IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
In Au gust 2007, Novartis re ceived Eu ro pean ap proval to ex pand the in di ca tions of daptomycin to in clude
right-sided in fec tive endocarditis (RIE) and Staph y lo coc cus aureus bacteremia (SAB), in cases as so ci -
ated with RIE or com pli cated skin and soft-tis sue in fec tions (cSSTI). In Sep tem ber 2007, Novartis an -
nounced that it had launched Cubicin for the treat ment of both methicillin-sen si tive and -re sis tant S.
aureus (MSSA and MRSA) blood stream in fec tions (bacteremia) and RIE in the UK.
Li cens ing: Orig i na tor Cub ist Pharmaceuticals (USA) has rights in North Amer ica, Ja pan, Is rael, Ko rea
and China. In 2003, Chiron, which is now part of Novartis, ac quired rights in West ern Eu rope, East ern Eu -
rope, the Mid dle East, Aus tra lia, New Zea land, Cen tral Amer ica, South Amer ica and In dia. In 2007, Merck
& Co agreed with Cub ist to de velop and com mer cial ize daptomycin in Ja pan. Oryx (now part of Sepracor)
has rights in Can ada and launched it there in early 2008.
Com pe ti tion: Ac cord ing to IMS, in the 12-month pe riod to the end of Sep tem ber 2008, Cubicin was the
num ber two prod uct in the ‘Other Antibacterials’ class with a 10.7% mar ket share and 43% fixed rate
dol lar growth. Num ber one was Pfizer’s Zyvox (linezolid), with a 31.7% mar ket share and 13% fixed rate
dol lar growth. Num ber three was sanofi-aventis’ Targocid (teicoplanin), with a 10.4% mar ket share and
4% fixed rate dollar growth.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) put 2007 sales at $14 mil lion and fore -
cast sales of $20 mil lion in 2008 ($125 mil lion by 2013).
DENAVIR/VECTAVIR (penciclovir), a top i cal cream an ti vi ral for the treat ment of her pes labilis (cold
sores).
Li cens ing: Penciclovir was ac quired from GlaxoSmithKline in 2000 to gether with Famvir (famciclovir).
In 2006, Novartis granted Bar rier Ther a peu tics (USA) ex clu sive rights to mar ket and dis trib ute the prod -
uct in Canada.
ENCEPUR (vac cine, tick borne en ceph a li tis), a tick-borne en ceph a li tis vac cine, was launched in Ger -
many in 1991, and is now avail able in a num ber of mar kets, in clud ing Po land, Swit zer land, Swe den, Rus -
sia, Lat via, the Czech Re pub lic and Hungary.
FAMVIR (famciclovir), an an ti vi ral in di cated for acute her pes zoster and the treat ment or sup pres sion of
her pes sim plex. In 2006, the FDA ap proved a sup ple men tal NDA for famciclovir as a sin gle-day treat ment
for immunocompetent pa tients with re cur rent gen i tal her pes (two 1,000mg doses) or with re cur rent her -
pes labialis (cold sores) (sin gle 1,500 mg dose). The de ci sion was based on re sults from two in ter na tional
clin i cal tri als in pa tients with re cur rent gen i tal herpes and patients with cold sores.
Li cens ing: Novartis ac quired global mar ket ing and man u fac tur ing rights to Famvir and
Vectavir/Denavir (penciclovir) from GlaxoSmithKline in 2000.
Pat ents: In 2004 Teva (Is rael) filed an ap pli ca tion with the FDA to sell a ge neric ver sion of Famvir.
Novartis filed suit, charg ing that Teva in fringed on one of its five pat ents for famciclovir. Teva sought to
chal lenge all five pat ents, but a dis trict court threw out its case re lated to the four pat ents for which
Novartis did not sue. In March 2007, a fed eral ap peals court re versed the dis trict court’s de ci sion and re -
in stated Teva’s pat ent case. Teva be gan sell ing its ge neric Famvir in Sep tem ber 2007, a day af ter a New
Jer sey dis trict court de nied Novartis’ re quest for a pre lim i nary in junc tion. In de ny ing the re quest, the
court con cluded that Novartis’ ba sic pat ent cov er ing famciclovir is ob vi ous and un en force able. Just hours
af ter Teva be gan sell ing its prod uct, the US Court of Ap peals for the Fed eral Cir cuit tem po rarily granted
Novartis’ emer gency mo tion for an in junc tion un til it could hear from both par ties. On Sep tem ber 28,
how ever, the court de nied Novartis’ mo tion, al low ing Teva to re sume sales of its ge neric Famvir while
Novartis ap peals the dis trict court rul ing. Novartis be lieves in the va lid ity of the Famvir com pound pat ent,
which ex pires in 2010, and the Famvir method-of-use pat ents, some of which will ex pire as late as 2015.
If Novartis wins the patent dispute, it could seek treble damages from Teva.
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