IMS Company Profiles - Report Buyer

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con trolled sub stance; the mech a nism of ac tion of Silenor is not fully un der stood but works by block ing
the re lease of his ta mine at the H1 re cep tor (most approved insomnia medications act via GABA
receptors).
New in som nia ther a pies in de vel op ment in 2008 in cluded sanofi-aventis’ eplivanserin and
volinanserin, 5-HT2A re cep tor an tag o nists both in phase III tri als. Reg u la tory fil ings for eplivanserin
were ex pected dur ing the sec ond half of 2008.
Also at the phase III stage is Akzo No bel’s (Neth er lands) esmirtazapine, an other 5-HT2A an tag o nist.
An a lysts ap pear to have high hopes for Vanda’s tasimelteon (VEC-162), a melatonin MT1/MT2 ag o nist
that be gan phase III tri als in 2006, and like Rozerem (which af fects just the MT1 re cep tor), should not be
a con trolled sub stance. Vanda an nounced pos i tive top-line re sults from one phase III study in June 2008,
where tasimelteon showed good ef fi cacy at treat ing chronic in som nia over a four-week pe riod. The com -
pany be lieves that the com pound may also have po ten tial as a ther apy for cir ca dian rhythm sleep
disorders.
Lilly is de vel op ing pruvanserin, a 5-HT2A an tag o nist li censed from Merck KGaA, in phase II tri als, and in
March 2007 an nounced the ac qui si tion of Hypnion, which fo cuses on in som nia ther a pies. Its lead com -
pound, HY10275, also in phase II tri als, tar gets 5-HT2A and the his ta mine H1 re cep tor. Lilly hopes nei -
ther drug would be a controlled substance.
At the end of 2007, Actelion (Swit zer land) ini ti ated a phase III study with almorexant, a first-in- class
orexin OX1/OX2 re cep tor an tag o nist, in chronic pri mary in som nia. In 2008 GlaxoSmithKline en tered a
$3.3 bil lion deal over this drug with Actelion. GSK is also de vel op ing an orexin an tag o nist, in phase II tri -
als: the neuropeptide plays a key role in main tain ing wake ful ness and reg u lat ing the sleep-wake cy cle,
and these new drugs are gar ner ing a lot of attention.
A num ber of com pa nies are de vel op ing novel for mu la tions of zolpidem. In De cem ber 2008, the FDA ap -
proved NovaDel’s Zolpimist, an oral spray prod uct for the short-term treat ment of in som nia. In May
2008, Orexo (Swe den) sub mit ted a 505(b)(2) NDA for Sublinox, which uses the com pany’s sublingual
tab let tech nol ogy, also as a short-term in som nia ther apy; Meda (Swe den) has the global rights to com -
mer cial ize Sublinox, which Orexo claims takes ef fect 30% faster than Ambien. In Oc to ber 2008,
Transcept filed a US NDA for In ter mezzo, an other sublingual formulation of zolpidem.
Sales/An a lyst Com ment: Backed by an ag gres sive Yen25 bil lion ($231.6 mil lion) sales cam paign,
with a di rect-to-con sumer (DTC) com po nent that started in 2006, Takeda aims for Rozerem to be come
its fifth block buster. Sales jumped 25% in the US to $111 mil lion in the year end ing March 2008; Yen12.6
bil lion, from Yen10.3 bil lion in the year to March 2007) and Mor gan Stan ley an a lysts (Au gust 2008) fore -
cast sales ris ing to Yen33.5 bil lion by the year end ing March 31 2013. Some Jap a nese an a lysts have es ti -
mated that peak global sales for Rozerem could reach Yen60-100 billion.
� Genitourinary System/Sex Hormones
IXENSE/UPRIMA (sublingual apomorphine), a do pa mine ag o nist, is in di cated in the treat ment of erec -
tile dys func tion (ED). It acts on the CNS and has a mech a nism of ac tion com pletely dif fer ent from that of
ex ist ing ED prod ucts. The drug has shown ef fec tive ness in men with erec tile dys func tion of or ganic, psy -
cho genic, and mixed eti ol ogy. Cau tion is rec om mended in pa tients us ing antihypertensive agents, ni -
trates or other drugs which might lower blood pres sure. Apomorphine has been used for many years in
the treat ment of Par kin son’s dis ease. It was launched in France, It aly and Ger many as Ixense by Takeda
in 2001, and in Thai land in 2002. In the UK, it was co-pro moted by Takeda and Abbott as Uprima. In the
rest of the EU, Takeda will use the Ixense trade name and Abbott Uprima. Li censee Abbott has launched
the prod uct as Uprima in a num ber of mar kets in Eu rope and Latin America, as well as New Zealand.
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