IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
The QMF 149 pro gram, which com bines QAB 149 with the once-daily in haled corticosteroid
mometasone (Asmanex), be gan tri als in 2007 with plans for the first reg u la tory sub mis sion in 2010. The
com bi na tion is be ing de vel oped in col lab o ra tion with Schering-Plough (USA).
The QVA 149 pro gram is as sess ing in COPD pa tients the po ten tial of a once-daily fixed-dose com bi na -
tion of QAB 149 and Novartis’ once-daily in haled long-act ing muscarinic an tag o nist NVA 237
(glycopyrronium bro mide). This novel com bi na tion is ex pected to show su pe rior bronchodilation
com pared to the in di vid ual com pounds alone due to their com ple men tary mechanisms of action.
An agree ment was signed in 2003 to com bine QAB 149 with SkyePharma’s multi-dose dry pow der in haler
de vice to be mar keted by Novartis as Certihaler.
Li cens ing: In 2006, Schering-Plough en tered into a col lab o ra tion with Novartis to de velop a fixed com bi -
na tion of the corticosteroid Asmanex (mometasone) and indacaterol, as a once-daily in haled treat ment
for asthma and COPD. The com bined prod uct, with once-daily dos ing, has the po ten tial to of fer pa tient
ben e fits in clud ing en hanced dis ease con trol and con ve nience. This pro gram is known as QMF 149.
Clin i cal Data: In No vem ber 2008 Novartis re ported re sults from an in ter na tional phase III trial of
indacaterol (QAB 149), in pa tients with COPD. The study, in volv ing over 6,000 pa tients, achieved its pri -
mary ob jec tive: indacaterol, ad min is tered once daily at 150 mcg or 300 mcg for 52 weeks, re sulted in a
sta tis ti cally sig nif i cant im prove ment in FEV1 lev els 24 h post-dos ing com pared with pla cebo. Indacaterol
had a fast on set of ac tion, sim i lar to sal buta mol, and the agent was safe when stud ied at 600 mcg dose for
one year.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $50 mil lion in
2009 ($300 mil lion by 2013).
FORMOTEROL + MOMETASONE (MFF 258): Un der the terms of a 2003 deal, Schering Plough and
Novartis are co-de vel op ing MFF 258, a com bi na tion prod uct com pris ing Schering-Plough’s corticosteroid
mometasone (Asmanex) and the Novartis beta2 ag o nist formoterol, as a treat ment for asthma and
chronic ob struc tive pul mo nary dis ease (COPD). Phase III tri als were un der way in 2008. Novartis plans to
file for ap proval in COPD and asthma in 2009.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008), fore cast ini tial sales of $50 mil lion in
2010 ($125 mil lion by 2013).
QAE 397 is be ing de vel oped for the po ten tial treat ment of asthma and chronic ob struc tive pul mo nary
dis ease (COPD). QAE 397 was in phase II tri als in Eu rope in 2008.
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.
QAT 370 is a po ten tial treat ment for asthma and chronic ob struc tive pul mo nary dis ease (COPD) in
phase II tri als with Novartis in Eu rope in 2008.
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 by 2013).
QAU 145 is be ing de vel oped by Novartis for the treat ment of cys tic fi bro sis. In 2007, a phase II trial was
ini ti ated in the USA to eval u ate safety, tolerability, pharmacokinetics and pharmacodynamics of QAU 145
ad min is tered via a na sal pump to 14 pa tients with cys tic fi bro sis. Pri mary out come mea sures in clude
pharmacodynamic re sponses and sec ond ary out come mea sures in clude safety and tolerability.
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