IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Sales/An a lyst Com ment: With sales of Yen16.5 bil lion in fis cal 2007 (end ing March 2008), up from
Yen16.2 bil lion the pre vi ous year, Mor gan Stan ley an a lysts (Au gust 2008) pre dict sales of Yen26.0 bil lion
by the year end ing March 2013.
DASEN (serrapeptase), an orally-ef fec tive anti-in flam ma tory bac te rial pro te ase, was first launched in
Ja pan in 1968. It was launched in France in 1981, and in Ger many in 1985 as Aniflazym.
Sales/An a lyst Com ment: With sales of Yen7.7 bil lion in fis cal 2007 (end ing March 2008), down from
Yen8.1 bil lion the pre vi ous year, Mor gan Stan ley an a lysts (Au gust 2008) pre dict sales of Yen7 bil lion by
the year end ing March 2013.
ENBREL (etanercept), a mod u la tor of in flam ma tion, was launched in Ja pan in March 2005 fol low ing ap -
proval in Jan u ary for the treat ment of rheu ma toid ar thri tis (RA) in pa tients who have had an in ad e quate
re sponse to ex ist ing ther a pies. Enbrel in hib its tu mor ne cro sis fac tor (TNF). In June 2008, Wyeth and
Takeda launched a once-fort nightly pre-filled self-in jec tion sy ringe for mu la tion of Enbrel, re duc ing the
healthcare bur den. Wyeth mar kets etanercept out side North Amer ica and co-pro motes the agent in
North America with licensor Amgen.
Enbrel was first launched in the USA in 1998 for the re duc tion in signs and symp toms of mod er ately to se -
verely ac tive rheu ma toid ar thri tis in adult pa tients who have an in ad e quate re sponse to one or more dis -
ease mod i fy ing anti-rheu matic drugs (DMARDs), and can be used in com bi na tion with methotrexate in
pa tients who do not re spond ad e quately to methotrexate alone. The prod uct is in di cated for the treat -
ment of RA, psoriatic ar thri tis, an ky los ing spondylitis, and pso ri a sis, and is ad min is tered as a sub cu ta ne -
ous in jec tion twice-weekly. In the USA, the FDA ap proved Enbrel for ju ve nile RA (1999), for psoriatic
ar thri tis in adults (2002), for the treat ment of ac tive an ky los ing spondylitis in adults (2003), as a treat -
ment to im prove phys i cal func tion in pa tients with mod er ate-to-se vere ac tive RA (2003) and an ex -
panded in di ca tion to im prove phys i cal func tion in pa tients with psoriatic ar thri tis (June 2005). In 2004,
the FDA ap proved a once-weekly 50 mg/mL pre-filled sy ringe for mu la tion of Enbrel for the treat ment of
all ap proved adult in di ca tions. This ad di tional for mu la tion eliminates the need to mix the drug prior to
injection and allows for once-weekly injections.
In Eu rope, Enbrel was ap proved for use in mod er ate-to-se vere RA and polyarticular course ju ve nile
chronic ar thri tis in chil dren aged 4-17 in 2000, for psoriatic ar thri tis in adults (2002), and for of ac tive an -
ky los ing spondylitis in adults in 2003. From 1999-2003 it was rolled out in Eu rope, Can ada, Asia and Latin
Amer ica. It is also be ing stud ied in a num ber of other in di ca tions. In 2006, Wyeth ini ti ated a phase II trial
of etanercept in Ja pan in pa tients with ju ve nile RA. In 2009 ap proval was granted for treat ment of chronic
se vere plaque pso ri a sis in children aged eight to 17 years.
Li cens ing: Enbrel was de vel oped by Immunex (now part of Amgen, USA) and is co-mar keted by Wyeth
(USA) in the USA. Wyeth KK, in which Takeda pre vi ously held a stake, is de vel op ing the drug in Ja pan.
Wyeth has rights to Enbrel out side the USA for all in di ca tions out side on col ogy, and the drug will be
co-mar keted with Takeda in Ja pan. Enbrel’s Jap a nese ap proval trig gered changes in the struc ture of
Wyeth’s 60%-owned jv with Takeda. Wyeth’s grad ual planned buy-out of Takeda’s share will con vert the
op er a tion into a wholly-owned sub sid iary. Un der the agree ment, Takeda will con tinue to dis trib ute Wyeth
prod ucts in Ja pan and will co-pro mote Enbrel and co-pro mote or co-market two other products.
Clin i cal Data: In De cem ber 2008, Wyeth and Takeda pub lished re sults from a 151-Jap a nese pa tient
study show ing that co-ad min is tra tion of etanercept with methotrexate gave better re sults than
etanercept alone.
In April 2007, at the An nual Sci en tific Meet ing of the Ja pan Col lege of Rheumatology, data from
post-mar ket ing sur veil lance on data from over 7,000 pa tients ad min is tered Enbrel since April 2005. High
ef fi cacy was shown with marked im prove ment in 28.9%; mod er ate im prove ment in 55.2% and no im -
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