IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
LGD 2226 is the lead ing com pound in a se ries of se lec tive an dro gen re cep tor mod u la tors (SARMs), orig i -
nally de vel oped by Ligand (USA). SARMs con trib ute to the pre ven tion and treat ment of cer tain dis eases,
in clud ing male and fe male sex ual dys func tion, male and fe male os teo po ro sis, frailty and male
hypogonadism. Pre clin i cal stud ies have been con ducted in the USA. Ligand and TAP re ported in De cem -
ber 2003 that the com pa nies had ex tended their agree ment to dis cover and de velop SARMs. The agents
have po ten tial in the treat ment of male and fe male sex ual dysfunction, osteoporosis and male
hypogonadism.
Li cens ing: In 2001, Ligand granted TAP Pharmaceuticals ex clu sive world wide rights to man u fac ture and
sell se lec tive an dro gen re cep tor mod u la tors (SARMs), in clud ing LGD 2226, which treat an dro gen-re lated
dis eases. Un der the terms of the deal, TAP has been granted ex clu sive world wide rights to man u fac ture
and sell any prod ucts re sult ing from the col lab o ra tion in its field, in clud ing treat ment and pre ven tion of
hypogonadism, male sex ual dys func tion, fe male os teo po ro sis, male HRT and other in di ca tions not re -
tained by Ligand. Ligand could po ten tially re ceive $44 mil lion in re search fund ing and mile stones if two
prod ucts are suc cess fully de vel oped dur ing the col lab o ra tion. It may also re ceive roy al ties if com pounds
are com mer cial ized. Ligand re tains cer tain rights in the an dro gen re cep tor field, in clud ing the prevention
or treatment of prostate cancer, BPH, acne and hirsutism.
Hormonal Agents
injectable gnrh modulator TAK 683 H4X, L1X9 I
lh-rh receptor antagonist TAK 385 H1C3 I
TAK 683, an in ject able GnRH mod u la tor was re ported to be in phase I tri als for pros tate can cer with
Takeda in 2008.
TAK 385, an oral luteinizing hor mone-re leas ing hor mone (LH-RH) re cep tor an tag o nist for the treat ment
of endometriosis and uterus myoma was re ported to be in phase I tri als in Ja pan with Takeda in 2009.
Musculoskeletal System Agents
febuxostat TMX 67, TEI 6720 M4A Approved
antirheumatic TAK 783 M1C II
P38 MAP kinase Inhibitor TAK 715 M1C II
inflammatory disease therapy MLN 3701 M1C I
COX inhibitor XEN 401 M1A1 Preclinical
MAb, interleukin-1, Amgen AMG 108 M1C Preclinical
FEBUXOSTAT (TMX 67) is an oral xanthine oxidase in hib i tor (XAO) with po ten tial in the treat ment of
gout. Febuxostat is await ing reg u la tory ap proval in the USA, where an NDA was filed in De cem ber 2004
by TAP, for the man age ment of hyperuricemia in pa tients with chronic gout, sup ported by data from over
4,000 pa tients. Takeda re ceived full North Amer i can rights to febuxostat in May 2008 fol low ing the con -
clu sion of a joint ven ture be tween Abbott and Takeda (TAP). In No vem ber 2008 Takeda an nounced that
the Ar thri tis Ad vi sory Com mit tee of the FDA has rec om mended ap proval of febuxostat for the treat ment
of hyperuricemia in pa tients with gout; the panel voted 12 to zero in fa vor of ap proval, with one ab sten -
tion. The panel did how ever flag a po ten tial car dio vas cu lar con cern which they ad vise the FDA to study
fur ther through post-ap proval chan nels. The ‘ap prov able’ let ter was a ma jor reg u la tory mile stone in it self
for febuxostat af ter two pre vi ous ‘ap prov able’ let ters over the safety profile and full FDA approval was
finally granted in February 2009.
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