IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Lundbeck’s pipe line for the treat ment of mood and anx i ety dis or ders. The part ner ship will ini tially fo cus
on co-de vel op ment and co-com mer cial iza tion of Lu AA21004 and Lu AA24530 for mood and anx i ety dis -
or ders, but the agree ment in cludes an op tion un der cer tain con di tions to in clude two other com pounds of
the same class in ear lier stages of de vel op ment. If ap proved, the com pa nies plan to co-pro mote the com -
pounds in the USA and Ja pan. Un der the terms of the agree ment, Lundbeck will re ceive an ini tial pay ment
of $40 mil lion and po ten tial max i mum of $345 mil lion in ad di tional de vel op ment mile stone pay ments.
Takeda and Lundbeck will jointly com plete the de vel op ment programmes, with Takeda book ing the to tal
sales and fund ing the ma jor ity of the re main ing de vel op ment ac tiv i ties. Lundbeck will re ceive a share of
the rev e nue gen er ated in the USA and Ja pan as well as roy alty pay ments on Takeda’s share of revenues.
Takeda considers that this alliance will enhance its core CNS franchise.
Clin i cal Data: Over 2,000 pa tients are ex pected to en rol in the phase III pro gram glob ally. Phase II tri als
dem on strated sig nif i cant im prove ments over pla cebo on pri mary end points and a good safety profile.
EFFEXOR (venlafaxine), a se ro to nin and noradrenaline reuptake in hib i tor, is a struc tur ally novel an ti de -
pres sant, first launched in the USA in 1994. Orig i na tor Wyeth has since launched it world wide out side Ja -
pan. Wyeth KK (Ja pan), in which Takeda has a 20% stake, is de vel op ing the drug in Ja pan. Phase III tri als
com menced in Ja pan to eval u ate venlafaxine for de pres sion and gen er al ized anx i ety dis or der (GAD) and
were reported to be ongoing in 2006.
Clin i cal Data: Re sults have been re leased from over 30 mul ti na tional, dou ble-blind, phase IV post-mar -
ket ing sur veil lance tri als in more than 7000 pa tients with ma jor de pres sive dis or der ran dom ized to re -
ceive ei ther Effexor, Effexor XR (venlafaxine ex tended-re lease for mu la tion), fluoxetine, paroxetine,
citalopram, fluvoxamine, or sertraline. Data showed that pa tients treated with Effexor and Effexor XR had
sig nif i cantly higher re mis sion rates than those treated with other SSRIs in the trial. Effexor and Effexor
XR were both more ef fec tive than the other SSRIs in the treat ment of the phys i cal anx i ety/somatization
symp toms of de pres sion. In the Effexor/Effexor XR group, 38% pa tients achieved res o lu tion of the gen -
eral so matic symp toms, com pared with 32% of pa tients re ceiv ing SSRIs and 25% of patients
administered placebo.
In Jan u ary 2004, phase III tri als com menced in Ja pan to eval u ate venlafaxine. Re sults were re leased
from over 30 mul ti na tional, dou ble-blind, phase IV post-mar ket ing sur veil lance tri als in more than 7000
pa tients with ma jor de pres sive dis or der ran dom ized to re ceive ei ther Effexor, Effexor XR (venlafaxine ex -
tended-re lease for mu la tion), fluoxetine, paroxetine, citalopram, fluvoxamine, or sertraline. Data showed
that pa tients treated with Effexor and Effexor XR had sig nif i cantly higher re mis sion rates than those
treated with other SSRIs in the trial. Effexor and Effexor XR were both more ef fec tive than the other
SSRIs in the treat ment of the phys i cal anx i ety/somatization symp toms of de pres sion. In the
Effexor/Effexor XR group, 38% pa tients achieved res o lu tion of the gen eral so matic symp toms, com pared
with 32% of pa tients re ceiv ing SSRIs and 25% of patients administered placebo.
LU AA24530 was re ported to have en tered phase I de vel op ment with Takeda in Ja pan in 2009 for mood
and anx i ety dis or ders/de pres sion while phase II de vel op ment was on go ing in Eu rope. The Eu ro pean trial
is ex pected to en rol 600 pa tients with a fil ing is anticipated from 2009.
Li cens ing: In Sep tem ber 2007, Takeda an nounced a stra te gic al li ance with Lundbeck (Den mark) for the
ex clu sive co-de vel op ment and co-com mer cial iza tion in the USA and Ja pan of sev eral com pounds in
Lundbeck’s pipe line for the treat ment of mood and anx i ety dis or ders. The part ner ship will ini tially fo cus
on co-de vel op ment and co-com mer cial iza tion of Lu AA21004 and Lu AA24530 for mood and anx i ety dis -
or ders, but the agree ment in cludes an op tion un der cer tain con di tions to in clude two other com pounds of
the same class in ear lier stages of de vel op ment. If ap proved, the com pa nies plan to co-pro mote the com -
pounds in the USA and Ja pan. Un der the terms of the agree ment, Lundbeck will re ceive an ini tial pay ment
of $40 mil lion and po ten tial max i mum of $345 mil lion in ad di tional de vel op ment mile stone pay ments.
Takeda and Lundbeck will jointly com plete the de vel op ment programmes, with Takeda book ing the to tal
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