IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Norwood Ab bey (Aus tra lia) is in volved with Takeda in an ad di tional clin i cal study which will pro vide a
greater un der stand ing of the ef fects of Lupron on the out put of new T-cells from the thy mus, as well as
changes in other cel lu lar com po nents of the im mune sys tem. The study is be ing con ducted in con junc tion
with TAP at a num ber of high-pro file US hos pi tals. The pro to col for this study is now be ing re viewed by the
eth ics com mit tee at Norwood. An IND is not re quired for this trial, as it is based on the anal y sis of blood
sam ples from pa tients al ready be ing treated with Lupron within in di ca tions al ready ap proved by the FDA.
The study is slated to commence in the first quarter of 2005.
A sig nif i cant new ther apy area for leuprorelin in Ja pan is endometriosis, which, with a po ten tial 70,000
cases a year, ex ceeds the mar ket for pros tate can cer (30,000 per year). Leuprorelin has also been ap -
proved for the treat ment of breast can cer and uter ine fib roids in Japan.
Com pe ti tion: Lupron/Enantone ac counts for al most half (48.9%) of the To tal Cytostatic Hor mones
ther a peu tic cat e gory. In the 12 month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Lupron
was num ber two in the class, with a mar ket share of 22.1%, down 5% in fixed rate dol lar terms, and
Enantone was third with 20.6% of the mar ket, steady over the pre vi ous year. Just ahead of Lupron alone
in terms of mar ket share was AstraZeneca’s (UK) Zoladex (goserelin), with a 26.8% mar ket share,
steady over the pre vi ous year in fixed rate dol lar terms. The GnRH sub-seg ment of the mar ket, dom i -
nated by Lupron and Zoladex, is worth around $2.5 billion globally.
In April 2005, data was re leased re veal ing that pros tate can cer pa tients treated with Zoladex im me di -
ately af ter ra di a tion ther apy live lon ger than men who wait to take the drug. Cur rently around half of
pros tate can cer pa tients treated with ra di a tion go on to take Zoladex. These re sults could also en cour age
ear lier use of Lupron as both drugs work in ex actly the same way and cost around the same. In May 2006,
AstraZeneca granted Biovail rights to pro mote Zoladex to ob ste tri cians and gy ne col o gists for the treat -
ment of endometriosis in the USA and Puerto Rico.
In 2004, Valera Pharmaceuticals (USA) re ceived FDA mar ket ing ap proval for the firm’s long-act ing
(12-month ad min is tra tion) im plant Vantas (histrelin), a syn thetic nonapeptide ag o nist of luteinizing hor -
mone-re leas ing hor mone (LHRH). LHRH agonists have rap idly be come a main stay in treat ing lo cally ad -
vanced and met a static pros tate can cer with the US mar ket, which could af fect the shorter du ra tion
Leupron Depot sales.
Sales/An a lyst Com ment: In the year to March 31 2008, ac cord ing to Takeda, do mes tic sales of
Leuplin were Yen66.4 bil lion, up 3.3%, while to tal global sales reached Yen124.0 bil lion (down 2.7%). In
the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Enantone was Takeda’s num ber
four in ter na tional phar ma ceu ti cal prod uct, gen er at ing 6.3% of cor po rate sales, up 1% over the pre vi ous
year in fixed rate dol lar terms. Mor gan Stan ley an a lysts (Au gust 2008) fore cast Leuprin to tal sales fall ing
to Yen112.5 billion by the year to March 2013.
MYLOTARG (gemtuzumab ozogamicin) is a hu man ized monoclonal an ti body, linked to calicheamicin,
which has been de vel oped by Wyeth in col lab o ra tion with Celltech Group (now part of UCB, Bel gium) and
was first launched by Wyeth in the USA in 2000 for the treat ment of acute myeloid leu ke mia. Wyeth KK
(Ja pan), gained ap proval for Mylotarg in Japan in 2005.
VELCADE (bortezomib), a small mol e cule protesome in hib i tor, was launched in the USA by Mil len nium
(now part of Takeda) in 2003 for the treat ment of mul ti ple myeloma (MM) in pa tients who have re ceived
at least two prior ther a pies and have dem on strated dis ease pro gres sion since the last ther apy. Velcade is
ad min is tered as an in jec tion. Li censee John son & John son from 2004 has launched it in many ex-US mar -
kets and in Sep tem ber 2008, J&J re ported that Velcade has been ap proved as a sec ond-line ther apy for
MM in 87 coun tries world wide. In Ja pan, Velcade was ap proved in Sep tem ber 2006 on the con di tion that
all-pa tient post-mar ket ing sur veil lance is con ducted, a guide book for proper use is dis trib uted and that
the pack age in sert con tains strong warn ings. Data from clin i cal tri als and ADR re ports from phy si cians
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