IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
ten tion def i cit hy per ac tiv ity dis or der (ADHD) in chil dren and ad o les cents. Li censee Cephalon (USA) has
dis con tin ued fur ther development of modafinil for this indication.
Li cens ing: Lafon (France) holds pat ent rights to modafinil, and Cephalon has li censed rights to the prod -
uct in the USA, UK, Ire land, Ja pan, It aly, Mex ico, Latin Amer ica and sev eral Asian coun tries. In June
2006, Cephalon and Takeda an nounced that they had en tered into an agree ment, un der which Takeda
will co-pro mote Provigil in the USA. The three-year deal will have an op tion to re new an nu ally, and
Cephalon will also have an op tion to use Takeda to pro mote Nuvigil (armodafinil). Cephalon will pay
Takeda a roy alty based on cer tain sales cri te ria for both prod ucts. Cephalon will re tain all re spon si bil ity for
de vel op ment, dis tri bu tion and sales of modafinil.
ROZEREM (ramelteon), a melatonin ag o nist de vel oped by Takeda, was launched in 2005 in the USA for
in som nia char ac ter ized by dif fi culty with sleep on set. Rozerem is the first and only non-sched uled pre -
scrip tion sleep med i ca tion to be ap proved (thus al low ing phy si cians to pre scribe for long-term use in
adults) and also is the first pre scrip tion in som nia med i ca tion with a novel mech a nism of ac tion to be
approved in the last 35 years.
Phase III tri als were on go ing in Ja pan and in Feb ru ary 2008, Takeda sub mit ted an NDA in Ja pan for ap -
proval of ramelteon in the treat ment of pri mary insomnia.
In March 2007 Takeda sub mit ted a Mar ket ing Au tho ri za tion Ap pli ca tion to the Eu ro pean Med i cines
Agency (EMEA) for this in di ca tion. Takeda’s ap pli ca tion was sub mit ted through the cen tral ized pro ce dure
and is sup ported by clin i cal trial data from 8100 pa tients aged 18 to 93. Takeda an nounced in Sep tem ber
2008 that it has with drawn its MAA for ramelteon in the EU, seek ing ap proval for the treat ment of pri mary
in som nia. The de ci sion fol lows the anal y sis of ad di tional clin i cal data, col lected af ter Takeda’s re quest for
re-ex am i na tion of the CHMP’s neg a tive opin ion in May 2008. Takeda re mains com mit ted to gain ing EU
ap proval of the agent, and plans to submit a new MAA to the EMEA in the future.
In March 2007, the FDA called for stron ger warn ings for 13 sleep ing pills in clud ing Rozerem of dan ger ous
po ten tial side ef fects like al ler gic re ac tions and sleep driv ing. The same month, the FDA also said that TV
ad ver tise ments of Rozerem that in cluded im ages of chil dren vi o lated rules as Takeda does not have ap -
proval for pe di at ric use and it is not known if Rozerem is safe in ad o les cents due to po ten tial ef fects on re -
pro duc tive hor mones. Fur ther more, Takeda failed to sub mit the ad ver tise ment be fore run ning and while
the FDA does not have to sign off be fore run ning, companies are required to submit beforehand.
Clin i cal Data: The FDA ap proval was backed by data from more than 4,200 pa tients aged 18 to 93, in -
clud ing a 472 pa tient trial with sin gle doses daily for up to a year. Rozerem was ad di tion ally shown to be
safe in adults with COPD or mild-to-mod er ate sleep apnea as well as el derly adults. Clin i cal stud ies also
re vealed that Rozerem had no more po ten tial for abuse or be hav ioral im pair ment than pla cebo, even at
up to 20 times the pro posed therapeutic dose.
In May 2007, a new study pre sented by TPNA showed that ramelteon did not im pair mid dle-of-the-night
bal ance, mo bil ity or mem ory per for mance in older adults with in som nia over pla cebo un like the zolpidem
treated pa tients who dem on strated im paired per for mance in these mea sures com pared with placebo.
Lifecycle Man age ment: Phase II tri als are be ing con ducted in the USA for sleep/cir ca dian rhythm dis -
or ders/jetlag. Ramelteon spe cif i cally tar gets melatonin ML-1 re cep tors within the hy po tha lamic re gion of
the brain.Takeda had ex pressed in tent to ex tend the use of Rozerem to treat Alz hei mer’s dis ease (TAK
375) but phase III tri als were dis con tin ued in 2007 fol low ing in suf fi cient num bers of pa tients re cruited
meeting inclusion criteria.
Com pe ti tion: The US in som nia mar ket is fore cast to grow sub stan tially but Takeda is not the only one
hop ing to tap into this growth. In 2005, Sepracor’s in som nia treat ment, Lunesta (eszopiclone), hit the
mar ket, around six months ahead of Rozerem. Lunesta of fers the ad van tage of long du ra tion of ac tion
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