CORPORATE OVERVIEW

FULL SERVICE US BASED GLOBAL CRO (973) 934-1171

CORPORATE OVERVIEW

FULLY INTEGRATED GLOBAL CRO

EARLY PHASE & BEYOND

Accomplish more with one service supplier• API Synthesis/Manufacturing • Preclinical / DMPK Services• Dosage Formulation Development • CTM Manufacturing • Clinical Study Execution in US and China• Bioanalysis & Biomarker / Immunology• Regulatory filing, GMP Consulting and Support

TargetDiscovery &Validation

HTSScreening Hits to Leads

LeadOptimization

DrugDevelopment

Candidate(ADMET)

RegistrationPhase I Phase II Phase III

•Expression analysis•In vitro function•In vivo validation•Bioinformatics

•Combinatorial chemistry•Structure-based drug design•In vitro, ex vivo & in vivo screening•HTS screening

•Traditional medicinal chemistry•Rational drug design•In silico drug design

•Medicinal chemistry•Rational drug design- Fast PK evaluation

•Bioavailability•Systemic exposure•Absorbance•Clearance•Distribution

- Safety- GMP Supplies- Regulatory- CMC consult

- Efficacy- GMP Supplies- Regulatory- CMC consult- Tech Transfer- Pharmacology

CommercialLaunch

CORPORATE OVERVIEW

FRONTAGE MILESTONES

20021 employee

2004 2006 2007 2008 2009 2011~250 employees

2010

Launch ofBeijing CMC Center

Launched Shanghai Facility

(Bioanalytical, Analytical Services)

LaunchedDMPK

Operations

AAALAC Certification

Expanded Analytical Services & CTM Mfg moved to Exton, PA

Launched Clinical Service Center in BeijingAcquired ABR CRO

Investment – Clinical Services with

ABR (CRO-1994)

Expanded Operations in Malvern, PA

(Bioanalytical, Analytical, PRD and API/Organic Synthesis)

InitiatedOperations in NJ

2009 Launched Zhengzhou Clinical

Center

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OUR LOCATIONS

4

Two Countries One Quality SystemBeijing, PRC• Clinical Services• Regulatory Affairs• CMC Services(Analytical, CTM Manufacturing, PRD)

Shanghai, PRC• Bioanalytical • Biomarkers• DMPK• Analytical Services

Hospital based Phase I-IIa units 120-beds Zhengzhou University 80-beds The First Teaching Hospital of Jilin University 80- beds at Henan TCM University Hospital - Q3 11 80 - bed at Zhongshan University Hospital - Q1 12

Hackensack, NJ• 72- bed Phase I-IIa Clinic• Late phase clinical studies• Data management/support

Malvern / Exton, PA• Bioanalytical Services• DMPK / Biomarkers• CMC Services

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API / Organic Synthesis

Pharmaceutical Analysis

Formulation Development

Clinical Manufacturing

GMP & CMC Consulting

Bioanalytical

DMPK

Biological / Immuno Assays

Biomarker Assays

CMC Drug Development

GLP

Preclinical/Bioanalytical Clinical

GCP

Clinical Studies Phase I/IIA

Data Analysis

Regulatory Affairs

GMP

Multiple Successful (10+) FDA Inspections

KEY SERVICE AREAS

A FULLY INTEGRATED GLOBAL CRO

•Helping US, EU and Chinese companies to introduce new products to the US marketplace, from IND submissions to NDA / ANDA filings

•Helping US and EU companies to introduce products to China

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CMC SERVICES

API /ORGANIC SYNTHESIS• GMP Synthesis of Small Molecules• Reference Standard Synthesis• Metabolite ID and Synthesis• Impurity Identification and Purification Projects• Process Development & Optimization• Sourcing & Scale-up to Commercial

GMP CONTRACT MANUFACTURING - CLINICAL TRIAL MATERIALS•Oral Solid Dosage Forms

•Sterile Dosage Forms

•Topical Dosage Forms

•API’s via chemical synthesis

PHARMACEUTICAL ANALYSIS• GMP Analytical Services

>200 Method Development/Validation since 2008• Impurity Identification and Characterization

FORMULATION•Pre-formulation characterization/screening• Immediate and Controlled Release Development Expertise

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CLINICAL SERVICES CLINICAL PHARMACOLOGY UNIT

Overview• 16 years of operational experience• Facilities in US and China• Full-time Principle Investigator with

Emergency Medicine background• BLS and ACLS trained staff• Close proximity to major medical center

Types of studies• First in Human

Single &multiple ascending dose• Absolute and Relative BA, fed /fasted BE,

food effect, PK/PD studies• Drug / drug interaction (DDI) and drug / alcohol

interaction studies• Thorough QT (TQT) and other cardiovascular

evaluations (Holter Gateway, etc)

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United StatesOne of the largest Phase I research facilities in the NJ/NY metropolitan area

• 72-bed (hospital-type) facility

China Two SFDA certified hospital-based clinical centers, operated according to US standards

• 120-bed Chinese clinical center on the campus, The First Affiliated Hospital of Zhengzhou University (>4000 beds)

• 80-bed clinical center within The First Teaching Hospital of Jilin University with focus on phase I for oncology drugs (>3000 beds)

Coming this Q3 2011 and Q1 2012 respectively• 80- beds at Henan TCM University Hospital• 80-beds at Zhongshan University Hospital with focus on diabetic disorders and

oncology (>3000 beds)

CLINICAL SERVICES _ GLOBAL FACILITIES

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CLINICAL SERVICES CRO SERVICES FOR PHASE I-IIA TRIALS

• Study Protocol Design• Project Management• Clinical Data Management (Oracle Clinical)• Biostatistical & Pharmacokinetic Analysis• SAS Programming• Medical Writing• Regulatory submissions

• Clinical Study Reports• PK Summaries• IND, IDE, NDA (505b1 and b2), PMA, ANDA

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CLINICAL AND REGULATORY CONSULTING _ CASE STUDIES

Successful completion of the clinical pharmacology and biopharmaceutics sections of an NDA for a pharmaceutical company in Europe • Provided clinical pharmacology and regulatory consulting for a specialized U.S. pharmaceutical company • Contributed to discussions with the FDA review division to waive a TQT study for an NDA • Contributed to the preparation of meeting package and discussions at an EOP2 FDA meeting

Ongoing work with two major Chinese pharmaceutical companies for their respective first NME drug development in the United States • Including consulting for the IND preparation (CMC, Pharmtox and clinical protocols), U.S. FDA interactions from pre-IND meeting, IND filing and clinical development programs

Recent ANDA approval of Amlodipine Besylate for Beijing Second Pharmaceutical Co., Ltd. • Frontage was responsible for CMC development, bioequivalence studies, GMP Consulting, Facility Qualification, Quality System development, and regulatory filing for this ANDA project

Ongoing work with a startup biotech company in U.S. on its first biosimilar drug product indented for FDA submission

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DMPK SERVICES

IN VITRO STUDIES • Metabolic Stability, Protein Binding, MDCK, CYP inhibition

etc

IN VIVO STUDIES (RATS AND MICE) – FAST PK• AAALAC Certified Vivarium• In-life + Bioanalytical Support + PK Report Using WinNonLin)

with a Turnaround time of 5 days after receipt of compound.

MASS BALANCE STUDIES• (C14 and tritium)

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BIOANALYTICAL SERVICES

In 2010• Over 90,000 Samples Analyzed (GLP/Regulated)• Over 80 Methods Developed (GLP/non-GLP)• 80% Repeat Customers

One of the largest laboratories in the East Coast, USA and China

• 28 LC/MS/MS Bioanalytical systems linked to Watson LIMS system

• Industry-leading staff with advanced degrees• GLP and non-GLP Analysis

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BIOANALYTICAL CAPABILITIES

Method Development/Validation and Sample Analysis in Compliance with FDA and GLP Guidance. • Track record of developing and validating difficult, highly sensitive methods • Development of stabilizing procedures for analyte with stability issues for

sample collection• Fast turnaround for preclinical and clinical sample analysis for TK, PK and BE

studies• Biomarker and immunogenicity method development/validations, PK, TK, PD

sample analysis• Integrated Services Between our Phase I Clinic and Bioanalytical labs

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BIOLOGY SERVICES _ Large Molecules

• GLP Labs• Assay Development / Transfer /

Validation• Clinical / Pre-clinical Sample Testing • ADA – Anti Drug Antibody Assays

(Immunogenicity)• PK/TK – Pharmacokinetics Assays• NAB – Neutralizing Antibody Assays• Cell Based Assays• Biomarker Assays

EQUIPMENT LIST• PCR (AB 7900HT-Real Time PCR System)• MSD 6000• Spectramax• Abbott AxSYM System • Packard: Multiprobe II ex robotic liquid handling

system• Tomtec: Quadra-3-SPE • Tecan: Genesis freedom 200 • Watson LIMS Ver. 7.3• BIORAD CHEMI-Doc (quantitation of SDS-PAGE/WB)

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FRONTAGE CHINA INTRODUCTION

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FRONTAGE CHINA _ OVERVIEW

China operations (established 2006): • Shanghai, laboratories• Beijing, clinical services and regulatory affair, CMC center• Zhengzhou, clinical center

China services:• Bioanalytical, DMPK• Product development (formulation and pharmaceutical analysis)• Early and late phase clinical trials, clinical data management and

regulatory affairs

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PEOPLE AND FACILITY

OVER 80 STAFF IN CHINA• Over 70% laboratory staff with advanced degrees (PhD, MD, Master)• All Director levels and above are trained either in the US or EU

EXPERIENCED MANAGEMENT TEAM WITH DIVERSE BACKGROUND • Pfizer, GSK, JNJ, Schering-Plough, etc.

STATE-OF-THE-ART FACILITY AND EQUIPMENT• 6 LC/MS/MS, MSD-6000• 10 HPLC, GC, IR, UV-VIS, dissolution• 5 stability chambers• Tablet press/coater, capsule filler, etc.• Clinical Research Center with over 300 beds

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BIOANALYTICAL/DMPK

SUPPORT DMPK AND TK STUDIES FOR DRUG DISCOVERY, PRE-CLINICAL, CLINICAL AND BIO-EQUIVALENCY (BE) STUDIES

METHOD DEVELOPMENT AND VALIDATION FOLLOWING FDA, OECD, ICH GUIDELINES (2-3 WEEKS); CROSS METHOD TRANSFERRING AND VALIDATION BETWEEN US AND CHINA

ANALYZE SAMPLES IN DIFFERENT BIOLOGICAL MATRICES PLASMA, URINE, BLOOD AND TISSUES

BIOASSAYS TO SUPPORT LARGE MOLECULE DRUG DEVELOPMENT; BIOMARKER FOR DRUG SAFETY AND EFFICACY, DIAGNOSTICS, DISEASE MODELING AND CLINICAL STUDIES

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PHARMACEUTICAL ANALYSIS

SUPPORT DRUG DEVELOPMENT FROM EARLY EXPLORATORY TO FULL DEVELOPMENT STAGES

WORK CLOSELY WITH CLIENT TO DEFINE• Stage oriented method development and validation• Stability testing strategy

ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND TESTING• For API, Drug Product, In-Process control• Experience in small molecules, peptides and proteins

STABILITY STUDY• Qualified stability chambers with 24/7 monitoring

REFERENCE STANDARD QUALIFICATION AND STRUCTURE ELUCIDATION

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FORMULATION DEVELOPMENT

FORMULATION DEVELOPMENT AT ALL STAGES: FROM INITIAL CONCEPT TO COMMERCIALIZATION

• Pre-formulation and formulation for preclinical, clinical, and ANDA studies

VARIOUS DOSAGE FORMS• Solid: tablets, capsules• Liquid: solution, suspension, emulsion for oral and parenteral

administration

RELEASE PROFILE: IMMEDIATE, DELAYED, EXTENDED COATING: FILM, ENTERIC, CONTROLLED RELEASE

cGMP CLINICAL TRIAL MATERIAL MANUFACTURING (SOLID AND STERILE DOSAGE FORMS)

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CLINICAL SERVICES

CLINICAL TRIAL MANAGEMENT UNDER GCP GUIDELINES• Two SFDA certified hospital-based clinical centers, operated according to US standards

• 120-bed Chinese clinical center on the campus, The First Affiliated Hospital of Zhengzhou University (>4000 beds)

• 80-bed clinical center within The First Teaching Hospital of Jilin University with focus on phase I for oncology drugs (>3000 beds)

• Coming this Q3 2011 and Q1 2012 respectively• 80- beds at Henan TCM University Hospital• 80-beds at Zhongshan University Hospital with focus on diabetic disorders and oncology (>3000

beds)

DATA MANAGEMENT AND BIOSTATISTICS• Oracle, SAS programming, ECTD, EDC applications, web-based study tracker Regulator strategy and

filings• Regulatory filings for new drug application • Import product registration (IDL, CPP),drugs, medical devices, diagnostic kits

MEDICAL WRITING, STUDY FEASIBILITY, MARKETING REVIEW• Medical writing• Feasibility and marketing review for foreign products registration for China market

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QUALITY SYSTEM

TWO COUNTRIES, ONE QUALITY SYSTEM WITH CONTINUOUS IMPROVEMENT, WORK UNDER GLP/GMP/GCP/ICH GUIDELINES

ONGOING TRAINING PROGRAM AND INTERNAL AUDIT PROGRAM

CONTROLLED DOCUMENTATION SYSTEM, MATERIAL HANDLING SYSTEM, INSTRUMENT QUALIFICATION/CALIBRATION SYSTEM

SUCCESSFUL INSPECTIONS BY CLIENTS SINCE 2006 (US FDA AUDITED MARLVEN SITE MORE THAN 10 TIMES)

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STRENGTH OF FRONTAGE CHINA

UNIQUE BUSINESS MODEL• Services provided in China are the routine services provided in the US

TWO COUNTRIES ONE SYSTEM• Using same quality system, same SOPs and same management system

CROSS METHOD VALIDATION• Controlled cross validation in support of multicenter clinical studies

FULLY SUPPORTED BY US TEAM

CORPORATE OVERVIEW

Thank YouRoseann Affinito

Business Development Manager – NJ

Phone: (973) 934-1171