IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
about 58% of net sales with 10% growth in lo cal cur rency terms. US sales were re ported to be up 10%.
Novartis noted that Diovan has bene fited from its sta tus as the only drug in the ARB class ap proved to
treat high blood pres sure, high-risk heart at tack and heart fail ure. Mor gan Stan ley an a lysts (Jan u ary
2009) fore cast 2009 sales of $5,819 mil lion, peak ing at $5,834 mil lion in 2010 ($1,264 mil lion by 2014).
Cowen & Co an a lysts (Au gust 2008) fore cast sales of $5,985 mil lion in 2008. They think sales will peak at
$6,405 mil lion in 2009 and fall to $1,500 mil lion by 2013. Ac cord ing to IMS, in the 12-month pe riod to the
end of Sep tem ber 2008, Diovan was Novartis’ num ber one in ter na tional phar ma ceu ti cal prod uct ac -
count ing for a 9.9% share of au dited cor po rate pharmaceutical sales, with 12% fixed rate dollar growth.
EXFORGE (valsartan + amlodipine), a fixed-dose com bi na tion of the cal cium chan nel blocker amlodipine
(Pfizer’s Norvasc) and Novartis’ Diovan (valsartan), was ap proved in Eu rope in Jan u ary 2007 for the
treat ment of hy per ten sion. In Jan u ary 2007, it was launched in its first world mar kets, Ger many and
Swit zer land. Later in 2007, it was launched in the USA, the UK, Greece, Ire land, Fin land, Bel gium, Cen -
tral Amer ica, Aus tria, Nor way, the USA, Den mark, the Neth er lands, France, Ec ua dor, the Do min i can Re -
pub lic, the Slo vak Re pub lic, South Ko rea, Co lom bia, Chile, In do ne sia, Peru, Leb a non, Ven e zuela, Po land,
Ar gen tina and Mex ico. In 2008, it was launched in Hun gary, Saudi Ara bia, Por tu gal, Bul garia, Spain, Tur -
key, and the United Arab Emirates. In Au gust 2008, the US FDA ap proved Exforge as a first-line treat -
ment for pa tients likely to need mul ti ple drugs to reg u late their blood pres sure. In 2008, Novartis filed for
approval of Exforge in Japan.
Ac cord ing to Novartis, Exforge is the first fixed-dose com bi na tion of the two most pre scribed
anti-hypertensives in the mar ket place, bring ing to gether all the ben e fits of these two lead ing agents in
one pill. Novartis says that “clin i cal data have shown nine of ten pa tients treated with Exforge reached
treat ment goals, con firm ing strong ef fi cacy cou pled with im proved con ve nience”. Pre lim i nary data from
ran dom ized, dou ble-blind phase III tri als con ducted in over 5,000 pa tients with hy per ten sion showed
that Exforge re duced sys tolic blood pres sure by up to 36mmHg, and di a stolic blood pres sure by up to
29mmHg. In ad di tion, there was a lower in ci dence of edema in pa tients re ceiv ing the fixed com bi na tion
prod uct than in patients receiving amlodipine alone.
Li cens ing: In Jan u ary 2009, Ipsen en tered into a deal with Novartis for the co-pro mo tion of Exforge in
France as a treat ment for hy per ten sion.
Lifecycle Man age ment: In Jan u ary 2009 Novartis re ported that it had de vel oped an Exforge plus hy -
dro chlo ro thi a zide com bi na tion and that it was an tic i pat ing approval in 2009.
Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, Exforge was the num ber eight
prod uct in the C9D class (An gio ten sin II An tag o nists, Com bi na tions), with a 3.4% mar ket share in its first
year on the mar ket. The lead ing prod uct in this class was Novartis’ Co-Diovan (valsartan + hy dro chlo ro -
thi a zide), with a 28% mar ket share and 14% fixed rate dol lar growth. Num ber two was Merck & Co’s
Hyzaar (losartan + hy dro chlo ro thi a zide), with a 16.9% mar ket share and 11% fixed rate dol lar growth.
Num ber three was sanofi-aventis’ Coaprovel (irbesartan + hy dro chlo ro thi a zide), with an 8.8% mar ket
share and 15% fixed rate dol lar growth. Num ber four was Bris tol-Myers Squibb’s Avalide (irbesartan +
hy dro chlo ro thi a zide), with a 7.5% mar ket share and 10% fixed rate dol lar growth. Num ber five was
AstraZeneca’s Atacand Plus (candesartan cilexetil + hy dro chlo ro thi a zide), with a 6.9% mar ket share
and 7% dol lar growth. Num ber six was Daiichi Sankyo’s Benicar HCT (olmesartan medoxomil + hy dro -
chlo ro thi a zide), with a 6.9% mar ket share and 31% dol lar growth. Num ber seven was Boehringer
Ingelheim’s Micardis HCT (telmisartan + hydrochlorothiazide), with a 6.0% market share and 25%
dollar growth.
Sales/An a lyst Com ment: Sales of Exforge rose 292% in lo cal cur rency terms in 2008 to $406 mil lion,
driven by the July 2008 ap proval in the USA and launches in the rest of the world. Exforge rose to be come
Novartis’ num ber 15 phar ma ceu ti cal prod uct by the end of 2008. Mor gan Stan ley an a lysts (Jan u ary
2009), fore cast sales of $676 mil lion in 2009 ($874 mil lion in 2011-12). They think sales will fall to $230
© 2009 IMS Health In cor po rated or its af fil i ates Page 39