IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
(six hours sleep) com pared with other hyp notic drugs on the mar ket like sanofi-aventis’ (France)
Stilnox/Ambien (zolpidem) and Wyeth/King’s (USA) So nata (zaleplon), which of fer just three hours
sleep and thus is more of a sleep in ducer than maintainer.
In the 12 month pe riod to the end of Sep tem ber 2008, Rozerem climbed to be come the fourth lead ing
prod uct in the global hyp notic mar ket ac cord ing to IMS with 2.4% share down 4% (fixed dol lar growth)
over the pre vi ous year. Stilnox/Ambien cur rently dom i nates with one-third of this mar ket 32.6% mar ket
share al though sales de clined by 46% fixed rate dol lar growth. Ambien first hit the US mar ket in 1993, of -
fer ing an al ter na tive to the older benzodiazepines such as Roche’s Val ium (di az e pam). US ex clu siv ity for
Ambien was due to ex pire in Oc to ber 2006, but in Sep tem ber 2005, a con trolled re lease ver sion
(Ambien CR) was ap proved by the FDA for the treat ment of in som nia, and with a broader ap pli ca tion
than its par ent, with out the re stric tion of use to 7-10 days. Pre vi ously Lunesta had been the only prod uct
with out this re stric tion, while Rozerem is the only prod uct not des ig nated as a con trolled sub stance.
sanofi-aventis’s other benzo diaz epine an tag o nist Imovane (zopiclone) now wits in fifth place in this
class with 2.4% market share and 17% growth.
While Lunesta has been crit i cized for its un pleas ant taste, an a lysts be lieved it has sig nif i cant com mer cial
po ten tial and in the year end ing Sep tem ber 2008, ac cord ing to IMS it took sec ond po si tion with a 17%
mar ket share and 7% fixed rate dol lar growth. Num ber three was Boehringer Ingelheim’s Lendormin
(brotizolam), with a 3.0% mar ket share and up 4% over the previous year.
Wyeth/King’s (USA) So nata (zaleplon) other benzo diaz epine an tag o nist has fallen to eighth place, with a
1.4% mar ket share, and with sales down 37% in fixed rate dol lar terms.
Many an a lysts are con tent with Takeda’s view that Rozerem of fers the best side ef fect pro file with vir tu -
ally no abuse po ten tial, re bound in som nia, with drawal ef fects or im pact on mo tor func tion (and no hang -
over like ef fects the next day). All other pre scrip tion in som nia drugs have been des ig nated sched ule IV
con trolled sub stances by the US Drug En force ment Ad min is tra tion, a cat e gory Rozerem avoided be cause
of lack of ev i dence of de pend ency or abuse, and this is a real sell ing point for Takeda. The prod uct acts on
neuronal ac tiv ity in the brain’s suprachiasmatic nu cleus to pro mote phys i o log i cal rather than sed a tive
sleep. Other an a lysts have ex pressed con cern over the nar row in di ca tion for Rozerem, which does not in -
clude sleep main te nance, a strong sell ing point for Lunesta; an a lysts at Merrill Lynch note that the treat -
ment of sleep main te nance in som nia represents a larger market opportunity than sleep onset insomnia.
A ma jor com pet i tor was ex pected to be indiplon, which Neurocrine Bio sci ences (USA) had part nered with
Pfizer (USA). Indiplon has been dem on strated to be as ef fec tive as Ambien in treat ing in som nia with out
caus ing next-day re sid ual ef fects. The drug hit prob lems in 2006, how ever, when the FDA gave only con -
di tional ap proval, and the com pany has to con duct an other trial. In June 2007, Neurocrine Bio sci ences
re sub mit ted the NDA for indiplon cap sules, but an a lysts are now skep ti cal about the prod uct’s po ten tial
with out Pfizer’s mar ket ing mus cle be hind it af ter the com pany ter mi nated its agree ment with Neurocrine.
In July 2008, Neurocrine Bio sci ences (USA) is sched uled to be meet ing with the FDA to dis cuss its De -
cem ber 2007 ‘ap prov able’ let ter for indiplon 5 and 10mg cap sules; the agency re quested an ob jec -
tive/sub jec tive clin i cal trial in the el derly, a safety study as sess ing the rates of ad verse events oc cur ring
with indiplon com pared with a prod uct on the mar ket, and a pre clin i cal study eval u at ing the ad min is tra -
tion of indiplon dur ing the third tri mes ter of preg nancy — al most halv ing Neurocrine’s share price to an
eight-year low. Indiplon is a nonbenzodiazapine agonist of the benzodiazepine site on GABA receptors.
At the end of Jan u ary 2008, Somaxon (USA) filed Silenor (doxepin) for ap proval in in som nia; this is ac -
tu ally an old, tricyclic an ti de pres sant, and is thus not ex pected to be come a sched uled prod uct. Silenor
could be come the first non sched uled in som nia treat ment to help pa tients fall asleep and main tain sleep
through out the night giv ing a dis tinct mar ket ing ad van tage over Rozerem which is in di cated spe cif i cally
for in som nia marked by dif fi culty with sleep on set. Rozerem is the first sleep aid with a new mech a nism of
ac tion launched in over 30 years and the only pre scrip tion treat ment for this use not to be des ig nated as a
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