IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
for the treat ment of MM by the US FDA in June 2006 and by the Eu ro pean Com mis sion in June 2007, by
the Aus tra lian Ther a peu tic Goods Ad min is tra tion in Jan u ary 2008, and in Can ada in Oc to ber 2008. In
June 2007 Celgene launched the agent in the UK and Ger many for the treat ment of MM in pa tients who
have re ceived at least one prior ther apy. In June 2008 pos i tive data from phase III tri als of Revlimid plus
dexa meth a sone in newly di ag nosed MM pa tients was re ported at ASCO. The two stud ies re ported a sur -
vival advantage and improved complete response rates.
In Feb ru ary 2006, Celgene launched Revlimid in the USA for the treat ment of trans fu sion-de pend ent
ane mia due to low or in ter me di ate-1-risk myelodysplastic syn dromes (MDS) as so ci ated with a de le tion
5q cytogenetic ab nor mal ity with or with out other cytogenetic ab nor mal i ties. An MAA was sub mit ted to
the EMEA in Au gust 2005 seek ing ap proval of the drug for the treat ment of trans fu sion-de pend ent ane -
mia due to low- or in ter me di ate-1-risk MDS as so ci ated with a de le tion 5q cytogenetic ab nor mal ity with or
with out ad di tional cytogenetic ab nor mal i ties; the EMEA ac cepted the MAA for re view in Oc to ber 2005.
How ever, in Jan u ary 2008, the EMEA is sued a negative opinion, and in June 2008 Celgene withdrew the
MAA.
In June 2008, Keryx Biopharmaceuticals (USA) re ported re sults from a multicenter, open-la bel US phase
II trial of its drug perifosine (KRX 0401) in pa tients with MM. The trial as sessed the safety and ef fi cacy of
perifosine alone and in com bi na tion with dexa meth a sone in pa tients with re lapsed and/or re frac tory MM.
Other drugs in de vel op ment for mul ti ple myeloma in clude carfilzomib from Proteolix (USA) which in July
2008 was in a phase II trial in pa tients with re lapsed MM in com bi na tion with lenalidomide and dexa meth -
a sone and was granted or phan drug des ig na tion in April 2008.
In the 12-month pe riod to the end of June 2008, Velcade was num ber eight in the ‘All Other
Antineoplastics’ class with a 3.3% mar ket share and 36% fixed rate dol lar growth. This class was led by
MabThera/Rituxan (rituximab) with an 18% mar ket share and 14% dol lar growth, fol lowed by Roche’s
breast can cer drug Herceptin (trastuzumab) with a 15.6% mar ket share and 14% dol lar growth.
Revlimid, Velcade’s di rect com pet i tor, is clas si fied as ‘To tal Immunosuppressive Agents’ in which it has a
mar ket share of 3.9% with 388% fixed dollar growth.
Sales/An a lyst Com ment: Ac cord ing to IMS, Velcade was Takeda’s eighth lead ing in ter na tional prod -
uct in the year end ing Sep tem ber 2008 with 2.5% of cor po rate sales, up 40% over the pre vi ous year
(fixed-dol lar growth). Velcade brought Takeda sales of Yen30.3 bil lion in fis cal 2007 (end ing March
2008). An a lysts at Mor gan Stan ley (Au gust 2008) fore cast sales of Yen76.7 bil lion by the year end ing
March 2013 for Takeda.
� Cardiovascular System Agents
ADECUT/CUPRESSIN (delapril), an ACE in hib i tor, was launched in Ja pan in 1989. It has since been
launched in sev eral mar kets in clud ing South Ko rea, Thai land, In do ne sia and the Phil ip pines. It is in di -
cated in the treat ment of es sen tial and re nal hypertension.
Li cens ing: Delapril was li censed-out to Chiesi (It aly) for Eu rope and Brazil and launched by Chiesi in It -
aly in 1995.
Lifecycle Man age ment: Li censee Chiesi has de vel oped a com bi na tion of delapril and the cal cium an -
tag o nist manidipine, with the trade name Vi vace. It was launched in Aus tria in Sep tem ber 2005 and in
Ger many in Feb ru ary 2006. In March 2006, it was launched in Brazil as Hipertil. Delapril, and the cal -
cium an tag o nist, manidipine were orig i nally de vel oped by Takeda, and li censed by Chiesi for Eu rope and
Brazil. Takeda does not ap pear to be de vel op ing this com bi na tion product in Japan, however.
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