IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
whereas Byetta needs to be in jected twice a day — though a once-weekly in ject able form is also in
late-stage de vel op ment. Byetta suf fered a fur ther set back in Au gust 2008, when it was as so ci ated with a
small num ber of deaths from pan cre ati tis. At the EASD meet ing in Rome the fol low ing month, how ever,
Lilly and Amylin pre sented data from a four-week study in 61 pa tients sug gest ing that Byetta re duced
glu cose lev els more than Januvia (by 112mg/dL, ver sus 37mg/dL two hours af ter a meal), with pa tients
us ing their body’s in su lin more ef fec tively. It was the first head-to-head trial of the two prod ucts. Novo
Nordisk filed its GLP-1 prod uct, liraglutide, for FDA and EU ap proval in May 2008, and is working with
Emisphere on the development of an oral version
Sales/An a lyst Com ment: Mor gan Stan ley an a lysts (Au gust 2008) fore cast a first year sales of Yen42
bil lion in the year to March 2010, ris ing to Yen187.5 bil lion by the year to March 2013.
ACTOPLUS MET XR (pioglitazone + metformin ex tended-re lease), con sist ing of Andrx’s ex tended-re -
lease for mu la tion of the biguanide metformin (Fortamet) and Takeda’s in su lin sensitizer pioglitazone
(Actos) is be ing co-de vel oped by Takeda and Andrx for the treat ment of type II di a be tes. Takeda filed for
ap proval of the prod uct in the USA dur ing March 2006 and in Eu rope in Oc to ber 2008; it will be mar keted
as Competact Pro longed-Re lease Tab let.
CETILISTAT (ATL 962) is a prod uct be ing de vel oped for the treat ment of obe sity and as so ci ated con di -
tions, such as Type 2 di a be tes. It was li censed in from Alizyme (UK). In De cem ber 2008, Takeda com -
menced phase III tri als of cetilistat for obe sity; de tails of this trial, or re sults of the phase II (pla cebo
con trolled) study in obese pa tients with di a be tes and dyslipidemia have not yet been disclosed.
Li cens ing: In 2003, Takeda gained an op tion from Alizyme to de velop, man u fac ture and mar ket the
prod uct in Ja pan. In 2004, Takeda ex er cised its rights to a li cense to de velop cetilistat in Ja pan on the ba -
sis of re sults from a phase IIb study. It now has an ex clu sive li cense to de velop, man u fac ture, and mar ket
cetilistat in Ja pan for the treat ment of obe sity and as so ci ated con di tions, such as Type 2 di a be tes. In
2006, upon com mence ment of a phase II trial, Alizyme re ceived a $2 mil lion milestone payment from
Takeda.
Clin i cal Data: In Jan u ary 2006, Takeda re ported that phase I tri als had com pleted and that it had ini ti -
ated a ran dom ized, pla cebo-con trolled, dou ble-blind, par al lel group, dose-rang ing 450-pa tient (BMI of at
least 25; over seas tri als tar get 30+) phase II trial in Ja pan, to eval u ate cetilistat in the treat ment of obe -
sity and re lated dis eases such as Type 2 diabetes.
The re sults of phase IIb tri als in Eu rope (look ing at 612 obese di a betic pa tients), an nounced in De cem ber
2005, di rectly com pared the prod uct with Roche’s (Swit zer land) Xenical (orlistat) show ing sim i lar ef fi cacy
with a marked re duc tion in side ef fects, al though a dif fer ent mech a nism of ac tion has not yet been
revealed.
Ac cord ing to Alizyme (UK), pre lim i nary phase IIb re sults sug gest that over a three-month pe riod, weight
loss is con sis tent with “other ap proved obe sity drugs of the same class”. The drug was well tol er ated, was
as so ci ated with im prove ments in blood lev els of LDL, HDL and cho les terol, and in duced com pa ra ble
weight loss at the three doses tested. Alizyme re port that the prod uct has 90% fewer gas tro in tes ti nal
events than Xenical.
Ac cord ing to Takeda, phase IIb tri als in volv ing 372 clin i cally obese pa tients in five Eu ro pean coun tries
met their pri mary end points of weight loss. The drug pro duced sta tis ti cally-sig nif i cant re duc tion in weight
at all doses com pared with pla cebo. The agent dem on strated ef fi cacy com pa ra ble to other ap proved obe -
sity drugs of the same class, with no safety or tolerability issues.
Com pe ti tion: If ap proved, ATL 962 will com pete with Abbott’s (USA) Meridia (sibutramine) which was
fi nally filed for ap proval in Ja pan in De cem ber 2007 with Eisai fol low ing a need to re peat clin i cal work and
was await ing ap proval in 2009. Obe sity drugs have faced hur dles in Ja pan how ever, as Chugai de cided in
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