IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
nist amlodipine in Ja pan, which will com bine two of Ja pan’s best sell ing drugs; in Ja pan doc tors of ten
co-pre scribe an ARB and cal cium an tag o nist to achieve blood pres sure tar gets with sin gle treat ment said
to achieve this in only half of pa tients. If ap proved this will com pete with other com pa nies de vel op ing
such com bi na tions in Ja pan: Daiichi Sankyo with Azor (olmesartan + amlodipine), ex pected to be filed for
ap proval in 2009 and Novartis with Exforge (valsartan + amlodipine), both mar keted in the US. Takeda
and AstraZeneca’s com bi na tion of candesartan cilexetil and hy dro chlo ro thi a zide (Blopress Comp) is
avail able in most mar kets world wide for the treat ment of hy per ten sion and ap proval as Ecard was
granted in Ja pan in Jan u ary 2009. Blopress had also been in de vel op ment for di a betic retinopathy but fol -
low ing non-sta tis ti cally sig nif i cant re sults from the four year DI RECT pro gram in volv ing over 5,000 pa -
tients, Takeda de cided not to pur sue this in di ca tion; candesartan re duced the in ci dence of di a betic
retinopathy by 18% compared with placebo however and results were published in The Lancet.
The ac qui si tion of Mil len nium brought Takeda its main stay prod uct Velcade (bortezomib), an anticancer
proteasome in hib i tor, mar keted world wide and in Ja pan by John son & John son. Al though an a lysts crit i -
cized the deal for be ing too ex pen sive, six months on, it looks to have been a well-planned move as 2008
sales of Velcade topped $1 bil lion, boosted by the June 2008 ap proval as a first-line ther apy for mul ti ple
myeloma. It was al ready used as sec ond and third line ther apy in mul ti ple myeloma and ad di tional clin i cal
re sults re leased at the Amer i can So ci ety for He ma tol ogy meet ing sug gest the drug will re main an im por -
tant cor ner stone of myeloma treat ment for years to come. Takeda hopes that this prod uct may help to
bridge the loom ing gap from up com ing pat ent ex pi ries of its main stay prod ucts where the pat ent ex pi ra -
tion of Actos and Prevacid alone is ex pected to amount to annual losses of over Yen500 billion in 2009
through 2011.
R&D
• Ag o niz ing de lays for alogliptin...
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
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