IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Crown ing Sandoz’s dif fi cult-to-make strat egy are biosimilars, fol low-on ver sions of ex ist ing bi o log i cal
med i cines. In 2007, Sandoz be came the first com pany to re ceive Eu ro pean Com mis sion ap proval for a
biosimilar epoetin alfa (EPO). The Sandoz ver sion of epoetin alfa was launched in Ger many and the Neth -
er lands in 2007. In a pre ce dent-set ting de ci sion in April 2006, Sandoz be came the first com pany to ob -
tain Eu ro pean ap proval for a biosimilar med i cine, the hu man growth hor mone Omnitrope. Ap proval of
Omnitrope in the US fol lowed a month later. As more biopharmaceuticals lose pat ent pro tec tion in com -
ing years, biosimilar prod ucts are ex pected to play a key role in the growth strat egy of Sandoz. It has
gone on to de velop biosimilar ver sions of filgrastim (Zarzio/Filgrastim Hexal), which was ap proved in the
EU in Feb ru ary 2009, and Extavia (in ter feron beta-1b), a biosimilar ver sion of Bayer’s
Betaseron/Betaferon. Novartis gained rights to de velop Extavia, its own branded ver sion of Betaferon,
un der an agree ment with Bayer Schering fol low ing Novartis’ ac qui si tion of Chiron. In Jan u ary 2009,
Extavia was launched in Ger many and Den mark, with fur ther European launches planned. A US launch is
also planned for 2009.
For 2008, Sandoz re ported that it had re ceived more than 100 prod uct ap prov als world wide and made
more than 1500 sub mis sions. Fur ther more, the com pany has more than 880 pro jects in de vel op ment,
in clud ing those de vel oped in-house, li censed pro jects and ac tive phar ma ceu ti cal in ter me di ates. At the
end of 2008 the com pany had 123 ANDAs pend ing at the FDA, in clud ing 68 para graph IV filings and 20
first-to-file.
In July 2008, Sandoz filed an ap pli ca tion with the US FDA to sell a ge neric ver sion of the Teva mul ti ple
scle ro sis drug Copaxone (glatiramer ac e tate), which has been de vel oped by Momenta (USA). Teva
main tains that it has pat ent pro tec tion on Copaxone in the USA un til May 2014 and in much of Eu rope un -
til 2015. Teva has re sponded by fil ing a suit against Novartis and Momenta in the US Dis trict Court in
Manhattan.
In Au gust 2008, Sandoz was also re ported to have sought US FDA ap proval for a ge neric ver sion of
Bayer’s lead ing oral con tra cep tive YAZ, pro vok ing a pat ent in fringe ment law suit from Bayer. Bayer says
that mar ket ing ex clu siv ity for YAZ, the lower dose ver sion of its Yasmin oral con tra cep tive, runs until
March 2009.
Con sumer Prod ucts
The Con sumer Health di vi sion cov ers all Novartis non-eth i cal phar ma ceu ti cal units (OTC, An i mal Health
and CIBA Vi sion). In 2007, Novartis sold its Med i cal Nu tri tion and Gerber baby food units. In 2008, Con -
sumer Health con tin u ing op er a tions sales rose 7.1% (4% in lo cal cur rency terms) to $5.8 bil lion. There
was strong growth in emerg ing mar kets, but a fall of 3% in the USA to $1,714 mil lion: sales in the rest of
the world grew 7% in lo cal cur rency terms to $4,098 mil lion. Mor gan Stan ley an a lysts (Jan u ary 2009)
pre dict 2009 sales of $6,152 mil lion rising to $7,555 million in 2014.
OTC:
Novartis’ OTC busi ness was boosted in 2005 by the ac qui si tion of Bris tol-Myers Squibb’s US and Ca na dian
OTC prod ucts. The deal in cluded the an al ge sic Excedrin and also al lowed Novartis to sell the prod ucts in
Latin Amer ica, Eu rope, the Mid dle East, and Af rica, al though 90% of their com bined sales are in the USA.
In 2008, the OTC busi ness ex panded thanks to con tin ued fo cus on stra te gic brands (such as Voltaren,
Theraflu, and Otrivin) and ex pan sion in emerg ing mar kets, in clud ing East ern Eu rope and Rus sia
(Novartis re ports it now has the top po si tion in Rus sia). In the USA, how ever, sales fell which Novartis
notes re flects changes in con sumer spend ing that have af fected the en tire in dus try. Novartis main tained
its po si tion as world’s num ber four OTC com pany in 2008.
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