IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Clin i cal Data: In 2000, re sults of a trial of Lupron in Alz hei mer’s dis ease were pre sented (go nad o tro pin
lev els are higher in women with Alz hei mer’s). TAP was spon sor ing fur ther re search in this area.
Li cens ing: Leuprorelin has been li censed out to Abbott for Can ada, Eu rope, Mex ico and sev eral other
Latin Amer i can coun tries. The TAP jv mar keted it in the USA. Abbott and Takeda con cluded their TAP joint
ven ture in May 2008 and Abbott re ceived rights to Lupron.
In No vem ber 2003, TAP ob tained an ex clu sive li cense from Norwood Ab bey (Aus tra lia) to ex pand the in -
di ca tions for Lupron. Norwood has been in ves ti gat ing ways in which LHRH can be used to boost T-cell
pro duc tion by the thy mus gland, pro duc tion which nor mally de clines with pu berty. LHRH may be able to
tem po rarily block pro duc tion of sex ste roids that are re spon si ble for this de cline. The two com pa nies will
jointly fund R&D to as sess ap pli ca tions in fields in clud ing bone mar row trans plan ta tion, can cer and
HIV/AIDS. TAP would have re spon si bil ity for fil ing any re sult ing sNDAs, and would pay mile stones and
roy al ties to Norwood. In ad di tion, TAP ac quired a $2 mil lion eq uity stake in Norwood Im mu nol ogy, a
wholly owned Norwood subsidiary based in the UK.
Pat ents: In 1999, Takeda filed law suits against OWL Pharmaceuticals and Oakwood Lab o ra to ries (USA)
with a US dis trict court claim ing in fringe ment of 12 pat ents re lated to its leuprorelin de pot for mu la tion.
OWL had sub mit ted an ANDA in the US for a ge neric ver sion of Lupron De pot. The suit called for a halt to
ac tiv i ties that in fringe Takeda’s pat ents and post pone ment of FDA ap proval un til those pat ents ex pire.
Ac cord ing to Takeda, the pat ents will re main in effect until after 2010.
Oakwood Lab o ra to ries (USA) has filed suit in the US Dis trict Court al leg ing that TAP and its co-own ers Ab -
bot and Takeda have been and are in fring ing the US ‘542 pat ent by mak ing and sell ing sus tained-re lease
leuprolide ac e tate prod ucts un der the trade name Lupron De pot. The suit fur ther al leges that TAP and its
par ent com pa nies had knowl edge of the pat ent, which was is sued in 1989, and that the in fringe ment was
will ful. The suit was filed by Oakwood Lab o ra to ries and the Uni ver sity of Ken tucky Re search Foun da tion,
the pat ent owner and li cen sor of rights under the ‘542 patent to Oakwood.
In 2003, TAP filed a suit against Atrix (now QLT, USA) and its li censee Sanofi-Synthelabo (now
sanofi-aventis, France) al leg ing that the use of the Atrigel de liv ery sys tem in their prod uct Eligard
(leuprolide ac e tate for in ject able sus pen sion) in fringes a Takeda and Waco US patent.
In Sep tem ber 2007, Takeda set tled lit i ga tion amount ing to Yen37.6 mil lion re lat ing to the be reaved fam -
ily of an em ployee who had been in volved in de vel op ing con trolled re leased for mu la tion of Leuplin.
Lifecycle Man age ment: The FDA ap proved an IND for a trial us ing Lupron De pot to re ju ve nate the thy -
mus gland and im prove im mune re sponse in pa tients who re ceived an autologous bone mar row trans -
plant, us ing an ap proach de vel oped by Aus tra lia’s Norwood Im mu nol ogy and will be co-funded by the US
Na tional Can cer In sti tute and the Na tional In sti tute of Al lergy and Infectious Disease.
TAP, Takeda’s fully-owned US sub sid iary, an nounced in 2003 that LuproLoc be came avail able for use
with Lupron De pot (leuprolide ac e tate for de pot sus pen sion) as the first prod uct in its class to of fer a nee -
dle safety de vice on pre-filled sy ringes. LuproLoc, which was ap proved by the US FDA, fea tures an in no -
va tive, in te grated safety mech a nism at tached to pre-filled sy ringes con tain ing Leupron De pot. The new
prod uct is de signed to of fer healthcare work ers ad di tional pro tec tion from needlestick in jury, which is a
cause of oc cu pa tional ex po sure to dis eases such as HIV, hep a ti tis B and hep a ti tis C. The FDA ap proval is
the re sult of fil ings with both the FDA’s cen ter for Drug eval u a tion and Re search (CDER) and its Cen ter for
De vices and Ra dio log i cal Health (CDRH). The de vice is the first prod uct to come to mar ket fea tur ing tech -
nol o gies li censed by TAP from Spe cial ized Health Prod ucts In ter na tional (SHPI). Takeda has now de vel -
oped 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 six-monthly in jec tion was
awaiting approval in 2007 in Germany, Italy and France following filings in 2005.
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