IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
also an in ject able prod uct. NPS (USA) and li censee Nycomed Pharma launched Preotact (parathyroid
hor mone) in Eu rope in a num ber of European countries in 2006-8.
Sales/An a lyst Com ment: Zometa re corded sales of $1.4 bil lion in 2008, up 3% in lo cal cur rency
terms, mak ing it Novartis’ num ber three prod uct. Novartis noted that Zometa re turned to growth in 2008
due to im proved com pli ance for ex ist ing in di ca tions and new data show ing its sig nif i cant anticancer ben e -
fits. In the USA, sales rose 3% to $666 mil lion. In the rest of the world, sales rose 3% to $716 mil lion.
Aclasta/Reclast re corded sales of $254 mil lion in 2008. Mor gan Stan ley an a lysts (Jan u ary 2009) fore cast
Zometa sales of $1,553 mil lion in 2009 (peak ing at $2,287 mil lion in 2013 and fall ing to $1,030 mil lion by
2014). In De cem ber 2008, the an a lysts stated that Zometa is an underappreciated as set and con sen sus
es ti mates are too low. They re port on the pos i tive feed back from cli ni cians on the use of Zometa as an
adjuvant ther apy in breast can cer and that pre scrip tions have al ready in creased based on the results of
the ABCSG-12 trial released in June 2008 at ASCO.
Cowen & Co an a lysts (Au gust 2008) fore cast sales of $1,370 mil lion for Zometa alone in 2008 ($750 mil -
lion by 2013). They give a sep a rate sales fore cast for Aclasta ($300 mil lion in 2008, $580 mil lion in 2009,
ris ing to $675 mil lion by 2012 and fall ing to $550 mil lion by 2013). Ac cord ing to IMS, in the 12-month pe -
riod to the end of Sep tem ber 2008, Zometa was Novartis’ num ber four in ter na tional prod uct ac count ing
for 3.9% of au dited cor po rate phar ma ceu ti cal sales, with 14% fixed rate dollar growth.
Parasiticidal Agents
COARTEM (lumefantrine + artemether): Novartis an nounced in Sep tem ber 2008 that the US FDA has
granted Pri or ity Re view for Coartem, its fixed dose com bi na tion of artemether 20 mg and lumefantrine
120 mg, for the treat ment of ma laria. The prod uct, a three-day oral ther apy for ma laria, has been
launched in sev eral mar kets, in clud ing French West Af rica, In do ne sia, the Phil ip pines and cer tain Eu ro -
pean coun tries. Novartis pro vides Coartem free of profit to the pub lic sec tor in many de vel op ing coun tries
through the Med i cines for Ma laria Ven ture (MMV). Artemether is a semi-syn thetic de riv a tives of the Chi -
nese plant artemisinin, which has been used in Chi nese herbal med i cine for many years to treat ma laria.
In Jan u ary 2009, Novartis and the Med i cines for Ma laria Ven ture launched a new pe di at ric for mu la tion of
Coartem, Coartem Dispersible. Pre vi ously the very bit ter tab lets had to be crushed for chil dren to swal -
low. The for mu la tion has re ceived ap proval in Swit zer land and in many Af ri can coun tries and will be
provided to the public sector without profit in the developing world.
Be cause artemisinin has poor bioavailability, semi-syn thetic de riv a tives of artemisinin, in clud ing
artemether and artesunate have been de vel oped. How ever, their ac tiv ity is not long last ing, with sig nif i -
cant de creases in ef fec tive ness af ter one to two hours. To coun ter this draw back, artemisinin is of ten
given with lumefantrine (also known as benflumetol) to treat un com pli cated falciparum ma laria.
Lumefantrine has a half-life of about 3 to 6 days. Such a treat ment is called ACT (artemisinin-based com -
bi na tion ther apy); other ex am ples are artemether-lumefantrine, artesunate-mefloquine,
artesunate-amodiaquine, and artesunate-sulfadoxine/pyrimethamine. Re cent tri als have shown that
ACT is more than 90% ef fec tive, with a re cov ery of ma laria af ter three days, es pe cially for the
chloroquine-re sis tant Plasmodium falciparum.
Pat ents: Ciba Geigy (later part of Novartis) pat ented the com po si tion of lumefantrine with artemether in
1990. In 1994, Ciba es tab lished a deal with Cititech, In sti tu tion of Mi cro bi ol ogy and Ep i de mi ol ogy, and
Kunming Phar ma ceu ti cal Fac tory (all China) to co-de velop Coartem for malaria.
Clin i cal Data: In De cem ber 2008 the US FDA re ported data in sup port of reg u la tory ap proval of
Coartem. Coartem, given bid for three days, ap peared su pe rior to treat ment us ing the sep a rate con stit u -
ents. Tri als con ducted by Novartis in Asia found that ap prox i mately 90% of ma laria pa tients were cured
28 days af ter re ceiv ing treat ment with the fixed com bi na tion; the rate of cure in Eu ro pean trav el lers was
74%, which may have been a con se quence of in com plete fol low-up for one month (re sult ing in out comes
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