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NAEJA Pharmaceutical Inc. INTEGRATED MEDICINAL CHEMISTRY. International Research for Global Health. Drug discovery Contract Research Organization (CRO) Previously SynPhar Privately owned 63,000 ft 2 facility Based in Edmonton, Canada. Core Expertise Pre-Clinical Development. IND &
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NAEJA Pharmaceutical Inc. INTEGRATED MEDICINAL CHEMISTRY International Research for Global Health
Drug discovery Contract Research Organization (CRO) • Previously SynPhar • Privately owned • 63,000 ft2 facility • Based in Edmonton, Canada
Core ExpertisePre-Clinical Development IND & Clinical Trials Lead Optimization Target Validation HIT Validation Lead Identification
Success Stories: Anti-infectives SYNPHAR TAIHO IND & Clinical Trials Lead Optimization HIT Validation Lead Identification Tazobactam Design, Synthesis, & Screening of -Lactamase Inhibitor 4 Year Program Collaboration with Taiho Pharmaceuticals Marketed by Wyeth
Success Stories: Inflammation SYNPHAR TAIHO IND & Clinical Trials Lead Optimization HIT Validation Lead Identification Mofezolac (DisopainTM) Design & Synthesis of NSAID 4 Year Program Collaboration with Taiho Pharmaceuticals Marketed by Mitsubishi Pharmaceuticals
NAEJA Track Record Past 5 Years* Large Pharma Biotech New market 2008 Longest collaboration 12 years Longest contract 4 years Multiple projects & clients Proven IP security *(% revenue)
Single Client – Multiple ProgramsAnti-infectives & inflammation Lead Optimization Hit Generation and Validation Hit to Lead Candidate CLIENT NAEJA Phase 2 Phase 2b { On hold: biological liability One program Phase 1: 2009 Candidate selection: 2009 Lead declaration
CASE STUDY Anti-infective Program = NAEJA = CLIENT Project starts: Q1 Hit structure: narrow activity spectrum Racemic Limited SAR Undeveloped chemistry: unusual scaffold No crystal structure Q1: Validated thigh model Q3: Pre-candidate #1 put on hold: biological liability Q1: ½ Kg pre-candidate synthesized Q1: Chemistry development, SAR, MIC panel Q1: Process development Q4: Racemic lead #1 declared Candidate declaration >98% purity >98% eefffff Q3: Molecular modeling & SBDD Q2: chiral HPLC Q1: ADME Q3: Crystal structure Q1: Racemic lead #2 declared 2007 2008 2009
Successful Recent Programs Lead Optimization Hit Generation and Validation Hit to Lead Candidate NAEJA Phase 1b/2: Cardiovascular disease Clinical trials: Pain management Clinical trials: anti-bacterial Clinical trials: anti-fungal Alzheimer's program Anti-viral program
Medicinal Chemistry Projects Papers 4 Patents 9 Papers 4 Patents 10 Papers 42 Patents 19 Papers 3 Papers 5 Patents 1 Papers 15 Patents 4 Papers 2 Patents 5 Papers 20 Patents 5
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)
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.
Contact Information Dr Sameeh Salama Dr Chris Diaper Senior Director Associate Business & Development Business & Development ssalama@naeja.com cdiaper@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