IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Ac cord ing to IMS, Glivec was the num ber four prod uct in the ‘All Other Antineoplastics’ class in the
12-month pe riod to the end of Sep tem ber 2008, with a 12.9% mar ket share and 13% fixed rate dol lar
growth. Roche’s MabThera (rituximab) led the class with a 17.8% mar ket share and 14% dol lar growth,
fol lowed by Roche’s Avastin (bevacizumab) in sec ond place, with a 15.6% mar ket share and 38% dol lar
growth. Roche’s Herceptin (trastuzumab) was num ber three, with a 15.4% mar ket share and 12%
fixed rate dol lar growth. In fifth place was sanofi-aventis’ Eloxatine (oxaliplatin) with a 9.0% mar ket
share and 2% fixed dol lar rate growth. Sutent was the num ber nine prod uct in the class, with a 3.2%
mar ket share and 49% fixed rate dol lar growth. BMS’s Sprycel was in num ber 11 po si tion, with a 1.0%
mar ket share, but 123% fixed rate dollar growth.
Sales/An a lyst Com ment: In 2008, Glivec sales were $3.67 bil lion, up 15% in lo cal cur rency terms,
mak ing it Novartis’ num ber two prod uct. Sales rose 26% in the USA to $902 mil lion, and up 12% in the
rest of the world to $2,768 mil lion. Novartis noted that it bene fited from wider use in pa tients with GIST
and in var i ous rare dis eases. Mor gan Stan ley an a lysts (Jan u ary 2009) pre dict 2009 sales of $3,902 mil -
lion ($4,973 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast sales of $3,820 in 2008
($5,100 by 2013). Ac cord ing to IMS, in the 12 months to the end of Sep tem ber 2008, Glivec was
Novartis’ num ber two in ter na tional phar ma ceu ti cal prod uct, ac count ing for 8.5% of au dited cor po rate
phar ma ceu ti cal sales, with 12% fixed rate dollar growth.
MYFORTIC (mycophenolate so dium), an en teric coated for mu la tion of the so dium salt of mycophenolic
acid, was ap proved in Swit zer land in 2002 for the pre ven tion of acute re jec tion in kid ney (re nal) trans -
plant pa tients. Myfortic has since been launched in over 50 mar kets world wide, in clud ing Eu rope, the
USA, Brazil, Can ada and In dia for use in com bi na tion with stan dard ther a pies (ciclosporin and
corticosteroids) to pre vent or gan re jec tion in kid ney trans plant pa tients. Ad junc tive ther apy with Roche’s
MPA prod uct CellCept (mycophenolate mofetil) is stan dard in over 70% of new re nal trans plant pa tients.
How ever, se ri ous GI side ef fects (some times lead ing to dis con tinu a tion of ther apy) are seen with
CellCept, and Myfortic has a better GI side-ef fect pro file due to its en teric coat ing, mean ing it is ab sorbed
in the small in tes tine rather than the stom ach. Data from 11 tri als con ducted in Eu rope, in volv ing 877 re -
nal trans plant pa tients were col lected and Myfortic shows im proved gastrointestinal tolerability compared
with mycophenolate mofetil.
In No vem ber 2007, the FDA added a new safety warn ing to Myfortic’s la bel out lin ing the in creased mis -
car riage risk in the first tri mes ter of preg nancy and raised risk for mal for ma tions of the ex ter nal ear and
the face, such as cleft lip and pal ate. Other drug-re lated birth de fect risks in clude anom a lies of dis tal
limbs, which in clude fin gers and toes, and of the heart, esoph a gus, and kid ney. In April 2008, it was re -
ported that the FDA was re view ing whether Myfortic and a sim i lar Roche drug, CellCept, could be linked to
a rare CNS dis or der, pro gres sive multifocal leukoencephalopathy (PML).
Com pe ti tion: Myfortic is tar geted at pa tients tak ing CellCept and ex pe ri enc ing se vere GI side ef fects, as
well as new kid ney trans plant pa tients. In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing
to IMS, Myfortic was the num ber eight prod uct in the L4A class (Immunosuppressive Agents), with a
1.6% mar ket share and 38% fixed rate dol lar growth. Num ber one was J&J’s Remicade (infliximab),
with a 40.7% mar ket share. Remicade 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 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 four was Novartis’ Sandimmun
(ciclosporin), 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), also not a com pet i tor to Myfortic, with a 4.5% mar ket share and
240% fixed rate dol lar growth. 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. Novartis’ Certican
(everolimus) was the num ber 12 prod uct world wide with a 0.6% market share and 48% fixed rate dollar
growth.
© 2009 IMS Health In cor po rated or its af fil i ates Page 33