IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Lifecycle Man age ment: In 1998, Novartis and SkyePharma (UK) an nounced an agree ment to jointly
de velop a new for mu la tion of Foradil, us ing SkyePharma’s pat ented multi-dose dry pow der in haler
(MDDPI) de vice Certihaler. Novartis was to re ceive an ex clu sive world wide li cense to mar ket the Foradil
Certihaler. In 2002, it was filed for ap proval by Novartis in the USA and Eu rope, and an ap prov able let ter
was re ceived from the FDA in 2003. Since March 2003, it has been ap proved in Swit zer land, Aus tria, Fin -
land, Por tu gal, the Neth er lands, and Ger many. In the USA, Foradil Certihaler was ap proved in 2006 but
not launched by Novartis due to lim ited sales po ten tial. In late 2008 it was re ported that SkyePharma had
been in dis cus sions with a third-party (not Novartis) to com mer cial ize the prod uct with a launch set for
2009, but the de ci sion of the FDA ad vi sory com mit tee in De cem ber 2008 to with draw the asthma in di ca -
tion from Foradil, means that now the product is unlikely to be commercialized in the USA.
In 2003, Novartis signed a deal with Ivax (now part of Teva, Is rael) re gard ing Ivax’s new MDDPI Airmax.
The agree ment cov ers the use of Airmax to de liver Novartis’ Foradil and Miflonide (budesonide) in Eu -
rope and other coun tries.
In 2005, Chiesi (It aly) signed a li cens ing and sup ply deal with Novartis re gard ing Chiesi’s Modulite
HFA-based pres sur ized me tered-dose in haler (pMDI) ver sion of formoterol. Un der the terms of the deal,
Novartis will have semi-ex clu sive pro mo tion, sales and dis tri bu tion rights for the prod uct fol low ing ap -
proval in Den mark, France, Ger many, Greece, Neth er lands, South Af rica, Spain, Switzerland and Turkey.
Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, Foradil was the num ber five prod -
uct in the ‘B-2 Stim u lants’ class (R3A), with an 8.4% mar ket share, but sales down 4% in fixed rate dol lar
terms. The class was led by Sepracor’s Xopenex (levosalbutamol), with a 17.6% mar ket share and 10%
fixed rate dol lar growth. Num ber two was GSK’s Vento lin (sal buta mol), with an 11.7% mar ket share
and 7% fixed rate dol lar growth. GlaxoSmithKline’s Serevent (salmeterol) was num ber three, with an
11.0% mar ket share and sales down 11% in fixed rate dol lar terms. Num ber four was Teva’s branded ge -
neric sal buta mol prod uct, Salamol, with an 11% mar ket share and 33% growth.
The FDA’s ad vi sory com mit tee rec om men da tion for with drawal of the asthma in di ca tion ap plied to all
long-act ing beta-agonists used as monotherapy, but not to prod ucts where the LABA is used in com bi na -
tion with a corticosteroid, such as GSK’s Advair and AstraZeneca’s Symbicort. Foradil will no lon ger be
able to com pete against these two prod ucts. Advair is re ported to have largely re placed the use of
Serevent and the use of Symbicort in the US mar ket is grow ing (it was only launched in June 2007).
Sales/An a lyst Com ment: Foradil was Novartis’ num ber 16 prod uct in 2008 with global sales of $387
mil lion ($373 mil lion out side the USA), but zero growth in lo cal cur rency terms. Mor gan Stan ley an a lysts
(Jan u ary 2009) fore cast 2009 sales of $399 mil lion ($462 mil lion by 2014). Cowen & Co an a lysts (Au gust
2008) fore cast sales of $415 mil lion in 2008 ($430 mil lion in 2009 and $250 million by 2013).
MIFLONIDE (budesonide) is a sec ond gen er a tion in haled corticosteroid, mar keted by Novartis.
Lifecycle Man age ment: In 2003, Novartis signed a deal with Ivax (now part of Teva) re gard ing Ivax’s
MDDPI Airmax. The deal cov ers the use of Airmax to de liver the Novartis re spi ra tory drugs Foradil
(formoterol) and Miflonide.
XOLAIR (omalizumab), a hu man ized anti-IgE monoclonal an ti body, was first launched in 2003 in the
USA for the treat ment of mod er ate-to-se vere al ler gic asthma in ad o les cents and adults. The FDA had re -
quested new platelet mon i tor ing data and more pre clin i cal and clin i cal anal y sis and pharmacokinetics
prior to ap proval. The ad vi sory panel agreed that Xolair had a fa vor able risk-ben e fit pro file when the con -
di tion is in ad e quately con trolled with in haled corticosteroids in pa tients aged 12 to 65 years but the po -
ten tial for in creased risk of can cer is still a cause for con cern with the FDA. Xolair was also launched in
Aus tra lia in 2003. It is now re ported to be available in over 50 markets worldwide.
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