IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
2006. In De cem ber 2008, Novartis and Mylan en tered a set tle ment agree ment, un der which Mylan has a
pat ent li cense that will en able it to mar ket letrozole tab lets 2.5 mg prior to the ex pi ra tion of the pat ent.
Ad di tional terms of the agreement remain undisclosed.
Clin i cal Data: Re sults of the Breast In ter na tional Group (BIG) 1-98 trial were pub lished in 2005 in The
New Eng land Jour nal of Med i cine. This trial, in which 8,000 pa tients who un der went sur gery for early
breast can cer were ran dom ized to re ceive adjuvant ther apy with ei ther tamoxifen or letrozole, showed
that letrozole pro vided sig nif i cantly greater ben e fit than tamoxifen with re spect to dis ease-free sur vival
and re duc ing the spread of the dis ease. Fur ther anal y sis of re sults from this trial dem on strated that, at
me dian fol low-up of pa tients at 26 months, letrozole pro longed dis ease-free sur vival by re duc ing the risk
of re cur rence by an ad di tional 21% com pared with tamoxifen. In ad di tion, women treated with letrozole
had a 27% re duc tion in dis tant metastases as well as a 14% re duc tion in the risk of death, although this
did not reach statistical significance.
In De cem ber 2008 pos i tive data was re ported in a trial com bin ing GlaxoSmithKline’s Tykerb (lapatinib)
and Femara in breast can cer treat ment. The study, con ducted by GSK, found a sub set of pa tients with
ag gres sive HER-2 pos i tive met a static breast can cer given the com bi na tion had a lon ger time to dis ease
pro gres sion com pared to Femara treat ment alone (8.2 mo vs 3 mo).
Com pe ti tion: Femara’s clos est com pet i tor is AstraZeneca’s aromatase in hib i tor Arimidex
(anastrozole) as they are both ap proved for the first-line treat ment of breast can cer in postmenopausal
women with ad vanced, hor mone re cep tor-pos i tive dis ease and both have shown su pe ri or ity over the
older, gold stan dard treat ment for this pa tient pop u la tion, AZ’s Nolvadex (tamoxifen).
In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Femara was num ber three
prod uct in the Cyto Hor mone An tag o nists class (L2B), with a 19.1% mar ket share and 20% fixed rate
dol lar growth. AstraZeneca’s Arimidex (anastrozole) led this class, with a 34.2% mar ket share and 9%
fixed rate dol lar growth. Num ber two was AstraZeneca’s Casodex (bicalutamide), a treat ment for pros -
tate can cer, with a 24.3% mar ket share but sales down 1% in fixed rate dol lar terms. Pfizer’s Aromasin
(exemestane) was num ber four, with an 8.0% mar ket share and 11% fixed rate dol lar growth. Num ber
five was AstraZeneca’s breast can cer drug Faslodex (fulvestrant), with a 4.1% mar ket share and 8%
fixed rate dol lar growth. Nolvadex was in sixth place, with a 1.5% mar ket share, but sales down by 3% in
fixed rate dollar terms.
Sales/An a lyst Com ment: In 2008, Femara sales were $1.1 bil lion, up 17% in lo cal cur rency terms,
and it was Novartis’ num ber four prod uct. US sales rose 18% to $483 mil lion. In the rest of the world sales
rose 17% to $646 mil lion. Ge neric com pe ti tion has en tered some mar kets, in clud ing mar kets in Eu rope,
but Novartis notes that this has had a mod est im pact on global growth. Mor gan Stan ley an a lysts (Jan u ary
2009) fore cast sales of $1,238 mil lion in 2009, peak ing at $1,409 mil lion in 2011 ($508 mil lion by 2014).
Cowen & Co an a lysts (Au gust 2008) fore cast sales of $937 mil lion in 2008 and think that sales will peak at
$1,400 mil lion in 2010 (reach ing $300 mil lion by 2013). Ac cord ing to IMS, in the 12-month pe riod to the
end of Sep tem ber 2008, Femara was Novartis’ num ber six in ter na tional phar ma ceu ti cal prod uct ac -
count ing for 2.8% of au dited cor po rate pharmaceutical sales, with 21% fixed rate dollar growth.
GLIVEC/GLEEVEC (imatinib), an Ab1 ty ro sine kinase in hib i tor, was first launched in the USA in 2001 for
chronic myeloid leu ke mia as Gleevec. It is now avail able in more than 80 coun tries world wide, in clud ing
Can ada, Aus tra lia, Eu rope, Ja pan, Asia, and Latin Amer ica. It was first in di cated in the blast cri sis, ac cel -
er ated and chronic phases of the dis ease af ter in ter feron-al pha ther apy has failed. It was granted
fast-track ap proval in the USA fol low ing pos i tive re sults which in di cated that imatinib ef fec tively turns off
this rel a tively rare but fa tal can cer. In some parts of the world, it is sold as Glivec, which is the IMS
international pharmaceutical product name.
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