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 $100 mil lion in
2011 ($300 mil lion by 2013).
QAX 576 is an anti-interleukin-13 monoclonal an ti body in de vel op ment with Novartis for the treat ment
of asthma, al ler gic rhi ni tis and id io pathic pul mo nary fibrosis.
In De cem ber 2007, a phase II study was ini ti ated in Ger many and the UK to eval u ate the ef fects of QAX
576 on al ler gic in flam ma tion fol low ing out of al lergy sea son re peated na sal al ler gen chal lenge in 42 pa -
tients with sea sonal al ler gic rhi ni tis sen si tive to Tim o thy grass pol len. Pri mary out come mea sures will in -
clude mark ers of al ler gic in flam ma tion in the nose over 5-8 d post-dose and sec ond ary out come
mea sures will in clude na sal symp tom scores, blood lev els of the agent and a marker of allergic
inflammation three months post-dose.
In Oc to ber 2007, a phase II study of QAX 576 was ini ti ated in the USA to eval u ate a sin gle in tra ve nous
dose to de ter mine IL-13 pro duc tion in 50 pa tients with id io pathic pul mo nary fi bro sis. Pri mary out come
mea sures will in clude blood sam ples pre-dose and weekly af ter dos ing to in ves ti gate if some pa tients ex -
pe ri ence in creased IL-13 pro duc tion. Sec ond ary out come mea sures will in clude changes in biomarkers in
blood over time.
QAX 028 was in phase I tri als with Novartis for the treat ment of COPD in 2008. A phase I trial is un der
way in Den mark to as sess the safety, tolerability, pharmacokinetics and pharmacodynamics of QAX 028
com pared with open-la bel tiotropium bro mide and pla cebo in 36 mild-to-mod er ate COPD pa tients. Pri -
mary out come mea sures will in clude safety, tolerability and pharmacodynamics and sec ond ary out come
mea sures will in clude forced ex pi ra tory vol ume in one sec ond and time pro file us ing a ki netic
pharmacodynamic model.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $50 mil lion in
2013.
VAK 694 was in pre clin i cal stud ies in Swit zer land in 2007 with Novartis for the treat ment of asthma.
QAX 935 (TLR9 immunomodulatory oligonucleotides, Idera/Novartis): In Sep tem ber 2008 Idera an -
nounced the ini ti a tion of a phase I trial of QAX 935, a Toll-like re cep tor 9 (TLR9) ag o nist dis cov ered
through a re search col lab o ra tion be tween Idera and Novartis. In 2005, Hybridon (now Idera) and
Novartis en tered into re search col lab o ra tion and li cense agree ments for the dis cov ery, op ti mi za tion, de -
vel op ment and com mer cial iza tion of TLR9 im mune modulatory oligonucleotide can di dates, based on
Hybridon’s pro pri etary Im mune Modulatory Oligonucleotide (IMO) tech nol ogy plat form, for the treat -
ment of asthma and al lergy. In March 2007, Idera and Novartis ex tended the term of the re search phase
of their col lab o ra tion by one year. Novartis has in-li censed the ex clu sive rights to QAX 935 from Idera.
Ini ti a tion of this phase I trial triggered a milestone payment from Novartis to Idera.
Sensory Organ Agents/Ophthalmologicals
glaucoma therapy Y 39983 S1E II
glaucoma therapy RKI 983 S1E I
glaucoma therapy SAD 448 S1E I
Y 39983, a rho kinase in hib i tor for the top i cal treat ment of glau coma, was in phase II tri als in Ja pan in
2009. It has a new mech a nism of ac tion that reg u lates pres sure in side the eye.
Li cens ing: Novartis ac quired rights to Y 39983 in 2005 from Senju (Ja pan). Mitsubishi Pharma (now
Mitsubishi Tanabe, Ja pan) was the orig i na tor, but granted world wide rights to Senju in 2000.
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