IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
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 ($100 mil lion in 2013).
LUCATUMUMAB (HCD 122) is a fully hu man anti-CD40 monoclonal an ti body with po ten tial in many
B-cell ma lig nan cies. Pre clin i cal stud ies showed that HCD 122 has greater cytotoxicity against B-cells than
Roche’s MabThera (rituximab). Lucatumumab is in phase I tri als in the USA for the treat ment of mul ti ple
myeloma. A phase I trial, eval u at ing it as a ther apy for chronic lymphocytic leu ke mia, was dis con tin ued in
July 2008 be cause of lim ited patient enrollment.
In April 2008, Novartis and its part ner XOMA (USA) ini ti ated a phase I/II trial of lucatumumab in adults
with non-Hodg kin’s lym phoma or Hodg kin’s lym phoma. Dur ing this open-la bel, dose-es ca lat ing study,
up to 50 pa tients who have re ceived at least two prior ther a pies will re ceive the monoclonal in tra ve nously
once a week for four weeks. The safety, ac tiv ity and high est tol er ated dose will be eval u ated. This study is
be ing con ducted at sites in the USA, Aus tra lia, Bel gium, France, Germany and Italy.
Li cens ing: Lucatumumab is be ing co-de vel oped by Novartis and XOMA. Novartis ob tained rights to
lucatumumab via the 2005 pur chase of Chiron. In 2004, Chiron and Xoma agreed to jointly re search, de -
velop and com mer cial ize an ti body prod ucts for the treat ment of can cer. In No vem ber 2008 the deal with
XOMA that cov ers HCD 122 and five other pro jects was re struc tured as fol lows: Novartis will make an
upfront pay ment of $6.2 mil lion; fully fund all fu ture R&D ex penses; pay po ten tial mile stones of up to $14
mil lion and dou ble-digit roy alty rates for two on go ing prod uct pro grams, in clud ing HCD 122; and pro vide
XOMA with op tions to de velop or re ceive roy al ties on four ad di tional pro grams that are pend ing se lec tion.
Novartis now has con trol over the HCD 122 pro gram and one other on go ing pro gram, as well as the right
to ex pand the de vel op ment of these programs to additional indication outside of oncology.
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).
MCS 110, a monoclonal an ti body tar geted to col ony stim u lat ing fac tor-1, was in phase I/II tri als for the
treat ment of can cer in 2008 in the USA in pa tients with pros tate can cer and bone metastases.
PANOBINOSTAT (LBH 589) is an anticancer agent that in hib its histone deacetylase and in duces the
p21 tu mor sup pres sor gene. It has po ten tial as a ther apy for both solid and he ma to log i cal tu mors. The
com pound is be ing in ves ti gated in the treat ment of re frac tory cu ta ne ous T-cell lym phoma (CTCL),
chronic myeloid leu ke mia (CML) and mul ti ple myeloma. Novartis is de vel op ing both oral and in tra ve nous
for mu la tions of panobinostat. A reg u la tory submission is planned for 2009.
Novartis ini ti ated a phase II trial of oral panobinostat in 2007 to eval u ate the safety and ef fi cacy of the
agent in adult pa tients with re frac tory chronic myeloid leu ke mia (CML) pre vi ously treated with at least
two BCR-ABL ty ro sine kinase in hib i tors. Panobinostat is also in phase II tri als for mul ti ple myeloma. In
2006, a phase I trial of the agent was ini ti ated in Ja pan for the treat ment of ad vanced solid tu mors and
CTCL. A phase I trial of LBH 589 alone and in com bi na tion with docetaxel and pred ni sone ini ti ated in the
USA in 2006 in the treat ment of hor mone-re frac tory pros tate can cer. In Feb ru ary 2008, a phase Ib trial of
iv panobinostat with docetaxel and pred ni sone in pa tients with hor mone-re frac tory pros tate can cer was
ini ti ated in Can ada and the USA. Novartis in tends to ex plore the use of panobinostat in other challenging
malignancies.
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),
phase II data on panobinostat in CTCL were re ported. In this Eu ro pean, Aus tra lian and US phase II trial in
pa tients with re lapsed/re frac tory cu ta ne ous T-cell lym phoma (CTCL), 83 pa tients have been treated to
date with ei ther oral panobinostat 20 mg alone or oral bexarotene, prior to panobinostat. The agent was
well tol er ated. Among the 83 pa tients evaluable for safety, the most com mon ad verse events were di ar -
rhea (44.6% of pa tients; 4.8% with grade 3 and 4), thrombocytopenia (42.2% of pa tients; 13.3% with
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