IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Clin i cal Data: Novartis pre sented phase I data for dovitinib at the Amer i can So ci ety of Clin i cal On col ogy
An nual Meet ing in June 2008. In this US trial con ducted in 27 pa tients with ad vanced mel a noma, the
max i mum tol er ated dose was de ter mined as 400 mg po daily. There were no dose-lim it ing tox ic i ties be -
low this dose level. The most com mon ad verse events re ported were nau sea, di ar rhea, fa tigue, el e vated
al ka line phosphatase lev els, el e vated tri glyc er ides and an orexia. One pa tient treated with 200 mg
dovitinib had sta ble dis ease for nine months; one pa tient given 300 mg dovitinib was sta ble for 3.5
months; five pa tients treated with 400 mg were sta ble for four months, two of which for more than four
months, one for five months and one for six months; two pa tients given 500 mg had sta ble dis ease for
four and six months, re spec tively. En roll ment of 20 patients at the maximum tolerated dose has been
initiated.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $50 mil lion in
2012 ($75 mil lion in 2013).
BHQ 880, an anti-DKK1 (Dickkopf) monoclonal an ti body with po ten tial in the treat ment of solid tu mors,
is be ing de vel oped by Novartis and MorphoSys. BHQ 880 is in phase I tri als. The an ti body was gen er ated
us ing MorphoSys’ HuCAL GOLD tech nol ogy. A phase I trial of the an ti body be gan in Sep tem ber 2007 in
Ger many and Swit zer land. MorphoSys and Novartis es tab lished a col lab o ra tion to de velop an ti -
body-based ther a pies for a range of dis eases in 2004; the deal was ex panded to in clude a greater
number of antibody projects in 2006.
Clin i cal Data: At the Amer i can As so ci a tion for Can cer Re search An nual Meet ing 2008 (April 2008),
Novartis and MorphoSys pre sented pre clin i cal data for BHQ 880. The an ti body was eval u ated in mouse
mod els of tu mor-in duced osteolytic dis ease. BHQ 880 pro tected against tu mor-in duced bone loss in an
osteolytic MDA-MB-231 breast tu mor model that ex presses high lev els of DKK1 and an MMIS mul ti ple
myeloma model that ex presses low lev els of DKK1. The pro tec tive ef fect of the an ti body was greater in
the model with high DKK1 expression.
LBY 135 is a monoclonal an ti body ag o nist tar get ing DR5, which mim ics the ac tion of TRAIL and in duces
the apoptosis path way. Ac tiv ity has been dem on strated in mul ti ple tu mors. It is un der go ing a two-arm
phase I study in ad vanced solid tu mors: arm one as a sin gle agent and arm two in com bi na tion with che -
mo ther apy in advanced colorectal cancer.
Clin i cal Data: At the Amer i can So ci ety of Clin i cal On col ogy An nual Meet ing 2008 (30 May-3 June 2008),
re sults from a Eu ro pean two-arm phase I trial of Novartis’ LBY 135 in 56 pa tients with ad vanced solid tu -
mors were re ported. Pa tients re ceived ei ther LBY 135 alone (arm 1) or in com bi na tion with capecitabine
(arm 2). In this trial, LBY 135 was well tol er ated as sin gle agent and in com bi na tion with capecitabine at
doses up to 20 mg/kg. No dose-lim it ing tox ic i ties (DLTs) were ob served in arm 1 and two grade 3 DLTs
were re ported in arm 2: mucositis at 1 mg/kg and co li tis at 20 mg/kg. The most fre quent (at least 25%
in ci dence) ad verse events (AEs) re ported, mostly grade 1 or 2, in cluded hypotension, fa tigue and nau sea
in arms 1 and 2, and vom it ing, py rexia, dyspnea, di ar rhea, ab dom i nal pain and con sti pa tion in arm 2.
Fre quent AEs (15%) con sid ered as pos si bly treat ment-re lated in cluded hypotension and nau sea in arms
1 and 2, and ane mia, fa tigue, di ar rhea, hand foot syn drome, mucositis and vom it ing in arm 2. Grade 3
AEs con sid ered as pos si bly treat ment-re lated were ane mia in arm 1, and ane mia, co li tis, di ar rhea, fa -
tigue and mucositis in arm 2. LBY 135 ex po sure (AUC) was dose pro por tional with half-life eval u ated
around ten days. Sat u ra tion of an ti gen sink was reached at dose lev els greater than 3 mg/kg.
Immunogenicity was de tected in 13 out of 51 pa tients (25%); five of them had re duced ex po sure on re -
peat dos ing. In arm 1, 14 out of 32 pa tients (in clud ing six pa tients with me so the li oma) re ceived more
than four cy cles of treat ment. One pa tient (sar coma) had a mi nor re sponse and two pa tients (one
NSCLC, one pros tate can cer) had de creases in tu mor mark ers of 50% and 40%, re spec tively. In arm 2,
one pa tient (colorectal can cer) had a par tial re sponse (PR), one pa tient (ovar ian can cer) had a met a bolic
(PET) PR, and four patients (two ovarian cancer, one colorectal cancer, one pancreatic cancer) had
decreases in tumor markers of 60-73%.
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