IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
lh-rh receptor antagonist TAK 385 H1C3 I
neuroregeneration enhancer TAK 065 N4A, N7D9 I
oral her2 inhibitor TAK 285 L1X4 I
oral sex hormone synthesis inhibitor TAK 700 L1X9 I
potassium-competitive acid blocker (oral) TAK 438 A2B2 I
prostate cancer therapy TAK 448 L1X9 I
urinary incontinence therapy TAK 363, TRK 130 G4D I
VEGFR and PDGFR inhibitor TAK 593 L1X4 I
ANG receptor antagonist AMG 386 L1X9 Preclinical
asthma and allergic rhinitis therapy MLN 6095 R3X Preclinical
ceftaroline TAK 599, PPI 0903 J1D Preclinical
COX inhibitor XEN 401 M1A1 Preclinical
Crohn’s disease therapy MLN 3126 A7E Preclinical
MAb, hepatocyte growth factor, Galaxy TAK 701, HuL 2G7 L1X3 Preclinical
MAb, IGF-1, Amgen AMG 479 L1X3 Preclinical
MAb, interleukin-1, Amgen AMG 108 M1C Preclinical
MAb, interleukin-4/interleukin-13, Amgen AMG 317 R3X Preclinical
SARM LGD 2226 G3B, M5B Preclinical
vaccine, acellular pertussis, tetanus,
diphtheria, poliovirus, Takeda TAK 361S J7B1 Preclinical
Takeda is one of the six Jap a nese com pa nies with an an nual R&D bud get of around $1 bil lion, the spend -
ing of which is crit i cally im por tant in or der to pri or i tize in vest ment in their pipe line. R&D at Takeda is fo -
cused around four ar eas: on col ogy and urol ogy; life style dis eases, cen tral ner vous sys tem (CNS) and
gas tro in tes ti nal (GI) dis or ders. The ac qui si tion of Mil len nium, giv ing ac cess to mar keted prod uct Velcade
and 10 early stage mol e cules has been de scribed as the most sig nif i cant and stra te gi cally transformative
deal in Takeda’s his tory, giv ing a large boost to its on col ogy fran chise. The ad di tion of Velcade may be
Takeda’s lone bright spot as the pat ent ex pi ra tions of main stay prod ucts Actos and Prevacid near with lit -
tle other than Velcade to sig nif i cantly fill the gap fol low ing un for tu nate de lays from missed PDUFU dates
for both fol low-on prod ucts, Kapidex (TAK 390MR), a mod i fied re lease ver sion of an ac tive en an tio mer of
Prevacid (lansoprazole) for acid re lated dis eases and the dipeptidyl peptidase IV (DPP-IV) in hib i tor
alogliptin. Ex pected to be come Takeda’s two new main stay prod ucts, Kapidex was fi nally ap proved in
Jan u ary 2009, mean ing it will be launched be fore the loss of pat ent pro tec tion for Prevacid in No vem ber.
Ap proval of alogliptin is de layed un til June 2009 how ever, a de lay of eight months from the orig i nal date
and it now lags well be hind Merck &Co’s Januvia (sitagliptin), which has be come the ‘gold stan dard’ for
the DPP-IV in hib i tor class, with new prod ucts ex pected to show su pe ri or ity. An a lysts so far seem to be of
the opin ion that alogliptin only of fers sim i lar safety and ef fi cacy to Januvia, al though the ex act in di ca tion
Takeda seeks is not fully re vealed. Takeda does how ever have greater experience in diabetes, and that
approval of a pill combining alogliptin with Actos is also expected in the second half of 2009.
The ac qui si tion of Mil len nium also brought ex pan sion in the field of in flam ma tion with vedolizumab (MLN
002), a hu man ized monoclonal an ti body that spe cif i cally binds with cell ad he sion mol e cule for in flam ma -
tory bowel dis ease which Takeda in tends to file for ap proval in Ja pan, the US and Eu rope in 2011. Two
phase III tri als were ini ti ated in Jan u ary 2009, as part of the GEM INI pro gram that will study vedolizumab
in ul cer ative co li tis and Crohn’s dis ease, en roll ing 2,000 pa tients from 40 coun tries (in clu sion of Ja pan not
yet de cided) with mod er ate-to-se vere dis ease, un re spon sive to stan dard ther a pies. Takeda hopes this
will fur ther en hance its pres ence in the mar ket for gas tro in tes ti nal drugs which it has established with the
PPI lansoprazole.
The ac qui si tion of Amgen in Ja pan is a strong mes sage that Takeda will fully em bark on ad vanced phar -
ma ceu ti cal de vel op ment in the fields of on col ogy and an ti body pharmaceuticals. Takeda Bio pres i dent re -
vealed am bi tions to com mence clin i cal de vel op ment of the 10 pre clin i cal can di dates by 2010 and to file
for ap proval of prod ucts gained from the in au gu ra tion of Amgen Ja pan. This started with Vectibix
(panitumumab), a co lon can cer hu man monoclonal an ti body to the ep i the lial growth fac tor re cep tor
(EGFR), which was filed for ap proval in June 2008 for colorectal can cer. A fil ing for motesanib, an
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