Innovative Drug Pipeline Solutions




      Medicinal                                                                             cGMP
                          Biological           In Vitro             ADMET-PK /
      Chemistry                                                                           & Process
                          Screening         Pharmacology            Bioanalytical
                                                                                          Chemistry




SCYNEXIS, Inc. 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 eleven pre-clinical drug candidates over the last

five years. Our fully-integrated contract drug outsourcing services include medicinal chemistry, advanced biological screening, in

vitro pharmacology, ADMET-PK, bioanalytical and analytical chemistry, process chemistry and scale-up and cGMP manufacturing in

our FDA-inspected facility. SCYNEXIS is headquartered in Research Triangle Park, North Carolina and occupies more than 100,000

ft2 of laboratory and office space strategically located in close proximity to RDU International Airport, UNC-Chapel Hill, Duke

University and North Carolina State University. SCYNEXIS is registered with the FDA and the DEA.



   Medicinal Chemistry & Drug Discovery                                                            Selected Expertise Areas
   The SCYNEXIS medicinal chemistry and drug discovery                              Natural Product Optimization   Oncology
   team has a reputation equaling the very best in the global                       Antifungals                    Kinases
   pharmaceutical discovery industry. Our team has the size                         Antivirals                     Inflammation
   and experience to handle projects of any complexity and                          Antibacterials                 Pain
   members have been involved in the selection of multiple                          Antiparasitics                 Central Nervous System (CNS)
   candidates across a variety of therapeutic areas in both                         Nuclear Hormones               Ophthalmology
   human and animal health.                                                         Ion Channels                   Prodrugs




   Biological Screening, ADMET-PK & Bioanalytical
                                                                                                      Core Capabilities
   To support both lead optimization and candidate selection,
   SCYNEXIS provides rapid generation of reliable ADMET                   Solubility                          Method Development / Qualification
   and pharmacokinetic (PK) data for compounds in discovery               Permeability                        Tissue Distribution
   through pre-IND filing. SCYNEXIS rapidly screens for                   Caco-2 / MDCK / Transporters        Pharmacokinetic Studies
   properties such as metabolic stability, permeability and               Metabolic Stability                 Prodrug Studies
                                                                          Protein Binding                     Metabolite Identification
   cytotoxicity to prioritize and differentiate lead series based
                                                                          Cytotoxicity                        Rapid Analysis / HTS
   on these and other project-specific parameters.
                                                                          Cytochrome P450                     Any Species / All Matrices


                                                           WWW.SCYNEXIS.COM
Process Chemistry & cGMP Manufacturing

The SCYNEXIS process chemistry team is capable of solving the most complex chemical development issues in a fast and efficient manner.
A distinguishing feature of our team is the equal balance between experienced process and analytical chemists. The team is focused upon
developing safe, scalable processes and has an excellent track record of providing innovative solutions to drug development companies
across the globe.
                                                                                                 Core Capabilities
The FDA inspected our
GMP systems in 2009 and                  Custom Syntheses                                  Chemical Development                               cGMP API Production
SCYNEXIS received no 483’s.              Intermediates                                     Scale-up of MedChem                                Early Clinical Supplies
                                         Reference Standards                               Route Identification                               Small Scale Phase 3 Supplies
                                         Preclinical Toxicology Batches                    Route Development                                  Small Scale Commercial
                                         Degradants & Impurities                           Process Optimization                               Orphan Drugs
                                         Metabolites                                       Novel Route Design                                 Quality Assurance Auditing
                                         Controlled Substances                             Intellectual Property Protection                   Fully-Qualified cGMP Facility




Analytical Development & Validation
                                                                                                                          Core Capabilities
The SCYNEXIS analytical research and development (AR&D)
                                                                                          Chromatography (LC/GC/TLC)                       Method Development
team consists of highly-experienced, industry veterans who
                                                                                          Normal & Reverse Phase                           Method Validation
develop and validate analytical methods on state-of-the-art
                                                                                          Forced Degradation Studies                       Chiral / Enantiomeric Purity
instrumentation according to the most current regulatory
                                                                                          Moisture Determination                           Preparative Isolation
guidance documents. The team is focused upon developing
                                                                                          Total Organic Content (TOC)                      Structural Identification
and validating phase-appropriate methods for the analysis of
                                                                                          DEA Scheduled Compounds                          Potential Genotoxic Impurity ID
starting materials, active pharmaceutical ingredients (APIs) and
                                                                                          Stability Protocols & Testing                    LC-MS/MS; GC/MS; NMR; UPLC
in-process synthetic intermediates.




HEOS®: A SaaS, Secure, Web-Based Software Platform For
Drug Discovery Collaborations

HEOS® suite is a comprehensive web-based drug research information                                                                                    In Vivo
                                                                                                                                                     Partners
management software that supports geographically distributed scientists
and facilitates collaboration.                                                                               Chemistry
                                                                                                              Scientists
HEOS® is seamlessly integrated with the “best” scientific expert
software currently used in the pharmaceutical industry. It allows complex
                                                                                                                                                                Logistical
data (biology, chemistry, analytical, safety, PK, etc.) to be exchanged,                                                                                        Associates
consolidated and shared rapidly and securely across multiple sites
worldwide. It provides powerful searching capabilities to combine
substructure and biological criteria, interactive SAR capabilities and decision                                      HTS, In Vitro
                                                                                                                     Collaborators                   DMPK
tools to scientists and management.                                                                                                                  Contributors




                                                                  From Concept To Clinic With Speed And Innovation™

                     SCYNEXIS, Incorporated • PO Box 12878 • Research Triangle Park • North Carolina • 27709-2878 • USA • +1.919.544.8600
                                                                    WWW.SCYNEXIS.COM
                                 ©Copyright 2010, SCYNEXIS, Inc. From Concept To Clinic With Speed And Innovation is a trademark of SCYNEXIS, Inc.
                                                          SCYNEXIS and HEOS are registered trademarks of SCYNEXIS, Inc.

SCYNEXIS Overview 2010

  • 1.
    Innovative Drug PipelineSolutions Medicinal cGMP Biological In Vitro ADMET-PK / Chemistry & Process Screening Pharmacology Bioanalytical Chemistry SCYNEXIS, Inc. 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 eleven pre-clinical drug candidates over the last five years. Our fully-integrated contract drug outsourcing services include medicinal chemistry, advanced biological screening, in vitro pharmacology, ADMET-PK, bioanalytical and analytical chemistry, process chemistry and scale-up and cGMP manufacturing in our FDA-inspected facility. SCYNEXIS is headquartered in Research Triangle Park, North Carolina and occupies more than 100,000 ft2 of laboratory and office space strategically located in close proximity to RDU International Airport, UNC-Chapel Hill, Duke University and North Carolina State University. SCYNEXIS is registered with the FDA and the DEA. Medicinal Chemistry & Drug Discovery Selected Expertise Areas The SCYNEXIS medicinal chemistry and drug discovery Natural Product Optimization Oncology team has a reputation equaling the very best in the global Antifungals Kinases pharmaceutical discovery industry. Our team has the size Antivirals Inflammation and experience to handle projects of any complexity and Antibacterials Pain members have been involved in the selection of multiple Antiparasitics Central Nervous System (CNS) candidates across a variety of therapeutic areas in both Nuclear Hormones Ophthalmology human and animal health. Ion Channels Prodrugs Biological Screening, ADMET-PK & Bioanalytical Core Capabilities To support both lead optimization and candidate selection, SCYNEXIS provides rapid generation of reliable ADMET Solubility Method Development / Qualification and pharmacokinetic (PK) data for compounds in discovery Permeability Tissue Distribution through pre-IND filing. SCYNEXIS rapidly screens for Caco-2 / MDCK / Transporters Pharmacokinetic Studies properties such as metabolic stability, permeability and Metabolic Stability Prodrug Studies Protein Binding Metabolite Identification cytotoxicity to prioritize and differentiate lead series based Cytotoxicity Rapid Analysis / HTS on these and other project-specific parameters. Cytochrome P450 Any Species / All Matrices WWW.SCYNEXIS.COM
  • 2.
    Process Chemistry &cGMP Manufacturing The SCYNEXIS process chemistry team is capable of solving the most complex chemical development issues in a fast and efficient manner. A distinguishing feature of our team is the equal balance between experienced process and analytical chemists. The team is focused upon developing safe, scalable processes and has an excellent track record of providing innovative solutions to drug development companies across the globe. Core Capabilities The FDA inspected our GMP systems in 2009 and Custom Syntheses Chemical Development cGMP API Production SCYNEXIS received no 483’s. Intermediates Scale-up of MedChem Early Clinical Supplies Reference Standards Route Identification Small Scale Phase 3 Supplies Preclinical Toxicology Batches Route Development Small Scale Commercial Degradants & Impurities Process Optimization Orphan Drugs Metabolites Novel Route Design Quality Assurance Auditing Controlled Substances Intellectual Property Protection Fully-Qualified cGMP Facility Analytical Development & Validation Core Capabilities The SCYNEXIS analytical research and development (AR&D) Chromatography (LC/GC/TLC) Method Development team consists of highly-experienced, industry veterans who Normal & Reverse Phase Method Validation develop and validate analytical methods on state-of-the-art Forced Degradation Studies Chiral / Enantiomeric Purity instrumentation according to the most current regulatory Moisture Determination Preparative Isolation guidance documents. The team is focused upon developing Total Organic Content (TOC) Structural Identification and validating phase-appropriate methods for the analysis of DEA Scheduled Compounds Potential Genotoxic Impurity ID starting materials, active pharmaceutical ingredients (APIs) and Stability Protocols & Testing LC-MS/MS; GC/MS; NMR; UPLC in-process synthetic intermediates. HEOS®: A SaaS, Secure, Web-Based Software Platform For Drug Discovery Collaborations HEOS® suite is a comprehensive web-based drug research information In Vivo Partners management software that supports geographically distributed scientists and facilitates collaboration. Chemistry Scientists HEOS® is seamlessly integrated with the “best” scientific expert software currently used in the pharmaceutical industry. It allows complex Logistical data (biology, chemistry, analytical, safety, PK, etc.) to be exchanged, Associates consolidated and shared rapidly and securely across multiple sites worldwide. It provides powerful searching capabilities to combine substructure and biological criteria, interactive SAR capabilities and decision HTS, In Vitro Collaborators DMPK tools to scientists and management. Contributors From Concept To Clinic With Speed And Innovation™ SCYNEXIS, Incorporated • PO Box 12878 • Research Triangle Park • North Carolina • 27709-2878 • USA • +1.919.544.8600 WWW.SCYNEXIS.COM ©Copyright 2010, SCYNEXIS, Inc. From Concept To Clinic With Speed And Innovation is a trademark of SCYNEXIS, Inc. SCYNEXIS and HEOS are registered trademarks of SCYNEXIS, Inc.