IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
vaccine, Borrelia, Novartis — J7A9 Preclinical
vaccine, Candida, Novartis — J7A9 Preclinical
vaccine, Chlamydia, Novartis/Intercell — J7A9 Preclinical
vaccine, Group A Streptococcus, Novartis — J7A9 Preclinical
vaccine, Group B Streptococcus, Novartis/
Intercell — J7A9 Preclinical
vaccine, influenza, Dynavax — J7A1 Preclinical
vaccine, Klebsiella, Novartis/Intercell — J7A9 Preclinical
vaccine, otitis media, Novartis/Intercell — J7C Preclinical
vaccine, Streptococcus pneumoniae,
Novartis/Intercell — J7A7 Preclinical
TLR9 immunomodulatory
oligonucleotides, Idera/Novartis QAX 935 R3X Discovery
In Jan u ary 2009, Novartis stated that it had 152 pro jects in clin i cal de vel op ment. R&D ac tiv i ties are fo -
cused in par tic u lar on car dio vas cu lar and met a bolic dis eases, on col ogy and neu rol ogy as well as re spi ra -
tory and in fec tious dis eases. Novartis’ pipe line is vast, con tain ing com pounds in many ther a peu tic ar eas.
In Jan u ary 2009, Novartis re ported that in 2008 it had made 14 reg u la tory sub mis sions for key prod ucts
and re ceived 10 ap prov als for key prod ucts (in clud ing line ex ten sions for mar keted drugs). Novartis also
re ports that 25% of its ex plor atory pipe line is now bi o log i cal drugs. In 2008, Novartis invested $7.2 billion
in R&D, up 12%.
Sub mis sions for ap proval for key pipe line prod ucts in 2008 in clude, the men in gi tis vac cine Menveo in the
USA, the new can cer treat ment Afinitor (everolimus) in the USA and Eu rope, for the once daily long-act -
ing beta ag o nist indacaterol (QAB 149) for COPD in the USA and Eu rope, and the hu man monoclonal
an ti body to interleukin-1 beta, and ACZ 885, for the treat ment of Cryopyrin-As so ci ated Pe ri odic Syn -
dromes (CAPS) in the USA and Eu rope. Novartis an tic i pates ap proval in 2009 for Menveo, Afinitor, and
the Jap a nese en ceph a li tis vi rus vac cine, Ixiaro, which was filed for approval in 2007 in the USA and EU.
Novartis plans sub mis sions for sev eral new prod ucts in 2009: for fingolimod (FTY 720), which may be -
come the first oral, once-daily dis ease-mod i fy ing treat ment for pa tients with re laps ing mul ti ple scle ro sis
(MS), MFF 258, com bi na tion of formoterol and mometasone for COPD, and Albuferon (albinterferon
alfa-2b) for hepatitis C.
Novartis faces the pros pect of US ge neric com pe ti tion for its lead ing prod uct, Diovan (valsartan) in Sep -
tem ber 2012 (ear lier in some other mar kets). It has al ready launched a com bi na tion prod uct, Exforge
(valsartan + amlodipine) and the renin in hib i tor Tekturna (aliskiren) to bol ster its car dio vas cu lar fran -
chise. It is also de vel op ing a range of fixed-dose com bi na tion prod ucts in clud ing Diovan plus Tekturna
(filed in the USA in late 2008), Tekturna plus amlodipine, Exforge plus HCTZ, and Tekturna plus
amlodipine plus HCTZ. How ever, these prod ucts will not be able to re place the Diovan sales that will be
lost at pat ent ex piry. Novartis also has sev eral renin in hib i tors in early clin i cal tri als, fol low ing the 2008
ac qui si tion of Speedel, and a range of other cardiovascular products in early clinical trials.
In Feb ru ary 2009, Novartis gained a li cense to Portola’s ADP re cep tor an tag o nist, elinogrel, for the
treat ment and pre ven tion of throm bo sis in pa tients with acute cor o nary syn drome or un der go ing cor o -
nary in ter ven tion (PCI), and for the sec ond ary pre ven tion of MI and stroke. This is a new area for Novartis
but one that is be ing ac tively in ves ti gated by sev eral of its peers, but with prod ucts al ready filed for ap -
proval or in phase III, whereas elinogrel is in phase II tri als.
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