IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Sales/An a lyst Com ment: Sales in 2008 were $295 mil lion, up 6% in lo cal cur rency terms, and it was
Novartis’ num ber 19 in ter na tional phar ma ceu ti cal prod uct. Cowen & Co an a lysts (Au gust 2008) fore cast
sales of $295 mil lion in 2008 ($310 mil lion in 2009). They state that from 2010, sales of the cur rent TOBI
prod uct will be re placed by the sec ond-gen er a tion dry pow der prod uct (TMB 100). They think that sales
of the new ver sion will reach $300 mil lion by 2013. Mor gan Stan ley an a lysts (Jan u ary 2009) fore cast
TOBI sales of $293 mil lion in 2009 ($356 million by 2013-14).
TYZEKA/SEBIVO (telbivudine) is an oral once-daily nucleoside an a logue for the treat ment of hep a ti tis
B. It was first launched in the USA in 2006 as Tyzeka. In 2006, it was also launched by Novartis as
Sebivo in Can ada, Swit zer land and In do ne sia. Ap proval in the EU (where it is sold as Sebivo) was
granted in April 2007. In 2007, it was launched in the UK, Ger many, Brazil, Aus tria, Hong Kong, Ma lay sia,
Fin land, Thai land, the Phil ip pines, Ar gen tina, Sin ga pore, the Neth er lands and Nor way. In 2008, it was
launched in Tai wan, It aly, the Slo vak Re pub lic, South Ko rea, Rus sia, Swe den and Pa ki stan. It has also
been launched in China.
In Feb ru ary 2008, it was re ported that the Eu ro pean CHMP had rec om mended that warn ings about the
risk of pe riph eral neu rop a thy be added to the prod uct’s la bel. Sebivo has only been ap proved as a
monotherapy and the CHMP stated that cases of pe riph eral neu rop a thy had un com monly been re ported
in use as a monotherapy. How ever, an in creased risk of de vel op ing pe riph eral neu rop a thy was seen in a
clin i cal trial in ves ti gat ing a com bi na tion of telbivudine and Roche’s hep a ti tis C treat ment Pegasys
(peginterferon alfa-2a) dosed weekly.
Li cens ing: In 2003, Novartis paid $255 mil lion for around 54% of pri vately-owned Idenix’s out stand ing
cap i tal stock, gain ing rights to de velop and com mer cial ize telbivudine and other drug can di dates dis cov -
ered by Idenix. Novartis was re ported to hold a 56% stake in Idenix in 2008. In 2007, the com pa nies
amended their deal re lat ing to telbivudine. Un der the terms of the amended deal, Idenix will dis con tinue
all de vel op ment, man u fac tur ing, and com mer cial ac tiv i ties for the prod uct. Novartis will con tinue these
ac tiv i ties and as sume full re spon si bil ity for on go ing and fu ture clin i cal tri als and reg u la tory fil ings. Idenix
will receive a worldwide product sales-based royalty.
Com pe ti tion: In the past, hep a ti tis B was mainly treated with al pha-interferons and lamivudine. How -
ever, in 2002, Gilead’s Hepsera (adefovir dipivoxil), was first launched in the USA and this is now the
lead ing HBV treat ment. A ma jor new oral an ti vi ral for HBV is Bris tol-Myers Squibb’s Baraclude
(entecavir), a po tent nucleoside an a logue. Ap proved by the FDA in 2005, it has now been launched in a
num ber of mar kets. It has dem on strated su pe rior an ti vi ral ac tiv ity com pared with con tin ued lamivudine
in lamivudine-re frac tory pa tients. Sales are now gaining on those of Hepsera.
Sales/An a lyst Com ment: Mor gan Stan ley an a lysts (Jan u ary 2009) put 2007 sales at $88 mil lion and
fore cast $230 in sales in 2008 and $346 mil lion in 2009 ($600 mil lion by 2014).
Various
EXJADE (deferasirox) is an oral iron che lat ing agent for the treat ment of iron over load re lated dis eases.
It was first ap proved in the USA and Swit zer land in 2005 and launched in those coun tries in No vem ber
2005. Ap proval in the EU came in Au gust 2006, and a large num ber of launches across Eu rope fol lowed as
well as launches in Latin Amer ica and Asia. It was also launched in a num ber of mar kets in 2007, in clud ing
Greece, South Af rica, Chile, New Zea land, Fin land, Bel gium, Tur key, Tai wan, Ec ua dor, Bul garia and Sin -
ga pore. It was launched in Uru guay in 2008. Deferasirox has Or phan Drug Sta tus in the USA, EU and
Aus tra lia. It was filed in Ja pan in March 2007, a year ahead of sched ule, and launched in Ja pan in June
2008. It is avail able in over 90 coun tries world wide, according to Novartis in January 2009.
The phase III stud ies in volved around 800 adults and chil dren with beta-thalassemia myelodysplastic
syn drome. Thalassemia is a con gen i tal dis or der re sult ing in pro duc tion of ab nor mal he mo glo bin. Treat -
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