IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
This could be an im por tant in di ca tion as it in flu ences how the pa tients func tion in the day time. The same
doses also pro duced a 68.7% and 76.5% re duc tion in weekly in con ti nence ep i sodes ver sus 46% for pla -
cebo. Gen eral anticholinergic sys temic side ef fects (such as dry mouth, con sti pa tion, and blurred vi sion)
have been noted with the drug despite its specificity for M3 muscarinic receptors.
Com pe ti tion: Darifenacin’s main com pet i tors are the lead ing prod uct in this cat e gory, Pfizer’s
Detrusitol (tolterodine) and a newer treat ment, Astellas’ M3 se lec tive prod uct Vesicare (solifenacin).
Vesicare’s side ef fect pro file has dem on strated anticholinergic side ef fects (dry mouth/con sti pa tion), sim -
i lar to the older OAB treat ments and its mar ket ing cam paign seems more fo cused now on price, with
launch price at a dis count to older com pet i tors. Darifenacin, how ever, has shown lower lev els of these
side ef fects but com pa ra ble ef fi cacy to im me di ate-re lease oxybutynin al though the study did not com -
pare with the con trolled re lease ver sion. How ever, look ing at lat est IMS fig ures, sales of Vesicare are
grow ing faster than sales of Enablex in fixed rate dollar terms.
Ac cord ing to IMS, Enablex was the num ber three prod uct in the G4D class (Uri nary In con ti nence Prod -
ucts) in the 12-month pe riod to the end of Sep tem ber 2008, with a 7.1% mar ket share and sales up 27%
in fixed rate dol lar terms. Pfizer’s Detrusitol was num ber one prod uct, with a 41.7% mar ket share, up
5% in fixed rate dol lar terms. Vesicare was sec ond, with a 21.3% mar ket share and sales up 53% in fixed
rate dollar terms.
Sales/An a lyst Com ments: Mor gan Stan ley an a lysts (Jan u ary 2009) put sales at $210 mil lion in 2008.
They fore cast sales of $224 mil lion in 2009 ($288 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008)
fore cast sales of $205 mil lion in 2008 ($265 mil lion by 2013).
ESTRADERM MX/ESTRADERM MA TRIX (17beta estradiol), a new ma trix form of the orig i nal
Estraderm patch, was first launched in Swe den in 1995 for the treat ment of meno pausal symp toms and
the pre ven tion of post-meno pausal os teo po ro sis. It has since been launched in a num ber of mar kets
world wide. Estraderm MX is a sin gle layer patch, in which the ac tive in gre di ent, 17-beta estradiol, is con -
tained within a ma trix in the ad he sive layer. This makes it thin ner and more flex i ble than
Estraderm/Estraderm TTS (first launched in 1985), where the ac tive sub stance is mixed with eth a nol
to form a gel con tained within a res er voir in the patch. How ever, un like the TTS patches, the MX does not
re tain its efficacy if relocated during use.
Li cens ing: In 2000, Kissei took over mar ket ing of Estraderm MX and Estraderm TTS in Ja pan).
ESTRADOT/VIVELLE-DOT (drug de liv ery sys tem, trans derm al 17beta estradiol) is the world’s small -
est trans derm al es tro gen de liv ery sys tem, in di cated for the treat ment of meno pausal symp toms. It was
de vel oped by the women’s health joint ven ture of Novartis and Noven (USA), Novogyne Pharmaceuticals
(for merly Vivelle Ven tures), and launched in the USA in 1999 as Vivelle-Dot. It has sub se quently gained
EU ap proval and has been launched in a num ber of Eu ro pean coun tries, in clud ing Ger many, Bel gium,
France, Ire land, the UK, Po land, Spain and Den mark as Vivelle-Dot or Estradot. Estradot has also been
launched in Fin land, Nor way, Ven e zuela, Brazil, Ar gen tina, Aus tra lia, South Af rica and Uru guay. In 2002,
the FDA ap proved the ex panded use of Vivelle-Dot for the pre ven tion of post-meno pausal os teo po ro sis.
It was launched in Canada in 2001 as Estradot.
Li cens ing: In 1998, Novartis and Noven formed a jv, Vivelle Ven tures, to mar ket Vivelle and Vivelle-Dot
in North Amer ica (51%-owned by Novartis, and 49%-owned by Noven). Un der the jv agree ment, Noven
was to man u fac ture the prod uct, pro mote it to phy si cians and re ceive roy al ties from the Vivelle Ven tures,
and Novartis was to dis trib ute the prod uct. The com pa nies were to share prof its from Vivelle Ven tures. In
1999, Noven an nounced that the Vivelle jv would change its name to Novogyne Pharmaceuticals with the
launch of Vivelle-Dot.
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