IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Requip (ropinirole), with a 15.9% mar ket share but sales down 2% in fixed rate dol lar terms. Requip and
Sifrol have also been ap proved for use in rest less leg syn drome (RLS). Num ber three was Novartis’
Stalevo, with a 10.2% mar ket share and 22% fixed rate dol lar growth. Roche’s Madopar was num ber
four, with a 6.1% mar ket share and 3% fixed rate dol lar growth. Comtan was num ber five with a 4.2%
mar ket share, up 10%. Teva’s Azilect (rasagiline), first launched in 2005, was in sev enth po si tion, with a
3.8% mar ket share and 49% fixed rate dol lar growth. UCB’s Neupro (rotigotine), first launched in 2006,
is also grow ing rap idly. It was the num ber nine prod uct in this class, with a 2.6% mar ket share, but 128%
fixed rate dollar growth.
Sales/An a lyst Com ment: In 2008, the Comtan/Stalevo group of prod ucts was Novartis’ num ber 12
prod uct group, with com bined sales of $502 mil lion, up 15% in lo cal cur rency terms. Mor gan Stan ley an -
a lysts (Jan u ary 2009) fore cast sales of $532 mil lion in 2009 (peak ing at $672 mil lion by 2013 and fall ing
to $336 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast sales of $515 in 2008 (peak ing at
$750 mil lion in 2012 and fall ing to $350 million by 2013).
EXELON (rivastigmine), an acetylcholinesterase in hib i tor, was launched in Swit zer land, its first world
mar ket, in 1997 for the treat ment of Alz hei mer’s dis ease and ischemia-in duced ce re bral dis or ders. It has
now been ap proved in al most 70 coun tries (but not Ja pan). It was launched in China in 2001. It was
launched in the USA and Can ada in 2000 for the symp tom atic treat ment of mild-to-mod er ate Alz hei mer’s
dis ease. Novartis claims that Exelon is the first Alz hei mer’s dis ease ther apy to show clin i cal ben e fits for
key do mains used to as sess the dis ease, i.e. global func tion ing (in clud ing ac tiv i ties of daily liv ing, and be -
hav ior), and cog ni tion. In 2006, Exelon was also ap proved and launched in a num ber of mar kets, in clud -
ing the UK and the USA for the treat ment of mild-to-mod er ately se vere dementia associated with
idiopathic Parkinson’s disease.
Novartis has de vel oped a trans derm al patch for mu la tion of rivastigmine, Exelon Patch. In July 2007, it
was ap proved in the USA for the treat ment of mild-to-mod er ate Alz hei mer’s dis ease and mild-to-mod er -
ate de men tia as so ci ated with Par kin son’s dis ease. The fil ing was based on data from a phase III trial, des -
ig nated IDEAL (In ves ti ga tion of Exelon Patch in Alz hei mer’s dis ease), in nearly 2,000 pa tients with
mod er ate Alz hei mer’s dis ease. Exelon Patch had sim i lar ef fi cacy to rivastigmine cap sules, and was well
tol er ated at the rec om mended dose of 9mg/day, with three times fewer re ports of nau sea or vom it ing. It
was launched in the USA in Q4 2007. The prod uct was ap proved in Eu rope in Sep tem ber 2007 and
launched in the UK in Oc to ber 2007. The patch was launched in South Ko rea in 2008. Phase III trials with
Exelon Patch are ongoing in Japan.
Li cens ing: In 2005, Novartis and Ono (Ja pan) agreed to co-de velop and co-mar ket the rivastigmine
trans derm al patch in Ja pan. It is been de vel oped in Ja pan as ENA 713D. Rivastigmine was li censed-out
to Esteve for co-mar ket ing in Spain in 1999 by Novartis. Exteva co-mar kets it in Spain as Prometax.
Pat ents: Novartis granted Wat son (USA) a li cense for au tho rized ge neric ver sion of Exelon in De cem ber
2007. The agree ment pro vides that Wat son will not com mence mar ket ing its ge neric prod uct un til some -
time prior to the ex pi ra tion of the pat ents cov er ing Exelon. The spe cific date on which Wat son may launch
its prod uct has not been dis closed. Wat son has re ceived ten ta tive ap proval from the FDA for ge neric
Exelon. The Jap a nese pat ent on rivastigmine ex pired in March 2008. In most of Eu rope, the com pound is
re ported to be pro tected by sup ple men tary pro tec tion cer tif i cates run ning un til 2012. In the USA, the
pat ent ex pires in Feb ru ary 2014. In Jan u ary 2008, it was re ported that Dr Reddy’s (In dia) had en tered
into a set tle ment agree ment with Novartis, which in volved a stip u la tion of dis missal of US law suits re lat -
ing to Dr Reddy’s ANDA for a ge neric ver sion of rivastigmine. Un der the terms of the deal, Dr Reddy’s will
not launch its ge neric prod uct un til some time be fore the ex piry of the Or ange Book pat ents claim ing
rivastigmine. Dr Reddy’s re ceived final approval from the US FDA in October 2007 for its rivastigmine
capsules.
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