IMS Company Profiles - Report Buyer

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IMS COM PANY PRO FILES NOVARTIS Co-Diovan (valsartan + HCTZ) for hy per ten sion; and the wet age-re lated macular de gen er a tion drug Lucentis (ranibizumab). Sales in Japan in 2008 were $2,987 million. Novartis is also very pos i tive about the Chi nese mar ket. In 2008 sales in China were $456 mil lion. The com pany’s to tal in vest ment in China now to tals over $400 mil lion, with two ma jor de vel op ments an - nounced in 2006: a man u fac tur ing and de vel op ment cen ter in Changshu, and an in te grated bio med i cal R&D cen ter in Shang hai. The re search fa cil ity will fo cus ini tially on dis cov er ing med i cines to treat can cers caused by in fec tions, which make up a con sid er able pro por tion of the can cer cases di ag nosed in China. Few groups have con ducted ba sic drug dis cov ery work in China be cause of con cerns about in tel lec tual prop erty pro tec tion. In No vem ber 2008 Novartis was re ported to be in creas ing its in vest ment in this re - search cen ter and in creas ing its mar ket ing team by 20%. Novartis plans to ex pand in both its eth i cal and OTC busi ness and there have been re ports that the com pany is seek ing to ac quire a Chi nese OTC com - pany. The goal is a 30-40% an nual in crease in its busi ness in China for the next five to ten years, ac cord - ing to Jeffrey Li, Novartis’ China Pres i dent. Novartis currently ranks as the fourth largest pharmaceutical company in the Chinese hospital market. Ther a peu tic Fo cus • Key Growth Driv ers: Car dio vas cu lar & On col ogy Novartis is in an un usual po si tion of run ning both a generics and an in no va tive R&D com pany, which it does suc cess fully with sep a rate boards of man age ment and thus avoid ing the ob vi ous ideo log i cal dif fer - ences be tween the two con cepts. This strat egy also aims to pro long the lifecycle of its pro pri etary pharmaceuticals when they come off pat ent al though would have to be care ful not to en ter into obvious competition issues. Novartis’ Phar ma ceu ti cal Di vi sion is com prised of the fol low ing ther a peu tic ar eas: car dio vas cu lar; on col - ogy; neu ro sci ence; re spi ra tory; ophthalmics, der ma tol ogy, gas tro in tes ti nal and urol ogy; ar thri tis/bone; and in fec tious dis eases, transplantation and immunology. In 2008, Novartis’ port fo lio in cluded five block bust ers and was led by Diovan, for hy per ten sion, with sales of $5.7 bil lion. In sec ond po si tion was Gleevec/Glivec (imatinib), for chronic myeloid leu ke mia, launched in 2001, with sales of $3.7 bil lion, with Zometa (zoledronic acid), used in treat ing bone prob lems as so ci - ated with can cer and os teo po ro sis, in third place with sales of $1.4 bil lion. Femara (letrozole) for breast can cer be came the com pany’s fourth block buster in 2008 with sales of $1.1 bil lion, fol lowed by Sandostatin (octreotide), for acromegaly, in fourth place, also with $1.1 billion in sales. New prod ucts that have per formed par tic u larly well in 2008 con trib ut ing $2.9 bil lion to sales over all, in - clude Lucentis (ranibizumab) for the treat ment of age-re lated macular de gen er a tion, sales up 125% to $886 mil lion, Exjade (deferasirox) for iron over load up 49% to $531 mil lion, and Exforge (valsartan + amlodipine) for hy per ten sion up 294% to $406 mil lion. Sales of the com pany’s lead ing Alz hei mer’s drug Exelon (rivastigmine) have been re vived by the launch of the Exelon Patch and sales were up 29% to $815 mil lion. The com pany has not had any new ma jor launches in 2008 but com pleted 14 ma jor sub - mis sions in the US, Eu rope and Ja pan, with 2009 poised to be a big year for launches. A re cent im por tant launch for the com pany was Tekturna (aliskiren), a di rect renin in hib i tor for the treat - ment of hy per ten sion. Novartis is re ported to be in vest ing heavily in de vel op ing this drug, with a ma jor global tri als pro gram un der way and two com bi na tion prod ucts al ready close to mar ket: Tekturna plus Diovan and Tekturna plus the di uretic hy dro chlo ro thi a zide. Novartis hopes that Tekturna will achieve sales of more than $1 billion annually. In 2003, Novartis united its generics ac tiv i ties un der a sin gle global name: Sandoz. Ranked as the sec - ond-larg est generics com pany in the world based on sales, Sandoz has made a se ries of tar geted ac qui si - © 2009 IMS Health In cor po rated or its af fil i ates Page 10

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 © 2009 IMS Health In cor po rated or its af fil i ates Page 11

<strong>IMS</strong> COM PANY PRO FILES NOVARTIS<br />

Co-Diovan (valsartan + HCTZ) for hy per ten sion; and the wet age-re lated macular de gen er a tion drug<br />

Lucentis (ranibizumab). Sales in Japan in 2008 were $2,987 million.<br />

Novartis is also very pos i tive about the Chi nese mar ket. In 2008 sales in China were $456 mil lion. The<br />

com pany’s to tal in vest ment in China now to tals over $400 mil lion, with two ma jor de vel op ments an -<br />

nounced in 2006: a man u fac tur ing and de vel op ment cen ter in Changshu, and an in te grated bio med i cal<br />

R&D cen ter in Shang hai. The re search fa cil ity will fo cus ini tially on dis cov er ing med i cines to treat can cers<br />

caused by in fec tions, which make up a con sid er able pro por tion of the can cer cases di ag nosed in China.<br />

Few groups have con ducted ba sic drug dis cov ery work in China be cause of con cerns about in tel lec tual<br />

prop erty pro tec tion. In No vem ber 2008 Novartis was re ported to be in creas ing its in vest ment in this re -<br />

search cen ter and in creas ing its mar ket ing team by 20%. Novartis plans to ex pand in both its eth i cal and<br />

OTC busi ness and there have been re ports that the com pany is seek ing to ac quire a Chi nese OTC com -<br />

pany. The goal is a 30-40% an nual in crease in its busi ness in China for the next five to ten years, ac cord -<br />

ing to Jeffrey Li, Novartis’ China Pres i dent. Novartis currently ranks as the fourth largest pharmaceutical<br />

company in the Chinese hospital market.<br />

Ther a peu tic Fo cus<br />

• Key Growth Driv ers: Car dio vas cu lar & On col ogy<br />

Novartis is in an un usual po si tion of run ning both a generics and an in no va tive R&D com pany, which it<br />

does suc cess fully with sep a rate boards of man age ment and thus avoid ing the ob vi ous ideo log i cal dif fer -<br />

ences be tween the two con cepts. This strat egy also aims to pro long the lifecycle of its pro pri etary<br />

pharmaceuticals when they come off pat ent al though would have to be care ful not to en ter into obvious<br />

competition issues.<br />

Novartis’ Phar ma ceu ti cal Di vi sion is com prised of the fol low ing ther a peu tic ar eas: car dio vas cu lar; on col -<br />

ogy; neu ro sci ence; re spi ra tory; ophthalmics, der ma tol ogy, gas tro in tes ti nal and urol ogy; ar thri tis/bone;<br />

and in fec tious dis eases, transplantation and immunology.<br />

In 2008, Novartis’ port fo lio in cluded five block bust ers and was led by Diovan, for hy per ten sion, with sales<br />

of $5.7 bil lion. In sec ond po si tion was Gleevec/Glivec (imatinib), for chronic myeloid leu ke mia, launched<br />

in 2001, with sales of $3.7 bil lion, with Zometa (zoledronic acid), used in treat ing bone prob lems as so ci -<br />

ated with can cer and os teo po ro sis, in third place with sales of $1.4 bil lion. Femara (letrozole) for breast<br />

can cer be came the com pany’s fourth block buster in 2008 with sales of $1.1 bil lion, fol lowed by<br />

Sandostatin (octreotide), for acromegaly, in fourth place, also with $1.1 billion in sales.<br />

New prod ucts that have per formed par tic u larly well in 2008 con trib ut ing $2.9 bil lion to sales over all, in -<br />

clude Lucentis (ranibizumab) for the treat ment of age-re lated macular de gen er a tion, sales up 125% to<br />

$886 mil lion, Exjade (deferasirox) for iron over load up 49% to $531 mil lion, and Exforge (valsartan +<br />

amlodipine) for hy per ten sion up 294% to $406 mil lion. Sales of the com pany’s lead ing Alz hei mer’s drug<br />

Exelon (rivastigmine) have been re vived by the launch of the Exelon Patch and sales were up 29% to<br />

$815 mil lion. The com pany has not had any new ma jor launches in 2008 but com pleted 14 ma jor sub -<br />

mis sions in the US, Eu rope and Ja pan, with 2009 poised to be a big year for launches.<br />

A re cent im por tant launch for the com pany was Tekturna (aliskiren), a di rect renin in hib i tor for the treat -<br />

ment of hy per ten sion. Novartis is re ported to be in vest ing heavily in de vel op ing this drug, with a ma jor<br />

global tri als pro gram un der way and two com bi na tion prod ucts al ready close to mar ket: Tekturna plus<br />

Diovan and Tekturna plus the di uretic hy dro chlo ro thi a zide. Novartis hopes that Tekturna will achieve<br />

sales of more than $1 billion annually.<br />

In 2003, Novartis united its generics ac tiv i ties un der a sin gle global name: Sandoz. Ranked as the sec -<br />

ond-larg est generics com pany in the world based on sales, Sandoz has made a se ries of tar geted ac qui si -<br />

© 2009 <strong>IMS</strong> Health In cor po rated or its af fil i ates Page 10

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