IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
The reg u la tory fil ing was sub mit ted to the EMEA in early 2006 and was con sid ered ‘mock-up’ be cause it
laid the ground work for a more rapid ap proval (af ter sub mis sion of a re vised fil ing) and avail abil ity of the
vac cine upon dec la ra tion of a pan demic by the WHO. The fil ing was based on re sults from tri als in volv ing
the MF59 adjuvant and po ten tially pan demic in flu enza strains, including H5N1 and H9N2.
MYCOGRAB (efungumab) is a hu man ge net i cally re com bi nant an ti body that tar gets heat shock pro tein
90 (HSP90). Novartis is de vel op ing efungumab as a po ten tial treat ment for in va sive candidiasis, can cer
and cryptococcal men in gi tis. It was orig i nally de vel oped by NeuTec (ac quired by Novartis in 2006).
NeuTec sub mit ted an ap pli ca tion seek ing Eu ro pean ap proval for the treat ment of in va sive candidiasis in
2005. It re ceived a num ber of ques tions from the EMEA, which later is sued a neg a tive opin ion for the
prod uct. Novartis and NeuTec ap pealed, but in March 2007, the EMEA maintained its negative opinion.
In June 2006, a multicenter, ran dom ized, dou ble-blind, pla cebo-con trolled, phase III trial ini ti ated in
Swit zer land as sess ing the ef fi cacy and safety of efungumab as ad junc tive ther apy for cryptococcal men -
in gi tis in 150 pa tients with AIDS. The trial is ex pected to com plete in June 2009. In Jan u ary 2009,
Novartis noted that a fil ing for ap proval in men in gi tis and a fil ing for use in in va sive candidiasis may take
place in 2012 or later.
A phase Ib trial for use in the treat ment of breast can cer has been com pleted. Mycograb has Or phan Drug
sta tus in the US and the EU for use against in va sive fun gal in fec tions, and has dem on strated su pe ri or ity
in clin i cal out comes in com bi na tion with amphotericin B over amphotericin B monotherapy, with re duc -
tion in Candida-re lated mor tal ity and mycological superiority.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $25 mil lion in
2010 ($100 mil lion by 2013).
IXIARO (vac cine, Jap a nese en ceph a li tis vi rus, Intercell) is a pro phy lac tic vac cine against Jap a nese en -
ceph a li tis vi rus in fec tion, orig i nated by Intercell (Aus tria). It was sub mit ted for ap proval in the US and the
EU in 2007. Global, multicenter phase III tri als as sessed the immunogenicity and safety of the com pound
in more than 4,900 sub jects. Immunogenicity stud ies in Aus tria, Ger many and the USA were de signed to
show non-in fe ri or ity in com par i son with the JE-VAX vac cine. Ad di tional phase III tri als are ex pected to
gather more data from 4,000 sub jects re cruited in Aus tria, Aus tra lia, Bul garia, Ger many, Is rael, the
Neth er lands, New Zea land, Ro ma nia, the UK and the USA. In Jan u ary 2009, Novartis, which has rights in
the EU and USA, plus a num ber of other coun tries, stated that it ex pects an EU ap proval in the first half of
2009 af ter re ceiv ing a pos i tive rec om men da tion from the CHMP in December 2008. It also anticipates US
approval in H1 2009.
Li cens ing: In 2005, Intercell signed an agree ment with Bi o log i cal E, un der which the lat ter will de velop,
man u fac ture and mar ket the vac cine in Asia. In 2006, Intercell granted Novartis rights in the USA, Eu -
rope and other mar kets in clud ing Asia and Latin Amer ica. In re turn, Novartis will make an eq uity in vest -
ment in Intercell of up to Euro30 mil lion. This will grant Novartis first ne go ti a tion rights to cer tain Intercell
tech nol ogy de rived prod uct can di dates. Intercell will also re ceive mile stone pay ments re lated to fi nal
phase III data, and upon US and EU ap proval of the prod uct. In Jan u ary 2009, Intercell an nounced that
the Aus tra lian Ther a peu tic Goods Ad min is tra tion (TGA) has granted ap proval for the vac cine, fol low ing a
pos i tive opin ion rec om mend ing ap proval by the Aus tra lian Drug Eval u a tion Com mit tee (ADEC) in De -
cem ber 2008. The vac cine will be mar keted as Jespect by CSL, which has ex clu sive mar ket ing and dis tri -
bu tion rights for the vaccine in Australia, New Zealand, Papua New Guinea and the Pacific Islands.
Clin i cal Data: In 2006, Intercell re ported ini tial re sults from its phase III safety trial of IC51 in 2683
healthy vol un teers. Re sults from the multicenter, mul ti na tional, dou ble-blind, pla cebo-con trolled, ran -
dom ized trial showed that IC51 was sys tem i cally and lo cally well tol er ated with the over all lo cal
tolerability and gen eral safety pro file com pa ra ble to pla cebo. This on go ing trial is part of a global,
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