Multi-centre, retrospective cohort study in 308 nursing homes reporting ≥1 confirmed or suspected norovirus outbreak (USA; ) Primary endpoints: all-cause mortality and hospitalisation rates during outbreak periods vs non-outbreak periods During 616 nursing-home-years of follow-up: –407 norovirus outbreaks –26,055 deaths –67,730 hospitalisations Impact of norovirus outbreaks in nursing homes on hospitalisation and mortality rates Trivedi TK et al. JAMA 2012;308: of 2

Daily registered nurse hours per resident <0.75h: associated with increased mortality rate during norovirus outbreak periods (vs non-outbreak periods): Risk ratio: 1.26; 95% CI: ; P<0.001 Impact of norovirus outbreaks in nursing homes on hospitalisation and mortality rates Norovirus outbreaks in nursing homes seem to be associated with significant increases in all-cause hospitalisation and mortality Trivedi TK et al. JAMA 2012;308: of 2

Safety, immunogenicity and efficacy of norovirus (NoV) GI.1/GII.4 virus-like particle (VLP) vaccine: phase I/II study Multi-centre, double-blind, randomised, placebo-controlled phase I/II human challenge trial (USA) in healthy adults aged yr: –Bivalent NoV GI.1/GII.4 VLP vaccine adjuvanted with monophosphoryl lipid A (MPL) and alum: 2 im vaccinations 28 days apart: N=50 (PP) –Placebo: N=48 (PP) ≥28 days after 2 im vaccinations: oral challenge with heterologous GII.4 NoV (4,000 RT-PCR genome equivalents) Safety and immunogenicity No serious AEs attributable to NoV throughout observation period Bernstein DI. IDWeek 2013 abs. LB2 1 of 2 Data from oral presentation

Safety, immunogenicity and efficacy of norovirus (NoV) GI.1/GII.4 virus-like particle (VLP) vaccine: phase I/II study Efficacy (30 days post-challenge) NoV shedding 10 days post-challenge: Vaccine: 22.4% − Placebo: 36.2%; P=0.179 In healthy subjects, the bivalent NoV GI.1/GII.4 VLP vaccine may provide some protection against vomiting and/or diarrhoea Bernstein DI. IDWeek 2013 abs. LB2 2 of 2 Data from oral presentation

Phase II study: N=168 adult pts (median age: 59 yr) who had recovered from CDI and completed a course of metronidazole or oral vancomycin: –Placebo: 1x/day –Oral suspension of VP20621 spores: starting 1-2 days after last day of antibiotic treatment: 10 4 x 7 days, 10 7 x 7 days or 10 7 x 14 days Safety Most common AEs in NTCD group: diarrhoea (50%), flatulence (20%), abdominal pain (19%), headache (10%) VP20621, spores of a non-toxigenic Clostridium difficile (NTCD) strain: safety and efficacy for prevention of recurrence of C. difficile infection (CDI) Villano S. IDWeek 2013 abs. LB7 1 of 2 Data from oral presentation

VP20621, spores of a non-toxigenic Clostridium difficile (NTCD) strain: safety and efficacy for prevention of recurrence of C. difficile infection (CDI) Efficacy (at week 6) VP20621 seems to be well tolerated at all doses and may reduce CDI recurrences and the need for antibacterial Tx by ≥50% vs placebo Villano S. IDWeek 2013 abs. LB7 2 of 2 Data from oral presentation

Efficacy and safety of rifamycin SV MMX ® (RIF- MMX) for treatment of traveller’s diarrhoea (TD) RIF-MMX: novel, broad-spectrum, poorly-absorbed antibiotic, coupled with technology to target drug delivery to the colon Multi-centre, double-blind, phase III RCT (Guatemala, Mexico): N=264 adult tourists presenting within 72h of TD onset, randomised to: –RIF-MMX: 400 mg orally 2x/day during 3 days: N=199 –Placebo: N=65 Safety Most common AEs (N=264): diarrhoea (6.1%), headache (8.7%), infectious diarrhoea (5.7%), constipation (3.0%) Dupont H. IDWeek 2013 abs of 2 Data from poster

Efficacy and safety of rifamycin SV MMX ® (RIF- MMX) for treatment of traveller’s diarrhoea (TD) Efficacy Primary endpoint: Time from first dose of study drug to last unformed stool (soft or watery) (TLUS) prior to the start of clinical cure RIF-MMX seems to shorten the duration of traveller’s diarrhoea compared with placebo and seems to be well tolerated Dupont H. IDWeek 2013 abs of 2 Data from poster