IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
� Antineoplastics/Immunomodulating Agents
CANFERON-A (in ter feron al pha-2a), a cytostatic and an ti vi ral (re com bi nant hu man in ter feron), was
launched in 1986 in Ja pan. It was jointly de vel oped with Roche (Swit zer land) un der li cense from
Genentech (USA) and is co-mar keted with Roche in Ja pan. Roche mar kets it world wide (in clud ing in Ja -
pan) for a num ber of can cer and an ti vi ral in di ca tions as Roferon-A. Al pha-in ter feron is in di cated in Ja pan
for ma lig nant mel a noma, re nal cell car ci noma and vi ral hep a ti tis. Sales of in ter feron prod ucts in Ja pan
have been in de cline since a warn ing in 1994 by Ja pan’s then Min is try of Health and Wel fare that al -
pha-interferons may cause de pres sion and ex ac er bate sui cidal ten den cies. In late 2003, the Min is try of
Health, La bor and Wel fare in sisted that a range of side-ef fect warnings be added to the product label of
Canferon and other interferons.
CELEUK (celmoleukin), a re com bi nant interleukin-2 prod uct, was de vel oped in-house by Takeda. It was
the first prod uct of its kind to be mar keted in Ja pan and was in tro duced in 1992. It is in di cated pri mar ily as
an anticancer agent, par tic u larly for the treat ment of ma lig nant hemangioendotheliomas, and also for
Ep stein-Barr virus infections.
ISOVORIN (cal cium levofolinate), an in ject able methotrexate res cue in osteosarcoma and mod u la tion
of 5-FU drug ther apy in colorectal, breast, head, and neck can cers. Isovorin re duces the side ef fects of
methotrexate on cells lin ing the mouth and gut as well as blood cells in volved in fight ing in fec tion.
Levofolinic acid is given by in tra ve nous in jec tion or in fu sion, or by in tra mus cu lar (into muscle) injection.
Sales/An a lyst Com ment: Mor gan Stan ley an a lysts (Au gust 2008) fore cast sales de clin ing to Yen10.0
bil lion by the year to March 2013.
LEUPLIN/LUPRON (leuprorelin), a luteinizing hor mone-re leas ing hor mone (LHRH) an a logue, is in di -
cated in the treat ment of pros tate can cer, endometriosis and uter ine fib roids. It is also in di cated in the
treat ment of pre co cious pu berty and breast can cer in some mar kets. Leuprorelin was Takeda’s first prod -
uct to be sold on a global ba sis. It was orig i nally launched as a daily in jec tion in the USA in 1985 by TAP,
Takeda’s joint ven ture with Abbott which was con cluded in May 2008 with Abbott re tain ing US rights to
this product.
It was launched in Ja pan (as Leuplin) and is now avail able in over 60 mar kets world wide. In 2005 the Min -
is try of Health, La bor and Wel fare added pre cau tions of pi tu itary ap o plexy and blurred vi sion to the prod -
uct la bel. Leuprorelin was de vel oped over seas be fore be ing launched on the do mes tic mar ket be cause of
the higher in ci dence of pros tate can cer over seas. In France and It aly leuprorelin is mar keted as
Enantone. Takeda Pharma mar kets it in Ger many and Aus tria (as Enantone), and a pre-filled sy ringe
im plant ver sion was launched in Ger many as Trenentone in 2003. An a lysts state that the key to the
prod uct’s suc cess is its availability in long-acting dosage forms.
Lupron De pot was orig i nally a monthly dos age form, slowly re leased from a “de pot” in jected into a mus -
cle. Takeda has been de vel op ing a num ber of slow-re lease ver sions, in clud ing Lupron De pot-4, where
pa tients only re quire an in jec tion ev ery four months and Lupron De pot-3 (once ev ery three months). A
four monthly Leuplin SR for In jec tion Kit for pros tate can cer us ing a new microcapsule base was
launched in Ja pan in Au gust 2002 for pros tate can cer. In Au gust 2005 Takeda an nounced that the Jap a -
nese Min is try of Health, La bor and Wel fare has granted mar ket ing ap proval for sus tained-re lease
leuprorelin (Leuplin SR) as an ad junct to pre vent re lapses of premenopausal breast can cer. The clear ance
is for the 11.25mg three-month microcapsule de pot kit for mu la tion, and the 3.75mg kit, and stan dard
foruulations are also ap proved for use in help ing post op er a tive re cur rence. A six-month de pot for mu la -
tion suit able for pros tate can cer ther apy was ap proved in the USA in 2004 and in Eu rope in 2008 where it
has been launched (France, Germany and Austria).
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