IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
The epi der mal growth fac tor re cep tor is over-ex pressed in a va ri ety of can cers in clud ing lung, breast,
pan cre atic, blad der, pros tate, colorectal, kid ney, head and neck cancers.
Li cens ing: Amgen and Takeda an nounced in Feb ru ary 2008 that they have signed an agree ment un der
which Takeda will de velop and com mer cial ize in Ja pan up to 13 of Amgen’s early- to mid-stage clin i cal
can di dates. The al li ance in cludes Amgen’s Vectibix (panitumumab), motesanib (AMG 706) and other
ther a pies for can cer, in flam ma tion and neu rol ogy/pain. With the ex cep tion of motesanib, all mol e cules
in cluded in the part ner ship are biologics. Amgen is en ti tled to an upfront cash pay ment of $200m, up to
$340m in world wide de vel op ment costs, $362m in suc cess-based mile stone pay ments and dou ble-digit
roy al ties on sales in Ja pan. Takeda will be come Amgen’s world wide part ner for motesanib, and will pay
Amgen $100m upfront, $175m in suc cess-based mile stones for the first two in di ca tions and dou ble-digit
roy al ties on sales in Ja pan. Takeda will pay 60% of on go ing clin i cal de vel op ment ex penses out side Ja pan
and share po ten tial prof its out side Ja pan on a 50/50 ba sis. Amgen re tains cer tain co-pro mo tion rights in
Ja pan on all pro grams. In con nec tion with these agree ments, Takeda ac quired Amgen’s sub sid iary in Ja -
pan, Amgen KK and all shares of Amgen KK were trans ferred to Takeda dur ing 2008 and consequently,
Takeda has exclusive development and commercialization rights in Japan.
Clin i cal Data: Anal y sis of re sults in re la tion to biomarker KRAS in 2007 showed that Vectibix was in ef -
fec tive in the 40% of met a static colorectal can cer pa tients who har bor a mu tated KRAS onco gene where
this is al ways ‘turned on’ ir re spec tive of whether EGFR has been ac ti vated or ther a peu ti cally in hib ited.
KRAS is part of the RAS fam ily of pro teins, long im pli cated in can cer and just down stream of the EGFR re -
cep tor. This there fore in volves iden ti fy ing subpopulations within a larger in di ca tion (e.g. breast or
colorectal) who will or will not respond to specifically targeted therapy.
Amgen is con duct ing a phase III PRIME trial in 1,200 pa tients that com pares first line treat ment FOLFOX
che mo ther apy with and with out Vectibix ef fects while a sec ond rial in 1,200 pa tients ex plores FOLRIEI
(irinotecan-based) che mo ther apy with and with out Vectabix as sec ond line ther apy. Both tri als look at
pro gres sion free sur vival (PFS) and over all survival (OS).
In 2008, the most com mon side ef fect re ported from in terim anal y sis of on go ing colorectal tri als in 601
pa tients was re ported to be skin rash, which oc curred in over half of the group com pared with 11% on the
che mo ther apy group.
In 2005, Amgen and Abgenix re ported re sults from a piv otal phase III trial of panitumumab in pa tients
with met a static colorectal can cer who had failed stan dard che mo ther apy, in clud ing oxaliplatin and
irinotecan. The study, in volv ing 463 pa tients at sites in Eu rope, Aus tra lia and Can ada, achieved its pri -
mary end point of im prov ing pro gres sion-free sur vival in this pa tient pop u la tion; pa tients who re ceived
panitumumab ev ery two weeks showed a 46% de crease in tu mor pro gres sion rate ver sus those who re -
ceived best sup port ive care alone. This re sult ex ceeded the pre-spec i fied mea sure of pro gres sion-free
sur vival that the trial was de signed to dem on strate (a 33% de crease in tu mor pro gres sion rate in
panitumumab-treated pa tients ver sus pa tients re ceiv ing best sup port ive care). The study also met its
sec ond ary end point of ob jec tive re sponse rate, as as sessed by cen tral ra di ol ogy re view. Ini tial safety
data showed that ad verse events ob served were con sis tent with pre vi ous tri als of panitumumab, with the
most com mon side ef fects be ing acneiform rash, fa tigue, nau sea and mild di ar rhea. No human
anti-human (HAHA) or anti-panitumumab antibody formation was observed.
Up dated re sults from an on go ing phase II study of panitumumab was pre sented in May 2005 at the 41st
ASCO meet ing. The re sults dem on strate that panitumumab has antitumor ac tiv ity when ad min is tered as
a sin gle-agent treat ment to pa tients with met a static colorectal can cer (mCRC) who have failed stan dard
che mo ther apy. An in de pend ent cen tral ra di ol ogy re view de ter mined that treat ment with panitumumab
re sulted in a 9% over all re sponse rate and me dian time to pro gres sion of 11.4 weeks. In ves ti ga tors re -
ported that pa tients with mCRC tu mors ex press ing the EGFr pro tein who re ceived panitumumab
monotherapy dem on strated a me dian sur vival time of 37.6 weeks and a me dian du ra tion of tu mor re -
© 2009 IMS Health In cor po rated or its af fil i ates Page 64