IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Lifecycle Man age ment: Novartis has con ducted the AC COM PLISH trial pro gram to gain ap proval for
Lotrel in high-risk hy per ten sion pa tients. A fil ing is es ti mated for some time after 2009.
Com pe ti tion: Ac cord ing to IMS, Lotrel was no lon ger the leader in the ‘ACE in hib i tors, Com bi na tions’
class in the 12-month pe riod to the end of Sep tem ber 2008, hav ing been dis placed by the Teva ge neric
prod uct, Amlodip/Benaz Teva, with a 16.1% mar ket share and 110% fixed rate dol lar growth. In sec -
ond place was Servier’s Bipreterax (indapamide + perindopril), with a 12.6% mar ket share and 16%
fixed rate dol lar growth. Lotrel was num ber three, with an 11.4% mar ket share, but sales down 67% in
fixed rate dol lar terms. Num ber four was Novartis’ own ge neric ver sion of Lotrel, Amlodip/Benaz Novt,
with a 7.1% mar ket share and 260% fixed rate dollar growth.
Sales/An a lyst Com ment: Lotrel was Novartis’ num ber 17 phar ma ceu ti cal prod uct in 2008 with sales
of $386 mil lion, down 48%, due to ge neric com pe ti tion. Novartis noted that sales in 2008 came from
higher-dose for mu la tions that still have mar ket ex clu siv ity. Mor gan Stan ley an a lysts (Jan u ary 2009) an -
tic i pate 2009 sales down to $182 mil lion ($67 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore -
cast sales of $375 mil lion in 2008 ($50 million by 2013).
NITRODERM TTS/TRANSDERM-NI TRO (ni tro glyc er ine), a trans derm al patch in di cated in the pre -
ven tion of an gina pectoris, was first launched in 1982. It is now avail able in sev eral coun tries world wide,
in clud ing Ja pan. It uses ALZA’s (USA) patch de liv ery technology.
TEKTURNA/RASILEZ (aliskiren), a renin in hib i tor, was first launched in the USA in March 2007 for the
treat ment of high blood pres sure as monotherapy or in com bi na tion with other high blood pres sure med i -
ca tions. In the USA, it is mar keted as Tekturna. In other mar kets it is called Rasilez. It was ap proved in
all 27 EU mem ber states in Au gust 2007. It has since been launched in a num ber of Eu ro pean mar kets,
plus Can ada, Spain, Nor way, Brazil, Mex ico and the Phil ip pines. Rasilez was filed for ap proval in Japan in
February 2008.
Tekturna is the first in a new class of antihypertensives called di rect renin in hib i tors. A once-daily oral tab -
let ther apy, the drug acts by tar get ing renin, an en zyme re spon si ble for trig ger ing a pro cess that can con -
trib ute to high blood pres sure. The prod uct has po ten tial for use in monotherapy as well as in com bi na tion
with Diovan to give synergistic effect.
Li cens ing: Novartis li censed aliskiren to Speedel (Swit zer land) in 2000 in a deal whereby it had an op tion
to re ac quire rights upon com ple tion of phase II tri als by Speedel. Novartis ex er cised this op tion in 2002,
and Speedel is now en ti tled to pay ments and roy al ties. Novartis paid a de vel op ment mile stone in
mid-2004 in cor po rat ing a cash el e ment as well as an eq uity par tic i pa tion. In July 2008, Novartis be came
the ma jor ity owner of Speedel, fol low ing the ac qui si tion of an ad di tional 51.7% stake in the com pany. A
man da tory pub lic ten der of fer be gan in Au gust 2008 to buy the re main ing shares in Speedel. Novartis
states that to tal ac qui si tion costs are es ti mated at around $880 mil lion. Novartis states that Speedel’s
R&D pipe line is a strong fit with its leading position in cardiovascular disease.
Clin i cal Data: In Oc to ber 2007, Novartis ini ti ated a ran dom ized, dou ble-blind, pla cebo-con trolled, par -
al lel group, phase III trial (AL TI TUDE) in the USA, Ar gen tina, Aus tria, Bel gium, Brazil, China and Thai land
to de ter mine whether, in 8600 pa tients with type II di a be tes at high risk for car dio vas cu lar and re nal
events, aliskiren, on top of con ven tional treat ment, re duces car dio vas cu lar and re nal mor bid ity and mor -
tal ity. Pri mary out come mea sures will in clude car dio vas cu lar death, re sus ci tated sud den death, non-fa tal
myo car dial in farc tion and non-fa tal stroke. Sec ond ary out come mea sures will in clude time from ran dom -
iza tion to the first event of the fol low ing car dio vas cu lar end points: car dio vas cu lar death, re sus ci tated
sud den death, non-fa tal myo car dial in farc tion, non-fa tal stroke and un planned hospitalization for heart
failure. The trial is expected to complete in January 2012.
© 2009 IMS Health In cor po rated or its af fil i ates Page 42