IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Systemic Anti-Infective Agents
epetirimod TAK 851, R 851 J5B II
CCR5 antagonist — J5C9 I
ceftaroline TAK 599, PPI 0903 J1D Preclinical
vaccine, acellular pertussis, tetanus,
diphtheria, poliovirus, Takeda TAK 361S J7B1 Preclinical
R 851, an im mune re sponse mod i fier (IRM) mol e cule, was in phase II tri als in the USA and Eu rope in
2008 as a ther apy for cer vi cal hu man papilloma vi rus (HPV) in fec tion and cer vi cal dysplasia. Cer vi cal
dysplasia is ab nor mal cell growth on the cer vix, usu ally caused by strains of HPV, and is the first stage
pre ced ing the de vel op ment of cer vi cal can cer, al though not all cer vi cal dysplasia becomes cancerous.
Li cens ing: In 2005, orig i na tor 3M (USA) and Takeda en tered into an ex clu sive co-de vel op ment and joint
mar ket ing agree ment for R 851. Un der the terms of the deal, 3M and Takeda will share de vel op ment
costs. Upon suc cess ful clin i cal de vel op ment and reg u la tory ap prov als, both com pa nies will jointly com -
mer cial ize the prod uct in the USA and Eu rope. Takeda has ex clu sive rights in Ja pan and cer tain Asian
coun tries, and 3M will have ex clu sive com mer cial iza tion rights in the rest of the world. In March 2007 this
agree ment was up dated granting Takeda full rights to the drug from 3M.
A CCR5 an tag o nist, be ing de vel oped as an HIV en try in hib i tor, was in phase I tri als in Ja pan. Takeda
pre sented pre clin i cal data at the 229th Amer i can Chem i cal So ci ety na tional meet ing, March 2005, San
Diego, USA.
Li cens ing: In Au gust 2007, Tobira (USA) ac quired ex clu sive world wide rights from Takeda to de velop,
man u fac ture and com mer cial ize TAK 220 and TAK 652. Fur ther de tails of the agree ment were not dis -
closed. Both agents are orally avail able CCR5 an tag o nists with po ten tial for the treat ment of HIV in fec -
tion. TAK 220 and TAK 652 are un der phase I eval u a tion in Eu rope and the USA. Tobira plans to start
phase II tri als of TAK 652, with TAK 220 being developed as a back-up.
CEFTAROLINE (TAK 599/PPI 0903) is a cephalosporin an ti bi otic, in de vel op ment for the treat ment of in -
fec tions caused by methicillin re sis tant Staph y lo coc cus aureus (MRSA), pen i cil lin-re sis tant Strep to coc cus
pneumoniae and Haemophilus influenzae. It is an N-phosphono prodrug of the cephalosporin de riv a tive T
91825. Pre clin i cal mon key and rat stud ies have dem on strated bac te ri cidal activity against MRSA.
Li cens ing: In 2003, Pen in sula li censed rights from Takeda to de velop and com mer cial ize ceftaroline in
all world wide ter ri to ries ex cept Ja pan. Cerexa (part of For est) is now de vel op ing the prod uct, now in
phase III trials globally.
TAK 361S, a vac cine for the pre ven tion of po lio my eli tis, per tus sis, tet a nus and diph the ria was in pre clin i -
cal eval u a tion in Ja pan with Takeda in 2008.
Discontinued Compounds
De vel op ment of the fol low ing has been dis con tin ued:
LAPAQUISTAT (TAK 475), a squalene synthase in hib i tor, was in phase III tri als with Takeda in the USA
and Eu rope, and phase II in Ja pan, in 2008 for the treat ment of hyperlipidemia. In March 2008 how ever,
Takeda an nounced that de vel op ment had been dis con tin ued; based on a judg ment that the safety and
ef fi cacy pro file of the com pound was not su pe rior to ex ist ing mar keted drugs. This fol lowed a rec om -
mended sus pen sion of tri als us ing higher dos ages of the drug as well as ad di tional clin i cal tri als in Oc to ber
2007 by the FDA fol low ing the emer gence of safety is sues re lat ing to liver func tion (transaminase el e va -
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