Poster P06.131 AAN Seattle 2009
`
`Page 29 of 62
`
`Page 29 of 62
`
`
`
`Natalizumab: EU license
`
`Two indications under European
`License
`Suboptimal therapy group defined
`as:
`
`RES group defined as:
`
`• Two or more disabling relapses in
`• One or more gadolinium
`
`one year
`
`enhancing lesions on MRI or a
`significant increase in T2 lesion
`load
`
`• Patients on beta interferon
`• One or more disabling relapses in
`• One or more gadolinium enhancing
`
`lesions on MRI or at least nine T2
`hyperintense lesions
`
`one year
`
`NICE recommends treatment only for the RES
`group on basis of cost-effectiveness
`
`Page 30 of 62
`
`Page 30 of 62
`
`
`
`Redefining Efficacy in Highly Active RRMS
`
`Disease
`improvement
`
`
`Freedom from
`disease activity
`
`
`Relapse rate
`reduction
`
`y
`n
`
`Disability
`progression
`reduction
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 31 of 62
`
`Page 31 of 62
`
`
`
`Why the worry?
`
`Why the worry?
`
`Page 32 0f 62
`
`Page 32 of 62
`
`Page 32 of 62
`
`
`
`Phase IV monitoring
`•Infusion reactions
`•Liver injury
`•NAbs
`•PML
`
`Page 33 of 62
`
`Page 33 of 62
`
`
`
`RRMS Treatment Algorithm
`
`• CIS*
`• RRMS < 1 relapse in a year
`
`• Highly Active RRMS
`• > 2 relapses in a year
`• May be treatment-experienced
`or treatment-naive
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 34 of 62
`
`Page 34 of 62
`
`
`
`Unmet need
`efficacy > first line drugs
`safety > second line drugs
`oral medication
`
`Page 35 of 62
`
`Page 35 of 62
`
`
`
`Emerging drugs
`•2011– cladribine
`•2013–peg IFN-b
`–fingolimod
`–daclizumab
`•2012–BG12
`–BAF
`–TV-1102
`–ofatumumab
`–laquinimod
`–MS vaccine
`–teriflunamide
`–alemtuzumab
`
`– …
`
`Page 36 of 62
`
`Page 36 of 62
`
`
`
`Fingolimod
`
`Fingolimod
`
`Page 37 0f 62
`
`Page 37 of 62
`
`Page 37 of 62
`
`
`
`Fingolimod
`
`- placebo trial
`(FREEDOMS)
`
`0 significant reduction ino.4
`sustained disability
`
`0.35
`
`0.45
`
`0.3
`
`0.25
`
`0.2
`
`0.15
`
`0.1
`
`0.05
`
`0
`
`
`
`
`
`
`
`Page 38 of 62
`
`FREEDOMS: NEJM
`
`placebo
`
`fingolimod
`0.5mg
`
`fingolimod
`1.25mg
`
`
`
`Fingolimod
`
`- head to head
`(TRANSFORMS)
`
`- VS Avonex
`
`— TRANSFORMS
`
`— + MRI data
`
`— reduced brain
`atrophy
`
`
`
`
`
`
`
`Page 39 of 62
`
`TRANSFORMS trial: ECTRIMS 2009
`
`Avonex
`
`fingolimod
`0.5mg
`
`fingolimod
`1.25mg
`
`
`
`Fingolimod
`•no long term safety
`•oral
`data
`•once daily
`•two deaths
`•proven better than
`interferon
`•hypertension
`•eyes
`•existing safety data
`acceptable
`•pregnancy
`•reversible
`•ongoing treatment
`•independent effect
`needed
`within brain?
`•?prescribing
`restrictions
`
`Page 40 of 62
`
`Page 40 of 62
`
`
`
`Clinical efficacy of BG-12 in DEFINE study
`
`. At 2 years, 36-12 significantly reduced:
`
`— Proportion of patients relapsing by 49% (BID) and 50% (TID)
`
`— ARR by 53% (BID) and 48% (TID)
`
`— Risk of disability progression by 38% (BID) and 34% (TID)
`
`. Both doses demonstrated a favourable safety profile
`
`Annualized relapse rate at 2 yrs (2° EP)
`0.6 —
`
`ARR(95%CI)
`
`Reduction
`53%*
`48%*
`
`l
`
`
`
`0.4 —
`
`0.2 ,
`
`0
`
`Cumulative probability of relapse (10 EP)
`(D
`(0
`3 0-5 _ P30 (“408)
`
`
`E) 04 — BID (”=410)
`“5
`— TID (n=416)
`
`
`
`
`
`a, 0.3
`"E 0.2
`(U
`‘9’ 0.1
`'3'
`0
`BL
`
`PEG
`(n=408)
`
`BG-12 BID
`(n=410)
`
`BG-12 TID
`(n=416)
`
`12
`
`24
`
`50
`48
`3‘?
`“"19 (weekS)
`
`72
`
`84
`
`96
`
` BG-12 is an effective oral disease modifying treatment in RRMS
`
`Gold R, et al. ECTRIMS 2011, Amsterdam. 95
`*p<0.00hgs.413[5fi2‘pts were censored if they withdrew or switched to alternative MS medication without a relapse
`
`
`
`Alemtuzumab
`
`Crippled by MS, golfer Tony was
`told he'd never play again. But an
`astonishing new drug has proved
`all the doctors wrong
`
`By Jill Parsons
`Last updated at 12:44 AM on 11th
`November 2008
`
`Page 42 of 62
`
`Page 42 of 62
`
`
`
`CAMSZZB results 3yr (2008)
`
`- Rebif44 Alemtuzumab
`
`
`
`sustained accumulation
`of disability
`
`-7 1%
`
`MRI T2
`
`43.3% 46.4%
`
`Page43 of62
`
`
`
`next 24 months
`•teriflunomide (Sanofi-Aventis)
`•laquinimod (Teva)
`
`Page 44 of 62
`
`Page 44 of 62
`
`
`
`Where will they all fit?
`
`riSk
`
`<> mitoxantrone
`
`<> Campath
`
`<> Tysabri
`
`Q fingolimod
`
`
`
`laquinimod
`
`9
`
`. teriflunamide
`
`Avonex
`
`Rebif
`
`9 36”
`
`efficacy
`
`<><><>
`
`Copaxone
`
`Betaferon/Extavia
`
`Page 45 of 62
`
`disclaimer: to no scientific scale
`
`
`
`CCSVI
`
`CCSVI
`
`Page 46 of 62
`
`Page 46 of 62
`
`
`
`Chronic cerebrospinal venous insufficiency in
`patients with multiple sclerosis
`
`P Zamboni,‘ R Galeotti,1 E Menegatti,1 A M Malagoni,1 G Tacconi,1 S DaII’Ara,1
`| Bartolomei,2 F Salvi2
`
`Results: CDMS and TCCS—ECD venous outflow anomalies
`
`were dramatically associated (OR 43, 95% Cl 29 to 65.
`p<0.0001). Subsequently, venography demonstrated in
`CDMS, and not in controls, the presence of multiple
`severe extracranial stenosis, affecting the principal
`cerebrospinal venous segments; this provides a picture of
`chronic cerebrospinal venous insufficiency (CCSVI) with
`four different patterns of distribution of stenosis and
`substitute circle. Moreover, relapsing-remitting and
`secondary progressive courses were associated with
`CCSVI patterns significantly different from those of
`primary progressive (p<0.0001). Finally, the pressure
`gradient measured across the venous stenosies was
`shghflylnn fignflmanfly Mgher
`Conclusion: CDMS is strongly associated with CCSVI, a
`scenanothathas notpueWOUSW been descnbed,
`characteNSed by abnonnalvenous haernodynanflcs
`determined by extracranial multiple venous strictures of
`unknown origin. The location of venous obstructions plays
`a key role in determining the clinical course of the
`disease.
`
`Page 47 0f 62
`
`J Neurol Neurosurg Psychiatry 2009 80: 392-399 originally published online
`December 5, 2008
`doi: 10.1136/jnnp.2008.157164
`
`
`
`IOURNAL OF VASCULAR SURGERY
`
`Volume 50, Number 6
`
`Zamboni at a! 1351
`
`A prospective open—label study of endovascular
`treatment of chronic cerebrospinal venous
`insufficiency
`
`Paolo Zamboni, MD,a Roberto Galeotti, MLD,a Erica Menegatti, RVT,“ Anna Maria Malagoni, MD,“
`Sergio Gianesini, MD,“l Ilaria Bartolomei, MD,b Francesco Mascoli, MD,“ and
`Fabrizio Salvi, MD,“ Fermat's: and Boqumz, Italy
`
`•n=65
`•35 RRMS
`•20 SPMS + 10 PPMS
`
`- n=65
`
`- 35 RRMS
`
`- 20 SPMS + 10 PPMS
`
`Page 48 of 62
`
`Page 48 of 62
`
`Page 48 of 62
`
`
`
`results
`
`Zamboni et al. J Vasc Surg 2009
`
`Page 49 of 62
`
`Page 49 of 62
`
`
`
`results
`
`Zamboni et al. J Vasc Surg 2009
`
`Page 50 of 62
`
`Page 50 of 62
`
`
`
`Data
`
`03 O
`
`(I) O
`
`J}. O
`
`
`
`HC
`
`CIS
`
`0ND
`
`MS
`
`n=
`
`163
`
`21
`
`26
`
`289
`
`Page 51 of 62
`
`Zivadinov et a1: poster AAN 2010
`
`
`
`Where are we with CCSVI?
`•are there venous abnormalities in PwMS?
`•is there an association?
`•if so, is the association causative?
`•is treatment beneficial?
`•is treatment safe?
`•is treatment superior to existing therapies?
`
`Page 52 of 62
`
`Page 52 of 62
`
`
`
`Sativex Sativex
`
`Page 53 of 62
`
`
`
`Page 53 of 62
`
`Page 53 of 62
`
`
`
`Sativex
`
`Figure 1. Effect of Sativex in
`responders during Phase A single-
`blind active treatment period
`(n=241), and Phase B randomised
`double blind period, during which
`patients continued to receive Sativex
`(n=124) or were switched to
`placebo (n=117).
`
`Page 54 of 62
`
`Page 54 of 62
`
`
`
`Sativex UK license
`
`Sativex® is indicated as add-on treatment for symptom improvement in
`patients with moderate to severe spasticity due to MS who have not
`responded adequately to other anti-spasticity medication and who
`demonstrate clinically significant improvement in spasticity related
`symptoms during an initial trial of therapy
`
`Page 55 of 62
`
`Page 55 of 62
`
`
`
`Date
`
`Appraisal
`
`Details
`
`Recommendation
`
`NETAG
`
`12th October 2010
`
`Sativex® oromucosal spray for spasticity due to
`multiple sclerosis
`The North East Treatment Advisory Group
`considered the use of Sativex®, a cannabinoid
`oromucosal spray, for use within its licensed
`indication for the treatment of moderate to severe
`spasticity due to multiple sclerosis
`Sativex® is not recommended for use within
`NHS North East for the treatment of spasticity
`due to multiple sclerosis.
`Clinical evidence for the efficacy of Sativex® was
`considered to be of low quality and demonstrated
`a modest but clinically unclear benefit. Combined
`with a high acquisition cost, Sativex® was
`considered unlikely to meet conventional cost-
`effectiveness criteria.
`Individual patients in exceptional circumstances
`may be suitable for treatment. Such cases must
`be referred via local individual funding request
`mechanisms.
`
`Page 56 of 62
`
`Page 56 of 62
`
`
`
`Fampridine
`Fampyra
`
`Fampridine
`Fampyra
`
`Page 57 of 62
`
`Page 57 of 62
`
`Page 57 of 62
`
`
`
`The Lancet 2010; 373:732 -738
`
`Sustained-release oral fampridine in multiple sclerosis: a randomised,
`double-blind, controlled trial
`
`Summary
`
`The proportion of timed walk responders was higher in the fampridine group (78/224 or
`35%) than in the placebo group (6/72 or 8%; p<0·0001). Improvement in walking speed in
`fampridine-treated timed walk responders, which was maintained throughout the treatment
`period, was 25·2% (95% CI 21·5% to 28·8%) and 4·7% (1·0% to 8·4%) in the placebo
`group. Timed walk responders showed greater improvement in 12-item multiple sclerosis
`walking scale scores (−6·84, 95% CI −9·65 to −4·02) than timed walk non-responders (0·05,
`−1·48 to 1·57; p=0·0002). Safety data were consistent with previous studies.
`Fampridine improved walking ability in some people with multiple sclerosis. This
`improvement was associated with a reduction of patients' reported ambulatory disability,
`and is a clinically meaningful therapeutic benefit
`
`Interpretation
`
`Page 58 of 62
`
`Page 58 of 62
`
`
`
`2 trials
`
`2 trials
`
`
`E 0%
`
`3 10%
`
`E 20%
`
`E 30%
`
`3 £10%
`
`2 50%
`
`E 00%
`
`fiunrnnn Pnrnnn'l'lnnrnntn in Walkinn Erma-r! frnrn Flntnlirm
`
`Fatients{rm].
`
`hU‘IIII[3:553@3232
`
`30%
`
`20%
`
`10%
`
`0%
`
`Page 59 of 62
`
`Page 59 of 62
`
`Page 59 of 62
`
`
`
`Vit D/Ca
`•open label
`•big doses needed (>>OTC preparation)
`•+ve effect on relapse rate
`–-17% placebo
`–-41% VitD/Ca
`•effect more marked over winter
`
`(Cettomai et al. AAN 2008)
`
`Page 60 of 62
`
`Page 60 of 62
`
`
`
`What should I do to stay well?
`•DMT if appropriate
`•look after general health, weight and fitness
`•good diet
`–?vit D (+ get outdoors)
`–?linoleic acid
`–water
`•keep professionally and socially active
`
`Page 61 of 62
`
`Page 61 of 62
`
`
`
`
`
`
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