IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
SIMULECT (basiliximab), a monoclonal an ti body for the pro phy laxis of acute re jec tion ep i sodes fol low -
ing re nal trans plan ta tion, was launched in Swit zer land and the USA in 1998. It has sub se quently been
launched in most Eu ro pean coun tries and in Ja pan. Basiliximab in hib its white blood cell pro lif er a tion by
block ing interleukin-2 re cep tors. It is de signed to work with Novartis’ immunosuppressant Neoral
(ciclosporin). The US CMS ac cepted Simulect as one of seven new prod ucts el i gi ble for payment as
Orphan Drugs.
Li cens ing: In 2006, Cerimon (USA) ac quired ex clu sive world wide rights to basiliximab for the treat ment
of in flam ma tory bowel dis ease (IBD). Un der the terms of the deal, Cerimon will be re spon si ble for de vel -
op ment and mar ket ing of the prod uct for IBD; Novartis will con tinue to mar ket the prod uct for trans plant
re jec tion. Cerimon will re ceive per for mance-based mile stones from Novartis and, af ter reg u la tory ap -
proval, will share rev e nue from net sales of basiliximab with Novartis.
Lifecycle Man age ment: Cerimon has con ducted an early proof-of-con cept clin i cal trial of basiliximab in
the treat ment of IBD and be gan phase IIb tri als in ul cer ative co li tis in 2007. In July 2008, it an nounced
that it has ini ti ated a phase II proof-of-con cept study for the treat ment of non-in fec tious uveitis, a chronic
and po ten tially sight-threat en ing in flam ma tion of the eye.
In March 2008, Cerimon an nounced that it has en tered into an agree ment with Novartis to con duct a
proof-of-con cept study for basiliximab for the treat ment of non in fec tious uveitis, an au to im mune in flam -
ma tion of the in ter nal struc tures of the eye.
TASIGNA (nilotinib), an orally ac tive in hib i tor of ty ro sine kin ases, such as BCR-ABL and mu tant forms of
BCR-ABL, was launched in Swit zer land, its first world mar ket, in Au gust 2007 for the treat ment of pa -
tients with ad vanced chronic myelogenous leu ke mia (CML) who do not re spond to Glivec (imatinib).
Tasigna was launched in the USA in Oc to ber 2007. 2007 also saw launches in South Ko rea, In do ne sia and
Mex ico. It was ap proved in No vem ber 2007 in all 27 mem ber states of the EU plus Nor way and Ice land.
2008 saw launches in Ger many, Aus tria, France, Nor way, Fin land, Swe den, Den mark the UK, the Czech
Re pub lic, the Phil ip pines, Po land, Ire land, Greece, Bel gium, Spain, the Slo vak Re pub lic and Can ada.
Tasigna is now ap proved in about 40 coun tries. It was sub mit ted for ap proval in Ja pan in June 2007 and
was ap proved in Jan u ary 2009. The FDA has granted Tasigna Or phan Drug sta tus in the USA, and the
EMEA has granted the product Orphan Medicinal Product status in the EU.
Tasigna was de signed to be a more po tent and se lec tive in hib i tor of Bcr-Abl, the cause of Ph+ CML, and
its mu ta tions than Glivec. Sep a rate phase III stud ies are un der way com par ing Tasigna and Glivec in
newly di ag nosed CML pa tients as well as those with sub-op ti mal re sponses to pre vi ous ther apy. A reg is -
tra tion study is also un der way in pa tients with gas tro in tes ti nal stromal tu mors (GIST) who are re sis tant
or intolerant to prior treatment.
Clin i cal Data: In De cem ber 2008 at the Amer i can So ci ety of He ma tol ogy re sults were pre sented of two
phase II tri als in newly di ag nosed pa tients with Phil a del phia chro mo some-pos i tive chronic myeloid leu ke -
mia (Ph+ CML). In both phase II stud ies, 96% of pa tients with Phil a del phia chro mo some-pos i tive chronic
myeloid leu ke mia (Ph+ CML) achieved a com plete cytogenetic re sponse (CCyR) af ter six months of
Tasigna treatment.
Com pe ti tion: In 2006, Bris tol-Myers Squibb launched Sprycel (dasatinib) in the USA and the EU for the
treat ment of CML and Phil a del phia-pos i tive ALL in Glivec-re sis tant pa tients. This prod uct was al ready
num ber ten in the All Other Antineoplastics class (L1X) in the 12-month pe riod to the end of Sep tem ber
2008, with a 1.0% mar ket share, but 123% fixed rate dol lar growth. Sales stood at around $236 mil lion,
according to IMS.
Sales/An a lyst Com ment: Sales in 2008 were $89 mil lion. Novartis re ports that it has quickly gained
ac cep tance as a new ther apy in the sec ond-line set ting. The com pany be lieves it shows po ten tial to be -
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