IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Lifecycle Man age ment: Everolimus is be ing de vel oped for on col ogy in di ca tions, with the labcode RAD
001 and the brand name Afinitor, and it is pend ing ap proval in the USA, the EU and Swit zer land for met -
a static re nal cell car ci noma fol low ing reg u la tory sub mis sions in 2008. Novartis an tic i pates an ap proval in
2009 and more reg u la tory fil ings. A phase III pro gram has been com pleted in met a static re nal cell can cer
(mRCC), and phase II tri als on go ing in mul ti ple can cer types, in clud ing neuroendocrine tu mors, lym -
phoma, hepatocarcinoma, gas tric can cer, nonsmall cell lung can cer and breast can cer. In Sep tem ber
2008, 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 mRCC af ter fail ure of stan dard treat ment. How ever, in No vem ber 2008 Novartis
reported that the FDA had requested additional information.
In No vem ber 2008, Novartis stated, “Afinitor, an oral in hib i tor of the mTOR path way, is ex pected to re -
ceive a reg u la tory de ci sion from the FDA within the Q1 2009 for pa tients with ad vanced kid ney can cer.
The FDA has re quested some data clar i fi ca tion and re for mat ting re lated to pre vi ously sub mit ted on col ogy
stud ies as well as ad di tional data from the on go ing trial in pan cre atic neuroendocrine tu mors (pNET). As a
re sult, the ac tion date has been ex tended by three months, but the FDA has not asked for ad di tional stud -
ies. Afinitor was ac cepted for pri or ity re view in mid-2008 based on re sults of the RE CORD-1 tri als that
showed it more than dou bled the time with out tu mor growth in pa tients with ad vanced kid ney can cer af -
ter fail ure of stan dard treat ment. Clinical trials are continuing as planned in other cancers.”
Clin i cal Data: In May 2008 at ASCO, Novartis re ported that everolimus for the treat ment of can cer
(Afinitor) more than dou bled the time with out tu mor growth in pa tients with ad vanced kid ney can cer af -
ter fail ure of stan dard treat ment. The phase III re sults from the RE CORD-1 trial, which was stopped early
based on these re sults pre sented at ASCO, will form the ba sis for global reg u la tory sub mis sions in 2008
for ap proval in treat ing pa tients with ad vanced met a static re nal cell can cer. The com pany re ported that
reg is tra tion tri als in other can cers are un der way. Early proof-of-con cept stud ies pre sented at ASCO
showed Afinitor may of fer a novel treat ment strat egy for breast can cer by over com ing re sis tance and en -
hanc ing the ef fi cacy of sev eral com monly used breast can cer treat ments. Novartis stated that a new trial
to ex plore the po ten tial of Afinitor in breast can cer will be ini ti ated in early 2009. Afinitor acts by di rectly
in hib it ing tu mor cell growth and me tab o lism as well as the formation of new blood vessels
(angiogenesis).
Com pe ti tion: Certican re port edly has ad van tages over its com pet i tors, most no ta bly Wyeth’s
Rapamune (sirolimus), in that it is given in a solid, oral-dose form, has a shorter half-life and can be
dosed at the same time as Novartis’ Neoral/Sandimmun. There is also some ev i dence that Certican
has a neuroprotective (and pos si bly nephroprotective) ef fect not seen with other immunosuppressants.
In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Certican (everolimus) was the
num ber 12 prod uct world wide in the class, with a 0.6% mar ket share and 48% fixed rate dol lar growth.
Num ber one was J&J’s Remicade (infliximab), with a 40.7% mar ket share and sales up 16% in fixed rate
dol lar terms. It is in di cated in var i ous au to im mune con di tions, but is not a di rect com pet i tor to Certican in
the trans plan ta tion field. Num ber two was Astellas’ Prograf (tacrolimus), with a 15.9% mar ket share
and 14% fixed rate dol lar growth. Num ber three was Roche’s CellCept (mycophenolate mofetil), with a
14.9% mar ket share and 12% dol lar growth. Novartis’ Sandimmun was the num ber four prod uct
world wide in the immunosuppressive agents class (L4A), with a 7.7% mar ket share but sales down 3% in
fixed rate dol lar terms. Num ber five was Celgene’s Revlimid (lenalidomide), with a 4.5% mar ket share
and 240% fixed rate dol lar growth: this is also not a di rect com pet i tor to Certican as it is in di cated for
myelodysplastic syn drome. Num ber six was Biogen Idec’s Tysabri (natalizumab), which is used in MS,
with a 3.9% mar ket share and 249% fixed rate dol lar growth. Num ber seven was Wyeth’s Rapamune
(sirolimus), with a 2.5% mar ket share and 1% dol lar growth. Num ber eight was Novartis’ Myfortic
(mycophenolic acid), with a 1.6% market share and 38% fixed rate dollar growth.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast sales of $50 mil lion in 2010,
($150 mil lion by 2013). They fore cast sales of $80 mil lion in 2009 for Afinitor ($300 mil lion by 2013).
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