SCYNEXIS provides fully integrated drug discovery and development solutions including medicinal chemistry, lead optimization, ADMET-PK testing, and cGMP manufacturing. They have over 140 employees across two campuses with experience from major pharmaceutical companies. SCYNEXIS has delivered 11 pre-clinical drug candidates over the last 5 years and developed a chemical manufacturing process for an NDA.
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. SCYNEXIS also 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
● Flexible Teams & Unique Risk/Reward Partnering Business
◆ FTE’s, Time & Materials, Fixed-Bid Project Work Proposals
◆ Profitable Service Business
◆ Product and Partnership Upsides
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4. SCYNEXIS: By the Numbers
● 140+ Employees Across Two Campuses
18+ Years of Experience (Average)
+60% 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
$29M for 2010
Service/Milestones/Royalties
>60% CAGR of Revenues
11 Preclinical Candidates
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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 ~18 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
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6. Publicly Disclosed SCYNEXIS Clients
*All publicly disclosed prior to January 2010
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7. Innovative Drug Pipeline Solutions
SCYNEXIS Process Chemistry
Dr. Bob Rodebaugh
Director, Process & Analytical Chemistry
Robert.Rodebaugh@scynexis.com
SCYNEXIS® Proprietary and Confidential Information
8. 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
65+ Global Clientele
~ 600 Completed Projects
81 in 2008, 85 in 2009, 128 in 2010
$1K - $2 M Range
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10. 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
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11. SCYNEXIS cGMP Manufacturing
● FDA Registered, Inspected
● Controlled Access, 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
● <15kg GMP API / <25kg GMP Intermediate
● State of the Art Equipment
◆ 25L to 200L Capacity
♦Glass-Lined Stainless Steel
♦Glass Fixed Reactors, -80 to +200 °
C
♦ Huber Temperature Controllers
◆ Dedicated Air Handlers
◆ Parr 2 Gallon Pressure Reactor
◆ Preparative Chromatography
SCYNEXIS® Proprietary and Confidential Information
12. 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
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13. 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
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14. Innovative Drug Pipeline Solutions
SCYNEXIS Medicinal Chemistry
Dr. Mike Peel
Director, Medicinal Chemistry
Mike.Peel@scynexis.com
15. 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
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16. 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 ◆ Ophthalmology
◆ Ion Channels ◆ Prodrug Design
17. Innovative Drug Pipeline Solutions
SCYNEXIS DMPK & Biology
Dr. Steve Wring
Director, DMPK-Tox & Bioanalytical
Steve.Wring@scynexis.com
18. 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
19. HEOS® Drug Development Collaboration Tool
Secure web-based portal for real-time data sharing and communication
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TXT
SDF
Third-Party Software
SCYNEXIS® Proprietary and Confidential Information
20. 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
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21. 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
22. 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)
◆ Integrated Drug Development Solutions
◆ State of the Art Facilities
◆ 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!
23. Thank You!
Contact Information
Mike Peel, Ph.D.
Director, Medicinal Chemistry
Mike.Peel@SCYNEXIS.com
Steve Wring, Ph.D.
Director, DMPK
Steve.Wring@SCYNEXIS.com www.scynexis.com
Bob Rodebaugh, Ph.D.
Director, Process, GMP & Analytical Chemistry
Robert.Rodebaugh@SCYNEXIS.com
Bryce Chaney, M.B.A.
Market Development Manager, Process & Analytical Chemistry
Bryce.Chaney@SCYNEXIS.com
Terry Marquardt
Executive Director, Market Development
Terry.Marquardt@SCYNEXIS.com
SCYNEXIS Inc.
3501-C Tricenter Blvd
Durham, NC 27713
www.scynexis.com
SCYNEXIS® Proprietary and Confidential Information