IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
RKI 983 is a po ten tial treat ment for glau coma, in phase I tri als with Novartis in Eu rope in 2008.
SAD 448 was in phase I tri als with Novartis for the treat ment of glau coma and oc u lar hy per ten sion in
2008.
Clin i cal Data: In April 2007, a ran dom ized, pla cebo-con trolled, dou ble-masked, 4-arm par al lel, phase I
trial ini ti ated in Aus tra lia as sess ing the tolerability, safety and ef fi cacy of two doses of Novartis’ SAD 448
in 80 pa tients with oc u lar hy per ten sion. Pri mary out come mea sures will in clude rates of ad verse events
and se ri ous ad verse events as well as changes in oph thal mic eval u a tions, lab o ra tory val ues, ECGs and vi -
tal signs from base line up to 24 h post-dos ing. Sec ond ary out come mea sures will in clude changes in oc u -
lar hy per ten sion and sys temic ex po sure to SAD 448 following administration of the two doses.
Systemic Anti-Infective Agents
vaccine, pandemic influenza, Novartis — J7A1 Approved
efungumab — J2A, L1X3 Filed
vaccine, Japanese encephalitis virus,
Intercell IC51 J7A9 Filed
vaccine, meningococcal ACWY, Novartis MenACWY J7A8 Filed
albinterferon alfa-2b ABF 656 J5B, L3B1 III
vaccine, Neisseria meningitidis group B,
Novartis MenB J7A8 III
vaccine, pre-pandemic influenza, Novartis — J7A1 III
carbapenem antibiotic PTZ 601, SMP 601, SM 216601 J1P2 II
HCV therapy IDX 184 J5B1 II
reverse transcriptase inhibitor IDX 899 J5C3 II
RSV therapy RSV 604, A 60444 J5B5 II
vaccine, HCV epitope-based, Intercell IC41, IC 41, IC 41202 J7A3 II
vaccine, pseudomonas aeruginosa,
Intercell — J7A9 II
hepatitis C therapy NIM 811, SDZ 811 J5B1 I
vaccine adjuvant IC31 J7C, L3A9 I
vaccine, cytomegalovirus, Novartis — J7A9 I
vaccine, Group B Streptococcus, Novartis — J7A9 I
vaccine, H pylori, Novartis — J7A9 I
vaccine, HIV infection, Novartis — J7A9, J5C9 I
HCV NS3/4A protease inhibitors, Idenix — J5B1 Preclinical
RNA polymerase inhibitor IDX 375 J5B1 Preclinical
vaccine, Borrelia, Novartis — J7A9 Preclinical
vaccine, Candida, Novartis — J7A9 Preclinical
vaccine, Chlamydia, Novartis/Intercell — J7A9 Preclinical
vaccine, Group A Streptococcus, Novartis — J7A9 Preclinical
vaccine, Group B Streptococcus, Novartis/
Intercell — J7A9 Preclinical
vaccine, influenza, Dynavax — J7A1 Preclinical
vaccine, Klebsiella, Novartis/Intercell — J7A9 Preclinical
vaccine, otitis media, Novartis/Intercell — J7C Preclinical
vaccine, Streptococcus pneumoniae,
Novartis/Intercell — J7A7 Preclinical
FOCETRIA (vac cine, pan demic in flu enza, Novartis) is a vac cine for use in a pan demic in flu enza out -
break. It will be man u fac tured to con tain the pan demic in flu enza vi rus strain de clared at the time of a
pan demic, com bined with Novartis’ pro pri etary MF59 adjuvant that al lows smaller amounts of vi ral an ti -
gens to be used. The vac cine was ap proved in the EU, Nor way and Ice land for vac ci na tion against pan -
demic in flu enza strains in May 2007. Novartis will sub mit a re vised ap pli ca tion to the EMEA to in cor po rate
the vi ral strain once the WHO declares a pandemic.
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