IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
sion to a four-week dou ble-blind, piv otal trial; the sec ond trial was a 48-week, 250-pa tient, open-la bel
trial, 82 of whom were in volved in a seven-week ran dom ized with drawal study pe riod be fore the open-la -
bel phase of the trial; and the third trial was a 48-week, open-la bel trial in 325 treat ment-na ive pa tients.
Pa tients were given twice-daily, oral lubiprostone 24 mcg for six or 12 months, as re quired; they then re -
mained on a daily dos ing sched ule or stopped lubiprostone ther apy de pend ing on their per ceived needs.
Pa tients could re turn to lubiprostone ther apy if re quired, but were to re start dos ing of lubiprostone at 24
mcg twice daily. The daily dose could be al tered by in ves ti ga tors in re sponse to pharmacodynamic events
or treat ment-re lated ad verse events. Pe ri odic res cue med i ca tion use was per mit ted. Re sults from the tri -
als showed that lubiprostone dem on strated good tolerability and sig nif i cantly im proved symp toms (sub -
jec tively as sessed) of CIC. There were sta tis ti cally sig nif i cant im prove ments in sec ond ary end points such
as con sti pa tion se ver ity, abdominal bloating and abdominal discomfort, assessed by patients using a
five-point scale.
Com pe ti tion: Most pa tients with chronic con sti pa tion are treated with di etary fi ber, os motic lax a tives
and bulk ing agents be fore try ing phar ma ceu ti cal treat ments. Amitiza is the first se lec tive chlo ride chan -
nel ac ti va tor to be ap proved and ac cord ing to Takeda, the only one in de vel op ment, work ing to in creased
fluid se cre tion and mo til ity in the in tes tine speed ing up the pas sage of stool and thus re duc ing symp toms
of con sti pa tion. Most other prod ucts in this area are tar geted at opioid-in duced con sti pa tion. Amitiza will
com pete with Novartis’ 5HT4 par tial ag o nist, Zelnorm/Zelmac (tegaserod maleate), ap proved in 2004
in the USA, and the first prod uct tar geted at this mar ket. Ac cord ing to IMS, Zelmac lost its pre vi ous po si -
tion as the lead ing gas tro in tes ti nal sensorimotor mod u la tor in the 12-month pe riod to the end of Sep tem -
ber 2008, with sales down 94% in fixed rate dol lar terms. It now sits in sec ond place, with 45.2 % of the
mar ket, be hind its only ma jor com pet i tor, also launched in the US in 2004, GlaxoSmithKline’s Lotronex
(alosetron) with a 51.7% mar ket share (sales up 43% in fixed rate dol lar terms), and some ge neric ver -
sions of tegaserod sold in In dia, Ban gla desh, Pa ki stan, Chile, Peru and Co lom bia. Due to prob lems with
side ef fects, Zelnorm was with drawn in 2000. It has been re-launched in the USA in 2002 for lim ited use
(in women with se vere di ar rhea-pre dom i nant IBS who have not re sponded to con ven tional treat ment
and whose symp toms can not be ac counted for by other gas tro in tes ti nal dis or ders). Lotronex tar gets di -
ar rhea-pre dom i nant IBS (and is a 5HT3 an tag o nist), while Zelmac tar gets con sti pa tion-pre dom i nant IBS
(and is a 5HT4 agonist). In 2007, Prometheus Laboratories (USA) gained exclusive rights to Lotronex in
the USA.
Sales/An a lyst Com ment: Sales in the year end ing March 2008 more than tri pled to Yen19.5 bil lion. In
the year end ing Sep tem ber 2008, Amitiza be came Takeda’s eighth lead ing in ter na tional prod uct ac cord -
ing to IMS with 1.4% mar ket share and growth of 66%. An a lysts at Mor gan Stan ley, re port ing on Takeda
in Au gust 2008, es ti mates sales of Yen36.8 bil lion in the year ending March 2013.
BASEN (voglibose), an orally ac tive al pha-glucosidase in hib i tor, was launched in Ja pan in 1994 for the
con trol of post-pran dial hyperglycemia in di a betic pa tients. Li censee CJ Corp (for merly Cheil, South Ko -
rea) has launched the prod uct in South Ko rea and the prod uct is also avail able in Thai land and the Phil ip -
pines. In 2004, Takeda launched a fast dis in te grat ing tab let for mu la tion of voglibose in Ja pan. It was also
in phase III tri als in Ja pan for im paired glu cose tol er ance and filed for ap proval in De cem ber 2007. Re sults
re leased in May 2008, dem on strated a 40.5% re duc tion in on set of type II di a be tes and 53.9% in crease
in achieve ment of nor mal iza tion of oral glu cose tol er ance test com pared with pla cebo, al though
Voglibose-treated pa tients were more likely to suf fer ad verse events but none serious and overall safety
was comparable.
In 2003, new warn ings were added at the re quest of the Jap a nese Min is try of Health, Wel fare and La bor
re gard ing the risk of hepatic side ef fects in clud ing fulminant hep a ti tis and jaun dice. Voglibose had been in
phase III tri als in the USA and was pend ing ap proval in Eu rope with li censee Abbott (USA) in 2000, but
Abbott re turned all rights to Takeda in 2002. In June 2006, Takeda an nounced that it had dis con tin ued
de vel op ment of voglibose for the European and US markets.
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