IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Clin i cal Data: In Feb ru ary 2008, Intercell re ported re sults from a phase I Aus trian trial of the adjuvant
IC31 in com bi na tion with Novartis’ sea sonal tri va lent in flu enza vac cine Agrippal. In this ran dom ized,
con trolled trial, 72 healthy adult vol un teers re ceived Agrippal plus one of two dif fer ent con cen tra tions of
IC31 or Agrippal alone. Most of the vol un teers showed a pre-ex ist ing im mune re sponse against in flu enza
strains. The trial as sessed the gen eral safety, lo cal tolerability and im mune re sponses elic ited by vac ci na -
tion with the IC31 adjuvant. Even in vol un teers re ceiv ing the high est dose of IC31 in ad di tion to Agrippal,
the adjuvant was shown to be safe and well tol er ated com pared with Agrippal alone. Vac ci na tion with
Agrippal and IC31 led to the in duc tion of vi rus spe cific T-cells and pro tec tive lev els of an ti body responses
against the three included influenza strains.
VAC CINE, CYTOMEGALOVIRUS, NOVARTIS: In De cem ber 2008, AlphaVax granted Novartis an ex -
clu sive li cense to its cytomegalovirus (CMV) vac cine. Un der the terms of the deal, Novartis will be re spon -
si ble for phase II tri als; AlphaVax will fi nal ize phase I tri als and pro vide clin i cal trial ma te rial for the phase
II tri als. Reg is tra tion and world wide com mer cial iza tion will be the re spon si bil ity of Novartis. AlphaVax has
re ceived a $20 mil lion upfront pay ment from Novartis for the CMV pro gram. At the end of phase II tri als,
Novartis has an op tion to make an eq uity in vest ment for 4 mil lion shares. AlphaVax will be en ti tled to re -
ceive mile stone pay ments and roy al ties. The agree ment also grants Novartis rights of first ne go ti a tion to
AlphaVax’s pre clin i cal re spi ra tory syncytial vi rus (RSV) pro gram. Novartis ex pects to be gin phase II tri als
of the CMV vac cine in 2009. The vac cine is based on an al pha vi rus replicon par ti cle en cod ing CMV
phosphoprotein 65, immediate early protein 1(IE1) and soluble gB protein.
VAC CINE, GROUP B STREP TO COC CUS, NOVARTIS: Novartis is de vel op ing a monovalent
glycoconjugate an ti gen vac cine against Group B Strep to coc cus, for use in the pre ven tion of neo na tal sep -
sis and mor tal ity caused by Group B Strep to coc cus in fec tion. In De cem ber 2007 a phase I trial of the vac -
cine ini ti ated in Swit zer land; a sec ond phase I trial be gan in Feb ru ary 2008. Novartis also has a li cense to
Intercell’s (Aus tria) Group B Strep to coc cus vac cine, which is in preclinical studies.
VAC CINE, H PYLORI, NOVARTIS: Novartis is de vel op ing a vac cine against Helicobacter pylori. Early
trial data showed that the vac cine was safe and immunogenic. Phase I tri als were on go ing in 2009.
VAC CINE, HIV IN FEC TION, NOVARTIS: Novartis is de vel op ing an intranasal vac cine to pre vent HIV
in fec tion in col lab o ra tion with the Na tional In sti tutes of Health (USA). DNA and pro tein vac cines have
been eval u ated. Ac cord ing to Novartis, it was in phase I trials in 2008.
HCV NS3/4A PRO TE ASE IN HIB I TORS, IDENIX: In April 2008, Idenix re ported re sults from pre clin i -
cal stud ies of its se ries of pro te ase in hib i tors for the treat ment of hep a ti tis C vi rus (HCV) in fec tion. Com -
pounds in the se ries showed subnanomolar an ti vi ral ac tiv ity against HCV ge no type 1b NS3/4A pro te ase
tar get and sin gle nanomolar ac tiv ity in the HCV replicon. The agents showed high in vi tro se lec tiv ity and
did not in hibit hu man cel lu lar pro teas es. The pro te ase in hib i tors showed ac tiv ity against cer tain HCV re -
sis tant mu tants as so ci ated with first gen er a tion pro te ase in hib i tors in de vel op ment. Data from
pharmacokinetic stud ies showed ad e quate oral bioavailability and sus tained liver con cen tra tions, in di cat -
ing po ten tial for once-daily or twice-daily dos ing. Idenix expects to have a candidate from this series in
clinical development by mid-2009.
Li cens ing: In 2003, Novartis paid $255 mil lion for ap prox i mately 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 Tyzeka (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.
IDX 375: Idenix is de vel op ing IDX 375, a non-nucleoside poly mer ase in hib i tor, as a po ten tial treat ment
for hep a ti tis C vi rus (HCV) in fec tion. Pre clin i cal stud ies were un der way in the USA in 2008.
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