IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
EXTAVIA (in ter feron beta-1b ): In May 2008, Novartis’ biosimilar prod uct Extavia (in ter feron beta-1b)
was ap proved in the EU for the treat ment of early and re laps ing forms of mul ti ple scle ro sis (MS). It was
launched in Ger many and Den mark in Jan u ary 2009. Fur ther Eu ro pean launches are planned for 2009.
The agent is ap proved for re laps ing-re mit ting MS and for pa tients who have ex pe ri enced a sin gle ep i sode
in volv ing loss of my elin, pa tients who have an ac tive in flam ma tory pro cess need ing in tra ve nous
corticosteroid treat ment, and pa tients who are at high risk of de vel op ing clin i cally def i nite MS. Novartis
plans to launch Extavia in the USA in the first half of 2009.
Novartis and Bayer Schering (the phar ma ceu ti cal arm of Bayer, Ger many) are jointly de vel op ing in ter -
feron beta-1b as a treat ment for MS. In ter feron beta-1b was launched in the USA, its first world mar ket in
1993 as a ther apy for re laps ing-re mit ting MS. It is cur rently mar keted world wide by Bayer Schering as
Betaferon or Betaseron. In 2007, Bayer Schering and Novartis signed a deal fol low ing the lat ter’s ac qui si -
tion of Chiron, which al lows Novartis to mar ket its own branded interferon beta-1b.
Pat ents: In Oc to ber 1982, Cetus, an af fil i ate of the US com pany Chiron (now part of Novartis), filed a
pri or ity prod uct pat ent ap pli ca tion in the USA. In Feb ru ary 1986, Cetus and Tri ton Bio sci ences, a sub sid -
iary of Shell, formed a joint ven ture, Tritus, to de velop the prod uct. In 1990, Tri ton Bio sci ences was ac -
quired by Schering AG (now Bayer Schering) and merged with Schering AG’s US sub sid iary, Berlex. In
1993 Schering AG and Chiron signed an agree ment re lat ing to the reg u la tory fil ing, de vel op ment and
sup ply of in ter feron beta-1b. In Sep tem ber 2007, Bayer Schering and Novartis signed an agree ment that
al lows Novartis to mar ket its own branded interferon beta-1b product.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $25 mil lion in
2008 ($195 mil lion by 2013).
FEMARA (letrozole), a po tent, oral, non-steroidal aromatase in hib i tor, was launched in the UK, its first
world mar ket, in 1996. It is now avail able in over 90 coun tries, in clud ing the USA, Can ada and Ja pan,
where li censee Chugai launched it in 2006. This once-a-day ther apy was first ap proved as a sec ond-line
treat ment for breast can cer in post-meno pausal women in whom antiestrogen ther apy has failed.
Aromatase in hib i tors act by re duc ing the amount of es tro gen cir cu lat ing in the body by bind ing to the en -
zyme aromatase, which is in volved in the syn the sis of es tro gen in tis sues such as fat, liver and mus cle.
Use as a first-line ther apy for ad vanced hor mone-de pend ent breast can cer in postmenopausal women
was approved in the USA and Europe in 2001.
In 2004, the FDA ap proved letrozole for the ex tended adjuvant treat ment of postmenopausal women
with early breast can cer who have re ceived post-sur gery tamoxifen ther apy for five years. Letrozole was
ap proved for this in di ca tion in more than 40 coun tries. These ap prov als were based on re sults from an in -
ter na tional 5,200-pa tient study (des ig nated MA-17). Af ter five years of tamoxifen ther apy, ben e fits be -
gin to wane and the risks of endometrial can cer, pul mo nary em bo lism and stroke in crease; how ever, the
risk of breast can cer re mains and Femara is the first hor monal ther apy to of fer a post-tamoxifen op tion to
re duce the risk of breast cancer recurrence.
In 2005, ini tial data from the BIG 1-98 study showed Femara pro vided a dis ease-free sur vival ad van tage
over tamoxifen in the adjuvant treat ment (post-sur gery) of early breast can cer. Ap proval for this in di ca -
tion was granted in the USA in 2006, based on the re sults of the BIG 1-98 study, which showed that
Femara re duced the risk of breast can cer re turn ing by an ad di tional 21% over the re duc tion of fered by
tamoxifen. Ap proval in the EU also came in the first quarter of 2006.
Li cens ing: Un der the terms of a 1994 cross-li cens ing deal, Novartis and Chugai (Ja pan) co-de vel oped
and co-mar ket letrozole in Japan.
Pat ents: Mylan (USA) re ceived ten ta tive ap proval for a ge neric ver sion of Femara in May 2007. Novartis
has a com pound pat ent on Femara un til 2011 and filed a pat ent in fringe ment law suit against Mylan in
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