IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
has weak car ci no genic po ten tial. Ritalin is a stim u lant with prop er ties sim i lar to co caine and am phet -
amines, and like co caine it in creases the level of do pa mine in the brain. This sim i lar ity of mechanism has
led to debate about its addictive nature.
Pat ents: Barr (USA) filed an ANDA con tain ing a para graph IV cer tif i ca tion for a ge neric Ritalin LA prod uct
with the FDA in May 2007 and re ceived no ti fi ca tion of the ap pli ca tion’s ac cep tance for fil ing in Sep tem ber
2007. Novartis and Celgene filed suit to pre vent Barr from pro ceed ing with the com mer cial iza tion of its
product.
Com pe ti tion: In 2002, Novartis launched a chirally pure ver sion of Ritalin, Focalin
(dexmethylphenidate), which it li censed-in from Celgene (USA). This is a long-act ing for mu la tion of
methylphenidate, which was de vel oped to elim i nate the need for sub jects with ADHD to self-ad min is ter a
mid-day dose. Novartis has rights in mar kets outside Canada.
There are now a num ber of ge neric methylphenidate prod ucts on the mar ket in com pe ti tion with Ritalin.
Many com pa nies have aimed to pro duce long-act ing for mu la tions for ex tra con ve nience. This is es pe -
cially im por tant with chil dren, as they may need to take med i ca tion at school, which means that su per vi -
sion is needed. In 2000, John son & John son’s Concerta (methylphenidate) was launched as the first
once-a-day treat ment for ADHD, effective for 12 hours.
An other strong com pet i tor is Shire’s (UK) Adderall (mixed am phet amine salts). Shire also mar kets a
once-daily ver sion, Adderall XR. In 2002, Eli Lilly’s (USA) se lec tive noradrenaline reuptake in hib i tor
Strattera (atomoxetine) was ap proved by the FDA, as the first ADHD treat ment that is not a stim u lant
un der the Con trolled Sub stances Act. Strattera was launched in the USA in 2003 and is now avail able in a
num ber of mar kets. Strattera has the ad van tage in that, un like the methylphenidate and am phet -
amine-based prod ucts, it is not a stim u lant and there fore does not need a con trolled sub stance des ig na -
tion and thus re peat pre scrip tions will be eas ier to ob tain. It is a se lec tive norepinephrine re-up take
in hib i tor, orig i nally de vel oped as an an ti de pres sant. Its spe cific mech a nism of ac tion in ADHD has not
been elu ci dated. Strattera can be taken once or twice a day, and is not linked to in som nia. It is also ap -
proved for use in adults with ADHD, and some an a lysts have pre dicted peak sales of up to $1.4 bil lion. In
2005, how ever, Lilly had to add a bolded warning about liver injury to the Strattera label.
In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Ritalin was the num ber six
prod uct in the ‘Psychostimulants’ class (N6B), with a 4.0% mar ket share and 1% fixed rate dol lar growth.
The lead ing prod uct was Shire’s Adderall (am phet amine + dex am pheta mine), with a 27.3% mar ket
share and 9% fixed rate dol lar growth. Num ber two was J&J’s Concerta (methylphenidate), with a
25.7% mar ket share and 6% dol lar growth. Num ber three was Cephalon’s Provigil (modafinil), with an
18.5% mar ket share and 9% dol lar growth. Novartis’ Focalin was num ber four, with a 6.2% mar ket
share and 19% fixed rate dol lar growth. In fifth place was Shire’s Vyvanse (lisdexamfetamine), with a
6.1% mar ket share with 595% growth.
Sales/An a lyst Com ment: In 2008, the Ritalin/Focalin group was Novartis’ num ber 14 phar ma ceu ti cal
prod uct group, with com bined sales of $440 mil lion, up 16% in lo cal cur rency terms. Mor gan Stan ley an -
a lysts (Jan u ary 2009) fore cast sales will peak at $575 mil lion in 2013 and fall to $547 mil lion by 2014.
Cowen & Co an a lysts (Au gust 2008) fore cast sales of $415 mil lion in 2008 ($490 million by 2013).
STALEVO (entacapone + levodopa + carbidopa), Orion (Fin land) and Novartis’ com bi na tion drug for
Par kin son’s dis ease, was first launched in the USA in 2003 by Novartis. In 2003, it was also launched by
Orion in Fin land, Swe den, the UK, Ire land, Ger many, and Den mark. In 2004, Orion launched it in Nor way
and Novartis launched it in Bel gium, Hun gary, Ar gen tina, Aus tria, Greece, Spain, Swit zer land, and Brazil.
It has since been launched in many mar kets world wide, in clud ing Por tu gal, Mex ico, South Ko rea, Hong
Kong, Is rael, Chile, Sin ga pore, Ven e zuela, Uru guay, It aly, Peru, South Af rica, Tai wan and Egypt. Stalevo
was not con ceived as a re place ment for Comtan (entacapone), but is in di cated for pa tients with signs
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