IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
In In dia, Novartis has been fight ing to have its pat ent pro tec tion for Glivec rec og nized and en forced. In dia
in tro duced a new pat ent re gime in 2005 to com ply with the WTO agree ment on trade re lated as pects of
in tel lec tual prop erty rights that rec og nizes pat ents for chem i cal prod ucts filed there af ter 1995. In March
2004, Novartis was vic to ri ous in its first bat tle to pro tect Glivec from ge neric com pe ti tion in In dia; the
High Court in Ma dras has is sued an in junc tion stop ping mar ket ing of ge neric lines and four man u fac tur ers
im me di ately with drew their ver sions (Cipla, Ranbaxy, Intas and Sun Pharma). In Oc to ber 2004, Novartis
reached an out-of-court set tle ment with two In dian com pa nies (Natco and Natchem), who have agreed
they will not im port their ge neric ver sion of imatinib called Veenat 100 into coun tries cov ered by the Eu -
ro pean pat ent. In 2006, the In dian Pat ent Of fice ter mi nated the ex clu sive mar ket ing rights granted to
Novartis in 2003 for Glivec and re fused to pro ceed fur ther with Novartis pat ent ap pli ca tion for Glivec, fol -
low ing op po si tion by sev eral do mes tic firms in clud ing Cipla, Natco Pharma and NGO Can cer Pa tients Aid
As so ci a tion. Novartis ar gued that the ap pli ca tion was for a new sub stance, but the claim was re jected.
The Of fice of Con trol ler of Pat ents ruled that the pat ent ap plied for by Novartis did not qual ify as an in ven -
tion on the grounds that it is merely a modification of the key component of the drug, for which a patent
had already been filed in 1993.
In 2007, Novartis ap pealed against the ap point ment of the for mer Pat ent Con trol ler Mr S.
Chandrasekaran on the In tel lec tual Prop erty Ap pel late Board (IPAB), to look into the case. The con ten -
tion be ing that the for mer Pat ent Con trol ler was head ing the Pat ent Of fice when it orig i nally re jected
Novartis’ pat ent ap pli ca tion in Jan u ary 2006. The Ma dras High Court ruled that a two mem ber bench
com pris ing the Chair man and Vice-Chair man of the IPAB could look into the re jec tion of Novartis’ patent
application on Glivec.
In Feb ru ary 2008, it was re ported that Thai land had de cided not to pro ceed with a com pul sory li cense for
Glivec af ter Novartis of fered to ex pand a scheme for the free sup ply of the prod uct to pa tients cov ered by
the com pany’s uni ver sal healthcare scheme.
Lifecycle Man age ment: Novartis is in ves ti gat ing imatinib in phase III tri als in pa tients with CML and for
the adjuvant set ting in GIST. In De cem ber 2008 imatinib was ap proved by the US FDA for post op er a tive
treat ment of adult pa tients fol low ing com plete sur gi cal re moval of CD 117-pos i tive GIST. Imatinib was
granted Pri or ity Re view sta tus by the FDA for this in di ca tion in Au gust 2008. Novartis has filed for ap -
proval for this in di ca tion in the EU, Swit zer land and other mar kets with launches for the in di ca tion ex -
pected in 2009. The sub mis sions were based on data from a US and Ca na dian phase III trial, des ig nated
ACOSOG Z90001, show ing an 89% re duc tion in the risk of GIST re cur rence af ter sur gery in pa tients
given imatinib com pared with pla cebo. The com pany also re ports phase II stud ies with Glivec in non-on -
col ogy in di ca tions. Stud ies have no ticed po ten tial for Glivec in Alz hei mer’s dis ease, via low er ing pro duc -
tion of beta-am y loid thought to un der lie the de vel op ment of the dis ease. In early 2009 Glivec was in
phase II tri als for pulmonary arterial hypertension with a filing for this indication projected for 2011.
In No vem ber 2008, it was re ported that Glivec can pre vent the de vel op ment of Type 1 di a be tes in a
mouse model of the dis ease and in mice al ready with the con di tion, the drug can put the mice into re mis -
sion which then con tin ues for some time af ter the drug has been stopped.
Com pe ti tion: Glivec is al ready used as a first-line ther apy in more than 75% of the el i gi ble CML and
GIST pa tients across all ma jor mar kets and has been vir tu ally alone in the CML space. Com pe ti tion, how -
ever, is com ing from Bris tol-Myers Squibb’s SRC-ABL kinase in hib i tor Sprycel (dasatinib), which has
shown ef fi cacy in CML Glivec fail ures and was launched in the USA in 2006.
Mean while, Pfizer’s multi-tar geted angiogenesis in hib i tor, Sutent (sunitinib), was also de vel oped to treat
GIST pa tients with Glivec re sis tance. It was ap proved by the FDA in 2006 for met a static re nal cell and
GIST in di ca tions. An a lysts be lieve it could be come a blockbuster.
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