NAEJA Pharmaceutical Inc.INTEGRATED MEDICINAL CHEMISTRY International Research for Global Health
1987 1998 SYNPHAR DRISCORP Inc. LABORATORIES INC.Drug Discovery Company Contract Research CompanyOver 120 published patents (ID, Major Pharma ContractsInflammation, Cancer) 25 Scientific staff60 Scientific staff Strong Chemistry teamMultidisciplinary teamState of the art facilitiesWorldwide Contacts 1999 NAEJA PHARMACEUTICAL INC.
NAEJA PHARMACEUTICAL INC.Drug Discovery Contract Research OrganizationPrivate, revenue generating companyBased in Edmonton, Alberta, Canada
NAEJA PHARMACEUTICAL INC.Drug Discovery Contract Research OrganizationPrivate, revenue generating companyBased in Edmonton, Alberta, Canada63,000 ft2 well equipped laboratory facilityVast medicinal chemistry expertiseWell-established multidisciplinary teams
Staff 75% Chemistry 10% Biological/ADME 5% Analytical Support 10% G & A The majority of scientists (over 90%) hold Ph.D. degrees
NAEJA’s Core Expertise New Lead Early Early DevelopmentMedicine Target Hit identifi Lead IND Clinical Clinical Portfolio Phase PhaseProposal Validation Validation cation Optimization Enabling Safety Efficacy Preparation II III Launched MILESTONE MILESTONE MILESTONE MILESTONE MILESTONE MILESTONE MILESTONE MILESTONE MILESTONE MILESTONE MILESTONE Lead Optimization Ligand Identification Computational Chemistry Pharmacokinetics / Computational Chemistry Metabolism (ADME) Parallel Synthesis QSAR Preclinical Compound Library Targeted Library Toxicology Medicinal Chemistry Generation Microbiology Process Development Enzyme Kinetics Scale-up
Medicinal Chemistry Programs by Disease Area (%) 5 15 25 Antibacterial Antifungal Antiviral Cancer CVD 15 CNS Other 20 5 5
Clients by Geographical Location since 1999 (%) 10 US 25 Canada 52 Europe Asia 26
Clients by Industry Category since 1999 (% revenue) 30 Large Pharma Mid-Size 65 Small Biotech 15
Chemistry ServicesFull FTE: medicinal, synthetic, and process chemists.Medicinal chemistry programs: hit to candidate including process development (22 L).Custom synthesis.Chemical Information SupportSciFinder™, Reaxys™, ACS journals online, & CISTI.
Analytical Equipment: Instrumentation Details internal / external 1 LC-MS Systems Waters:ZQ with Alliance LC , SQD with Aquity UPLC Internal systems with PDA detectors 2 LC-MS/MS Systems Waters: Quattro-II with Alliance LC with PDA Detector, Internal TQD with Aquity UPLC systems with PDA detector 3 HPLC Waters HPLC (Alliance, 600 Series) and Aquity UPLC with Internal PDA and ELSD detectors 4 Elemental Analysis (CHN) Costech Internal 5 NMR Varian – 400 MHz Internal 6 IR Shimadzu IR 460 Internal 7 Prep-HPLC Preparative HPLC, One complete MS, UV directed Internal Auto-purification unit
Drug Metabolism / Pharmacokinetics: In vitro Bioanalytical Assay Development Solution Properties (Solubility, Stability) In vitro Absorption (Caco 2, Transport Mechanism) In vitro Metabolism (CYP 450 – Inhibition, Drug-Drug Interaction) Animal studies
Drug Metabolism / Pharmacokinetics: In vivo Bioavailability Plasma Concentration (AUC, Half-life, Cmax, Clearance and volume of distribution Tissue concentration/distribution In vivo metabolite profiling Acute & sub acute toxicological evaluation in rodents
Case Studies: Med Chem ProgramsAntibacterial: •β-Lactamase Inhibitor - Tazobactam •4-year SAR Program •Design, Synthesis, Screening Hit Lead Pre-Candidate Candidate Market
Case Studies: Med Chem ProgramsNSAID: •COX-1 Inhibitor – Mofezolac (Disopain™) •Design, Synthesis Hit Lead Pre-Candidate Candidate Market
Case Studies: Med Chem ProgramsAntifungal: •Undisclosed Target •2-year SAR Program •6 FTE’s at NAEJA supported by client •Design, Synthesis, Screening and DPMK •2 Patents: US 2005/0070503; WO 2005/013892 Hit Lead Pre-Candidate Candidate PIII
Case Studies: Med Chem ProgramsAntibacterial: •β-lactamase inhibitors (Syn2190) •3-year SAR Program •13 FTE’s at NAEJA supported by client •Synthesized >700 analogues •Tested in vitro and in vivo efficacy/DMPK Hit Lead Pre-Candidate Candidate Market* * Diagnostic tool
Case Studies: Med Chem ProgramsCardiovascular: Factor Xa (Fxa) inhibitors 2-year SAR Program 8 FTE’s at NAEJA supported by client Designed and Synthesized >200 analogues Hit Lead Pre-Candidate Candidate PII
Case Studies: Med Chem ProgramsCardiovascular: Undisclosed targets 3-year SAR Program 13 FTE’s at NAEJA supported by client Design, Synthesis, DMPK, animal efficacy Hit Lead Pre-Candidate Candidate PIIb
Case Studies: Med Chem ProgramsDermatology: Androgen Receptor Antagonist - Acne 2-year SAR and Process Development 2 FTE’s at NAEJA supported by client Design and Synthesis Hit Lead Pre-Candidate Candidate PI
Director NAEJA FTE’s 100% PhD’s PhD’s & postdocs by location Project CanadaCoordinator 100% PhD’s US Europe Asia Japan Scientist 90% PhD’s
Competitive Advantage• A proven track record of achievements• Established Integrated Multi-Disciplinary Teams: – Medicinal Chemistry- Lead Optimization/Scale Up Synthesis – Biopharmaceutical Profiling – Biochemistry – Microbiology• Fully Equipped Drug Discovery Laboratories• Highly Competitive Rates• Access to State of the Art Animal Facilities
Contact InformationMr. Christopher G. MicetichPresident and CEOcmicetich@naeja.com Dr. Sameeh M. Salama Senior Director, Business Development email@example.com 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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