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International Research for Global Health NAEJA Pharmaceutical Inc. INTEGRATED MEDICINAL CHEMISTRY
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Drug discovery Contract Research Organization (CRO) Previously SynPhar Privately owned 63,000 ft 2 facility Based in Edmonton, Canada
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Core Expertise Pre-Clinical Development HIT Validation Lead Identification Lead Optimization Target Validation IND & Clinical Trials
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Track Record
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Success Stories: Anti-infectives Tazobactam Design, Synthesis, & Screening of -Lactamase Inhibitor 4 Year Program Collaboration with Taiho Pharmaceuticals Marketed by Wyeth SYNPHAR TAIHO HIT Validation IND & Clinical Trials Lead Identification Lead Optimization
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HIT Validation Lead Identification Lead Optimization IND & Clinical Trials Success Stories: Inflammation Mofezolac (Disopain TM ) Design & Synthesis of NSAID 4 Year Program Collaboration with Taiho Pharmaceuticals Marketed by Mitsubishi Pharmaceuticals SYNPHAR TAIHO
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NAEJA Track Record Past 5 Years* *(% revenue) Large Pharma Biotech Longest collaboration 12 years Longest contract 4 years New market 2008 Multiple projects & clients Proven IP security
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Services
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Single Client – Multiple Programs Anti-infectives & inflammation NAEJA Hit Generation and Validation Hit to Lead Lead Optimization Candidate CLIENT Phase 2 Phase 2b Phase 1: 2009 On hold: biological liability Candidate selection: 2009 Lead declaration { One program
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2007 20082009 Project starts: Q1 Hit structure: narrow activity spectrum Racemic Limited SAR Undeveloped chemistry: unusual scaffold No crystal structure Project starts: Q1 Hit structure: narrow activity spectrum Racemic Limited SAR Undeveloped chemistry: unusual scaffold No crystal structure Q3: Crystal structure Q1: ½ Kg pre-candidate synthesized Q1: ½ Kg pre-candidate synthesized Candidate declaration >98% purity >98% eefffff Candidate declaration >98% purity >98% eefffff Q4: Racemic lead #1 declared Q4: Racemic lead #1 declared Q1: Validated thigh model Q1: Validated thigh model Q3: Pre-candidate #1 put on hold: biological liability Q3: Pre-candidate #1 put on hold: biological liability Q1: Chemistry development, SAR, MIC panel Q1: Process development Q2: chiral HPLC Q1: ADME Q1: Racemic lead #2 declared Q3: Molecular modeling & SBDD CASE STUDY Anti-infective Program = NAEJA = CLIENT
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Successful Recent Programs NAEJA Hit Generation and Validation Hit to Lead Lead Optimization Candidate Phase 1b/2: Cardiovascular disease Clinical trials: anti-fungal Alzheimer's program Anti-viral program Clinical trials: Pain management Clinical trials: anti-bacterial
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Medicinal Chemistry Projects Papers 42 Patents 19 Papers 15 Patents 4 Papers 2 Patents 5 Papers 20 Patents 5 Papers 5 Patents 1 Papers 3 Papers 4 Patents 10 Papers 4 Patents 9
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The NAEJA Package Included in the price of an FTE: Consumables (solvents, silica etc., chemicals not included) Patent/literature searches (SciFinder™, Reaxys™, NERAC) Waste disposal (overseen by safety committee, SOP’s in place) IP 100% owned by the client (confidentiality SOP in place)
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NAEJA Summary Experience 22 year track record in drug discovery. Collaborations with over 125 pharmaceutical companies. Delivered candidates in a number of therapeutic areas. Expertise 90% of our research scientists are PhDs. Services Pre-clinical discovery Custom services to full range medicinal chemistry programs.
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Contact Information Dr Sameeh SalamaDr Chris Diaper Senior DirectorAssociate Business & Development Business & Development ssalama@naeja.comcdiaper@naeja.com Tel: (780) 989-9833(780) 989-9836 NAEJA Pharmaceutical Inc. 4290-91A Street, Edmonton, Alberta, Canada. T6E 5V2 Tel: (780) 462-4044; Fax: (780) 461-0196 www.naeja.com
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