IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Lifecycle Man age ment: Novartis is study ing Exelon in com bi na tion with For est’s (USA) Namenda
(memantine) for Alz hei mer’s dis ease. En roll ment for an open-la bel, 26-week, sin gle-arm study in 150
pa tients with prob a ble Alz hei mer’s dis ease started in 2006.
Com pe ti tion: Exelon’s main com pet i tor is Pfizer/Eisai’s Aricept (donepezil), the first prod uct of this
type to reach the mar ket. Aricept and Exelon have sim i lar ef fi cacy, but Aricept is dosed once per day,
whilst Exelon has twice-daily dos ing, and un like Aricept it should be taken with food. Exelon la bel ing also
notes sig nif i cant GI ad verse re ac tions, in clud ing nau sea and vom it ing, an orexia and weight loss. An other
AchE in hib i tor, John son & John son’s Reminyl (galantamine) was first launched in the UK in 2000 and
was launched in the USA in 2001. It is now avail able in a number of markets.
In 2003, the FDA ap proved For est’s NMDA an tag o nist Namenda (memantine), which is now in creas ing
its mar ket share in this sec tor. Memantine was orig i nally de vel oped by Merz (Ger many) for the treat ment
of de men tia, Alz hei mer’s dis ease and spasticity. It was first mar keted in Ger many in 1982, but was first
pat ented for use in treat ing Alz hei mer’s dis ease in 1989, and has since then been suc cess fully de vel oped
for this in di ca tion by Merz. It has been li censed-out to Lundbeck (Den mark) for world mar kets out side the
USA and Ja pan and to For est for the USA. It is li censed to Daiichi Suntory (Ja pan) for Ja pan, where it is in
clin i cal tri als. Gruenenthal also has non-exclusive rights in Spain and Portugal.
Ac cord ing to IMS, Exelon was the world’s num ber three Anti-Alz hei mer prod uct (class N7D) in the
12-month pe riod to the end of Sep tem ber 2008, with an 11.6% mar ket share, and 22% fixed rate dol lar
growth. Aricept led the class with a 53.1% mar ket share and 16% fixed rate dol lar growth. Num ber two
was For est’s Namenda, with a 14.4% mar ket share, and 18% fixed rate dol lar growth. J&J’s Reminyl was
num ber four with a 9.9% mar ket share and 5% fixed rate dol lar growth. Ebixa, the IMS in ter na tional
phar ma ceu ti cal prod uct name for memantine sold by Lundbeck, was num ber five, with a 5.9% mar ket
share and 16% fixed rate dol lar growth. Axura, the name for memantine sold by Merz, was num ber six
with a 2.3% mar ket share and 13% fixed rate dollar growth.
Sales/An a lyst Com ment: Exelon/Exelon Patch sales in 2008 were $815 mil lion, up 24% in lo cal cur -
rency terms, and it was Novartis’ num ber eight phar ma ceu ti cal prod uct. Novartis notes that this fran -
chise has been re vived by the launch of the Exelon patch, which has quickly gained ac cep tance with
pa tients. Sales in the USA grew 32% to $279 mil lion, and 20% in the rest of the world to $536 mil lion.
Mor gan Stan ley an a lysts (Jan u ary 2009) pre dict sales of $841 mil lion in 2009 (peak ing at $936 mil lion in
2011 and fall ing to $479 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast sales of $790 mil -
lion in 2008 ($975 mil lion by 2011 and $800 mil lion by 2013). Ac cord ing to IMS, in the 12 month pe riod to
the end of Sep tem ber 2008 Exelon was Novartis’ num ber nine in ter na tional prod uct ac count ing for a
2.1% share of revenue with 22% fixed rate dollar growth.
FOCALIN/FOCALIN XR/ATTENADE (dexmethylphenidate), Celgene’s (USA) long-act ing for mu la tion
of the al pha adrenergic ag o nist methylphenidate, was launched in the USA, its first world mar ket, in 2002
by Novartis. It was de vel oped to elim i nate the need for sub jects with at ten tion def i cit dis or der to self-ad -
min is ter a mid-day dose. This is a fol low-up prod uct to (and chirally pure ver sion con tain ing the ac tive
iso mer of) Novartis’ Ritalin. In No vem ber 2008 the US FDA ap proved for in clu sion on its la bel ing of a 30
min ute onset of action for Focalin XR.
Li cens ing: In 2000, Focalin was li censed to Novartis by Celgene. Novartis made a mile stone pay ment of
$10 mil lion to Celgene and a joint Celgene-Novartis com mit tee was formed for the de vel op ment and
com mer cial iza tion of Focalin world wide, out side Can ada (where Biovail has rights). Novartis agreed to
fund all re main ing de vel op ment costs to com plete phase III tri als in the USA and Can ada. The deal also
cov ers all re lated in tel lec tual prop erty rights and pat ents, in clud ing new for mu la tions of Novartis’ cur -
rently mar keted methylphenidate prod uct Ritalin (in clud ing Ritalin LA). Celgene will re ceive upfront
fees, mile stone pay ments, and roy al ties on all for mu la tions of dexmethylphenidate (a chirally pure ver -
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