IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
There were an es ti mated 115,000 new cases of colorectal can cer in Ja pan in 2005, the coun try’s sec ond
most com mon can cer (af ter stom ach) with around one-quar ter of pa tients pre sent ing with dis ease that
has al ready metastasized; the in ci dence is said to be ris ing with around 38,000 deaths annually.
Sales/An a lyst Com ment: Sales of Vectibix for Amgen were $153 mil lion in 2008, down 10% over
2007, its first full-year on the mar ket, sales of $170 mil lion. An a lysts at Mor gan Stan ley, writ ing on
Amgen in Jan u ary 2009, es ti mate peak global sales of $400 mil lion for Vectibix. They com mented that al -
though Amgen has a win dow of op por tu nity with the KRAS data in first and sec ond line colorectal can cer,
and can po ten tially beat Erbitux to this more lu cra tive front-line pa tient pool, Amgen will still need to
over come Erbitux’ ‘first mover’ ad van tage. The an a lysts view it highly un likely that data could be strong
enough for Vectibix to be come com pe ti tion for Avastin but more on a par with Erbitux, al low ing it to take
share in the $1.5 bil lion EGFR an ti body mar ket. The an a lysts fore cast sales of $195 mil lion in 2009, rising
to $276 million by 2013 for Amgen.
MOTESANIB, an antiangiogenic small mol e cule that in hib its mul ti ple kin ases in volved in ep i the lial ma -
lig nan cies and angiogenesis, in clud ing VEGFR, PDGFR and c-kit was in phase III tri als with Takeda, Mil -
len nium and Amgen (the Takeda On col ogy Com pany) in the USA, Eu rope and Japan in 2009.
In No vem ber 2008, the tem po rary sus pen sion of pa tient en roll ment in the MONET1 trial of motesanib
(AMG 706) in the treat ment of nonsmall cell lung can cer (NSCLC) was an nounced. This fol lows a rec om -
men da tion by the trial’s in de pend ent Data Mon i tor ing Com mit tee (DMC) af ter a planned re view of safety
data from 600 pa tients. The DMC’s de ci sion is based on the ob ser va tion of a higher early mor tal ity rate in
the motesanib group com pared with the pla cebo group. Ad di tion ally, the DMC rec om mended im me di ate
dis con tinu a tion of motesanib ther apy in pa tients with squamous NSCLC be cause of a higher than ex -
pected hemoptysis rate in these pa tients. The DMC did not rec om mend dis con tinu a tion of motesanib
ther apy in pa tients with non-squamous NSCLC. In Feb ru ary 2009, an in de pend ent data mon i tor ing com -
mit tee (DMC) has rec om mended the re sump tion of en roll ment of pa tients with non-squamous nonsmall
cell lung cancer (NCSLC) into the phase III MONET1 trial of motesanib.
Li cens ing: In Feb ru ary 2008, as part of a col lab o ra tion with Amgen in Ja pan, Takeda con cluded a li cense
agree ment for 13 com pounds in clud ing motesanib that Takeda has ob tained rights to ex clu sively de velop
and mar ket in Ja pan and co-de velop and co-mar ket with Amgen Inc out side of Ja pan. Takeda will pay
$100 mil lion upfront and pay 100% of de vel op ment in Ja pan and 60% over seas, in ad di tion to mile stone
pay ments of up to Yen175 million as well as royalties.
Clin i cal Data: The pla cebo-con trolled, dou ble-blind in ter na tional MONET1 (MOtesanib NSCLC Ef fi cacy
and Tolerability study) phase III trial has en rolled 1100 of 1240 planned pa tients with ad vanced
squamous or non-squamous NSCLC. Pa tients were ran dom ized 1:1 to re ceive carboplatin and paclitaxel
given ev ery three weeks with or with out once-daily 125 mg motesanib. The pri mary end point is over all
sur vival; sec ond ary end points in clude pro gres sion-free sur vival, ob jec tive re sponse rate in pa tients with
mea sur able dis ease and duration of response and safety.
At the ASCO Meet ing 2007, Amgen pre sented data from a multicenter, open-la bel phase II trial of
motesanib in the treat ment of pa tients with I-131-re sis tant dif fer en ti ated thy roid can cer. The pri mary
end point was ob jec tive re sponse rate per mod i fied RECIST cri te ria; sec ond ary end points were du ra tion of
re sponse, pro gres sion-free sur vival and safety. The agent was given orally at 125mg once-daily for up to
48 weeks or un til ev i dence of dis ease pro gres sion, death or un ac cept able tox ic ity. Tu mor re sponse was
eval u ated ev ery eight weeks and blood thy ro glob u lin lev els were an a lyzed at study day one and ev ery
four weeks there af ter. Four teen per cent, 35% and 49% of pa tients achieved a con firmed par tial re -
sponse, du ra ble sta ble dis ease for 24 weeks or lon ger and clin i cal ben e fit, re spec tively. Eighty-two per -
cent of pa tients with post-base line thy ro glob u lin as sess ment achieved a de crease in thy ro glob u lin
con cen tra tion af ter motesanib ther apy. Me dian trough plasma con cen tra tions af ter daily ad min is tra tion
of 125mg motesanib were be tween IC50 and IC90 val ues (as cer tained by in vi tro HUVEC method).
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