IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
ACTOS (pioglitazone), an in su lin sensitizer, for use in the ther apy of non-in su lin de pend ent (Type 2) di a -
be tes, was launched in Ja pan and the USA in 1999. The drug low ers mean blood sugar and glycosylated
he mo glo bin lev els, and also re duces mean triglyceride lev els whilst in creas ing lev els of ‘good’ HDL cho -
les terol. Actos is the cor ner stone of Takeda’s strat egy of in creased glob al iza tion. It was the first Jap a nese
‘block buster’ drug to be mar keted by the orig i na tor in the USA (al beit jointly with li censee Lilly). Actos re -
ceived four in di ca tions from the FDA: monotherapy, and in com bi na tion with sulfonylureas, metformin or
in su lin to im prove glycemic con trol in Type 2 di a bet ics. Actos was ap proved in the EU in 2000 for use with
sulfonylureas or metformin. It has been launched by Takeda in var i ous markets worldwide, some by
licensees Lilly and Abbott.
In Au gust 2008, Takeda filed for ap proval of pioglitazone in the USA for use in de lay ing the pro gres sion of
ath ero scle ro sis.
Ap proval was granted in Ja pan in De cem ber 2008 for use of pioglitazone in com bi na tion with biguanides
fol low ing the fil ing in Jan u ary 2007.
Takeda ap plied for ap proval of orodispersible tab lets of Actos in Sep tem ber 2008, ‘Actos OD tab lets.
Takeda mar kets Duetact (pioglitazone + glimepiride) in the US and Eu rope; phase III tri als of this
fixed-dose com bi na tion, were un der way in Ja pan in 2009.
In Jan u ary 2006, rare cases of macular edema were re ported to the Eu ro pean Med i cines Agency in con -
nec tion with piogiltazone (Actos) and rosiglitazone prod ucts (GlaxoSmithKline’s Avandia, Avandamet
and Avandaryl, a new fixed-dose com bi na tion prod uct ap proved and launched in Feb ru ary 2006). The
agency’s sci en tific com mit tee, the CHMP says that fur ther re view of a pos si ble as so ci a tion is re quired;
edema was noted as a po ten tial side ef fect in pioglitazone tri als. In May 2007 the FDA re quested a ‘black
box’ warn ing on the la bel of pioglitazone be cause of data in di cat ing an in creased risk of con ges tive heart
failure in patients given rosiglitazone.
Li cens ing: Lilly (USA) has co-pro mo tion rights in the Can ada, the USA, Eu rope, Asia (ex clud ing Ja pan),
Af rica, Aus tra lia and the Mid dle East. In the USA, Actos is co-pro moted by Lilly and Takeda
Pharmaceuticals North Amer ica (TPNA). The TPNA sub sid iary has nearly 700 sales rep re sen ta tives de tail -
ing Actos. In 1999, Takeda agreed to co-mar ket Actos in Ja pan with Novo Nordisk (Den mark). In 2000,
Takeda granted Abbott (USA) ex clu sive rights to pioglitazone in Ar gen tina, Brazil, Chile, Co lom bia, Ec ua -
dor, Par a guay, Peru, Uru guay and Ven e zuela. Most li cens ees use the Actos brand name. Takeda re ceived
mar ket ing approval in South Korea in 2003.
Clin i cal Data: Takeda has con ducted two phase III tri als (PERI SCOPE) and CHI CAGO (in volv ing over
500 pa tients) com par ing the ef fects of Actos ver sus glimepiride in pa tients with type 2 di a be tes. The pri -
mary end points were: ca rotid in tima-me dia thick ness (CIMT) in the CHI CAGO trial and the vol ume of
plaque build-up in the cor o nary ar ter ies in PERI SCOPE. Actos in hib ited the pro gres sion of ar te rio scle ro sis
in both tri als and based on the trial results,
Takeda is eval u at ing pioglitazone in phase III tri als in the USA and Eu rope for its abil ity to de lay the pro -
gres sion of ath ero scle ro sis. In No vem ber 2006, Takeda re ported re sults from an 18-month, multicenter,
ran dom ized trial, des ig nated CHI CAGO, con ducted to com pare the ef fects of pioglitazone with
glimepiride on the pro gres sion of ath ero scle ro sis in 462 pa tients with Type 2 di a be tes. The pro gres sion of
ath ero scle ro sis was mea sured by ca rotid in tima-me dia thick ness (CIMT), de fined as the thick ness of the
in ner lin ing of a pa tient’s neck ar ter ies. In ad di tion, the trial as sessed the oc cur rence of car dio vas cu lar
events and car dio vas cu lar dis ease risk fac tors. Re sults from the trial, con ducted in the USA, showed that
pa tients treated with pioglitazone had a -0.001mm change in ar te rial thick ness from base line com pared
with an in crease of 0.012mm in pa tients treated with glimepiride. The re sults also showed a sig nif i cant
rel a tive change in the max i mum CIMT val ues. Pa tients treated with glimepiride showed a 0.026 in crease
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