IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
inflammatory diseases therapy AVP 28225 L4A, M1C Preclinical
mitotic kinesin Eg5 inhibitor BQS 481 L1X9 Preclinical
mitotic kinesin Eg5 inhibitor LCL 161 L1X9 Preclinical
PI3K inhibitor BKM 120 L1X9 Preclinical
SMO inhibitor LDE 225 L1X9 Preclinical
ZARZIO/FILGRASTIM HEXAL (filgrastim): In Feb ru ary 2009, Novartis gained Eu ro pean ap proval for
a biosimilar ver sion of filgrastim, a col ony stim u lat ing fac tor, as a ther apy for neutropenia.
XYOTAX (drug de liv ery sys tem, poliglumex paclitaxel) uti lizes a polyglutamic acid com plex-based, wa -
ter sol u ble sys tem to de liver paclitaxel. The prod uct, co-de vel oped by orig i na tor Cell Ther a peu tics (USA)
and Novartis, is in phase III tri als for the treat ment of nonsmall cell lung can cer (NSCLC) and ovarian
cancer.
Li cens ing: Novartis ac quired world wide ex clu sive de vel op ment and com mer cial iza tion rights to Xyotax
from Cell Ther a peu tics in Sep tem ber 2006. In re turn, Cell Ther a peu tics will re ceive up to $270 mil lion in
prod uct reg is tra tion and sales mile stones. Novartis will also make a $15 mil lion eq uity in vest ment in Cell
Ther a peu tics. Cell Ther a peu tics will re tain an op tion for co-de tail ing Xyotax in the USA un der the di rec tion
of Novartis. The clos ing of this trans ac tion is sub ject to an ti trust clear ance and cer tain other con di tions.
As part of the agree ment, Novartis also has an op tion to de velop and com mer cial ize Cell Ther a peu tics’
pixantrone, a topoisomerase II in hib i tor which in ter ca lates DNA, in phase III trial as a therapy for
aggressive non-Hodgkin’s lymphoma.
FINGOLIMOD (FTY 720), an immunosuppressant (S1P-R ag o nist), is de rived from a Chi nese cat er pil lar
fun gus and is be ing de vel oped for the treat ment of au to im mune dis eases, such as mul ti ple scle ro sis
(MS). Novartis thinks fingolimod has the po ten tial to be come the first oral dis ease-mod i fy ing treat ment
for MS. It is be ing stud ied in a ma jor phase III pro gram, which has en rolled over 3,000 pa tients world -
wide. Tri als for use in kid ney trans plant pa tients have been dis con tin ued. Novartis says that a fil ing
should take place by the end of 2009. Fingolimod has been des ig nated as Or phan Drug in Ja pan. Phase II
trials in MS in Japan began in 2007.
In July 2008, Novartis re ported that fingolimod is pro gress ing to ward sub mis sions at the end of 2009,
and noted that it has the po ten tial to be come the first once-daily oral ther apy for MS. It stated that var i -
ous tri als are un der way in the larg est phase III pro gram to be con ducted in MS. About 3,200 peo ple with
MS are en rolled in five tri als world wide, with a com bined 2,300 pa tient-years of ex pe ri ence. The com pany
noted that in Q2 2008, two in fec tion-re lated in ci dents oc curred among FTY 720 pa tients, in clud ing one
fa tal ity (dis sem i nated zoster). In for ma tion on these cases was shared with in ves ti ga tors and rel e vant
health au thor i ties, and re viewed by an in de pend ent Data Safety Mon i tor ing Board. Pa tients in the tri als
are being notified and studies are progressing as planned.
In No vem ber 2008, Novartis stated “FTY 720 (fingolimod) has the po ten tial to be the first
sphingosine-1-phos phate re cep tor (S-1-P) mod u la tor, a new class of ther a peu tics that act on in flam ma -
tion and may have a di rect ben e fi cial ef fect on the cen tral ner vous sys tem. First re sults from the phase III
TRANS FORMS trial com par ing this once-daily oral com pound against the once-weekly in ter feron beta-1a
in jec tion in re laps ing re mit ting MS pa tients are ex pected by early 2009. Reg u la tory sub mis sions are on
track for the end of 2009 that will in clude com pleted data from the TRANS FORMS and FREE DOMS I tri als
as well as a sub set of data from the FREE DOMS II trial. A new Phase III trial called INFORMS was started
in the third quar ter of 2008 in pa tients with pri mary pro gres sive MS, a form of this disease for which there
is no available treatment.”
Li cens ing: Fingolimod was li censed-in from Yoshitomi, now part of Mitsubishi Tanabe (Ja pan). It was
orig i nally de vel oped by Yoshitomi and Taito (Ja pan), in col lab o ra tion with the Na tional Chil dren’s Med i cal
Cen ter (Ja pan) and Toho Uni ver sity (Ja pan). In 1997, Novartis gained ex clu sive world wide rights out side
Ja pan, where Mitsubishi Tanabe re tains co-de vel op ment and co-marketing rights.
© 2009 IMS Health In cor po rated or its af fil i ates Page 78