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SCYNEXIS Overview 2010: Fully Integrated Drug Discovery CRO Solutions
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SCYNEXIS Overview 2010: Fully Integrated Drug Discovery CRO Solutions


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SCYNEXIS, Inc. is a fully-integrated drug discovery and development CRO located in Research Triangle Park, NC with 120,000 sq.ft. of state-of-the-art facilities and equipment. SCYNEXIS is registered …

SCYNEXIS, Inc. is a fully-integrated drug discovery and development CRO located in Research Triangle Park, NC with 120,000 sq.ft. of state-of-the-art facilities and equipment. SCYNEXIS is registered with both the FDA and DEA.

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  • 1. Fully-Integrated Drug Discovery & Development Solutions SCYNEXIS® Proprietary and Confidential Information March 31, 2010
  • 2. About SCYNEXIS SCYNEXIS delivers integrated, efficient and innovative drug discovery and development SOLUTIONS to our global health and pharmaceutical partners. Our record of success is exemplified by the delivery of 11 pre-clinical drug candidates over the last five years. Additionally, SCYNEXIS has developed the chemical manufacturing process for a customer’s NDA. We are registered with and inspected by both the FDA and DEA. SCYNEXIS provides Fully-Integrated Contract Research SOLUTIONS including: ● Medicinal Chemistry ● Lead Optimization ● Computational Chemistry ● ADMET-PK ● Bioanalysis ● Process / cGMP Chemistry ● Analytical Chemistry We provide more than just compounds… We provide you with DRUGS SCYNEXIS® Proprietary and Confidential Information
  • 3. About SCYNEXIS: Founding & Personnel ● Founded in July 2000 in Research Triangle Park, NC ● Former Sanofi-Aventis (Rhône-Poulenc) Researchers ● 140+ Team Members across the 120,000 ft2 Facilities ● Experienced Leadership ◆ Merck, GSK, Sanofi-Aventis, Pfizer, BMS, AstraZeneca, BASF, Lilly, Trimeris, DSM ● Unique Risk/Reward Partnering Business ◆ Profitable Service Business ◆ Product and Partnership Upsides SCYNEXIS® Proprietary and Confidential Information
  • 4. SCYNEXIS: By the Numbers ● 140+ Employees Across Two Campuses 17+ Years of Experience (Average) 50% Ph.D.’s on Chemistry Teams ● 120,000 ft2 facilities in RTP, NC 64 Fume Hoods Largest “Chemistry House” in Southeast LC/MS/MS, HPLC, GC/MS, NMR, DSC ● 100+ Clients Spanning the Globe Virtual/Biotech/Midsize/Top 25 MedChem/Process/DMPK ● Strong Financials & Proven Success $32.5M for 2008 Service/Milestones/Royalties 80% CAGR of Revenues 11 Preclinical Candidates SCYNEXIS® Proprietary and Confidential Information
  • 5. Why SCYNEXIS? Drug Discovery & Development Expertise Innovation & Creativity Fully-integrated Research Units (DMPK-MedChem-GMP API) World-class Scientists & Proven Track Record Concept to Marketed Drugs 11 PCC’s, multiple IND’s/NDA’s ~17 years Experience per FTE Integrity & Confidentiality Focus on Teamwork CLIENT US Operations, Data Security, Clients own IP Integrated Project Management & Weekly Client Updates Proven Success with Customer Service Excellence SCYNEXIS >90% Return Rate of Business 11 Compounds Nominated as Clinical Candidates SCYNEXIS® Proprietary and Confidential Information
  • 6. Publicly Disclosed SCYNEXIS Clients *All publicly disclosed prior to January 2010 SCYNEXIS® Proprietary and Confidential Information
  • 7. Working with SCYNEXIS ● SCYNEXIS’ Goal ◆ Develop Long-Term Relationships via Dedicated Project Resources Fully-integrated Research Units Dedicated Project Team Project Leader Medicinal Chemists Computational Chemists Analytical & Bioanalytical Chemists DMPK & Toxicology Biochemistry & Screening Scientists Process Chemists ● Key Attributes ◆ Flexibility of the Team ◆ Multiple Scientific Disciplines ◆ Seamless Functional Transitions ◆ 1 – 35 FTE’s
  • 8. Innovative Drug Pipeline Solutions Success with SCYNEXIS
  • 9. Success with SCYNEXIS ● Structure-aided Lead Optimization Programs ◆ CNS Target – Multiple Clinical Candidates for Sepracor ◆ Anti-Fungal* – 3 Clinical Candidates for Merck ◆ Ion Channel Blocker* – Ophthalmology Compound for Merck ◆ Anti-Parasitic – Potent Compound for Merck ◆ Nuclear Hormone Receptors – Novel Ligands for GSK ◆ Anti-inflammatory – Scaffold-hopping for Teijin ◆ GPCR Kinase 2 – Novel Series of Inhibitors Generated ◆ Oncology Target – Novel, Potent Inhibitor Templates ◆ Pain – Novel Prodrug Series Identified * Natural Product Optimization
  • 10. Success with SCYNEXIS ● Classical Medicinal Chemistry Programs ◆ IP Generation Engine ■ Anti-Parasitics – Novel, Safer Compound Identified. Now in Phase III. ■ Anthelmintics – Novel Series Invented and Compound Identified ■ CNS – Novel Series Invented and 4 Patent Applications Submitted to USPTO ■ SCYNEXIS Medicinal Chemists Solely Responsible for IP Development ◆ Pharmacophore Based Screening ◆ Application of New Chemistry to Old Templates
  • 11. Success with SCYNEXIS ● Knowledge Base of Chemical and Clinical Development ◆ SCYNEXIS team members have assembled >20 IND packages ■ FUZEON: Anti-HIV Drug from Discovery to NDA ■ Cystic Fibrosis Drug from Discovery to Phase Ib ■ Anti-HCV Drug from Discovery to Phase II ■ Chemical Process Developed for NDA
  • 12. Innovative Drug Pipeline Solutions SCYNEXIS Medicinal Chemistry Dr. Mike Peel Director, Medicinal Chemistry
  • 13. The SCYNEXIS Medicinal Chemistry Team Medicinal Chemistry Expertise 51 Team Members Globally Recognized Excellence 27 Ph.D’s / Medicinal / Computational Experienced Leadership CLIENT GSK, AstraZeneca, Sanofi-Aventis, Pfizer, Lilly, Merck Broad Expertise Multi-factorial Optimization, Parallel Synthesis/Purification, KITTM Numerous Therapy Areas Computational & Cheminformatics Support HEOS® Data Management & Collaboration Software Suite SCYNEXIS® Proprietary and Confidential Information
  • 14. Medicinal Chemistry Expertise ● Broad range of expertise in multiple therapeutic areas including: ◆ Natural Product Optimization ◆ Oncology ◆ Antifungals ◆ Kinases ◆ Antivirals ◆ Inflammation ◆ Antibacterials ◆ Pain ◆ Antiparasitics ◆ Central Nervous System (CNS) ◆ Nuclear Hormones ◆ Opththalmology ◆ Ion Channels ◆ Prodrug Design
  • 15. SCYNEXIS’ Medicinal Chemistry Expertise Areas Potency, efficacy Solubility, stability CNS penetration Heterocycle Ion Channel Complex Natural Product Peptide Kinase Inhibitor Potency, Potency SCYNEXIS MedChem Selectivity Natural Product Nuclear Receptor Ligand Potency, PK Potency, Selectivity Efficacy, Tox. Metabolism, PK
  • 16. Innovative Drug Pipeline Solutions SCYNEXIS DMPK & Biology Dr. Steve Wring Director, DMPK-Tox & Bioanalytical
  • 17. The SCYNEXIS DMPK & Biochemistry Team Full Discovery DMPK Function Integrated into MedChem Decision Process Broad Areas of Expertise 17 Team Members Full Support for Discovery - Development 7 Ph.D.’s / 3 MSc / 7 BSc’s 5 LC/MS/MS Systems Cell Culture Suite CLIENT Experienced Leadership Large and Small Pharma/Biotech Experience & Research Investigators Multiple Concurrent Programs Hits-to-Lead to Lead-Opt Lead-Opt to Candidate Selection Exploratory Development Supporting Broad Healthcare Initiatives Neglected Diseases, CNS, Anti-Infectives, Oncology, Metabolic Diseases, Ophthalmology, Pain, Animal Health SCYNEXIS® Proprietary and Confidential Information
  • 18. SCYNEXIS DMPK Provide Fast & Efficient Decision Support to Medicinal Chemists for Rapid Lead Optimization & Candidate Selection ● Discovery DMPK ◆ Permeability ◆ Transporters ◆ Metabolic stability ◆ CYP450 inhibition ◆ Mechanistic metabolism ◆ Metabolite ID ◆ Protein binding ◆ Tissue distribution ◆ Animal PK ◆ Pilot toxicity studies
  • 19. SCYNEXIS DMPK Bioanalytical State-of-the-art facility with 5 dedicated LC-MS/MS Systems API3000 (3) / API4000 (1) / 4000 Q-Trap (1) ● Bioanalysis ◆ Method Development ◆ Validation ◆ Rapid Sample Analysis ◆ Pharmacokinetics ◆ High Sensitivity ◆ In Vitro DMPK Assays ◆ Discovery PK Studies ◆ Metabolite Identification ◆ Clinical Support SCYNEXIS® Proprietary and Confidential Information
  • 20. SCYNEXIS Biology and Biochemistry Target Validation and Biological Support for Drug Discovery Projects ● Integrated In Vitro Pharmacology & Biochemistry ◆ Genetic confirmation of drug target ◆ Activity based kinase screening (Luminescence) ◆ Chaperone binding assays ◆ Cytokine release assays ◆ Protein association studies (inc. Y2H) ◆ Cellular cytotoxicity assays ◆ Phenotypic screens for parasiticides ◆ Receptor assays (Including GPCR & ligand-gated ion channels) ◆ Ion channels SCYNEXIS® Proprietary and Confidential Information
  • 21. SCYNEXIS Biology and Biochemistry ● Screening ◆ New target screening, forward/reverse genetics (RNAi) ◆ Assay development/optimization ◆ Enzymatic, binding and functional assays ■ Including medium throughput screening on ion channels, GPCR’s & kinases ◆ Cell culture and high content screening modalities ◆ Whole organism assays (C. elegans, drosophila, trypanosomes) ● Core Capabilities ◆ Extensive liquid handling capabilities for compound management ◆ Automated screening methods ◆ Fluorescence microscopy/ cell morphology ◆ ELISA ◆ Gene manipulation and protein expression ◆ Enzymology ◆ Radioisotope license in progress SCYNEXIS® Proprietary and Confidential Information
  • 22. Innovative Drug Pipeline Solutions SCYNEXIS Process Chemistry Dr. Bob Rodebaugh Director, Process & Analytical Chemistry SCYNEXIS® Proprietary and Confidential Information
  • 23. The SCYNEXIS Process Team Process Development Focused Expert Problem Solvers 24 Team Members Developed Chemical Process for NDA 12 Ph.D.’s / 13 Process Chemists / 11 Analytical Chemists CLIENT Experienced Leadership Merck, GSK, Aventis, Pfizer, BASF, DSM, Lilly FDA Audited PAI – October 2009 No Observations No 483’s 40+ Global Clientele ~ 500 Completed Projects 81 in 2008, 85 in 2009 $1K - $2 M Range SCYNEXIS® Proprietary and Confidential Information
  • 24. SCYNEXIS Process Development ● Rapid Turnaround & Efficient Custom Synthesis Intermediates Reference Standards Process Impurities Analog Synthesis Preparative Chromatography High Pressure Reactions ● Chemical Development Expertise Scale-Up of Medicinal Chemistry Routes Novel Route “Scouting” & Development Route & Process Optimization Developed Process for NDA SCYNEXIS® Proprietary and Confidential Information
  • 25. SCYNEXIS cGMP Manufacturing ● FDA Registered, Inspected ● Controlled Access ● Pre-Clinical Through Phase Ill ● World-Class Facilities ◆ Chemical Development Labs ◆ Kilo Scale Lab for non-GMP Scale up ◆ GMP Kilo Scale Manufacturing Suite ● Small Scale Commercial Manufacturing ◆ PAI October 2009 – No Observations/483s ● State of the Art Equipment ◆ 25L to 200L Capacity ♦ Glass Fixed Reactors, -80 to +200 ° C ♦ Huber Temperature Controllers ◆ Dedicated Air Handlers ◆ Parr 2 Gallon Pressure Reactor ◆ Preparative Chromatography Systems SCYNEXIS® Proprietary and Confidential Information
  • 26. SCYNEXIS Analytical R&D ● Capabilities & Expertise 1:1 Ratio of Process : Analytical GMP/GLP Method Development by Ph.D. Level Scientists Validation & Stability Studies to ICH Guidelines Impurity, Degradation Product, Structural Identification ● Key Analytical Instrumentation 29 HPLC Systems (Waters/Agilent) PAD, ELSD, UV-Vis, Fluorescence, UPLC 12 LC/MS & LC/MS/MS Systems 3 GC/MS & GC/FID Headspace/Liquid GMP 400 & 500 MHz Varian NMR 4 Semi-prep Chromatography Systems DSC/TGA, K-F, TOC, FTIR SCYNEXIS® Proprietary and Confidential Information
  • 27. HEOS® Drug Development Collaboration Tool Secure web-based portal for real-time data sharing and communication O NH2 Ar N PDF N … TXT SDF Third-Party Software SCYNEXIS® Proprietary and Confidential Information
  • 28. SCYNEXIS Quality Systems GMP Regulatory Mission FDA Regulatory Guidelines Ensuring Quality, Purity & Strength 21 CFR Parts 210 & 211 FDA Audited GMP General Inspection & Pre-Approval Inspection (PAI) October 2009 No Observations, No Form 483s Issued GMP Foundations Master Validation Plan / SOPs & Document Control / Production & Testing Controls / Project Documentation GMP Foundations Qualified Personnel / Qualified Equipment / Validated Software / Facility Design SCYNEXIS® Proprietary and Confidential Information
  • 29. SCYNEXIS Values Integrity We will treat all employees with respect Teamwork and ethically conduct business We will work together towards achieving company goals Innovation SCYNEXIS We will continuously generate creative solutions to both technical and business challenges. Quality We will deliver superior products and services exceeding our customer’s expectations Safety Safety concerning employees, customers, public and the environment. Safety impacts every action and decision SCYNEXIS® Proprietary and Confidential Information
  • 30. SCYNEXIS Summary SCYNEXIS is a fully-integrated drug discovery & development company: ◆ Experienced & Highly-Skilled Personnel ◆ Proven Record of Success ◆ Delivered 11 Preclinical Candidates (IND’s) ◆ State of the Art Facilities ◆ Integrated Drug Development Solutions ◆ FDA & DEA Registered ◆ Commercial API Supplier – PAI October 2009 ◆ Rapid DMPK / Lead-Optimization Studies ◆ Dedicated Project Management ◆ Desire Long-Term Relationships Providing more than just compounds… SCYNEXIS provides you with DRUGS!
  • 31. Thank You! Contact Information Terry Marquardt Executive Director, Market Development Mike Peel, Ph.D. Director, Medicinal Chemistry Steve Wring, Ph.D. Director, DMPK Bob Rodebaugh, Ph.D. Director, Process, GMP & Analytical Chemistry Bryce Chaney, M.B.A. Market Development Manager, Process & Analytical Chemistry SCYNEXIS Inc. 3501-C Tricenter Blvd Durham, NC 27713 SCYNEXIS® Proprietary and Confidential Information