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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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ts in 2013

In 2thedruentove Howevethe centhese suapprov(peram

Looking ahthat the tallin 2013. Sefor approvasignificant c

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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

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epot zole

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tem inistration

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mpany D

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en Idec Msc

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ck In

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st eon ter

Scandi(mep

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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



PDUFA acdate


ion Drug User Forepinephrine re

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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

013 RI ression.

014 orexin ia.

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ts in 2013

Q1: FPDUFAAbilify

DatamonitoformulationFebruary 2time to imp52-week, P2013, provits US pateAbilify oral

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or expects thn of aripipraz28. This futurpending relapPhase III trialiding a sizea

ent expirationas the highe

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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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nce-monthlynia in adults oificantly delafinal analyseake place in

m oral Abilify pr the mantle us through to

y depot will bna. Moreovets in which Rwell-tolerate

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eer, the Risperdal edon than of Abilify

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ts in 2013

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;

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Q3 Standelicit levom

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o be when thesorder (MDD

across late-stplacebo afte

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dout antidepry and side-efnd insurers w

blicly announiew after the a standard 1

xpecteal for Fon depre

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013, levomilnSNRI) producong competiteric duloxeti

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nce whether company file0 month rev

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oves Forestʼsidate has dewith one of teek.

nacipran will ct approved ion from Effene.

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ts in 2013

Q4: OGo-ahBrintePDUFA

Datamonitoin depressiantidepressstudy. Aftestrong evidpatients an

Although Bthe drug wivortioxetinevortioxetineinconclusivefficacy thaServier) annotable sciantidepressperceived aof tolerabililine antidepmonothera

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dence for vornd demonstra

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s due to rendn October 2,

ober 2n depreLundb

he FDA to graOctober, withdata from sixes in Phase rtioxetineʼs efated a good t

benefit from petition from action) and g

essant efficacnd Datamonittitors as a reroaches beination or diffeabsence of

her SSRI antinitor expects nds, as well

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ant approvalh US launch px short-term III developmfficacy, inclutolerability pr

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esult. In additng explored irentiation froclear marketidepressant Brintellix willas slowly tak

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om long-stanting, vortioxethat only offel take share king share fr

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cted foOctob

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dose Phase Ipse preventio

e in the antidhares some first clear evient only cam

g may have wred to Valdoxe, vortioxetinding SSRI a

etine is in daners incremenfrom existing

rom first-line

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depressant seof

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for major dep

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ts in 2013

Q4: CariprUS sanschizo

Datamonitotreatment oof the highlto file for aptook when developersindication e

Cariprazineavailabilityhindering upositioned predominasecond lineon accountmanageme

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white paper cns catalysts in 2013: which new drugs are set .../media/informa-shop-wind… ·...

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