IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008 the C9D class (An gio ten sin II An -
tag o nists, Com bi na tions), was led by Co-Diovan (valsartan + hy dro chlo ro thi a zide), with a 28% mar ket
share and 14% fixed rate dol lar growth, ac cord ing to IMS. 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 + hy dro chlo ro thi a zide), with a 6.0% market share and 25%
dollar growth.
Sales/An a lyst Com ment: Diovan/Co-Diovan was Novartis’ num ber one brand in 2008 with sales of
$5.7 bil lion ($3.3 bil lion from the US), up 15%. Mor gan Stan ley an a lysts (Jan u ary 2009) fore cast sales of
$5,819 mil lion in 2009, 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 $5,985 mil lion in 2008 and think sales will peak at $6,405 mil lion in 2009 ($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 Co-Diovan was
Novartis’ num ber three in ter na tional prod uct ac count ing for a 6.8% share of rev e nue with 14% fixed rate
dollar growth.
DIOVAN (valsartan), an an gio ten sin II an tag o nist/an gio ten sin re cep tor blocker (ARB), was first
launched in Ger many by Novartis for the treat ment of hy per ten sion in 1996. It is now avail able in around
90 coun tries world wide for this in di ca tion, in clud ing Eu rope, the USA, Latin Amer ica, Ja pan and China. In
2002, the FDA ap proved Diovan as a treat ment for heart fail ure in pa tients who are in tol er ant to ACE in -
hib i tors. Ap proval for this in di ca tion was re ceived in Swit zer land in 2003. In 2005, Novartis re ceived an
ap prov able let ter from the FDA for its sNDA seek ing ap proval for im prov ing sur vival and re duc ing car dio -
vas cu lar events in pa tients at high risk af ter sur viv ing a heart at tack. Ap proval was granted in Au gust
2005. Diovan has re ceived ap proval for this in di ca tion in more than 50 coun tries, in clud ing the EU. In De -
cem ber 2004, the drug was ap proved in Swe den, which acted as the ref er ence mem ber state for ap prov -
als, in May 2005, in 14 EU states plus Ice land via the mu tual rec og ni tion pro ce dure. The fil ing was based
on the re sults of the VAL IANT trial, which dem on strated the com pa ra ble ef fi cacy of Diovan and ACE in hib -
i tor Captopril, in this indication.
Novartis an nounced in De cem ber 2007 that the FDA had ap proved Diovan for the treat ment of hy per ten -
sion in chil dren and ad o les cents aged 6-16 years, fol low ing a pri or ity review.
In March 2008, Health Can ada ap proved Diovan for the treat ment of chronic heart fail ure in pa tients who
can not tol er ate ACE in hib i tors.
Li cens ing: In 1999, Schwarz (Ger many, now part of UCB, Bel gium) ac quired Ger man co-mar ket ing
rights for valsartan from Novartis, and launched the drug as Provas/Provas Comp. Novartis will con -
tinue to mar ket Diovan in Ger many. Provas Comp is a com bi na tion with hy dro chlo ro thi a zide. The deal
with Schwarz was later ex tended to cover Spain. In It aly, valsartan is co-mar keted by Novartis and
Menarini (It aly). In 2000, Novartis and Choong-Wae (South Ko rea) agreed to co-pro mote Diovan in
South Ko rea. In 2003, Ipsen (France) ob tained rights to mar ket valsartan (Nisis) in France, where it was
pre vi ously dis trib uted by Aventis. In Jan u ary 2007, Mochida (Ja pan) and Novartis signed a co-pro mo tion
agree ment for Diovan in Ja pan, start ing Feb ru ary 2007. How ever this deal was terminated in January
2009.
Pat ents: In Au gust 2007, Diovan was granted pe di at ric ex clu siv ity by the FDA based on stud ies con -
ducted in chil dren with high blood pres sure. This ac tion ex tends mar ket ing ex clu siv ity as so ci ated with the
valsartan pat ent by six months from March to Sep tem ber 2012. In Oc to ber 2007, Ranbaxy re ceived ten -
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