IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Sale/An a lyst Com ment: In 2008, Novartis re ported that sales stood at $290 mil lion, up 47% in lo cal
cur rency terms, mak ing it Novartis’ num ber 20 prod uct. Cowen & Co an a lysts (Au gust 2008) fore cast
sales of $320 mil lion in 2008 ($525 mil lion by 2013).
SANDIMMUN/NEORAL (ciclosporin), an immunosuppressant, was first launched as Sandimmun in
1983. A newer for mu la tion, Neoral, a pat ented soft gel cap sule that of fers more pre dict able re lease
char ac ter is tics and better bioavailability than stan dard Sandimmun, has now been launched in many
mar kets. Ciclosporin is mainly used in pre vent ing or gan trans plant re jec tion, but is also used for pso ri a -
sis, ne phritic syn drome, der ma ti tis, uveitis and rheu ma toid ar thri tis in a num ber of mar kets, in clud ing
the USA. Neoral was launched in Ja pan in 2000 and Novartis re ceived ap proval in Ja pan for the drug in
my as the nia gra vis in 2006. Sandimmun is gradually being replaced by Neoral.
Li cens ing: Ciclosporin was li censed-out to Allergan (USA) in 1993 for top i cal oph thal mic uses world wide
out side Ja pan and cer tain other Asian coun tries.
Pat ents: Ciclosporin is now a ma ture drug and open to ge neric com pe ti tion. Abbott has a branded ge -
neric ver sion called Gengraf, and Eon Labs and Apotex also mar ket sig nif i cant ge neric ver sions of
ciclosporin. The Neoral for mu la tion is pro tected by new pat ents, but it is re ported that these will ex pire
before 2008.
Lifecycle Man age ment: Neoral’s in di ca tions have now been ex panded to in clude the treat ment of pso -
ri a sis, uveitis, se vere atopic der ma ti tis, nephrotic syn drome and RA. Novartis is now de vel op ing suc ces -
sors to ciclosporin. It also aims to de fend its fran chise through the de vel op ment of NeoralChek, a
di ag nos tic in clin i cal tri als for mon i tor ing plasma lev els of the drug to al low tai lored, in di vid u al ized ther -
apy. Tri als have al ready shown that use of NeoralChek has im proved out comes in liver trans plant pa -
tients, and studies are also planned in kidney transplants.
Com pe ti tion: The launch of newer immunosuppressants, such as Astellas’ Prograf (tacrolimus) has
put pres sure on Neoral. In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS,
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 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 Sandimmun 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. 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 Sandimmun 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% mar ket share and 38% fixed rate dol lar growth. Novartis’
Certican (everolimus) was the num ber 12 prod uct world wide in the class, with a 0.6% market share and
48% fixed rate dollar growth.
Sales/An a lyst Com ment: In 2008, Novartis re ported that Sandimmun/Neoral sales were $956 mil -
lion, down 4% in lo cal cur rency terms, and it was its num ber six prod uct. In the USA sales fell 9% to $98
mil lion, and in the rest of the world sales were down 4% at $858 mil lion. Mor gan Stan ley an a lysts (Jan u -
ary 2009) fore cast sales of $869 mil lion in 2009 ($672 mil lion by 2014). Cowen & Co an a lysts (Au gust
2008) fore cast sales of $1,030 mil lion in 2008 ($900 mil lion by 2013). Ac cord ing to IMS, in the 12-month
pe riod to the end of Sep tem ber 2008, Sandimmun was Novartis’ num ber eight in ter na tional prod uct ac -
count ing for a 2.4% share of au dited cor po rate phar ma ceu ti cal sales, but sales were down 3% in fixed
rate dollar terms.
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