IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
tions to strengthen its prod uct port fo lio, tech no log i cal ex per tise, and geo graphic pres ence, led by the
ac qui si tions of Hexal and Eon Labs in 2005. The busi ness has grown well but in 2008 net sales rose just
5.4% to $7.6 bil lion, tem pered by the lack of new launches in the USA.
In 2006, Sandoz’s re com bi nant hu man growth hor mone Omnitrope (somatropin) be came the first bi o -
logic fol low-on prod uct (biosimilar) to be ap proved un der a new biosimilar path way in the EU. It was also
ap proved in the USA in 2006. Sandoz is now step ping up its at tack on the biotech mar ket. In 2007, it re -
ceived Eu ro pean ap proval for Binocrit (epoetin alfa), a biosimilar ver sion of Amgen’s Epogen and J&J’s
Procrit, which has now been launched in a num ber of mar kets. 2008 saw the ap proval in Eu rope of
Extavia (in ter feron beta-1b), a biosimilar ver sion of Bayer’s Betaseron/Betaferon for mul ti ple scle ro sis. It
was launched in Ger many and Den mark in Jan u ary 2009, with fur ther Eu ro pean launches planned for
2009 as well as a US launch. And in Feb ru ary 2009, Sandoz gained ap proval from Eu ro pean reg u la tors for
a fourth biosimilar med i cine, Zarzio/Filgrastim Hexal (filgrastim). In its 2008 an nual re port, Novartis
noted that the Sandoz de vel op ment pro gram for biosimilars in cludes 25 pro jects, one of the broad est
pro grams in the in dus try. The Kundl (Aus tria) site is one of the big gest de vel op ment and man u fac tur ing
centers for microbially expressed recombinant proteins.
Dr Gehard Schaefer, Head of Global Prod uct De vel op ment at Sandoz stated in the Novartis 2007 an nual
re port, “This is the be gin ning of a con stant flow of fol low-on prod ucts com ing out of our bio tech nol ogy de -
vel op ment.” He noted that Sandoz sci en tists are now as sess ing sec ond-gen er a tion, long-act ing bio tech -
nol ogy prod ucts as pos si ble pro jects. An other ma jor fo cus will be fol low-on ver sions of monoclonal
an ti bod ies that will be gin los ing pat ent pro tec tion in about five years. Dr Schaefer stated, “This is the fu -
ture and as one of the ma jor play ers in the field we clearly are looking into these opportunities.”
On a less pos i tive note for Sandoz, there have been me dia re ports of other large com pa nies mov ing in to
the area of biosimilars, in clud ing Merck & Co and Lilly. The lat ter has just ex panded its biotech ca pa bil ity
with the pur chase of ImClone Sys tems (USA).
Sandoz notes that dur ing 2008, it sub mit ted reg u la tory ap pli ca tions for 1,500 dif fer ent pro jects to au -
thor i ties around the world, as well as sub mit ting sup ple men tary reg u la tory ap pli ca tions in new mar kets
for many ex ist ing prod ucts, part of a growth ini tia tive prompted by the ac qui si tion of Hexal and Eon.
Sandoz also has a deep pipe line, en com pass ing more than 880 pro jects, in clud ing a sig nif i cant proportion
of difficult-to-make products.
R&D
• 152 Clin i cal Pro jects in the Pipe line
Novartis has a large R&D pipe line, with pro jects in clud ing both new mo lec u lar en ti ties and ad di tional in di -
ca tions or for mu la tions for mar keted prod ucts. Over all, Novartis stated that it had 152 pro jects in clin i cal
de vel op ment in Jan u ary 2009, and that in 2008 it had made 14 reg u la tory sub mis sions and had re ceived
10 key ap prov als. In 2008, Novartis in vested $7.2 bil lion in group R&D activities, up 12%.
Key ar eas of de vel op ment are on col ogy and car dio vas cu lar dis eases. In on col ogy, Novartis hopes to
launch five new drugs by 2012, and be lieves that at least one could achieve sales of $1 bil lion or more an -
nu ally. In Sep tem ber 2008, its prod uct Afinitor (everolimus) was granted Pri or ity Re view sta tus by the US
FDA for the treat ment of pa tients with ad vanced kid ney can cer af ter fail ure of stan dard treat ment. In No -
vem ber 2008 the FDA re quested more in for ma tion, but Novartis still an tic i pates a 2009 ap proval.
Novartis has also filed MAAs for Afinitor with the EMEA and the Swiss Agency for Ther a peu tic Prod ucts
(Swissmedic). Everolimus is also in late-stage tri als for other types of can cer (it is al ready mar keted as
Certican for the pre ven tion of or gan trans plant re jec tion). The other com pounds are vadimezan (ASA
404), in de vel op ment in part ner ship with Antisoma (UK) for non-small cell lung can cer with a fil ing sched -
uled for 2011, pasireotide (SOM 230) for a rare group of neuroendocrine tu mors with a fil ing sched uled
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