IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
DRUG DE LIV ERY SYS TEM, INDACATEROL + GLYCOPYRRONIUM BRO MIDE (QVA 149) is a
once-daily fixed dose com bi na tion of the once-daily, long-act ing beta-2 ag o nist indacaterol and the
long-act ing muscarinic an tag o nist, glycopyrronium bro mide (NVA 237), for the treat ment of chronic
ob struc tive pul mo nary dis or der (COPD). Phase II tri als are on go ing in Eu rope, Can ada and Aus tra lia. Ini -
tial for mu la tion of the prod uct has been com pleted, us ing Concept1 aerolizer de vice. Novartis be lieves
this prod uct has po ten tial to be the first once daily fixed-dose combination of two bronchodilators.
In No vem ber 2007, Sosei and Vectura an nounced the ini ti a tion, by Novartis, of a ran dom ized, dou -
ble-blind, pla cebo-con trolled, multicenter phase II trial of QVA 149 for the treat ment of COPD. The trial,
which is ex pected to en roll 250 pa tients aged 40 years or older with mod er ate to se vere sta ble COPD in
cen ters in Aus tra lia, Bel gium, Can ada, France, Ger many, It aly, Spain and Tur key, will in ves ti gate the ef -
fect of QVA 149 and indacaterol on the heart to en sure the prod uct is safe. In its 2008 an nual re port,
Novartis noted that it ex pects to file an NDA for QVA 149 in 2011.
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).
DRUG DE LIV ERY SYS TEM, IN HALED GLYCOPYRRONIUM BRO MIDE: NVA 237 is a once daily in -
haled long-act ing muscarinic an tag o nist, for the treat ment of chronic ob struc tive pul mo nary dis ease
(COPD), in phase II tri als in 2008. It was orig i nated by Sosei (Ja pan, for merly Arakis) and is be ing de vel -
oped us ing Vectura’s (UK) pro pri etary PowderHale in ha la tion tech nol ogy. Novartis hope to file for ap -
proval in 2010. NVA 237 be longs to the same class as Boehringer Ingelheim’s lead ing COPD treat ment
Spiriva (tiotropium bromide).
Li cens ing: Arakis (now Sosei) and Vectura signed a de vel op ment and com mer cial iza tion deal with
Novartis in 2005, un der which Novartis will be re spon si ble for de vel op ing NVA 237, both as a
monotherapy and in com bi na tion with Novartis’ QAB 149 (a long-act ing beta2 re cep tor ag o nist). The deal
stip u lates that Sosei and Vectura will each re ceive an ini tial pay ment of $15 mil lion. Fur ther pay ments on
achieve ment of pre-agreed tar gets could to tal up to $172.5 mil lion each for both the monotherapy and
com bi na tion prod uct. Roy al ties on prod uct sales will be paid for the monotherapy and com bi na tion prod -
uct. If Novartis de vel ops a third com bi na tion prod uct us ing AD 237/NVA 237, fur ther mile stones and
royalties may be payable on that product.
Clin i cal Data: In Oc to ber 2008, Sosei and Novartis pre sented new phase II data at the Eu ro pean Re spi -
ra tory So ci ety con gress in Ger many show ing that NVA 237 showed prom is ing re sults in two phase II tri -
als eval u at ing its ef fi cacy, safety and tolerability. The new data showed that NVA 237 pro vides sus tained
24-hour bronchodilation in pa tients with mod er ate-to-se vere COPD. NVA 237 showed sim i lar ef fi cacy
and du ra tion of ac tion to tiotropium with po ten tially a more rapid on set of ac tion. In ad di tion, stud ies last -
ing up to 28 days showed that NVA 237 was safe and well-tol er ated with no clinically relevant
cardiovascular findings.
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). In Oc to ber 2008, Helvea an a lysts fore cast peak sales of $500 mil lion and
said that there was still po ten tial up side to that fore cast. Also in Oc to ber 2008, Vontobel an a lyst An drew
Weiss in creased his peak sales es ti mate to $1 bil lion from $700 mil lion, not ing that the lat est data “con -
firms find ings that it is po ten tially as ef fi ca cious as Spiriva with a more rapid onset of action.
INDACATEROL + MOMETASONE (QMF 149): Novartis is de vel op ing QMF 149, a fixed com bi na tion of
the corticosteroid mometasone and the beta2 ag o nist indacaterol, as a once-daily in haled treat ment for
asthma and chronic ob struc tive pul mo nary dis ease (COPD). Phase II tri als were on go ing in 2008.
Novartis does not ex pect to file an NDA in the EU and USA un til af ter 2012. Mometasone is a
Schering-Plough prod uct, sold by Schering-Plough as Asmanex. This com bi na tion is be ing de vel oped in
part ner ship with Schering-Plough un der the terms of a 2006 deal.
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