IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Motesanib was tol er a ble with the most frequent adverse events being diarrhea, hypertension and fatigue
(generally manageable).
Amgen re ported in No vem ber 2006 re sults from a sin gle-arm, multicenter phase II trial of AMG 706 in
pa tients with ad vanced high-dose imatinib-re sis tant GISTs. 120 evaluable pa tients re ceived AMG 706
125mg po un til pro gres sive dis ease or tox ic ity (for at least eight weeks). A clin i cal ben e fit rate of 27%, in -
clud ing 3% of par tial re sponses and 24% of du ra ble sta ble dis ease greater than or equal to 22 weeks,
was de ter mined by the RECIST as sess ment. At week eight, 23% of pa tients showed an ob jec tive re -
sponse as de ter mined by fluorodeoxyglucose-pos i tron emis sion to mog ra phy (FDG-PET) and 33% of pa -
tients dem on strated an ob jec tive re sponse when eval u ated by Choi cri te ria. The me dian pro gres sion-free
sur vival was 16 weeks, with 26 week pro gres sion-free sur vival of 27%. Me dian sur vival was 59 weeks.
Treat ment-re lated ad verse events, which oc curred in 15% or more of all treated pa tients, in cluded di ar -
rhea (55%), hypertension (48%), fatigue (45%), headache (47%) and nausea (35%).
TAK 242 (resatorvid), which in hib its pro duc tion of in flam ma tory me di a tors such as cytokines by block -
ing Toll-like re cep tor 4 (TLR4) sig nal ing, is be ing de vel oped by Takeda for the novel treat ment of se vere
sep sis. It was in phase III tri als in Eu rope, the USA and Ja pan in 2009. The prod uct ob tained Fast Track
sta tus in the US in July 2005. Se vere sep sis of ten re sults in or gan dys func tion and has a high mor tal ity
rate. Lilly’s (USA) Xigris (drotrecogin al pha) is cur rently the only ther apy avail able for the con di tion with
sev eral ther a peu tic can di dates fail ing over the past few years in clud ing Chiron’s (now Novartis, Swit zer -
land) tifacogin (still in de vel op ment for other uses) and Shionogi’s (Ja pan) varespladip.
CBP 501, a G2 check point abrogater (in jec tion) be gan phase II eval u a tion in the US in De cem ber 2008
with CanBas and Mil len nium (Takeda’s wholly-owned sub sid iary) for ma lig nant pleu ral me so the li oma.
The trial is ex pected to com plete in De cem ber 2010. The drug in duces can cer cell death by block ing the
tran si tion of can cer cells through the cell cy cle. Data from a phase I study in di cated that when com bined
with se lected chemotherapeutic drugs, CBP 501 en hances the anticancer cytotoxic ac tiv ity of these es -
tab lished treat ments. a phase I trial in lung can cer was also re ported to be underway with CanBas in
2009.
Li cens ing: Takeda gained ex clu sive rights to de velop, man u fac ture and mar ket this and backup can cer
com pounds world wide, ex cept in the US where ac tiv ity will be jointly con ducted from CanBas (USA) in
March 2007. Takeda will pay CanBas an upfront sum upon the ini ti a tion of the col lab o ra tion and will make
an eq uity in vest ment in CanBas. Takeda will also make mile stone pay ments to CanBas re lated to clin i cal
and reg u la tory prog ress, and roy alty payments on sales of the agent.
GNRH AN A LOGUE: TAP (now Takeda) and Norwood Im mu nol ogy funded a pre clin i cal study at Mas sa -
chu setts Gen eral Hos pi tal on the po ten tial use of GnRH an a logues in the trans plant set ting, pre vent ing
or gan re jec tion with out need for long-term immunosuppresssants. Phase II tri als were on go ing in the US
in 2008. The TAP jv was concluded in May 2008.
LESTAURTINIB (CEP 701), an orally-avail able ty ro sine kinase in hib i tor, was li censed to TAP (the
Takeda/Abbott joint ven ture) in 1999 for the US by Cephalon (USA). This po ten tial treat ment for pros tate
and pan cre atic can cers be gan phase II tri als in pros tate can cer in 2000 with TAP. Cephalon planned clin i -
cal stud ies for the treat ment of pan cre atic can cer, and in 2002 an ad di tional phase II study was un der
way for acute myelogenous leukemia.
The TAP jv was con cluded in May 2008.
Li cens ing: Cephalon gained rights to this prod uct and a se ries of re lated mol e cules from Kyowa Hakko
(Ja pan).
MLN 1202, a hu man ized monoclonal an ti body that tar gets the CCR2 chemokine re cep tor has po ten tial
util ity for the treat ment of mul ti ple scle ro sis, as well as other in flam ma tory con di tions, in clud ing ath ero -
© 2009 IMS Health In cor po rated or its af fil i ates Page 67