Adenium Biotech. Management: - Peter Nordkild, MD, CEO, ex Novo Nordisk, Ferring, Egalet - Søren Neve, PhD, project director, ex Lundbeck, Novozymes

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2 Adenium Biotech Management: - Peter Nordkild, MD, CEO, ex Novo Nordisk, Ferring, Egalet - Søren Neve, PhD, project director, ex Lundbeck, Novozymes Board of Directors: - Stephan Christgau, PhD, chairman, Novo A/S - Anker Lundemose, MD, ex Novo Nordisk, ex OSI Pharmaceuticals - Khalid Islam, PhD, ex Arpida - Ejner Bech Jensen, MSc, VP R&D Novozymes A/S Current Investor: - Novo A/S

3 Bad Bugs need new drugs The total US market of hospital acquired infections was in 2006 estimated at USD 7.9 billion. 65% of hospital acquired infections are caused by Gram-negative bacteria (Clin Infect Dis 2005;41: ) Resistance

4 Resistance is inevitable and requires novel antibiotics Antibiotic Year deployed Resistance observed Sulfonamides 1930s 1940s Penicillin Streptomycin Chloramphenicol Tetracycline Erythromycin Vancomycin Methicillin Ampicillin Cephalosporins 1960s Late 1960s

5 Key antibacterial needs 2011 Source: Datamonitor 02/2011.

6 Arenicin A new Gram-negative antibiotic

7 Arenicin program highlights Spin out from Novozymes AMP group Novel mode of action, no cross resistance to existing antibiotics Bactericidal on broad range of multidrug resistant Gram-negative bacteria Development plan includes orphan drug opportunity Few competing bactericidal products in development Strong lead/back up product candidates Stable IV formulations Strong IP ( ) Addresses significant unmet Gram-negative clinical need Large, growing and non-generic hospital market of USD 8 billion Hospital and primarily ICU based specialist target group requiring small sales force

8 Healthcare associated infections in the US 2010 Source: Datamonitor 02/2011

9 Nosocomial indications - volume/value Source : Datamonitor 03/2007

10 ESKAPE Pathogens Enterococcus faecium Staphylococcus aureus Klebsiella species Acinetobacter baumannii Pseudomonas aeruginosa Enterobacter E.coli E. aerogenes E. cloacae

11 Generation of new variants

12 Arenicin-3 NZ17000 Isolated from lugworm (Arenicola marina) 21 amino acids Very stable beta-hairpin structure MW kda pi ~ 11.27

13 Variant generation through consecutive screening of yeast libraries variants Evaluation of variants Output 1. screen S. cerevisiae ( ) - plate screen vs. E. coli in the presence of 5% blood - retest vs. other Gram- bacteria 2. screen purified peptide (250) - MICs vs. 11 bacteria +/- serum - killing kinetic - protein binding 3. screen chemical synthesis (10) - a range of in vitro & in vivo parameters - MTD, peritonitis, cystitis etc NZ17143 and NZ17211 with distinct features Improved protein binding properties Improved toxicological properties 2 new Arenicin variants

14 Antimicrobial spectrum and protein binding of NZ17000, NZ17143 and NZ17211 Arenicin variant E. coli (μg/ml) K. pneumoniae (μg/ml) E. cloacae (μg/ml) P. aeruginosa (μg/ml) S. maltophilia (μg/ml) A. baumanii (μg/ml) M. catarrhalis (μg/ml) NZ NZ NZ Protein Binding

15 Antimicrobial activity against selected resistant Gram-negative strains Bacteria No NZ17000 NZ17143 NZ17211 Carbapenem resistant Klebsiella pneumoniae (KPC2) Carbapenem resistant Pseudomonas aeruginosa Carbapenem resistant Klebsiella pneumoniae (NDM-1) MIC (µg/ml) MIC (µg/ml) MIC (µg/ml) Tigecycline resistant Salmonella Hadar

16 MoA - localization of Arenicin 15 min 30 min 45 min Control Fosfomycin Polymycin B Arenicin-3 A. E. coli exposed for 30 min to NZ17000 and stained with TRITC. Treatment with NZ17000 results in influx of TRITC into the E. coli B. E. coli exposed for 30 min with TRITC labelled NZ Clusters of NZ17000 were localized in the bacterial membrane At OD600 =0.4 E.coli cells were exposed to 32ug/ml Arenicin, 64ug/ml Fosfomycin and 16ug/ml Polymycin B. Even at very high concentration of Arenicin-3, no dramatic morphological changes of the cells were observed.

17 Fold change MoA - ATP efflux after treatment with Arenicin Extracellular ATP after 10 min 25 Arenicin: Ar col pip Perturbs the membrane potential increasing the permeability of the bacterial membrane x MIC Inhibits the protein synthesis Arenicin-3 (Ar), colistin (col), and piperacillin (pip) induced release of ATP from E. coli. Exponential cells were incubated with drug for 10 minutes and ATP measured. y-axis is fold change relative to untreated (0xmic) and x-axis is fold MIC applied.

18 CFU/ml CFU/ ml of Pseudomonas Time kill of NZ17000 vs E.coli and Pseudomonas Time kill kinetics for Escherichia coli ATCC25922 NZ17000 in ca-müller Hinton broth Time (minutes) Growth control 10 x MIC Arenicin-3 (5µg/ml) 10 x MIC Gentamicin (5µg/ml) NZ17000 Time killing kinetics for Pseudomonas aeruginosa ATCC Time (minutes) Growth Control 0.25 x MIC NZ17000 ( 0.125µg/ml) 2 x MIC NZ17000 (1µg/ml) 10 x MIC NZ17000 (5µg/ml)

19 Dose response of NZ17000 in the UTI mouse model ED 50 ~1.5 mg/kg in urine and ~ 1.8 mg/kg in the bladder

20 Dose response of NZ17143 in the UTI mouse model ED 50 < 0.8 mg/kg in urine, bladder and in the kidneys

21 Dose response of NZ17211 in the UTI mouse model ED 50 < 0.8 mg/kg in urine, bladder and in the kidneys

22 NZ17143 NZ17211 NZ17000 Dose response in neutropenic mouse peritonitis model against a multi-resistant E. coli at 5 hours after treatment Blood Peritoneal fluid

23 Log 10 CFU/ml Log 10 CFU/ml Log 10 CFU/ml Efficacy of NZ17143/NZ17211 against multi-resistant E. coli in the murine Urinary Tract Infection model (UTI) 8 7 Urine 2 day post infection Urine day 2 post infection 8 7 Bladder 3 days post infection Bladder day 3 post infection 4 Kidney 3 days post infection Kidneys day 3 post infection vehicle NZ mg/kg NZ mg/kg Meropenem 40 mg/kg vehicle NZ mg/kg NZ mg/kg Meropenem 40 mg/kg vehicle NZ mg/kg NZ mg/kg Meropenem 40 mg/kg

24 Pharmacokinetic properties after IV administration Arenicin-3 variant Protein binding (%) T ½ (min) AUC (min*ug/ml) C max (ug/ml) Bioavailability (%, SC vs IV) NZ17000 > NZ NZ

25 Toxicological overview of NZ17000, NZ17143 and NZ17211 Variant NZ17000 (mg/kg) NZ17143 (mg/kg) NZ17211 (mg/kg) MTD (IV) NOAEL (IV) 7,

26 Arenicin summary New mode of action Spontaneous mutational frequency for E. coli is 3X10-9 and P. aeruginosa >10-8 Potent in vitro activity against a wide spectrum of Gramnegative bacteria Rapidly bactericidal MBCs ~ MICs No cross resistance to known antibiotics No or little inoculum effect Favorable efficacy in experimental animal models of infection Septicemia against E. coli and P. aeruginosa UTI against E. coli Thigh infections against E. coli.

Received 30 March 2005; returned 16 June 2005; revised 8 September 2005; accepted 12 September 2005

Received 30 March 2005; returned 16 June 2005; revised 8 September 2005; accepted 12 September 2005 Journal of Antimicrobial Chemotherapy (2005) 56, 1047 1052 doi:10.1093/jac/dki362 Advance Access publication 20 October 2005 Evaluation of PPI-0903M (T91825), a novel cephalosporin: bactericidal activity,

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