IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
TAK 438, an oral po tas sium-com pet i tive acid blocker was in phase I tri als with Takeda in 2009 for treat -
ment of acid re lated dis ease in clud ing GERD, pep tic ulcer.
MLN 3126, a chemokine re cep tor 9 (CCR9) an tag o nist, for the treat ment of Crohn’s dis ease was in pre -
clin i cal stud ies with Mil len nium (now Takeda) in 2008.
Antineoplastics/Immunomodulating Agents
panitumumab AMG 706 L1X3 Filed
motesanib AMG 706 L1X4 III
resatorvid TAK 242 L4A, V3X III
G2 checkpoint abrogater CBP 501 L1X1 II
GnRH analogue, Norwood Immunology/
Takeda — L2A3 II
lestaurtinib CEP 701 L1X4 II
MAb, CCR2, Millennium MLN 1202 L4A, N7X, C6A II
tandutnib MLN 0518 L1X4 II
advanced malignancies therapy MLN 4924 L1X9 I
advanced malignancies therapy MLN 8054 L1X4 I
advanced malignancies therapy MLN 8237 L1X4 I
cancer therapy MLN 2238 L1X9 I
conatumumab AMG 655 L1X3, T1G I
oral her2 inhibitor TAK 285 L1X4 I
oral sex hormone synthesis inhibitor TAK 700 L1X9 I
prostate cancer therapy TAK 448 L1X9 I
VEGFR and PDGFR inhibitor TAK 593 L1X4 I
ANG receptor antagonist AMG 386 L1X9 Preclinical
MAb, hepatocyte growth factor, Galaxy TAK 701, HuL 2G7 L1X3 Preclinical
MAb, IGF-1, Amgen AMG 479 L1X3 Preclinical
VECTIBIX (panitumumab) is a XenoMouse-de rived fully hu man IgG2kappa monoclonal an ti body
tar geted to epi der mal growth fac tor is a po ten tial ther a peu tic for EGF-de pend ent can cers. Vectibix was
co-de vel oped by Abgenix (USA, later ac quired by Amgen) and Amgen. It was launched in the USA in Oc -
to ber 2006 for the sec ond-line treat ment of pa tients with epi der mal growth fac tor re cep tor ex press ing
met a static colorectal can cer af ter dis ease pro gres sion on, or fol low ing, che mo ther apy. Out side the US,
mar ket ing ap pli ca tions have been sub mit ted in Eu rope, Can ada, Aus tra lia, and Swit zer land. In May
2007, the CHMP of the EU reg u la tory agency adopted a neg a tive opin ion for panitumumab for the treat -
ment of met a static colorectal can cer in pa tients who have failed che mo ther apy. Amgen re quested a
re-ex am i na tion of the opin ion and in De cem ber 2007 the EMEA is sued a con di tional mar ket ing au tho ri za -
tion of panitumumab. The agency rec om mended the drug only for pa tients whose tu mors do not have a
mu ta tion of KRAS — a gene that can stim u late can cer if mu tated. Amgen has launched a screen ing test to
ver ify non-mu tated KRAS ex pres sion. Sub se quent launches of Vectibix for colorectal can cer were re -
ported to have taken place through out Eu rope and other coun tries in clud ing the UK, Ire land, Ger many,
Fin land, Aus tria, Swe den and the Slo vak Re pub lic as well as South Ko rea and France in 2008 in pa tients
with metastatic colorectal cancer expressing the epidermal growth factor receptor (EGFR) and wild type
KRAS gene.
In June 2008, Takeda filed a sub mis sion for ap proval in Ja pan for panitumumab in colorectal can cer. This
was the first fil ing to be made by Takeda through the Takeda Bio De vel op ment Cen tre, the re named and
for merly wholly-owned Jap a nese sub sid iary of Amgen ac quired as part of an al li ance in February 2008.
Phase III tri als were un der way for panitumumab in com bi na tion with che mo ther apy as first and sec ond
line ther apy met a static colorectal and in head and neck as well in 2008/9 and will en roll 20-30 pa tients
from Ja pan. Fur ther re sults are ex pected in late 2009 and fil ing within three years. Ad di tion ally, phase II
tri als were in ves ti gat ing panitumumab in lo cally ad vanced head and neck cancer in 2008.
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