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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 with both the FDA and DEA.
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SCYNEXIS® Proprietary and Confidential Information
Fully-Integrated Drug Discovery
& Development Solutions
March 31, 2010
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
SCYNEXIS® Proprietary and Confidential Information
About SCYNEXIS
We provide more than justcompounds…
We provide you with DRUGS
● 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
About SCYNEXIS: Founding & Personnel
SCYNEXIS® Proprietary and Confidential Information
SCYNEXIS: By the Numbers
● 140+ Employees Across Two Campuses17+ Years of Experience (Average)50% Ph.D.’s on Chemistry Teams
● 120,000 ft2 facilities in RTP, NC64 Fume HoodsLargest “Chemistry House” in SoutheastLC/MS/MS, HPLC, GC/MS, NMR, DSC
SCYNEXIS® Proprietary and Confidential Information
● 100+ Clients Spanning the Globe Virtual/Biotech/Midsize/Top 25MedChem/Process/DMPK
● Strong Financials & Proven Success$32.5M for 2008Service/Milestones/Royalties80% CAGR of Revenues11 Preclinical Candidates
Focus on TeamworkIntegrated Project Management &
Weekly Client Updates
Customer Service Excellence>90% Return Rate of Business
Proven Success with Proven Success with SCYNEXISSCYNEXIS
CLIENT
Why SCYNEXIS?
Drug Discovery & Development ExpertiseFully-integrated Research Units (DMPK-MedChem-GMP A PI)
Concept to Marketed Drugs~17 years Experience per FTE
Integrity & ConfidentialityUS Operations, Data Security, Clients own IP
Innovation & CreativityWorld-class Scientists & Proven Track Record
11 PCC’s, multiple IND’s/NDA’s
11 Compounds Nominated 11 Compounds Nominated as Clinical Candidatesas Clinical Candidates
SCYNEXIS® Proprietary and Confidential Information
Publicly Disclosed SCYNEXIS Clients
*All publicly disclosed prior to January 2010
SCYNEXIS® Proprietary and Confidential Information
● SCYNEXIS’ Goal◆ Develop Long-Term Relationships via Dedicated Proje ct Resources
Working with SCYNEXIS
Dedicated Project TeamProject LeaderMedicinal ChemistsComputational ChemistsAnalytical & Bioanalytical ChemistsDMPK & ToxicologyBiochemistry & Screening ScientistsProcess Chemists
● Key Attributes◆ Flexibility of the Team◆ Multiple Scientific Disciplines◆ Seamless Functional Transitions◆ 1 – 35 FTE’s
Fully-integrated Research Units
Success with SCYNEXIS
Innovative Drug Pipeline Solutions
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
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
Success with SCYNEXIS
● Knowledge Base of Chemical and Clinical Development◆ SCYNEXIS team members have assembled >20 IND packag es
■ 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
SCYNEXIS Medicinal Chemistry
Innovative Drug Pipeline Solutions
Dr. Mike PeelDirector, Medicinal [email protected]
The SCYNEXIS Medicinal Chemistry Team
Medicinal Chemistry ExpertiseGlobally Recognized Excellence
Experienced LeadershipGSK, AstraZeneca, Sanofi-Aventis,
Pfizer, Lilly, Merck
51 Team Members27 Ph.D’s / Medicinal / Computational
Broad ExpertiseMulti-factorial Optimization,
Parallel Synthesis/Purification, KIT TM
Numerous Therapy Areas
CLIENT
Computational & Cheminformatics SupportHEOS® Data Management & Collaboration Software Suite
SCYNEXIS® Proprietary and Confidential Information
Medicinal Chemistry Expertise
● Broad range of expertise in multiple therapeutic areas including:
◆ Natural Product Optimization◆ Antifungals◆ Antivirals◆ Antibacterials◆ Antiparasitics◆ Nuclear Hormones◆ Ion Channels
◆ Oncology◆ Kinases◆ Inflammation◆ Pain◆ Central Nervous System (CNS)◆ Opththalmology◆ Prodrug Design
SCYNEXIS’ Medicinal Chemistry Expertise Areas
Solubility, stability
Potency, SelectivityMetabolism, PK
Potency, PKEfficacy, Tox.
Potency,SelectivityPotency
Potency, efficacyCNS penetration
Peptide
Heterocycle Ion ChannelComplex Natural Product
Kinase Inhibitor
Nuclear Receptor LigandNatural Product
SCYNEXIS MedChem
SCYNEXIS DMPK & Biology
Innovative Drug Pipeline Solutions
Dr. Steve WringDirector, DMPK-Tox & [email protected]
The SCYNEXIS DMPK & Biochemistry Team
Broad Areas of ExpertiseFull Support for Discovery - Development
Experienced LeadershipLarge and Small Pharma/Biotech Experience
& Research Investigators
17 Team Members7 Ph.D.’s / 3 MSc / 7 BSc’s
5 LC/MS/MS SystemsCell Culture Suite
Multiple Concurrent ProgramsHits-to-Lead to Lead-Opt
Lead-Opt to Candidate SelectionExploratory Development
CLIENT
Supporting Broad Healthcare InitiativesNeglected Diseases, CNS, Anti-Infectives, Oncology,
Metabolic Diseases, Ophthalmology, Pain, Animal Hea lth
SCYNEXIS® Proprietary and Confidential Information
Full Discovery DMPK Function Integrated into MedChe m Decision Process
SCYNEXIS DMPK
Provide Fast & Efficient Decision Support to Medici nal 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
● Bioanalysis◆ Method Development◆ Validation◆ Rapid Sample Analysis◆ Pharmacokinetics◆ High Sensitivity ◆ In Vitro DMPK Assays◆ Discovery PK Studies◆ Metabolite Identification◆ Clinical Support
SCYNEXIS DMPK Bioanalytical
State-of-the-art facility with 5 dedicated LC-MS/MS Systems
API3000 (3) / API4000 (1) / 4000 Q-Trap (1)
SCYNEXIS® Proprietary and Confidential Information
● 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 Biology and Biochemistry
Target Validation and Biological Support for Drug Discovery Projects
SCYNEXIS® Proprietary and Confidential Information
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
SCYNEXIS Process Chemistry
Innovative Drug Pipeline Solutions
Dr. Bob Rodebaugh Director, Process & Analytical [email protected]
SCYNEXIS® Proprietary and Confidential Information
The SCYNEXIS Process Team
Process Development FocusedExpert Problem Solvers
Developed Chemical Process for NDA
Experienced LeadershipMerck, GSK, Aventis, Pfizer, BASF, DSM, Lilly
24 Team Members12 Ph.D.’s / 13 Process Chemists /
11 Analytical Chemists
40+ Global Clientele~ 500 Completed Projects
81 in 2008, 85 in 2009$1K - $2 M Range
CLIENT
SCYNEXIS® Proprietary and Confidential Information
FDA AuditedPAI – October 2009No Observations
No 483’s
SCYNEXIS Process Development
● Rapid Turnaround & Efficient Custom SynthesisIntermediates
Reference Standards
Process Impurities
Analog Synthesis
Preparative Chromatography
High Pressure Reactions
● Chemical Development ExpertiseScale-Up of Medicinal Chemistry Routes
Novel Route “Scouting” & Development
Route & Process Optimization
Developed Process for NDA
SCYNEXIS® Proprietary and Confidential Information
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
SCYNEXIS Analytical R&D
● Capabilities & Expertise1:1 Ratio of Process : Analytical
GMP/GLP Method Development by Ph.D. Level Scientists
Validation & Stability Studies to ICH GuidelinesImpurity, Degradation Product, Structural Identification
● Key Analytical Instrumentation29 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 NMR4 Semi-prep Chromatography Systems
DSC/TGA, K-F, TOC, FTIR
SCYNEXIS® Proprietary and Confidential Information
HEOS® Drug Development Collaboration Tool
Secure web-based portal for real-time data sharing and communication
N
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Ar
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Third-Party Software
SDFTXT
…
SCYNEXIS® Proprietary and Confidential Information
SCYNEXIS Quality Systems
GMP Regulatory MissionEnsuring Quality, Purity & Strength
FDA AuditedGeneral Inspection & Pre-Approval Inspection (PAI)
October 2009No Observations, No Form 483s Issued
FDA Regulatory Guidelines21 CFR Parts 210 & 211
GMP FoundationsMaster Validation Plan / SOPs & DocumentControl / Production & Testing Controls /
Project Documentation
GMP
GMP FoundationsQualified Personnel / Qualified Equipment /
Validated Software / Facility Design
SCYNEXIS® Proprietary and Confidential Information
SCYNEXIS Values
IntegrityWe will treat all employees with respect
and ethically conduct business
InnovationWe will continuously generate creative solutions to
both technical and business challenges.
TeamworkWe will work together towards
achieving company goals
SafetySafety concerning employees, customers, public
and the environment. Safety impacts everyaction and decision
SCYNEXIS
QualityWe will deliver superior products and services exceeding our customer’s
expectations
SCYNEXIS® Proprietary and Confidential Information
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
SCYNEXIS Summary
Providing more than just compounds… SCYNEXIS provide s you with DRUGS!
Terry Marquardt Executive Director, Market Development
Mike Peel, Ph.D. Director, Medicinal [email protected]
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 Ch emistry
SCYNEXIS Inc.3501-C Tricenter Blvd
Durham, NC 27713www.scynexis.com
Contact Information
www.scynexis.com
SCYNEXIS® Proprietary and Confidential Information
Thank You!