IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
gle sc dose of canakinumab at 0.5-9 mg/kg. Eleven of 19 pa tients showed at least 50% im prove ment in
dis ease ac tiv ity within two weeks. Four pa tients were clas si fied as dis ease free. Canakinumab was well
tol er ated, with the most com mon ad verse event be ing up per respiratory tract infection.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $35 mil lion in
2010 ($175 mil lion by 2013).
DRUG DE LIV ERY SYS TEM, HU MAN PARATHYROID HOR MONE: In 2006, Novartis elected to ex er -
cise an op tion agree ment to de velop and com mer cial ize oral parathyroid hor mone us ing Emisphere’s
(USA) Eligen tech nol ogy. In 2008, Novartis ini ti ated a phase I trial in Switzerland.
Clin i cal Data: In No vem ber 2008 Emisphere an nounced re sults from a study of its oral for mu la tion of
parathyroid hor mone, which uti lizes Emisphere’s eligen tech nol ogy. The study, which in volved 20
healthy postmenopausal women (40 to 70 years old), dem on strated that the max i mum plasma con cen -
tra tions of parathyroid hor mone fol low ing ad min is tra tion of Emisphere’s eligen for mu la tion were in the
same range as those ob tained with teriparatide (Lilly’s Forteo). There were no dis con tinu a tions re lated to
drug ex po sure, and no sig nif i cant ad verse events or hypocalcaemia were observed.
ATF 936, an orally-ad min is tered com pound, is be ing de vel oped by Novartis for the treat ment of os teo -
po ro sis. A phase I trial is on go ing in the USA in ap prox i mately 65 healthy male and fe male sub jects. Pri -
mary out come mea sures will in clude safety, tolerability, pharmacokinetics and pharmacodynamics of
sin gle doses of each drug in healthy male and fe male sub jects, head-to-head com par i sons of each drug
at the ef fec tive dose, and sim i lar ity of pharmacokinetic and pharmacodynamic pro files in healthy
postmenopausal women.
QAL 964 is a new treat ment for rheu ma toid ar thri tis, in phase I tri als with Novartis in 2008.
Respiratory System Agents
indacaterol QAB 149 R3A Filed
formoterol + mometasone MFF 258 R3F III
asthma and COPD therapy QAE 397 R3X II
asthma/COPD therapy QAT 370 R3G II
cystic fibrosis therapy QAU 145 R7X II
drug delivery system, indacaterol +
glycopyrronium bromide QVA 149 R3G, V7A II
drug delivery system, inhaled
glycopyrronium bromide NVA 237, AD 237 R7X II
indacaterol + mometasone QMF 149 R3F II
MAb, interleukin-13, Novartis QAX 576 R3X, R7X, R1B II
COPD therapy QAX 028 R3X I
asthma therapy VAK 694 R3X Preclinical
TLR9 immunomodulatory
oligonucleotides, Idera/Novartis QAX 935 R3X Discovery
INDACATEROL (QAB 149), a once-daily long-act ing beta 2 adrenoceptor ag o nist for the treat ment of
chronic ob struc tive pul mo nary dis ease (COPD) and asthma, was filed for ap proval in the USA and EU in
De cem ber 2008 for COPD. QAB 149 is be ing de vel oped as a monotherapy ini tially, how ever, sev eral
com bi na tion prod ucts are be ing eval u ated in par al lel. The com pany stated, “This com pound is ex pected
to form the foun da tion of the Novartis re spi ra tory fran chise, led by the po ten tial com bi na tions, QMF 149
(in com bi na tion with the corticosteroid mometasone) and QVA 149 (in com bi na tion with the
anti-muscarinic NVA 237 or glycopyrronium bromide) in COPD and asthma.”
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