IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
In April 2007, the Brit ish Med i cal Jour nal warned of ‘turn ing healthy peo ple into pa tients’ through use of
drugs such a s rosiglitazone in the pre ven tion of di a be tes when life style changes can be just as ef fec tive
as well as safer and cheaper. Re sults of one Takeda-spon sored, 600-pa tient study showed that ‘pre-di a -
betic’ sub jects tak ing pioglitazone were much less likely to de velop di a be tes than placebo patients.
Sales/An a lyst Com ment: In the year to March 31, 2008, ac cord ing to Takeda, do mes tic sales of Actos
were Yen41.6 bil lion, up 23.6%. To tal global sales were up 17.8% to Yen396.2 bil lion. In the 12-month
pe riod to the end of Sep tem ber 2008, Actos was Takeda’s sec ond lead ing in ter na tional phar ma ceu ti cal
prod uct, mak ing up 26.7% of cor po rate sales, with sales up 10% in fixed rate dol lar terms, ac cord ing to
IMS. Mor gan Stan ley an a lysts, (Au gust 2008), ex pect to tal sales to peak at Yen513.5 bil lion by the year
to March 2011, fall ing steeply to Yen321.5 billion two years later.
ALINAMIN vi ta min and tonic prod ucts: Alinamin is Takeda’s best-sell ing OTC brand. The range in cludes
Alinamin A25 (vi ta min B1 tab lets), Alinamin EX (a vi ta min E-for ti fied vi ta min B1, B6 and B12 com -
pound), Alinamin V, a 50ml vi ta min B com plex health tonic drink, launched in 1987, Alinamin Dy -
namic, a 100ml tonic drink, launched in 1996, and New Alinamin A, which con tains more vi ta min B6
and B12 than the orig i nal prod uct, launched in 1999.
AMITZA (lubiprostone), a func tional fatty acid and chlo ride chan nel opener for the treat ment of cer tain
mo til ity-as so ci ated gas tro in tes ti nal dis or ders like Ir ri ta ble Bowel Syn drome (IBS), launched in the USA in
April 2006. Takeda Pharmaceuticals Amer ica and Sucampo (USA) jointly mar ket the drug in the US. The
prod uct should be taken twice-daily with food help ing to pre vent nau sea, one of the re ported side ef fects
(along with head ache, di ar rhea, ab dom i nal pain and dis ten sion) and safety in preg nancy is not yet es tab -
lished. It was orig i nally de vel oped by Sucampo and li censed-out to Takeda for the USA and Canada.
Lubiprostone was ap proved by the FDA in April 2008 in the USA in adults (fe male) for con sti pa tion-pre -
dom i nant ir ri ta ble bowel syn drome (IBS-C) fol low ing the fil ing of a sNDA in July 2007. The sNDA was
based on the re sults of three stud ies in volv ing over 1,500 adults dem on strat ing that a sta tis ti cally sig nif i -
cant re sponse was twice as likely in pa tients re ceiv ing 8 mcg lubiprostone twice daily over pla cebo over
12 weeks and this ef fi cacy was con tin ued over 52 weeks with sim i lar adverse events to the placebo
group.
Li cens ing: Un der the terms of a 2004 deal, Takeda ac quired rights to mar ket lubiprostone in the USA
and Can ada, with Sucampo hav ing an op tion to jointly mar ket in these coun tries. Takeda also ac quired an
op tion to mar ket lubiprostone in other ter ri to ries such as Ja pan and Eu rope. Sucampo will re ceive from
Takeda ini tial and mile stone pay ments worth up to $210 mil lion, and post-launch roy alty pay ments.
Takeda will fund a ma jor part of costs to de velop the agent for chronic con sti pa tion, con sti pa tion-pre -
dom i nant ir ri ta ble bowel syn drome and other gas tro in tes ti nal in di ca tions. The fil ing in July 2007 ini ti ated
a pay ment from Takeda to Sucampo. Ex clu sive man u fac tur ing and sup ply of the prod uct will be carried
out by Sucampo’s subsidiary R-Tech Ueno.
In Feb ru ary 2007, Takeda and TAP agreed to jointly pro mote the prod uct in the USA; the TAP (jv with
Abbott) was con cluded in May 2008.
Lifecycle Man age ment: In De cem ber 2008, Takeda/Sucampo con firmed that en rol ment for phase III
tri als in the USA in Opioid-In duced Bowel Dys func tion (OBD), had com pleted with a to tal of 875 patients.
Clin i cal Data: The NDA, filed in March 2005, in cluded data from two piv otal, dou ble-blind, pla cebo-con -
trolled phase III tri als of lubiprostone, which dem on strated that ap prox i mately 60% of pa tients ex pe ri -
enced spon ta ne ous bowel move ment within 24 hours of treat ment with the agent.
Sucampo re ported in Oc to ber 2008 data from three open-la bel, long-term (six and 12 months) clin i cal
tri als of lubiprostone in pa tients with chronic id io pathic con sti pa tion (CIC). The tri als were con ducted be -
tween No vem ber 2001 and Jan u ary 2005: the first trial was a 24-week, 308-pa tient, open-la bel ex ten -
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