IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
prove ment in 15.9%; the ef fi cacy rate was 84.1% (de ter mined by the DAS28 dis ease ac tiv ity score). Ad -
verse events were re ported in 30.6% and 5.7% were serious.
Com pe ti tion: With an es ti mated 700,000 RA suf fer ers (mostly women) in Ja pan, fewer than half of
which are treated, Ja pan rep re sents a po ten tially lu cra tive mar ket and com pe ti tion is in ten si fy ing.
Enbrel’s, main ri val, John son & John son’s Remicade (infliximab), was the first TNF-al pha an tag o nist to
reach the Jap a nese mar ket with its 2002 launch for RA (un re spon sive to other DMARDS). Remicade has
the ad van tage of in tra ve nous ad min is tra tion once ev ery eight weeks, com pared with Enbrel’s self-in jec -
tion twice weekly. Whilst Remicade acts to de stroy cells pro duc ing TNF al pha, Enbrel acts sim ply to in hibit
them, be ing an an ti body-like fu sion pro tein as op posed to an an ti body. An other ad di tion to the
monoclonal an ti body mar ket is Abbott‘s (USA) Humira (adalimumab), a fully hu man monoclonal an ti -
body di rected against tu mor ne cro sis fac tor-al pha, li censed to Eisai/Hokuriku‘s (Japan), where it won
approval in April 2008.
Ac cord ing to IMS, in the year end ing Sep tem ber 2008, Enbrel was Ja pan’s lead ing ‘to tal spe cific
anti-rheu matic’ (M1C class) with 49.9% share of the mar ket and 58% fixed dol lar growth over the pre vi -
ous year. Enbrel also dom i nated the world wide M1C mar ket with 53.4% share and 9% fixed dol lar
growth, fol lowed by Humira with 35.6% share, up 41%. Other sig nif i cant prod ucts in the M1C class in the
pe riod were BMS’ Orencia, Arava (leflunomide) from sanofi-aventis (France), Wyeth’s Ledertrexate
(methotrexate) and Amgen’s Kineret. Ac cord ing to IMS, Remicade be longs to the ‘Immunosuppressive
Agents’ (L4A) ther apy class, which it led in the same time pe riod with a world wide mar ket share of 40.7%
and registered 16% growth.
Sales/An a lyst Com ment: Enbrel gen er ated sales of Yen18.8 bil lion in the year end ing March 31 2008,
and an a lysts at Mor gan Stan ley (Au gust 2008) fore cast sales of Yen45 bil lion by the year end ing March
2013.
OSTEN (ipriflavone), an orally-ac tive agent against os teo po ro sis, was launched in Ja pan in 1988. It was
orig i nally de vel oped by Chinoin (Hun gary), now part of sanofi-aventis (France). For It aly, Chinoin li -
censed it to Chiesi (It aly). Chiesi has now sub-li censed it to Takeda Italia and the two groups are co-mar -
ket ing in It aly. Takeda launched it as Iprosten in It aly in 1991, while Chiesi mar kets it as Osteofix. In
2001, ipriflavone was launched in Mex ico and Co lom bia for the treat ment of postmenopausal
osteoporosis.
� Respiratory System Agents
BRONICA (seratrodast), an orally-ac tive thromboxane A2 re cep tor an tag o nist, was launched on its first
world mar ket, Ja pan, in 1996, for the treat ment of bron chial asthma. Bronica, the first thromboxane A2
re cep tor an tag o nist to be launched, is avail able in tab let and gran u lar for mu la tions. It works by in hib it ing
in creases in air way hy per sen si tiv ity and air way ste no sis by se lec tive an tag o nism of thromboxane A2 re -
cep tors. In 1998, Takeda re vised the pre cau tions sec tion of the pack age in sert for Bronica, fol low ing re -
ports of se vere hepatic dis or ders as so ci ated with the drug. Phase II/III tri als were un der way in Eu rope as
well as phase III in the USA, with the Takeda/Abbott jv TAP, which was dissolved in May 2008.
� Systemic Anti-Infective Agents
ACEL-IMUNE (acellular per tus sis + tet a nus + diph the ria vac cine) was first launched in Ja pan in 1981. It
was li censed to Lederle-Praxis Bi o log i cals, now part of Wyeth (USA), for mar kets out side Ja pan, and was
launched in the US in 1992. Wyeth has since launched it in a num ber of mar kets. Data sug gests that the
in ci dence of ad verse re ac tions af ter Acel-Imune, such as pain at the in jec tion site, fe ver and vom it ing are
re duced by up to 50% com pared to whole cell vaccine.
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