IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Li cens ing: In July 2006, Gal axy signed a li cens ing agree ment with Takeda, grant ing the lat ter ex clu sive,
world wide rights to de velop, man u fac ture and mar ket HuL 2G7. Gal axy will re ceive an upfront $2 mil lion
li cens ing fee from Takeda, as well as mile stone pay ments de pend ent on the achieve ment of cer tain de -
vel op ment and reg u la tory mile stones. Gal axy will also be en ti tled to roy al ties on prod uct sales. Takeda
will fund fur ther re search ac tiv i ties at Gal axy on HuL 2G7 and suc ces sor agents, for a period of four years.
AMG 479, a fully hu man monoclonal an ti body tar geted to in su lin-like growth fac tor 1 (IGF-1), with po -
ten tial in the treat ment of can cer was in phase II tri als in the USA with Amgen in 2009. In Feb ru ary 2008
Amgen and Takeda signed an agree ment un der which Takeda will de velop and com mer cial ize in Ja pan up
to 13 of Amgen’s early- to mid clin i cal-stage can di dates, including AMG 479.
Blood and Blood-Forming Organ Agents
pegylated erythropoietin receptor agonist AF 37702 B3X III
factor xa inhibitor TAK 442 B2C1 II
HEMATIDE (pegylated eryth ro poi e tin re cep tor ag o nist) was in phase III tri als in the US and Eu rope, and
phase II in Ja pan in 2009, for the treat ment of ane mia in di al y sis and predialysis chronic kid ney dis ease
pa tients with pure red cell aplasia (PCRA, an au to im mune re ac tion to re com bi nant eryth ro poi e tin). In -
terim re sults re leased in April 2008 sug gested that it is safe and ef fec tive in kid ney di al y sis pa tients and
suc cess fully main tained he mo glo bin lev els in the target range over 18 months of treatment.
A phase I trial (to en rol 100 pa tients with non small cell lung, breast or pros tate can cer) com menced in
the US in Jan u ary 2008 for ane mia in can cer pa tients un der go ing che mo ther apy and sim i lar phase I tri als
have al ready been ini ti ated in the EU and Ja pan. In Au gust 2008 how ever, Takeda and Affymax sus -
pended de vel op ment of Hematide as a treat ment for che mo ther apy-in duced ane mia, and will fo cus on
de vel op ing the agent as a treat ment for ane mia re lated to chronic kid ney dis ease be cause of un cer tain
reg u la tory pros pects for such agents in on col ogy in di ca tions; the FDA added ‘black box’ warn ings to
eryth ro poi e tin prod ucts in 2008. No fur ther en roll ment will take place in the ongoing phase I trial of
Hematide in cancer patients.
Li cens ing: In Feb ru ary 2006, Affymax granted Takeda an ex clu sive li cense to de velop and com mer cial -
ize Hematide in Ja pan. Takeda will pay $17 mil lion upfront and pur chase $10 mil lion of Affymax’s stock.
In ad di tion, Affymax is en ti tled to re ceive clin i cal and reg u la tory based mile stone pay ments to tal ing $75
mil lion as well as a dou ble-digit roy alty on sales upon Jap a nese launch; al to gether the deal was val ued at
$100m to Affymax. Takeda is re spon si ble for all de vel op ment and com mer cial iza tion costs in Ja pan.
Affymax will man u fac ture and sup ply the drug sub stance for Takeda to man u fac ture the fi nal com mer cial
prod uct for use in Ja pan. This agree ment was mod i fied in June 2006 to grant Takeda rights to de velop
and com mer cial ize Hematide out side the USA, and to col lab o rate with Affymax on the de vel op ment of the
prod uct in the USA. A $10 mil lion pay ment was made by Takeda in Feb ru ary 2007 fol low ing the com ple -
tion of phase I test ing in nor mal healthy volunteers. Takeda is to commercialize Hematide in Europe also
upon approval.
Clin i cal Data: In 2008, Affymax com pleted en roll ment in the phase III pro gram of Hematide in chronic
re nal fail ure (PEARL 1, PEARL2, EM ER ALD 1, and EM ER ALD 2) in volv ing a to tal of 2,600 chronic re nal fail -
ure pa tients with the aim of com ple tion, data col lec tion and NDA fil ing in 2010. Takeda an nounced re sults
of a phase II clin i cal trial of Hematide in No vem ber 2007 in dem on strat ing that six months of in jec tion
with the prod uct re stored he mo glo bin to the tar get range and elim i nated the need for red blood cell
transfusion in the patients studied.
Com pe ti tion: This syn thetic drug will com pete with bi o logic ane mia prod ucts that have faced re stric -
tions over safety and po ten tial over use con cerns. The Jap a nese mar ket for erythropoiesis agents is worth
around $1 bil lion an nu ally, cur rently dom i nated by re com bi nant erythropoietins such as Roche’s (Swit -
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