IMS Company Profiles - Report Buyer

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IMS COM PANY PRO FILES TAKEDA Re gional Strat egy • Takeda hopes to be in the US top 15 Takeda is a Jap a nese leader in es tab lish ing it self over seas and gen er ates a much higher pro por tion of its sales in the US mar ket than most Jap a nese com pa nies. This is how ever be ing threat ened with forth com - ing pat ent ex pi ra tions of lead ing prod ucts, and in fis cal 2007 (end ing March 2008) Takeda’s share of com pany sales gen er ated in the US dropped from nearly one-third to one-quar ter. Takeda now claims it will be one of 15 lead ing com pa nies in the US how ever, fol low ing the pur chase of Abbott’s share of TAP, which has now merged with Takeda to be come a wholly owned sub sid iary of Takeda Amer ica Hold ings, Inc, 100%-owned by Takeda. Takeda ex pects syn er gis tic ef fects of about Yen40 bil lion over the three-year pe riod fol low ing the merger, which com pleted in te gra tion and started busi ness as a new con - sol i dated com pany in July 2008. As sets were split equally. Abbott ob tained rights to Lupron De pot along with as sets pri mar ily re lated to this prod uct, and all em ploy ees as well as pay ments based on TAP’s other cur rent and cer tain fu ture prod ucts. The new TAP sub sid iary of TAH will re tain the other mar keted TAP prod uct, Prevacid (al though Abbott will re ceive around $1.5 bil lion from prod uct sales over five years). Around 2,600 of the 3,000 em ploy ees of TAP (in clud ing 1,400 MRs) were trans ferred to the Takeda group; the num ber of MRs of the new Takeda group has in creased to about 3,500. TAP de vel op ment func tions have been trans ferred to Takeda Global Re search and De vel op ment Cen tre (TGRD) by trans - fer ring TAP pipe line prod ucts: Kapidex (dexlansoprazole/TAK 390MR), a pro ton pump in hib i tor ap proved in Jan u ary 2009; an other pro ton pump inhibior, ilaprazole (IY 81149) and Uloric (febuxostat/TMX 67) for the treat ment of hyperuricemia in pa tients with gout, ap proved in Feb ru ary 2009. Takeda Phar ma ceu ti - cal North Amer ica (TPNA) will now have two new prod uct launches dur ing the first half of 2009. TPNA has grown from hav ing 6 em ploy ees in 1998, when it was in cor po rated, to 3,000 in 2006. In many ways, given the im por tance of the US market and the lack of growth opportunities elsewhere, the success of TPNA could be seen as a symbol for the success of Takeda itself. Takeda is cur rently pres ent in Ja pan, the US, six Eu ro pean coun tries and five Asian coun tries and in its last man age ment plan, it set it self the goal of main tain ing its lead ing po si tion in Ja pan, with a mar ket share of 7%. In the all-im por tant US mar ket, the com pany wants TPNA to achieve a mar ket share of more than 1.5%, and in Eu rope it ex pects more than 1.1% mar ket share in the six larg est coun tries. In the five main coun tries in Asia, Takeda has set a tar get of more than 1.4% mar ket share. The tar get over - all mar ket share is 2.5% in the coun tries where Takeda has its own sales chan nels. Takeda has how ever re cently ad mit ted to strug gling in its at tempts to strengthen its pres ence in Eu rope and fully entering emerging markets. Ther a peu tic Fo cus • On col ogy ac qui si tion may bridge loom ing gap Takeda is well po si tioned with re gard to ther a peu tic fo cus; for many years, a large pro por tion of sales have been gen er ated from the high growth di a be tes and on col ogy ar eas, as well as anti-ulcerants; oral antidiabetics; an gio ten sin II an tag o nists; and cephalosporin an ti bi ot ics. Its ma jor prod ucts are Prevacid/Takepron (lansoprazole), a pro ton pump in hib i tor; Actos (pioglitazone), an oral agent for di a be - tes; the can cer and hor monal prod uct Leuplin/Lupron (al though this is now ex clu sively owned by Abbott fol low ing the dis so lu tion of the TAP jv); and the an gio ten sin II in hib i tor Blopress/Atacand (candesartan cilexetil) for hy per ten sion. Takeda faces a huge chal lenge as all four prod ucts lose pat ent pro tec tion over the next five years with Prevacid in No vem ber 2009 fol lowed by Actos in 2011 then Blopress in 2012 and finally Leuplin in 2014. Blopress was the best sell ing phar ma ceu ti cal prod uct in Ja pan in the year end ing Sep tem ber 2008 ac - cord ing to IMS. Takeda is de vel op ing a fixed-dose com bi na tion of candesartan with the cal cium an tag o - © 2009 IMS Health In cor po rated or its af fil i ates Page 10

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 © 2009 IMS Health In cor po rated or its af fil i ates Page 11

<strong>IMS</strong> COM PANY PRO FILES TAKEDA<br />

Re gional Strat egy<br />

• Takeda hopes to be in the US top 15<br />

Takeda is a Jap a nese leader in es tab lish ing it self over seas and gen er ates a much higher pro por tion of its<br />

sales in the US mar ket than most Jap a nese com pa nies. This is how ever be ing threat ened with forth com -<br />

ing pat ent ex pi ra tions of lead ing prod ucts, and in fis cal 2007 (end ing March 2008) Takeda’s share of<br />

com pany sales gen er ated in the US dropped from nearly one-third to one-quar ter. Takeda now claims it<br />

will be one of 15 lead ing com pa nies in the US how ever, fol low ing the pur chase of Abbott’s share of TAP,<br />

which has now merged with Takeda to be come a wholly owned sub sid iary of Takeda Amer ica Hold ings,<br />

Inc, 100%-owned by Takeda. Takeda ex pects syn er gis tic ef fects of about Yen40 bil lion over the<br />

three-year pe riod fol low ing the merger, which com pleted in te gra tion and started busi ness as a new con -<br />

sol i dated com pany in July 2008. As sets were split equally. Abbott ob tained rights to Lupron De pot along<br />

with as sets pri mar ily re lated to this prod uct, and all em ploy ees as well as pay ments based on TAP’s other<br />

cur rent and cer tain fu ture prod ucts. The new TAP sub sid iary of TAH will re tain the other mar keted TAP<br />

prod uct, Prevacid (al though Abbott will re ceive around $1.5 bil lion from prod uct sales over five years).<br />

Around 2,600 of the 3,000 em ploy ees of TAP (in clud ing 1,400 MRs) were trans ferred to the Takeda<br />

group; the num ber of MRs of the new Takeda group has in creased to about 3,500. TAP de vel op ment<br />

func tions have been trans ferred to Takeda Global Re search and De vel op ment Cen tre (TGRD) by trans -<br />

fer ring TAP pipe line prod ucts: Kapidex (dexlansoprazole/TAK 390MR), a pro ton pump in hib i tor ap proved<br />

in Jan u ary 2009; an other pro ton pump inhibior, ilaprazole (IY 81149) and Uloric (febuxostat/TMX 67) for<br />

the treat ment of hyperuricemia in pa tients with gout, ap proved in Feb ru ary 2009. Takeda Phar ma ceu ti -<br />

cal North Amer ica (TPNA) will now have two new prod uct launches dur ing the first half of 2009. TPNA has<br />

grown from hav ing 6 em ploy ees in 1998, when it was in cor po rated, to 3,000 in 2006. In many ways,<br />

given the im por tance of the US market and the lack of growth opportunities elsewhere, the success of<br />

TPNA could be seen as a symbol for the success of Takeda itself.<br />

Takeda is cur rently pres ent in Ja pan, the US, six Eu ro pean coun tries and five Asian coun tries and in its<br />

last man age ment plan, it set it self the goal of main tain ing its lead ing po si tion in Ja pan, with a mar ket<br />

share of 7%. In the all-im por tant US mar ket, the com pany wants TPNA to achieve a mar ket share of<br />

more than 1.5%, and in Eu rope it ex pects more than 1.1% mar ket share in the six larg est coun tries. In<br />

the five main coun tries in Asia, Takeda has set a tar get of more than 1.4% mar ket share. The tar get over -<br />

all mar ket share is 2.5% in the coun tries where Takeda has its own sales chan nels. Takeda has how ever<br />

re cently ad mit ted to strug gling in its at tempts to strengthen its pres ence in Eu rope and fully entering<br />

emerging markets.<br />

Ther a peu tic Fo cus<br />

• On col ogy ac qui si tion may bridge loom ing gap<br />

Takeda is well po si tioned with re gard to ther a peu tic fo cus; for many years, a large pro por tion of sales<br />

have been gen er ated from the high growth di a be tes and on col ogy ar eas, as well as anti-ulcerants; oral<br />

antidiabetics; an gio ten sin II an tag o nists; and cephalosporin an ti bi ot ics. Its ma jor prod ucts are<br />

Prevacid/Takepron (lansoprazole), a pro ton pump in hib i tor; Actos (pioglitazone), an oral agent for di a be -<br />

tes; the can cer and hor monal prod uct Leuplin/Lupron (al though this is now ex clu sively owned by Abbott<br />

fol low ing the dis so lu tion of the TAP jv); and the an gio ten sin II in hib i tor Blopress/Atacand (candesartan<br />

cilexetil) for hy per ten sion. Takeda faces a huge chal lenge as all four prod ucts lose pat ent pro tec tion over<br />

the next five years with Prevacid in No vem ber 2009 fol lowed by Actos in 2011 then Blopress in 2012 and<br />

finally Leuplin in 2014.<br />

Blopress was the best sell ing phar ma ceu ti cal prod uct in Ja pan in the year end ing Sep tem ber 2008 ac -<br />

cord ing to <strong>IMS</strong>. Takeda is de vel op ing a fixed-dose com bi na tion of candesartan with the cal cium an tag o -<br />

© 2009 <strong>IMS</strong> Health In cor po rated or its af fil i ates Page 10

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