IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
R&D Fo cus). In Oc to ber 2008, it re ported pos i tive re sults from a sec ond phase III study which con firmed
that octreotide C2L 30mg ev ery six weeks can re place Sandostatin LAR 30mg ev ery four weeks in
acromegalic pa tients, with the same clin i cal ben e fit and no un ex pected or se ri ous ad verse ef fects. Dr
Philippe Calais, Ambrilia’s pres i dent and CEO stated, “These new data fur ther val i date C2L’s po ten tial to
be a safe, ef fec tive and cost ef fec tive ther apy, well po si tioned to cap ture a size able por tion of the $1 bil -
lion plus Sandostatin LAR mar ket.” Ambrilia aims to license-out or sell octreotide C2L.
Indevus (USA) is de vel op ing an octreotide ac e tate-con tain ing im plant, de vel oped us ing its pro pri etary
HYDRON drug de liv ery plat form. The im plant is de signed to pro vide con tin u ous six-month ad min is tra tion
of octreotide ac e tate for the treat ment of acromegaly. In Sep tem ber 2008, Indevus an nounced the ini ti a -
tion of a ran dom ized, open-la bel US and Eu ro pean phase III trial to in ves ti gate the ef fi cacy, safety and
tolerability of its octreotide im plant in pa tients with acromegaly. The trial will be con ducted at 34 clin i cal
sites in six coun tries, and the planned en roll ment will be 140 pa tients known to be re spond ers to
somatostatin an a logues, with well-main tained growth hor mone (GH) and in su lin-like growth fac tor-1
(IGF-1) lev els. Pa tients will be ran dom ized 3:1 to re ceive the octreotide im plant or monthly in jec tions of
octreotide (Sandostatin LAR). The pri mary ef fi cacy end point of the trial will be the sup pres sion of GH and
IGF-1. Indevus ex pects that this trial will serve as the basis for US and international marketing
applications.
Sales/An a lyst Com ment: Sandostatin/Sandostatin LAR sales were up 6% in lo cal cur rency terms in
2008 to $1.1 bil lion due to in creas ing use of the once-monthly Sandostatin LAR ver sion, which ac counts
for 85% of net sales. Sandostatin was Novartis’ num ber five phar ma ceu ti cal prod uct in 2008. Novartis
notes that new com pe ti tion in the USA has had min i mal im pact on Sandostatin LAR sales in 2008. Mor gan
Stan ley an a lysts (Jan u ary 2009) fore cast peak sales of $1,142 mil lion in 2009 ($380 mil lion by 2014).
Cowen & Co an a lysts (Au gust 2008) fore cast sales of $1,165 mil lion in 2008 (peak ing at $1,300 mil lion in
2011 and fall ing to $600 mil lion by 2013). Ac cord ing to IMS, in the 12-month pe riod to the end of Sep -
tem ber 2008, Sandostatin was Novartis’ num ber seven in ter na tional phar ma ceu ti cal prod uct, ac count ing
for 2.7% share of au dited cor po rate pharmaceutical sales, with 5% fixed rate dollar growth.
Musculoskeletal System Agents
PREXIGE (lumiracoxib), a sec ond-gen er a tion COX-2 in hib i tor, was first launched in Brazil in 2005 for the
treat ment of osteoarthritis and acute pain. Ap prov als fol lowed in var i ous mar kets, in clud ing the EU, but
not in the USA. Lumiracoxib was with drawn from many mar kets in 2007 due to safety is sues. How ever,
Prexige con tin ues to be avail able in some coun tries, and Novartis be lieves it is a valu able ther apy op tion
for ap pro pri ate pa tients, par tic u larly those at risk of se ri ous gas tro in tes ti nal com pli ca tions, and will con -
tinue discussions with health authorities.
The EU mu tual rec og ni tion pro ce dure was com pleted in Oc to ber 2006. In No vem ber 2007, how ever, the
UK’s Med i cines and Healthcare prod ucts Reg u la tory Agency (MHRA) sus pended the li cense for Prexige
fol low ing an in crease in the num ber of se ri ous liver re ac tions among pa tients tak ing a 100mg dose. In
De cem ber 2007, the EMEA’s Com mit tee for Me dic i nal Prod ucts for Hu man Use (CHMP) rec om mended
that the mar ket ing au tho ri za tions for all lumiracoxib-con tain ing med i cines be with drawn in all EU mem -
ber states because of serious liver-related side effects.
In the US, the FDA is sued a sec ond not ap prov able let ter for Prexige in Sep tem ber 2007. Prexige had also
been ap proved in Can ada and in Aus tra lia, but was with drawn from these mar kets in Au gust and Oc to ber
2007, re spec tively, be cause of liver problems.
In Sep tem ber 2008, it was re ported that Novartis has iden ti fied a ge netic se quence that may be a risk
fac tor for se ri ous liver in jury in pa tients re ceiv ing Prexige. Pre lim i nary re sults from genomic test ing in di -
cate that an ex tended Ma jor Histocompatibility Com plex Class II haplotype is as so ci ated with Prexige
hepatotoxicity. If the fi nal re sults bear out these find ings, Novartis will meet with the FDA to dis cuss what
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