IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Clin i cal Data: Voglibose acts by im prov ing glu cose tol er ance and re duc ing the in crease in blood glu cose
fol low ing su crose or starch in take. The drug’s mech a nism is unique in that it de lays/in hib its glu cose ab -
sorp tion in the small in tes tine, and thereby re duces the rapid rise of blood glu cose lev els af ter meals. It
acts by block ing an en zyme re spon si ble for de ac ti vat ing a fur ther en zyme in volved in glu cose me tab o -
lism. It does not di rectly cure di a be tes but is ex pected to im prove blood glu cose lev els and hence slow the
prog ress of the dis ease and pre vent the de vel op ment of chronic di a betic com pli ca tions, such as neu rop a -
thy. Basen’s mech a nism is ex pected to al low the drug to be used by pa tients un der go ing dietetic
treatment as well as those on drug therapies, such as insulin.
Lifecycle Man age ment: Voglibose was filed for ap proval in Ja pan in De cem ber 2007 for im paired glu -
cose tol er ance (IGT); no drug in Ja pan is cur rently ap proved for this indication.
Com pe ti tion: In the year end ing Sep tem ber 2008, Basen was Ja pan’s lead ing oral di a betic ac cord ing to
IMS with 28% share of do mes tic sales, down 6% (fixed dol lar rate) over the pre vi ous year. Takeda’s
Actos (pioglitazone) took sec ond place with 25.1% and 22% growth while Amaryl (glimepiride) took
third place with 13.3% (up 10%).
Novartis re leased re sults in May 2008 show ing that its DDP-IV in hib i tor Galvus (vildagliptin), await ing ap -
proval in Ja pan, was twice as likely to re duce HbA1c lev els to 6.5% of less in Jap a nese di a betic pa tients
than voglibose, which is avail able ge ner i cally in Ja pan and is one of the lead ing first-line ther a pies for type
2 diabetes.
Sales/An a lyst Com ment: In the year to March 31 2008, ac cord ing to Takeda, do mes tic sales of Basen
were Yen52.8 bil lion, down 5.2%, partly due to ge neric in fil tra tion. In the 12-month pe riod to the end of
Sep tem ber 2008, Basen was Takeda’s num ber five in ter na tional phar ma ceu ti cal prod uct, mak ing up
3.1% of cor po rate sales, with sales down 6% in fixed rate dol lar terms, ac cord ing to IMS. Mor gan Stan ley
an a lysts (Au gust 2008), fore cast that do mes tic sales have peaked and will grad u ally de crease to Yen37
billion by the year ending March 2013.
DUETACT (pioglitazone + glimepiride) a com bi na tion of pioglitazone with the sulfonylurea com pound,
glimepiride, was ap proved by the FDA for the treat ment of Type 2 di a be tes in July 2006, and launched in
the USA in No vem ber 2006. The prod uct is avail able in two dos ages con sist ing of 30mg/2mg and
30mg/4mg of pioglitazone and glimepiride, re spec tively. Glimepiride acts to in crease pan cre atic in su lin
pro duc tion. In Jan u ary 2007, EMEA ap proval of the fixed com bi na tion for the treat ment of Type 2 di a be -
tes was re ceived for the prod uct, to be named Tandemact in Eu rope. A com bi na tion of pioglitazone and
glimepiride was launched in Mex ico un der the name Diaberil by Rimsa (Mex ico) in June 2006. Phase III
tri als of this fixed-dose com bi na tion, Duetact (pioglitazone + glimepiride) were underway in Japan in
2009.
GASMOTIN (mosapride ci trate) is a 5HT4 ag o nist with gastroprokinetic prop er ties. It was orig i nally de -
vel oped by Dainippon (now Dainippon Sumitomo) and launched in Ja pan in 1998, as Gasmotin, for re -
duc ing the symp toms of chronic gas tri tis, such as heart burn. Dainippon de scribes mosapride as the first
se lec tive se ro to nin 5-HT4 re cep tor ag o nist that en hances gas tro in tes ti nal mo til ity. It has been launched
in Ar gen tina un der the trade names Mosar and Intesul by Phoe nix and Deta, re spec tively. Mosapride
was also launched in Cen tral Amer ica, and China by Dainippon Sumitomo in 2001. In 2001, it was
launched in Peru by Tecnofarma as Reflucil.
Li cens ing: In 2001, Takeda gained rights to de velop and mar ket mosapride world wide, ex clud ing Ja -
pan, China, Tai wan and South Ko rea (where it is sold by Daewoong). Mosapride was pre vi ously li censed
to AstraZeneca (UK) for the USA and Eu rope, but this deal was ter mi nated. In April 2006, Dainippon
Sumitomo and Eisai signed an agree ment un der which Eisai ac quires de vel op ment, man u fac ture and
mar ket ing rights to mosapride in 10 Asian coun tries, in clud ing coun tries be long ing to the As so ci a tion of
South East Asian Na tions (ASEAN) where it is await ing approval and being rolled out.
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