IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Novartis/QLT’s Visudyne photodynamic ther apy, ap proved in 2000, was the first prod uct for macular de -
gen er a tion. It is in di cated for pre dom i nantly clas sic dis ease. Genentech car ried out a phase III trial that
com pared Lucentis against Visudyne in wet AMD pa tients. On av er age, pa tients treated with Lucentis im -
proved their vi sual acu ity and those treated with Visudyne de clined. In jected in the arm, Visudyne is ac ti -
vated by shin ing a cold la ser into the eye. It is ex pen sive, at about $1,500 per dose, but re quires only four
or five doses for a full treatment.
OPKO Health (USA) is de vel op ing a siRNA agent, bevasiranib, in phase III tri als.
Sev eral com pa nies are ex plor ing RNA in ter fer ence as a treat ment for AMD. Sirna and Acu ity are re ported
to be study ing how to use RNA to shut down the pro duc tion of VEGF in stead of blocking it.
Ac cord ing to IMS, in the 12-month pe riod to the end of Sep tem ber 2008, Lucentis was the lead ing prod -
uct in the ‘Oc u lar Antineovascularisation Prod ucts’ class (S1P), with an 89.7% mar ket share and 50%
fixed rate dol lar growth. Visudyne was num ber two, with an 8.7% mar ket share, but sales were down
42% in fixed rate dol lar terms. Macugen was num ber three, with a 1.7% mar ket share and 2% fixed rate
dollar growth.
Sales/An a lyst Com ment: Lucentis sales stood at $886 mil lion in 2008, up 122% in lo cal cur rency
terms, and it was Novartis’ num ber seven phar ma ceu ti cal prod uct. Mor gan Stan ley an a lysts (Jan u ary
2009) fore cast sales of $1,006 mil lion in 2009 ($1,345 mil lion by 2014). Cowen & Co an a lysts (Au gust
2008) fore cast sales of $975 mil lion in 2008 ($1,500 mil lion by 2013). Ac cord ing to IMS, in the 12-month
pe riod to the end of Sep tem ber 2008 Lucentis was Novartis’ num ber ten in ter na tional phar ma ceu ti cal
prod uct, ac count ing for 1.9% of au dited cor po rate phar ma ceu ti cal sales, with 312% fixed rate dollar
growth.
VISUDYNE (verteporfin), a benzoporphyrin de riv a tive, was launched in Swit zer land, its first mar ket, in
1999, for the treat ment of wet, age-re lated macular de gen er a tion (AMD), in pa tients with pre dom i nantly
clas sic subfoveal choroidal neovascularization (CNV). AMD is a com mon cause of blind ness in the over
50s. Visudyne has been ap proved in over 65 coun tries world wide for its main in di ca tion and in more than
45 (in clud ing Eu rope, the USA and Can ada) for ad di tional in di ca tions. The drug’s in di ca tions have been
ex panded in Eu rope to the treat ment of subfoveal CNV sec ond ary to patho logic my o pia and the treat -
ment of oc cult CNV sec ond ary to AMD. How ever, in April 2007, the CHMP rec om mended that the oc cult
CNV in di ca tion be de leted. It has been ad di tion ally ap proved in the USA for macular con di tions such as
pathologic myopia and ocular histoplasmosis syndrome.
When stim u lated by light, verteporfin de stroys sur round ing tis sue. As the com pound is sen si tive to long
wave lengths of light, it is ca pa ble of ac ti va tion deep in tu mors and skin. The drug is given by in jec tion and
then ex posed to light from a la ser, which ac ti vates its cytotoxicity. The ad min is tra tion pro ce dure for
Visudyne takes less than 30 min utes. Visudyne was also in phase III tri als for the oc cult form of AMD and
phase II tri als in early 2005 for the minimally classic form of AMD.
Li cens ing: Verteporfin was dis cov ered at the Uni ver sity of Brit ish Co lum bia (Can ada) and was co-de vel -
oped by QLT Photo Thera peu tics (Can ada) and CIBA Vi sion. The Uni ver sity of Brit ish Co lom bia li censed
verteporfin to QLT, which in turn sublicensed it to CIBA Vi sion in 1995 for world wide co-de vel op ment and
co-mar ket ing. The deal be tween the two com pa nies cov ers cor neal neovascularization, intraocular tu -
mors, di a betic retinopathy and eval u a tion of other photosensitizers. It was later ex tended to cover cu ta -
ne ous on col ogy and pso ri a sis. The de vel op ment costs will be di vided 60% Novartis and 40% QLT
Photo Thera peu tics, with prof its from prod uct sales shared on a 50:50 ba sis. In 2000, QLT ex panded its
deal with Novartis. The two com pa nies will equally share de vel op ment costs and net sales of other com -
pounds for the treat ment of dis eases char ac ter ized by neurovascularization. CIBA Vi sion will main tain
sales and mar ket ing re spon si bil i ties. Ipsen (France) has European development rights to Visudyne in
cancerous/pre-cancerous indications.
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