IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
and symp toms of end-of-dose ‘wear ing off’; a study found that 55% of pa tients cited this as big gest
treat ment chal lenge and 92% of phy si cians sur veyed said that it was a sig nif i cant con cern. Stalevo was
the first new form of levodopa in more than a de cade. Re sults of stud ies have in di cated greater control of
PD symptoms as well as more convenient dosing.
Li cens ing: Un der the terms of a 2000 deal, Orion has re tained rights in Ger many, the UK, Ire land, the
Nordic and Bal tic coun tries, and some other re gions, and has the pos si bil ity of co-pro mot ing the new tri -
ple ther apy in the USA, France, Spain, and 10 other coun tries. Novartis has ex clu sive rights in the rest of
the world (ex cept Ja pan). The deal in cludes an upfront pay ment of $15 mil lion, and mile stone pay ments
at reg u la tory ap prov als. The US fil ing trig gered a $10 mil lion milestone payment to Orion.
Pat ents: In De cem ber 2008 Orion filed a pat ent in fringe ment suit against Wockhardt (In dia) fol low ing
the fil ing of an ANDA. An au to matic stay on ap proval of the ANDA of 30 months has now begun.
Clin i cal Data: Novartis and Orion are in ves ti gat ing the use of Stalevo as a first line ther apy to de lay the
on set of mo tor com pli ca tions.
In April 2008, Novartis re ported re sults from a phase III trial, des ig nated FIRST STEP (Favorability of Im -
me di ate-Re lease carbidopa + levodopa vs STalevo; Short-Term com par i son in Early Par kin son’s), de -
signed to com pare levodopa/carbidopa with Stalevo in pa tients with early Par kin son’s dis ease in 53
in ves ti ga tion cen ters in Can ada, the Czech Re pub lic, Is rael, It aly, Po land, Por tu gal, Tur key and the USA.
Stalevo showed sta tis ti cally sig nif i cant im prove ment com pared with levodopa/carbidopa in the pri mary
end point, which was the com bined Uni fied Par kin son’s Dis ease Rat ing Scale (UPDRS) part II-ac tiv i ties of
daily liv ing (eat ing, bath ing, dress ing) and part III-mo tor scores (agil ity, ri gid ity, trem ors)(p=0.045).
This pro spec tive, dou ble-blind, ran dom ized, par al lel group, fixed dose trial lasted 39 weeks and en rolled
423 pa tients. Novartis plans to sub mit reg u la tory fil ings in 2008 for use of Stalevo in pa tients with early
Par kin son’s dis ease who have not been treated with levodopa. These filings will be based on results from
this phase III trial.
Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, Boehringer Ingelheim’s Sifrol
(pramipexole) was the lead ing prod uct in the global Anti-Par kin son Drugs class (N4A), ac cord ing to IMS,
with a 26.5% mar ket share and 25% fixed rate dol lar growth. Num ber two was GlaxoSmithKline’s
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 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. Novartis’ 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).
TEGRETOL (carbamazepine), an antiepileptic, was first launched in the UK in 1963. Tegretol is also
avail able as a con trolled-re lease form as Tegretol CR/Tegretol Re tard and in sup pos i tory form. In
1996, the con trolled-re lease form, which uses ALZA’s (USA) OROS sys tem, was ap proved in the USA as
Tegretol XR.
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