IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Sales/An a lyst Com ment: Lescol sales were $645 mil lion in 2008, down 9% in lo cal cur rency terms,
and it was Novartis’ num ber ten phar ma ceu ti cal prod uct. Mor gan Stan ley an a lysts (Jan u ary 2009) fore -
cast sales of $645 mil lion in 2009 ($183 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast
sales of $640 in 2008 ($100 million by 2013).
LOPRESOR (metoprolol), a beta-blocker in di cated in the treat ment of an gina, car diac fail ure, and hy per -
ten sion, and in the pre ven tion of mi graine, was first launched in 1975. It is now avail able in most mar kets
world wide via Novartis and its part ner AstraZeneca (UK), which mar kets it as Betaloc and Seloken.
Lopresor is also avail able as a once-daily, slow-re lease for mu la tion as Lopresor SR. Due to ge neric com -
pe ti tion, sales of Lopresor have fallen in re cent years. Novartis mar kets ge neric ver sions of metoprolol in
various markets.
Li cens ing: Metoprolol was li censed-in from AstraZeneca for ex clu sive mar ket ing in the USA and non-ex -
clu sive mar ket ing in other coun tries. Sankyo Pharma in Ger many has li censed mar ket ing rights in France
It aly Bel gium, Swit zer land, and Portugal.
LOTREL (amlodipine + benazepril), a once-daily cal cium-chan nel blocker/ACE in hib i tor com bi na tion in -
di cated in the treat ment of hy per ten sion in ad e quately con trolled with ACE in hib i tors or cal cium an tag o -
nists alone, was launched in the USA and Puerto Rico in 1995. It is only avail able on these mar kets. A
Lotrel 10mg amlodipine/20mg benazepril dos age strength was launched in 2002.
Li cens ing: Pfizer granted Novartis rights to use its cal cium an tag o nist amlodipine (Norvasc) in com bi -
na tion with the Novartis ACE in hib i tor benazepril in the USA and It aly. In 2003, Novartis stated that there
are no plans to launch Lotrel in any mar kets out side the USA.
Pat ents: Novartis’ pat ent on Lotrel, a com bi na tion prod uct, ex pires in 2017, but amlodipine’s pat ent pro -
tec tion ex pired in Sep tem ber 2007. In 2004, the FDA re vealed that an un named com pany had filed for
ap proval of a ge neric ver sion of the drug and the fol low ing month Novartis filed a law suit against Teva (Is -
rael). Teva re ceived ten ta tive ap proval for its ge neric ver sion of Lotrel in July 2006 and fi nal ap proval in
May 2007, im me di ately launch ing the ge neric prod uct at risk. Novartis ob tained a tem po rary re strain ing
or der one day later. Both com pa nies were or dered not to sell or of fer fur ther ge neric prod ucts, be yond
what had al ready been com mer cial ized, in clud ing any au tho rized generics, un til the next court hear ing in
late May, when a judge ex tended the tem po rary re strain ing or der. In June, a court de nied a re quest from
Novartis to stop sales of Teva’s ge neric and al lowed re sump tion of ship ments to cus tom ers. Novartis sub -
se quently launched its own authorized generic version of Lotrel through Sandoz.
Clin i cal Data: In De cem ber 2008 fi nal re sults were an nounced from a ran dom ized, dou ble-blind, par al -
lel-group, multicenter phase III trial, des ig nated AC COM PLISH (Avoid ing Car dio vas cu lar Events through
COM bi na tion Ther apy in Pa tients LIv ing with Sys tolic Hy per ten sion), de signed to as sess the safety and
ef fi cacy of Lotrel, com pared with a fixed oral com bi na tion of benazepril plus hy dro chlo ro thi a zide (HCTZ)
in more than 11,000 pa tients with high-risk hy per ten sion. Lotrel sig nif i cantly de creased the risk of car -
dio vas cu lar events by 20% com pared with benazepril plus HCTZ. Ap prox i mately twice the num ber of pa -
tients tak ing ei ther of the fixed com bi na tions achieved tar get blood pres sure lev els com pared with their
pre vi ous sin gle agent or com bi na tion ther a pies. At study en try, ap prox i mately 37% of pa tients were at
the sys tolic blood pres sure tar get of less than 140 mmHg; af ter switch ing to a fixed com bi na tion and fol -
low ing dose ti tra tion, 75% of pa tients given Lotrel and 72% given benazepril plus HCTZ achieved blood
pres sure tar gets, and the mean sys tolic blood pres sure was ap prox i mately 130 mmHg. Both fixed com bi -
na tions were well tol er ated, with a low in ci dence of ad verse events lead ing to dis con tinu a tion from the
trial (ap prox i mately 15% in both treat ment arms). Hypotension oc cur ring as a se ri ous ad verse event was
re ported in 0.4% of pa tients given Lotrel and in 0.5% given benazepril plus HCTZ. Approximately 70 of
patients were continuing to take combination therapy at study closure.
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