IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
sion of Ritalin) and Novartis will pro vide funds for all fur ther development, and regulatory and marketing
costs.
Clin i cal Data: A head-to-head study, pub lished in the June 2008 Jour nal of Child and Ad o les cent
Psychopharmacology, con firmed that Focalin XR ex tended re lease cap sules of fer greater im prove ments
in man ag ing ADHD symp toms com pared with Concerta ex tended-re lease tab lets at two hour post-dose,
the pri mary study endpoint.
Pat ents: The FDA granted fi nal ap proval for Teva’s (Is rael) ge neric ver sion of Focalin in early 2007.
Novartis and Celgene have filed pat ent in fringe ment suits so launch by Teva is un cer tain. If Teva
launches and is later found to have will fully in fringed, it could be held li a ble for dam ages. Barr (USA) has
also filed for a ge neric Focalin XR with the FDA.
Lifecycle Man age ment: Novartis has de vel oped an ex tended re lease dexmethylphenidate (Focalin
XR), ap proved by the FDA in 2005 and launched sub se quently.
Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Focalin was the
num ber four prod uct in the ‘Psychostimulants’ class (N6B), with a 6.2% mar ket share and 19% 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. In fifth place was Shire’s
Vyvanse (lisdexamfetamine), with a 6.1% mar ket share and 595% growth. Novartis’s Ritalin
(methylphenidate) was num ber six, with a 4.0% mar ket share and 1% fixed rate dollar growth.
Lilly’s noradrenaline reuptake in hib i tor, Strattera (atomoxetine), first launched in the USA in 2003, is
the only ADHD treat ment not con trolled as a stim u lant un der the US Con trolled Sub stances Act and will
be avail able for use once or twice daily. Strattera is clas si fied by IMS as be long ing to the N7X class (all
other CNS drugs), where it was ranked as the lead ing prod uct. Other com pet i tors in de vel op ment in 2008
for ADHD in clude Addrenex/Sciele’s Clonicel (sus tained-re lease clonidine hy dro chlo ride) in phase III tri -
als in com bi na tion with stim u lants, Targacept/AstraZeneca’s AZD 3480 in phase II tri als, and Saegis
Pharmaceuticals’ (USA, now Lundbeck), SGS 742.
Sales/An a lyst Com ment: In 2008, the Ritalin/Focalin group of prod ucts was Novartis’ num ber 14
prod uct group with com bined sales of $440 mil lion, up 17%. 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).
CLOZARIL/LEPONEX (clozapine), a neuroleptic for use in schizo phre nia, was first launched in Aus tria
in 1972. It is now mar keted in most coun tries world wide, in clud ing the USA (launched in 1990). In 2002,
the FDA ap proved the use of Clozaril for the treat ment of re cur rent sui cidal be hav ior in pa tients with
schizo phre nia or schizoaffective dis or der who are at chronic risk. This was the first time that any med i ca -
tion has been ap proved to treat sui cidal be hav ior. It has since been ap proved in other mar kets for this
additional indication.
In 2003, an FDA ad vi sory com mit tee rec om mended fur ther re duc ing the fre quency of man da tory WBC
mon i tor ing for pa tients to ev ery month af ter they have been on Clozaril for one year. In the same year,
the FDA re quested prod uct la bel ing on all atyp i cal antipsychotics to in clude a warn ing about ad di tional in -
for ma tion on hyperglycemia and di a be tes. Al though not fully un der stood, ep i de mi o log i cal stud ies have
sug gested some in creased risk. In 2004, the Amer i can Di a be tes So ci ety (among other groups) re opened
the de bate sur round ing in creased obe sity and type 2 di a be tes in pa tients re ceiv ing atyp i cal
antipsychotics, where Clozaril came off badly. Novartis wel comed the ADA’s rec om men da tion to mon i tor
pa tients more closely, com ment ing that the la bel al ready con tains a di a be tes warn ing and that Clozaril is
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