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 ($75 mil lion in 2013).
NVP BEZ235/BEZ 235 is small-mol e cule phosphoinositide-3 kinase (PI3K) in phase I tri als tar get ing
pa tients with ad vanced breast can cer, glioma and pros tate can cer. Novartis ob tained the agent via the
ac qui si tion of Chiron in 2005.
Clin i cal Data: At the Amer i can As so ci a tion for Can cer Re search An nual Meet ing 2007 (14-18 April
2007), the MD An der son Can cer Cen ter (USA) pre sented pre clin i cal data for NVP BEZ235. In vi tro, NVP
BEZ235 in hib ited the growth of glioma cell lines with an IC50 of low nM con cen tra tion. In vivo,
xenografted mice treated orally with NVP BEZ235 (25 mg/kg daily for four weeks) showed in creased sur -
vival (p less than 0.05). No tox ic ity, as as sessed by glu cose lev els and weight mea sure ments, was
observed at this dose.
BGT 226, an in hib i tor of phosphoinositide 3-kinase (PI3K) and mam ma lian tar get of rapamycin (mTOR),
was in the phase I part of a phase I/II trial in late 2008 for the treat ment of can cer.
KRP 203, an orally-ac tive sphingosine-1-phos phate (S1P) re cep tor ag o nist, is in phase I tri als with orig i -
na tor Kyorin (Ja pan) in 2008 for use in trans plant re jec tion and graft ver sus host disease.
Li cens ing: In 2006, Kyorin granted Novartis a world wide ex clu sive li cense to de velop and com mer cial ize
KRP 203 for trans plan ta tion in di ca tions and ex clu sive rights to KRP 203 in the treat ment of au to im mune
dis eases world wide ex clud ing Ja pan, South Ko rea, China and Tai wan. Novartis re ported in 2008 that KRP
203 was in ex plor atory phase stud ies for multiple sclerosis.
BCR-ABL KINASE IN HIB I TORS were in de vel op ment in 2008 with li censee SGX (USA) and Novartis
for the treat ment of drug re sis tant chronic myelogenous leu ke mia (CML). SGX’s oral bcl-abl in hib i tors,
gen er ated us ing the com pany’s pro pri etary FAST tech nol ogy plat form, have po ten tial as monotherapies
in the sec ond-line treat ment of re frac tory or re lapsed CML, and in com bi na tion with other drugs in the
first-line treat ment of CML. Lilly (USA) acquired SGX in August 2008.
Li cens ing: Un der the terms of the deal, signed in March 2006, SGX will re ceive from Novartis $25 mil lion
in upfront pay ments and the pur chase of SGX com mon stock. To tal pay ments by Novartis to SGX, in clud -
ing a min i mum of two years of re search fund ing and suc cess-based mile stones, but ex clud ing roy al ties,
may ex ceed $515 mil lion. SGX will be re spon si ble for pre clin i cal de vel op ment of a lead can di date, fil ing an
IND with the FDA, and con duct ing an ini tial phase I trial; Novartis will be re spon si ble for fur ther clin i cal
eval u a tion and com mer cial iza tion of the com pound. SGX will re ceive roy al ties from prod ucts that reach
the mar ket. SGX re tains an op tion to co-com mer cial ize on col ogy products generated under the
collaboration, in the USA.
The deal was mod i fied in Sep tem ber 2007. SGX has ob tained the rights to de velop and com mer cial ize
one of the can di dates, SGX 393, out side of the col lab o ra tion, sub ject to a re ac qui si tion right of Novartis
that is ex er cis able at a fu ture date. The amend ment to the agree ment also gives Novartis re spon si bil ity
for the se lec tion of all fu ture de vel op ment can di dates and for the clin i cal de vel op ment of ad di tional com -
pounds from the col lab o ra tion. The financial terms of the deal remained unchanged.
AT 9311: Astex Ther a peu tics (UK, for merly Astex Tech nol ogy) and Novartis are de vel op ing AT 9311, a
cell cy cle in hib i tor, for the po ten tial treat ment of can cer. Pre clin i cal stud ies were un der way in the UK in
2006.
Li cens ing: In 2005, Astex Ther a peu tics granted Novartis an ex clu sive world wide li cense to AT 9311.
Astex Ther a peu tics has the op tion to ac quire US co-com mer cial iza tion rights. Novartis also ac quired an
op tion to gain rights to an other Astex cell; cy cle in hib i tor in R&D, AT 7519 (in phase I tri als). At the
Amer i can So ci ety of Clin i cal On col ogy An nual Meet ing 2008, re sults from a US and UK dose es ca la tion
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