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1
White paper
CNS catalysts in 2013: Which new drugs are set to enter the market this year?
By Charlotte MackeyFebruary 2013
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DISCLAIMWhile everstated are should notDatamonitanything ccurrent opito let anyo
ts in 2013
MER ry care is taken based on inform
t be relied upon or, its directors,ontained in or oinions; they are
one know if our o
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to ensure the amation and souras the sole sou
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subject to chanopinions change
accuracy of the irces which, whiurce of referencefor any loss occ
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Charlotte M
I am the Lea(CNS) team Datamonitorat the NationHealthcare N
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In 2thedruentove Howevethe centhese suapprov(peram
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Key Fdecis Date
Q1 2013 Feb 28TH
Mar 28th
Q3 2013 TBA
Q4 2013 TBA
Oct 2nd
TBA
CNS = centrFDA= Food TBA= To be
ts in 2013
FDA dsion d
Drug
Abilify de(aripiprazonce monthly)
h BG‐12 (dimethyfumarate
levomilnan
suvorexa
Brintellix(vortioxe
cariprazi
ral nervous systand Drug Adm
e announced
3
drug dates
Com
epot zole
)
LundOtsu
yl e)
Bioge
acipr ForesPierr
ant Merc
x etine)
LundTaked
ne ForesGedeRicht
tem inistration
apprs for C
mpany D
beck/ ka
Sc
en Idec Msc
st/ e Fabre
Mdedi
ck In
beck, da
Mdedi
st eon ter
Scandi(mep
PDU SNR
roval CNS
Disease
chizophrenia
Multiple clerosis
Major epressive isorder
nsomnia
Major epressive isorder
chizophrenia nd bipolar I isorder manic/ mixed pisodes)
UFA = PrescriptRI =serotonin-no
drug
Event
PDUFA acdate
DatamonexpectedPDUFA acdate
DatamonexpectedPDUFA acdate
DatamonexpectedPDUFA acdate
PDUFA acdate
DatamonexpectedPDUFA acdate
ion Drug User Forepinephrine re
gs, 20
Ex
ction FDAUS FouantUS Forlea
nitor’s d ction
FDAUS Thilau
nitor’s d ction
FDAUS Forpro
nitor’s d ction
FDAUS Firsdru
ction FDAUS
nitor’s d ction
FDAUS Fieexpaty
Fee Act euptake inhibitor
13
pected out
A approval launch Q1 20urth depot atytipsychotic to market. recast to be mder.
A approval launch: Q2 20ird oral MS drnch in US.
A approval launch: Q4 20rest’s first SNRoduct for depr
A approval launch: Q1 20st‐to‐market oug for insomn
A approval launch: Q4 20
A approval launch: Q1 20rce competitipected from gypical antipsyc
r
4
come
013 ypical enter
market
013 rug to
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014 orexin ia.
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014 on generic chotics.
4
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Q1: FPDUFAAbilify
DatamonitoformulationFebruary 2time to imp52-week, P2013, provits US pateAbilify oral
As the fourcompeting Abilify depoConsta andalternativeoral Abilify,depot outst
3
FebruA is exy depo
or expects thn of aripipraz28. This futurpending relapPhase III trialiding a sizea
ent expirationas the highe
rth depot atypwith Risperd
ot will comped InvegaSustto existing d
, along with itrip those of
uary pected
ot (Lund
he FDA to graole for the me successor pse compare (p<0.0001).
able window n in Q2 2015est selling sc
pical antipsydal Consta, Zete with Zyprtenna do not
depot antipsynheritance oits direct dep
28th
d to leadbeck/
ant approvalmaintenance
to oral Abilifed to placebo Datamonitoof opportunit. Abilify depohizophrenia
ychotic to entZyprexa Relprexa Relprevt show any e
ychotics and of a strong papot competito
ad to Q/Otsuk
of Lundbecktreatment of fy was succeo in both the or projects USty to switch pot is forecastdrug and ret
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essful in signinterim and fS launch to tpatients fromt to take overtain this statu
arket, AbilifyvegaSustenup of patienttioning as a onvenient tre
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m oral Abilify pr the mantle us through to
y depot will bna. Moreovets in which Rwell-tolerate
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Q1: LGo-ahin MS date
Late Marchfumarate) r(RRMS) withan interfesuccessful to overtake
Upon launcfollowing GGenzyme) therapy andused as a fefficacy.Bioinjectable p(interferon Idecʼs alreaconsiderab
Biogen IdeHowever, tapplicationthe FDA didcited by theprecedent; Novartis) a
3
Late Mhead an
after F
h is expectedreceives FDAth US launch
erons and Coin its recent
e older brand
ch, BG-12 wiGilenya (fingo
in Septembed will take mfirst-line therogen Idec haproducts marbeta-1a). Th
ady strong Mble experienc
cʼs FDA PDUthe FDAʼs Oc implies Mard not requese FDA as thethe FDA app
and Aubagio
MarcnticipaFDA’s 3
d to be when A approval foh tipped for Qopaxone andefforts to thw
ds and becom
ill represent tolimod; Novaer 2012. BG-
market share fapy, given its
as establisherketed for rel
herefore, as aMS franchise ce in the MS
UFA date forctober 2012 rch 28, 2013st additional se reason for tplied 3 mont(teriflunomid
ch ated fo3 mont
Biogen Idecor the treatmQ2 2013. BGd on a par witwart BG-12ʼsme the highe
the third oraartis) in Septe-12 is expectfrom existings relatively b
ed itself as thlapsing formsan oral theraand can expfield.
r BG-12 was announcemeas the revisestudies, withthe extendedh extensions
de; Sanofi) pr
or BG-1th exte
cʼs hotly anticent of relaps
G-12ʼs late-stth Gilenya. As market entrest-selling MS
l treatment foember 2010 ted to be preg first-line thebenign side-ee leading plas of MS; Tys
apy, BG-12 wpect to benef
originally slaent of a 3 moed PDUFA dʻadditional t
d PDUFA das to the PDUrior to their a
12 (Biognsion t
cipated BG-1sing remittingtage efficacy Assuming thary, DatamoniS drug.
or MS to enteand Aubagio
escribed soleerapies, notaeffect profile ayer in the Msabri (natalizuwill serve to afit from the co
ated for Deceonth extensiodate.Importanime for reviete. BG-12ʼs dFA dates of
approvals.
gen Ideto PDU
12 (dimethyl g multiple scl
data appearat Teva is noitor forecasts
er the US mao (teriflunomily as a mono
ably Gilenya.and high
MS market, wumab) and A
augment Biogompanyʼs
ember 28, 20on to review ntly for Bioge
ew of the appdelay is not wGilenya (fing
6
ec) UFA
erosis rs better
ots BG-12
arket,ide;otherapy It will be
with two Avonexgen
012.the
en Idec, plicationʼ withoutgolimod;
6
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Q3 Standelicit levom
Q3 2013 isfor major dantidepresssignificant
Upon projenorepinephlevomilnacPristiq(ven
In the abseplayers in ilater lines ofirst.
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Q4 Positiinsom
Datamonitoapproval inknown as Monset and sfailed orexi
Upon approinsomnia inHowever, Mdominated Demonstrasuvorexant
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Q4: OGo-ahBrintePDUFA
Datamonitoin depressiantidepressstudy. Aftestrong evidpatients an
Although Bthe drug wivortioxetinevortioxetineinconclusivefficacy thaServier) annotable sciantidepressperceived aof tolerabililine antidepmonothera
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Q4: CariprUS sanschizo
Datamonitotreatment oof the highlto file for aptook when developersindication e
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