IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
In No vem ber 2008, Novartis stated, “AFQ 056, a metabotropic glu ta mate re cep tor 5 (mGlu5) an tag o nist,
has the po ten tial to be come the first ap proved treat ment for Par kin son’s dis ease levodopa-in duced
dyskinesia (PD-LID). No ther apy has been ap proved for this dis ease, which is a com pli ca tion af ter do pa -
mine-re place ment ther apy in Par kin son’s pa tients and char ac ter ized by a va ri ety of hyperkinetic move -
ments. AFQ re cently showed pos i tive re sults in a proof-of-con cept trial in PD-LID and is pro ceed ing in
de vel op ment with planned sub mis sions af ter 2011. AFQ 056 shows po ten tial in other dis eases and a
proof-of-con cept study is un der way for symp tom atic treatment of adults with Fragile X syndrome.”
Clin i cal Data: In De cem ber 2008 Novartis re ported re sults from a ran dom ized, dou ble-blind,
proof-of-con cept trial of AFQ 056 in the treat ment of Par kin son’s dis ease as so ci ated levodopa-in duced
dyskinesia. AFQ 056 ad min is tra tion re sulted in im prove ments in both the Ab nor mal In vol un tary Move -
ment Scale and Uni fied Par kin son’s Dis ease Rat ing Scale com pared with pla cebo. Novartis plans to sub -
mit reg u la tory filings for AFQ 056 after 2011.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast sales of $50 mil lion in 2012
and $100 mil lion in 2013.
NIC O TINE-QBETA (NIC 002), a vac cine that uti lizes Cytos’ (Swit zer land) Immunodrug tech nol ogy, is
be ing de vel oped by Cytos and Novartis as a treat ment of nic o tine with drawal. Nic o tine-Qbeta con sists of
nic o tine mol e cules com bined with a highly re pet i tive car rier par ti cle, Qbeta, which mim ics the re pet i tive
ac tion of a vi rus, in duc ing a strong im mune re sponse. Cytos an tic i pates that the vac cine will block en try
of nic o tine into the brain. The vac cine is in phase II tri als and Novartis ex pects it to be filed for approval in
2012 or beyond.
Li cens ing: Cytos en tered into an ex clu sive global com mer cial li cense agree ment with Novartis to de -
velop, man u fac ture and com mer cial ize NIC 002 in April 2007. Un der the terms of the agree ment,
Novartis will re ceive world wide ex clu sive rights for NIC 002 and will be re spon si ble for late-stage clin i cal
de vel op ment, man u fac tur ing and com mer cial iza tion of the vac cine. In re turn, Cytos is el i gi ble to re ceive
up to SFr600 mil lion in upfront and de vel op ment, reg u la tory and sales mile stone pay ments, as well as
sales-re lated roy al ties. The upfront payment by Novartis will be SFr35 million.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $100 mil lion in
2012 ($200 mil lion by 2013).
CAD 106, for the treat ment of Alz hei mer’s dis ease, is an immunotherapeutic that can block the for ma -
tion of beta-am y loid plaques in the brain. In 2008, Novartis was con duct ing a dou ble-blind pla cebo-con -
trolled phase I trial in 60 pa tients with mild-to-mod er ate Alz hei mer’s dis ease to study the safety,
tolerability and beta-am y loid spe cific an ti body re sponse af ter CAD 106 treatment.
Li cens ing: CAD 106 was in-li censed from Cytos (Swit zer land) in 2001.
BGG 492 was in phase I tri als for the treat ment of ep i lepsy in Swit zer land in 2008.
BAF 312 is a se lec tive sphingosine 1-phos phate re cep tor ag o nist, in de vel op ment for the treat ment of
mul ti ple scle ro sis. A phase I trial has been com pleted and Novartis plans to be gin phase II trials in 2009.
ATI 355 is in de vel op ment with Novartis for use in the treat ment of spi nal cord in jury. A multicenter,
open-la bel, non-ran dom ized phase I trial to eval u ate the safety, tolerability and pharmacokinetics of four
dose reg i mens of intrathecal ATI 355 in pa tients with acute spi nal cord in jury is un der way in Ger many.
Novartis ex pects to file for ap proval of ATI 355 in this in di ca tion in 2010 or later. The US FDA has awarded
Or phan Drug des ig na tion to ATI 355 for the treat ment of spi nal cord in jury; Or phan Drug des ig na tion is
pending in the EU.
© 2009 IMS Health In cor po rated or its af fil i ates Page 91