Company Introduction

1. Company Introduction

2. THE FRONTAGE ADVANTAGE Attention, Efficiency, and Expertise

3. Who is Frontage Laboratories? • We are an early phase drug development company • Started in 2002 • Currently 225 people • We have grown organically and through acquisition (clinical) • selected as one of the fastest growing companies in the Philadelphia region – 4 years in a row • Facilities in US and China

4. Working with Frontage:Advantage #1 – Expediting your development program • ACCOMPLISH MORE WITH ONE SERVICE SUPPLIER • Frontage has all that you need to move your compound from preclinical development through Phase I – II clinical studies and beyond • API synthesis • Preclinical / ADME Services • Dosage form development • GMP manufacturing • Clinical study execution via 72-bed CRU • Bioanalysis & Biomarker / Immunology • Regulatory filing and support

5. Working with Frontage:Advantage #2 - 100% Attention • WHAT SETS FRONTAGE APART?? • Every project is on the front burner – 100% attention • Communications are easy to manage, coordinated, and routinely scheduled • Our project management leaders each have a minimum 15 years experience in the industry – You receive the best project leadership possible • Cross functional project teams allow for smoother working process and less administration • WE WORK HARD TO MAKE SURE YOUR COMPOUND IS FRONT AND CENTER !!!

6. Working with Frontage:Advantage #3 – Top Scientific Team • YOUR DRUG DEVELOPMENT PROGRAM REQUIRES THE BEST TALENT • Frontage has a significant number of advanced-degree scientists – >60% of our team • Extensive personal experiences in all phases of drug development – from discovery to clinical, from laboratory to commercial launch • Involved in numerous preclinical, first-in-man, late stage clinical, generic and OTC development projects

7. Working with Frontage: Advantage #4 – Frontage US –China Operation • QUALITY • Globally managed, centralized data (all sites WATSON LIMS) • Globally managed Quality System • SCIENCE • Frontage has the best training system in the industry • Management team has international experience • Scientists receive international training, working hands-on at US facilities • Uniform testing platforms and ability to pool resources to ensure best scientific coverage • Established method transfer procedures • LOGISTICS • Continuity of Service is guaranteed by Frontage – if there are any potential shipment issues to China, US laboratory will serve as back-up facility

8. FRONTAGE - BACKGROUND Service Offerings

9. Our Locations

10. Our Clients More than 200 clients around the world: US, EU, JP, China Global top 10, mid-size and virtual pharmaceutical and biotech firms Chinese generic and innovative drug companies Frontage has had successful FDA inspections (10+) and numerous client inspections and audits for both our US and China facilities

11. DMPK Preclinical ServicesOverview • WORLD-RENOWNED LEADERSHIP • Accomplished team of professionals • Thought leaders in drug metabolism - over 100 years of collective experience in DMPK and ADME support and published research • DMPK Services • Support for discovery pharmacokinetic studies • Discovery-stage in-vitro studies metabolism evaluations • Discovery-stage ADME studies • Drug development stage DMPK support and metabolic evaluations • EFFICIENT SYSTEMS • Technical leadership allows for quick completion of studies • Price leadership • Capabilities in US and China

12. Discovery DMPK Services:PK Studies DT Exploratory Discovery Pre-Selection Lead Candidates PK in Pharmacology Model(s) Help with POC, MED exposure In-Life and Non-GLP Bioanalytical • PK/PD Biomarker Assessment • PK in Other Species including Rodents and Non-Rodents(As Needed) • PK in Non-Rodent • Target Tissue Exposure(Total and Free) • High-dose Pharmacology Support • Salt Selection • Linearity Assessment • Renal/Biliary Clearance(As Needed) • Ascending Dose PK Rodent andNon-Rodent • TK and Formulation Support • Additional Species PK • Food Effect • Interspecies Scaling

13. Discovery DMPK Services:In-Vitro DMPK Studies DT Exploratory Discovery Pre-Selection Lead candidates • Metabolite Profiling/ • Structure Elucidation • - metabolic soft spots • - structure optimization • Metabolic Stability • (microsomes / hepatocytes) • Metabolism in human • plateable hepatocytes • Metabolic pathways • elucidated • Cross-species metabolism • (microsomes/hepatocytes) • Identification/isolation of • major human metabolites • Plasma Profiling/ • - pharmacology species • - PK and tox species • (rodents, dogs, monkeys) • Intrinsic Clearance • CYP IC50/MBI • Plasma/Microsomal Protein Binding • Blood/Plasma ratio • CYP Reaction Phenotyping • P-gp Transport/ Inhibition • CYP Induction(PXR/Human Hepatocyte) • Caco-2/MDCK permeability

14. Drug Development Phase DMPK:Metabolite Studies Phase 2 to Post-NDA POC NDA Phase 0 IND Phase 1 SAD & MAD • In vitro metabolism - [14C] compound • Single dose 14C metabolism and mass balance (rodent andnon-rodent) • Multiple dose metabolite profiles from IND enabling studies • Enzyme induction(ex vivo), if needed • Mechanistic studies to support safety assessment(as needed) • Metabolite profiles from SAD/MAD studies • Determination of exposure of major human metabolites in tox species • DDI support and kinetic assessment of metabolite formation [14C] in vitro • Tissue distribution, brain penetration/target tissue uptake • 3H mass balance and tissue distribution • Human [14C] ADME study • Metabolism support of clinical studies (DDI, pediatric, elderly, hepatic/renal, QTc, etc.) • Placental transfer, milk excretion

15. Discovery ADME Studies • Metabolic stability (2 time points) – microsomes / hepatocytes • Intrinsic clearance – microsomes / hepatocytes • In-vitro metabolite identification for structural optimization • Cross-species metabolite profiles across species – microsomes / hepatocytes • CYP-450 inhibition – LC/MS/MS based assays (available May 2010) • CYP reaction phenotyping – cDNA • Plasma protein binding

16. Discovery ADME Studies • Plasma metabolite profiling • Plasma/blood partitioning studies • Isolation and characterization of metabolites • In-Life PK studies (in-life conduct through partners – internal small mammal capabilities available June 2010) • CACO-2 / MDCK permeability studies (available July 2010) • Quantitative LC/MS analysis (non-GLP) from PK studies

17. Development DMPK Studies • Reaction phenotyping (cDNA & chemical inhibition) • Metabolite profiling and identification – Tox/FIH studies • Isolation and characterization of metabolites • Delineation of metabolic pathways • CYP inhibition studies. Definitive IC50 & k1 determinations (April 2010) • CYP induction in livers of rodents, canines & primates (June 2010)

18. Development ADME Studies • Synthesis of metabolites and stable-labeled materials • The Frontage team has specific expertise for development of Metabolites In Safety Testing (MIST) packages. • Identification of metabolites • Quantitation of metabolites • AUC determinations (using non-radiolabeled compounds) • Mass balance studies in rodents – 14C and 3H and tissue distribution studies will come on line second half of this year

19. DMPK Leadership Team • Abdul Mutlib: Twenty years of experience in pharmaceutical industry, • (PhD) DuPont-Merck, Pfizer, Hoechst-Roussel (Aventis), Wyeth • Five years post-doc in academia, 60+ publications, patents • Editoral Board: Chemical Research in Toxicology • Jack Wang: • Jim Burleigh: Experienced technical supervisor with over 25 years of experience • (BS) in conducting ADME studies in laboratory animals • Peter Liu: Experience in developing, validating and implementing complex (MS) LC/MS/MS assays for the quantitation of drugs in biological matrices in a GLP, GLP-like and non-GLP environments. Twenty • years experience in bioanalysis.

20. DMPK Leadership Team

21. DMPK Leadership Team continued:

22. Bioanalytical Services • INDUSTRY - LEADING TECHNICAL CAPABILITIES • Highest ratio of advanced degreed scientists working on the bench • From data management and sample handling to analysis platforms, Frontage has invested in state-of-art technology, including global Watson LIMS system • Streamlined method development - typically completed within 1 week • Analyte stabilization techniques help Frontage to overcome tough technical challenges – prevents degradation of analytes • One of the largest laboratories on the East Coast, USA and China • EFFICIENT PROJECT MANAGEMENT • Global study support • Over 35,000 samples analyzed per month in US and China

23. Bioanalytical Services • LC / MS / MS

24. Bioanalytical Services • GC & LC/MS/MS METHOD DEVELOPMENT & VALIDATION • Demonstrated success in developing methods for compounds requiring high sensitivity measurements (picogram / mL) • Small and large molecule analysis • One of the most proficient labs in US and China – tackling technically challenging projects globally • IMMUNOASSAY DEVELOPMENT & VALIDATION • MSD Electrochemiluminescence Platform • ELISA • Antibody and platform development • BIOMARKER ASSAY DEVELOPMENT & VALIDATION

25. State-of-Art Equipment and Processes • 17 LC/MS/MS systems in USA (10 API 4000, 3 API 5000, 3 4000 API Q-trap, API365), • 6 LC/MS/MS in China (4 API 4000, 1 API 5000, 1 API 4000 Q-trap) • More than 30 HPLC systems • 3 MSD Electro-chemilluminescence Instruments • Watson LIMS system – centralized data for US and China • Tomtec and Tecan Liquid handling systems • Ultrasonic Tissue Processing Equipment • Emergency Power Back up • Monitoring system for storage freezers

26. State-of-Art Equipment and Processes High Throughput Sample Preparation

27. State-of-Art Equipment and Processes Electrochemiluminescence – Large Molecule Analysis

28. State-of-Art Equipment and Processes Covaris Ultrasonic Extractor – Tissue Processing

29. Exton CMC Facilities • Analytical Labs– 8,000 Sq Ft • GMP Analytical Instrumentation • ICH Stability Storage • Formulation Development & GMP Area ( 10,000 Sq Ft) • Solids R&D • Liquids / Creams / Ointments R&D • Potent Compounds suite (GMP) • Solids Dosage Manufacturing (GMP) • Liquids / Creams / Ointments (GMP) • Sterile Compounding (GMP)

30. CMC Services - Analytical • GMP & GLP ANALYTICAL SERVICES • Method Development, Validations and Transfers • HPLC (25 systems), UPLC, GC, LC/MS/MS, GC/MS • ICH Stability Evaluations – over 4,500 cubic feet of storage • Standard and Custom Conditions • Dissolution Testing • Comparator Study Capability with On-line HPLC & UV • Unknown Impurity Identifications • Fraction Collection, Purification, Synthesis, ID by MS & NMR • Finished Product Release Testing & Customer Complaint Investigations – CTM and Commercial Products • Particle Size Analysis and Wet Chemistry

31. Analytical Equipment • 25 HPLC Systems – UV/PDA, CAD, Refractive Index, Fluorescence • Three vendor platforms for ease of method transfer / robustness (Waters, Agilent, Shimadzu) • UPLC Systems – PDA and MS • 3 GC Systems – FID with Headspace • Ion Chromatography (Dionex) • LC/MS/MS and GC/MS - Impurity ID • 10 Dissolution Systems • with on-line HPLC and UV analysis • Particle Size Analysis & Wet Chemistry (KF, Titrations)

32. CMC Services - Stability • Stability Chambers Are Fully Compliant With ICH Guidelines • 7 Walk-in Stability Chambers And 5 Reach-ins With Over 4,500 Total Cubic Feet • Smaller Chambers And Photo stability Chamber For Special Studies • Lab Watch Monitoring System • Emergency Back-up Power Generator for continuous operation

33. CMC Services - Formulations • FORMULATION DEVELOPMENT • Rational Development Processes (CTD / QBR formats) • Pre-formulation characterization and screening • Physicochemical evaluations • Excipient compatibility • Immediate and Controlled Release Development Expertise • Oral Solid Dosage Forms – Immediate and Controlled delivery systems • Sterile – Parenteral, Lyophilized, & Ophthalmic Forms • Creams, Ointments and Gels • Nasal Sprays (including characterization – droplet size, geometry • High Potency Suites • Proof of Concept Studies in Animals via China facilities • Process Optimization and Improvements

34. Clinical Manufacturing • Phase I –II Scale • Full Range of Capabilities • Oral Solids -High Shear, • Encapsulation, Compression, • Tablet Coating, Fluid Bed • Sterile manufacturing • utilizing disposable bag system • Semi Solids • Liquids capabilities to 100 L • High Potency Suites

35. CMC Services • GMP CONTRACT MANUFACTURING – CLINICAL TRIAL MATERIALS • Oral Solid Dosage Forms • API filling in Capsules – Accurate Dosing System • Standard Tablet and Capsule filling • Tablet in Tablet technology (Tri-layer Tablet Press) • Liquid – filled Capsules • Enteric Coating • Sterile Dosage Forms • Aseptically-filled vials using disposable mixing and filling technology • Nasal Sprays • Suspensions • Topical Dosage Forms • Creams, Ointments, Gels • API’s via chemical synthesis

36. CMC Services • API SYNTHESIS AND RESEARCH CHEMISTRY • GMP Synthesis of Small Molecules – up to 5 kg scale • Reference Standard Synthesis • Metabolite Synthesis & Cold Labeling • Impurity Identification and Purification Projects • Process Development & Optimization • Sourcing & Scale-up to Commercial

37. Collaborations • BEIJING PHARMACEUTICALS GROUP • Large Scale, FDA-inspected GMP manufacturing • PIERRE FABRE (FRANCE) • Patented Nanotechnologies for enhancing bioavailability of low permeability / low solubility drugs • Taste masking of bitter API’s • HERAEUS (GERMANY) • Cytotoxic API Manufacturing via chemical synthesis and fermentation • SINCLAIR RESEARCH (MISSOURI) & CALVERT LABORATORIES (PA) • GLP Preclinical research centers • PRECLINICAL RESEARCH CENTERS IN CHINA • Frontage - supervised studies for non-GLP evaluations

38. Biomarkers & Biologics • Frontage Laboratories will provide a full range of technology platforms, flexibility and customization to meet all your Biomarker and Biological Analytical requirements across various stages of preclinical & clinical development • Our collective experience ranges from all phases of drug development • Our team can provide guidance on issues that range from assay development, validation to biomarker, Pharmacokinetics and Immune response analysis • Comprehensive portfolio of technology platforms to accommodate virtually all of your biomarker testing requirements • Flexibility in choosing from assays commercially available or previously developed. We also work with you to develop and validate custom assays • 21CFR Part 11 compliant (adherence to 21 CFR Part 58 GLP)

39. Biomarker and Biologics

40. Immunoanalytical Testing (Ligand-Binding Assays)

41. Specialized Assays & Services

42. Biologics: Assays & Services

43. Biologics: Assays & Services CELL-BASED ASSAYS (PRE-CLINICAL AND CLINICAL) • Potency assay • Cytotoxicity and Proliferation assays • Immune function assays • Flowmetric assays • Tissue processing/staining for IHC • Custom assay development for client needs USA AND CHINA • Frontage provides these services at both facilities • Possible expansion to other countries

44. US Clinical Research Center: Background • Founded in 1994 – 16 year track record of service excellence • 72-bed unit located in Hackensack, New Jersey • On-site, full-time principal investigator with 20 years of emergency medicine experience • Phase 1 and 2a studies • On-site pharmacy (temperature controlled, limited access) for study drug storage, packaging / labeling and retention • Extensive subject database (healthy volunteers / special populations) and dedicated recruiting staff • Local clinical laboratory with 24-hour turn-around • Central IRB (rapid review process)

45. Clinical Research Centers:Phase 1 and 2 Studies • PHASE 1 AND 2A STUDY EXPERIENCE • First-in-human • Pharmacokinetics • Single dose escalation / repeated dose • Absolute and relative bioavailability • Bioequivalence studies (pilot, pivotal, fed, fasted) • Drug-drug interaction (DDI), drug-alcohol and drug-food interaction studies • Oral, injectable, inhaled, intranasal NCEs, peptides, hormones • Thorough QT (TQT) study evaluations • PD assessments / Biomarkers Safety and tolerability assessments

46. Clinical Research Centers:Subject Recruitment • Proactive recruitment planning & execution • Extensive volunteer database (5000+ subjects) • Wide-ranging media options – newspapers and local publications, employment guides, local flyers and postings, radio • Local networking – schools, businesses, health fairs • Dedicated recruiting staff

47. Clinical Research Centers:Proof-of Concept Studies • Proof of concept studies • Cardiovascular – endothelial dysfunction, HTN, early CV disease (Endo-PAT vascular compliance devices) • Metabolic – Type 1 and 2 DM, obesity, metabolic syndrome, dyslipidemias (dietician, on-site Hologic Dexascanner) • Gastroenterology – sigmoidoscopies, colonoscopies, gastroesophageal reflux, irritable bowel syndrome, diarrhea • Women’s health – pre- and postmenopausal women, osteoporosis, hormone replacement, sexual dysfunction • Men’s health – testosterone replacement, osteoporosis, sexual dysfunction • Dermatologic – acne, actinic keratosis, psoriasis • Inflammation – osteoarthritis, rheumatoid arthritis • Ophthalmologic assessments • Cognitive assessments • Excellent access to specialty physicians as needed

48. Clinical Research Centers:Study Time Lines • Rapid IRB submission process (Central IRB) • Study-specific approval typically within 8 business days of submission • Able to begin screening immediately with IRB-approved generic ICF • Dosing within 3 weeks of contract execution • Same-day shipment of plasma samples from CRC to Frontage BioA laboratory • Prompt (within 48 h) report of preliminary PK/BE results

49. Clinical Research Centers:Study Metrics Since 2006, we have performed: • Over 25 bioequivalence studies (pilot and pivotal) • 2-way and 3-way cross-over • Fed and Fasted • Over 700 healthy male/female volunteers enrolled • Enrollment rate >98% • Completion rate >90% • Over 25 Phase 1 studies • Over 1000 healthy male/female volunteers and special populations enrolled • First-in-human, single and multiple dose, bioavailabilty, formulation, DDI, PK, safety/tolerability • Enrollment rate >98% • Completion rate >93%

50. Clinical Services Moving Forward • New US clinic to be constructed • 160-bed state-of-the-art Phase 1 clinic • Northern New Jersey location • Access to public transportation and diverse subject population • Ability to run 3 separate 24/36 subject panels simultaneously • Separate area with hospital beds • Operational 24 hours per day / 7 days per week • On-site pharmacy (storage/preparation/retention) • Flexible site use / expanded recreation & dining areas • Expected to be operational Q2/Q3 2010 • 2009: 120-bed clinic became operational in Zhengzhou, China