IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Genentech and Novartis, which share co-mar ket ing rights in the USA, filed a Biologics Li cens ing Ap pli ca -
tion (BLA) in the USA in 2000, which was ap proved in 2003. In 2004, Novartis re sub mit ted its ap pli ca tion
for the treat ment of se vere al ler gic asthma to the Com mit tee for Me dic i nal Prod ucts for Hu man Use
(CHMP) in Eu rope. This is a slightly nar rower in di ca tion that ap proved in the USA where it can also be
used in pa tients with mod er ate dis ease. It gained EU ap proval in 2005, and was launched in the UK, Den -
mark, Po land, the Neth er lands and Ger many. Launches have taken place slowly world wide, most re -
cently in 2008 in Rus sia. Xolair was filed for ap proval in Ja pan in 2006 and received approval in January
2009.
Phase III tri als have been com pleted (with Tanox and Genentech) in chil dren aged be tween six and 12
years with mod er ate-to-se vere, per sis tent and in ad e quately con trolled al ler gic asthma. An ap proval in
this pa tient group could have a high im pact on sales. In De cem ber 2008, Xolair was sub mit ted for use in
chil dren from six to less than 12 years of age in the EU by Novartis and by Genentech in the USA. A new
liq uid for mu la tion re ceived a pos i tive rec om men da tion in the EU in November 2008.
Li cens ing: Genentech and Novartis share US co-mar ket ing rights. A 2003 co-mar ket ing deal with
Sankyo for Ja pan was ter mi nated in 2006, when Daiichi Sankyo re turned rights to Novartis.
In 1996, orig i na tor Tanox (now part of Genentech), Ciba and Genentech set tled law suits filed against
each other re lat ing to the de vel op ment of monoclonal an ti body prod ucts di rected against IgE. Un der the
terms of the set tle ment, Novartis will share mar ket ing op por tu ni ties with Genentech in the USA and Eu -
rope. Roche, Genentech’s par ent com pany, will also have an op tion to par tic i pate in mar ket ing in Ja pan.
Tanox will re ceive an ini tial pay ment from Genentech, as well as mile stones. Tanox will also re ceive roy al -
ties from sales of the prod uct world wide, ex cept for Tai wan, China, Hong Kong, Sin ga pore, and South Ko -
rea, where Tanox and Novartis will co-de velop the prod uct. In January 2007, Genentech acquired Tanox.
Clin i cal Data: Omalizumab is the first of a new class of ther a pies for asthma that tar get im mu no glob u lin
E, the an ti body trig ger of al ler gic re ac tions. It is ad min is tered by sub cu ta ne ous in jec tion and binds to free
IgE in the blood. Ad min is tra tion is likely to be once a month.
In Feb ru ary 2005, it was re ported by Novartis that a new anal y sis of re sults from seven clin i cal stud ies
shows that Xolair sig nif i cantly re duced the num ber of asthma at tacks and al most halved the rate of
emer gency vis its in pa tients with se vere asthma. The stud ies in volved more than 4,300 pa tients with se -
vere per sis tent asthma, who were in ad e quately con trolled de spite re ceiv ing the ther apy spec i fied in cur -
rent guide lines. The sum mary of data ap peared in Al lergy, the peer-re viewed jour nal of the Eu ro pean
Acad emy of Allergology and Clin i cal Im mu nol ogy (EAACI). The same pub li ca tion con tains the first de -
tailed re sults from one of the tri als, IN NO VATE, in di cat ing that “omalizumab is an ef fec tive add-on ther -
apy for these dif fi cult-to-treat patients who have an important unmet medical need.”
Com pe ti tion: Ac cord ing to IMS, in the 12-month pe riod to the end of Sep tem ber 2008, Xolair was the
lead ing prod uct in the R3X class (‘All Other Anti-Asthma and COPD Prod ucts’) with an 80% mar ket share,
but sales down 1% in fixed rate dol lar terms. Servier’s Pneumorel (fenspiride) was num ber two, with an
8.2% mar ket share and 4% fixed rate dol lar growth. Wyeth’s Primatene (ephed rine + theophylline +
epinephine) was third, with a 2.1% mar ket share and 34% fixed rate dollar growth.
Sales/An a lyst Com ment: In 2008, Xolair sales were $211 mil lion, up 42% in lo cal cur rency terms.
Genentech re ported sales of $517 mil lion in the USA in 2008. Mor gan Stan ley an a lysts (Jan u ary 2009)
fore cast sales of $217 mil lion in 2009 ($256 mil lion by 2011-14). Cowen & Co an a lysts (Au gust 2008)
fore cast sales of $190 mil lion in 2008 ($300 million by 2013).
ZADITEN (ketotifen), a non-steroidal anti-in flam ma tory agent, first launched in 1979. It is used in the
treat ment of asthma, al ler gies, and ec zema. Oral, oph thal mic, and top i cal for mu la tions are avail able. It is
now open to ge neric com pe ti tion and sales are in decline.
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