IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Swit zer land in Oc to ber 2008. In No vem ber 2008, it was rec om mended for ap proval in Eu rope, with a de -
ci sion by the Eu ro pean au thor i ties ex pected in early 2009. In Eu rope, it will be known as Rasilez HCT.
Clin i cal Data: In May 2008, Novartis re ported re sults from an eight-week study of Tekturna HCT in pa -
tients with high blood pres sure not ad e quately con trolled by hy dro chlo ro thi a zide alone. Pa tients re ceived
hy dro chlo ro thi a zide alone, or hy dro chlo ro thi a zide 25 mg with aliskiren 300 or 150 mg. The ef fect of ther -
apy on di a stolic and sys tolic blood pres sure was mea sured. Hy dro chlo ro thi a zide 25 mg with aliskiren 300
or 150 mg re duced sys tolic and di a stolic blood pres sure by 16.7/10.7 mmHg and 12.9/8.5 mmHg, re -
spec tively, com pared with 7.1/4.8 mmHg for hy dro chlo ro thi a zide alone (p less than 0.001). Tekturna
HCT was well tol er ated; fewer cases of hypokalemia were ob served for Tekturna HCT than
hydrochlorothiazide alone.
Central Nervous System Agents
COMTAN (entacapone), a catechol-O-methyltransferase (COMT) in hib i tor used in the treat ment of Par -
kin son’s dis ease, de vel oped by Orion (Fin land), was ap proved in the EU in 1998. Launches then took
place in Eu rope, through Orion or li censee Novartis. Out side Eu rope, in 1999, Novartis launched it in the
USA, and has since launched the prod uct in var i ous world wide mar kets. Entacapone was filed in Ja pan in
2005 and launched in April 2007. An entacapone-based com bi na tion drug Stalevo (levodopa +
carbidopa + entacapone) was first launched in the USA in 2003.
Li cens ing: Orion li censed entacapone out to Novartis in 1996. Orion re tains mar ket ing ex clu siv ity in
Scan di na via, the Bal tic States, Ger many, the UK and Ire land and mar kets it as Comtess. Novartis has
rights else where in the world as Comtan. Un der the terms of the deal, Novartis agreed to make an
up-front pay ment of $4.8 mil lion and un dis closed milestone payments.
Pat ents: In Au gust 2007, an un iden ti fied com pany filed an ANDA with the FDA for a ge neric ver sion of
Comtan. The ap pli cant has cer ti fied with the FDA that it would not seek ap proval to mar ket ge neric
entacapone be fore the ex piry of Orion’s pat ents, the lat est of which was due to ex pire on May 12, 2009.
In Sep tem ber 2007, Orion filed a pat ent in fringe ment law suit in the USA against generics com pany
Wockhardt (In dia). In 2008, IMS Pat ents Fo cus re ported that the US pat ent had been extended to 2013.
Clin i cal Data: Comtan be longs to a class of drugs called COMT in hib i tors that can en hance the ef fec tive -
ness of levodopa, a ge neric drug of ten used to treat Par kin son’s dis ease. Comtan blocks the break down of
levodopa be fore it reaches the brain, and there fore use of Comtan means that pa tients can take less
levodopa. Three stud ies in North Amer ica, Scan di na via and Ger many showed that Comtan helped im -
prove mo tor func tion in pa tients with a de te ri o rat ing re sponse to levodopa, par tic u larly in ar eas such as
speech, hand writ ing, walk ing and dress ing. Orion an tic i pates that entacapone will be use ful in im prov ing
the fail ing ther a peu tic re sponse of Par kin son’s dis ease pa tients. It may be ad min is tered con cur rently with
Merck & Co’s Sinemet (carbidopa + levodopa) and Roche’s Madopar (benserazide + levodopa). In
1998, the Eu ro pean CPMP de cided that Comtan did not ap pear to cause sig nif i cant liver tox ic ity, though
there had been some rare re ports of in creases in liver en zymes. The de ci sion came af ter the Eu ro pean
with drawal of a sim i lar drug, Roche’s Tasmar (tolcapone), due to se vere hepatotoxicity. Warn ing let ters
about the risk of rhabdomyolysis and neuroleptic ma lig nant syn drome have been sent out in a num ber of
Eu ro pean coun tries by Orion. US la bel ing for Comtan does not men tion any pos si bil ity of liver in jury or of
liver enzyme elevations with use of entacapone, nor is a possible COMT inhibitor class effect presumed.
Lifecycle Man age ment: Orion has de vel oped a com bi na tion prod uct Stalevo (entacapone + levodopa
+ carbidopa), which it also mar kets in part ner ship with Novartis.
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
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