IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
mil lion by 2014. Cowen & Co an a lysts (Au gust 2008) fore cast sales of $450 mil lion in 2008. They think
sales will peak at $1,050 mil lion in 2011 and fall to $700 million by 2013.
LESCOL (fluvastatin), a lipid-low er ing agent (HMG CoA reductase in hib i tor), first launched in Swit zer land
in 1993, and now avail able in over 90 coun tries world wide for the treat ment of pri mary hy per cho les ter ol -
emia in pa tients who do not re spond ad e quately to di etary con trol. An ex tended-re lease tab let for mu la -
tion, Lescol XL, was ap proved in the USA in 2000 and is now sold in a num ber of mar kets. Lescol and
Lescol XL 80mg were ap proved by the FDA in 2003 for re duc ing the risks of cor o nary revascularization
pro ce dures in pa tients with CHD, and, ac cord ing to Novartis, the prod ucts have al ready re ceived ap -
proval for the sec ond ary pre ven tion in di ca tion in the UK, Mexico, Germany, and several other key
markets.
Li cens ing: AstraZeneca has rights to fluvastatin in 10 coun tries, in clud ing Ger many, the Neth er lands,
Scan di na via, Mex ico, Aus tra lia, and New Zea land. AZ cur rently mar kets/co-mar kets it as Canef in Swe -
den, Mex ico, the Neth er lands, Nor way, Por tu gal, Fin land, and Den mark. Ger man rights were sub se -
quently (2001) li censed to Klinge (Ger many) and Fournier (now part of Sol vay, Bel gium) which
co-mar ket it as Cranoc. Fluvastatin was be ing co-mar keted in Ja pan with Tanabe Seiyaku (now
Mitsubishi Tanabe, Ja pan) un der the terms of a 1993 deal, which also in cluded a deal to co-mar ket
Tanabe’s Tanadopa (docarpamine). In Jan u ary 2008, Novartis and Mitsubishi Tanabe mod i fied their
fluvastatin li cens ing deal. From March 2008, Novartis will ex clu sively dis trib ute fluvastatin in Ja pan and
Mitsubishi Tanabe Pharma will ex clu sively man u fac ture the prod uct (for mu la tion and pack ag ing).
Fluvastatin is mar keted as Lochol in Japan.
In 2006, Biovail (Can ada) agreed to mar ket Lescol and Lescol XL in Can ada un til 2008. Biovail will pay
Novartis a fee based on a per cent age of Novartis’ net sell ing price over mu tu ally de ter mined per for mance
base lines, and has cer tain per for mance ob li ga tions re lated to mar ket ing and pro mo tional ac tiv i ties for the
products.
In 2006, Novartis and LG Life Sci ences (South Ko rea) en tered into a deal to co-mar ket ex tended-re lease
fluvastatin. LG plans to mar ket it as Xilep XL, Novartis will use the name Lescol XL.
In May 2008, Pi erre Fabre (France) ac quired French co-mar ket ing rights to fluvastatin, sold as Fractal in
France, from Novartis.
Pat ents: Lescol pat ents ex pired in Eu rope in 2003, but not un til 2008 in Ja pan (2011 in the USA). In Oc -
to ber 2008, Mylan (USA) stated that it has been sued by Novartis over its ge neric ver sion of Lescol. Mylan
said that it be lieved it was the first com pany to file for US ap proval of a ge neric ver sion of Lescol and that
Novartis filed a law suit on Oc to ber 10 in the US Dis trict Court in New Jer sey al leg ing patent infringement.
Lifecycle Man age ment: In 2003, Novartis re ceived ap proval from the FDA for the sec ond ary pre ven -
tion of ad verse CV events in pa tients who have un der gone percutaneous cor o nary in ter ven tion pro ce -
dures, such as angioplasty. The fil ing fol lowed the com ple tion of the Lescol In ter ven tion Pre ven tion Study
(LIPS). Novartis has also con ducted a clin i cal trial of Lescol in kid ney trans plant pa tients to in ves ti gate its
ef fect on car dio vas cu lar dis ease. The trial, known as ALERT (As sess ment of Lescol in Re nal Trans plant),
com pleted in 2004. Novartis is so cer tain of Lescol’s safety that it is re ported to be under consideration as
an OTC switch candidate.
Com pe ti tion: The cho les terol and triglyceride re duc ers class is dom i nated by Pfizer’s Lipitor
(atorvastatin). In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Lipitor had a
44.4% mar ket share, but sales were down by 1% in fixed rate dol lar terms. AstraZeneca’s Crestor
(rosuvastatin) was num ber two with a 12% mar ket share and 29% dol lar growth. Num ber three was
Merck & Co’s Zetia (ezetimibe), with a 7.9% mar ket share, up 3%. Lescol was the num ber seven prod uct
in the class, with a 2.1% mar ket share, but sales down by 9% in fixed rate dollar terms.
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