Xcelience Overview 2013

We are all in the business of improving the quality of human lives.

Each of us is joined in the commitment to reach critical milestones faster, deliver

clinical materials on time, control costs, and above all to ensure quality.

At Xcelience, we commit to hold ourselves to ever-increasing high standards of quality,

service performance, and drug development expertise that in turn enable our clients to

overcome drug development challenges and improve chances for compound success.

We are early drug development made easy – at last.

Core Principles

Xcelience is a premier provider of preformulation, analytical, formulation development, manufacturing and

clinical packaging solutions with an established reputation for accelerating project timelines.

Top 10 CMO in 20122012 Regulatory Recognition

1997

Established as Tricon

1998

Acquired by Top 6 Global CRO

2008

CEO Finalist for E&Y 2008 Entrepreneur of the Year

Tampa Chamber of Commerce Small Business Award Finalist

2006

Xcelience Formed by MBO

2007

Purchased Grace Street for Expansion

2009

Tampa Chamber of Commerce Small Business Award Finalist (2nd Year)

2010

CEO Cancer Gold Standard Accreditation

2011

4 Phase Facility Expansion

Company History

2012

Grace Street Expansion Completed for Expanded Clinical Supplies

Convenient Location

cGMP Compliant Tampa, Florida Location

• Laurel Facility (24,000 ft2)

• Grace Facility (24,000 ft2)

FDA Inspected

• 2008, December (PAI)

• 2006, June (General Systems)

• 2003, August (General Systems)

DEA Schedule License

• I to V Analytical–DEA Inspected 2012, January

• II to V Manufacturing–DEA Inspected 2010, January

• I to V Analytical–DEA Inspected 2009, December

Florida Dept. of Health Audit

• State of Florida Inspected 2010, September

European Union Requirements

• Multiple Qualified Person (QP) Audits

Core Competencies

Preformulation Services> Polymorph Screening, Salt Selection,

Drug Product Characterization

Analytical Services

> Method Development and Validation,

Waters and Agilent Instrumentation

Formulation Development

> Solids, Semi-solids, Oral Liquids

Manufacturing, Packaging and Labeling> Solids, Semi-solids, Oral Liquids> Direct Fill API into Capsules> Matching placebo formulation> Blinded reference product> Bottling or Blister Packaging

Stability Program Management

Broad variety of temperature and humidity

conditions

Preformulation Services

Solid and Solution Characterization Drug substance characterization can be conducted using the

following equipment (tests):– Thermal evaluation (DSC, TGA and/or Hot Stage)– Particle Size– FTIR– XRD– Morphology analysis (polarized microscope)– pKa determination (calculated or experimental)– log P / log D determination– Moisture content (Karl Fischer)– Moisture sorption profile (VSA)– pH solubility profiles– Solubility studies (visual, HPLC and/or UV)

Analytical Services

Method Development, Qualification, and Validation

Technical Packages for Drug Substances

HPLC/Dissolution Testing Residual Solvent Analysis

Raw Material Testing

Stability Sample Analysis

Chiral Determination

Cleaning Evaluations

Stability Program Mgmt and

Sample Analysis

Analytical Instrumentation

• Equipment– HPLC: 30 instruments, Waters and Agilent– UPLC: 2– GC w/ Headspace – Dissolution Stations w/ autosamplers: 9 instruments,

Vankel and Distek (apparatus 1 & 2 - bath and bathless)

– UV/Vis

– FTIR– Karl Fischer: Coulometric and Volumetric– Brookfield Viscometer

Formulation Services

Solids> Tablets, capsules, sustained release, coatings

Semi-Solids> Ointments, creams/emulsions, gels

Dispersed Systems> SEDDS/SMEDDS, suspensions

Liquids> Orals> Parenterals (tox only)

Formulation Development for Poorly Soluble Compounds

Conventional Formulations/Processes

Use water soluble excipients Micronize the API pH modifiers

> citric acid, succinic acid etc Solubilizing/wetting agents

> sodium laurel sulfate, Tween 80

Alternate Processing

Add drug to aqueous granulating solution containing wetting/solubilizing agent

Dissolve API in hydroalcoholic/ alcoholic granulating solution

> May alter API characteristics

Form Solid dispersion/solution in hot melt process using CFS1200™

Complexing agents (Cyclodextrins)

Liquid fill hard gelatin capsule

Manufacturing

Manufacturing

> Tablets and capsules• Sustained release• Coatings

> API in a capsule

> Liquids in a capsule• Suspensions• Emulsions

> Semi-solids

> Non-sterile liquid

Reference Product Blinding

Packaging and Labeling

Additional Expertise> Creation of matching placebo

formulation

> Creation and qualification of

blinded reference product

> Process qualification

> Technology transfer

> Process definition optimization

Partnering Advantage

Partnering with Xcelience can reduce product risk and accelerate timelines for

early phase drug development

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16API Characterization 1 2 3 4 5 6 7 8 9 10 11 12Analytical - API Method Evaluation / Dev 1 1 2 3 4 5 6 7 8Analytical - DP Evaluation / Method Dev 1 2 3 4 5 6 7 8Feasibility Study - Capsule Compatibility 1 2 3 4Create and Approve GMP Batch Records 1Manufacture GMP Batches 1 2Release Testing of GMP Material 1 2Initiate ICH Stability Study 1

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29API Characterization 1 2 3 4 5 6 7 8 9 10 11 12Exipient Compatibility 1 2 3 4 5 6 7 8 9 10 11 12 13 14Formulation Development / Selection 1 2 3 4 5 6 7 8Analytical - DP Evaluation / Method Dev 1 2 3 4 5 6 7 8Prototype Stability 1 2 3 4 5 6 7 8 9 10 11 12Create /Approve GMP Batch Records 1Manufacture of GMP Batches 1 2Release Testing of GMP Material 1 2Initiate ICH Stability Study 1

Week

Week

API in Capsule

Traditional Formulation

13 Weeks

Accelerate Timelines. Conserve API. Minimize Downstream Problems.

Market Leadership

Powder-in-Capsule> Faster time to FIH studies> Market leading experience

> 100 APIs, >130 batches

> Defined programs, proven results API into capsule projects are on average

completed 45% faster than traditional formulation development efforts, shave 13-17 weeks from total development time

> Greater global capacity Three dedicated Xcelodose® systems 3 NA, 1 EU Xcelodose® systems in the experimental

area enable clients to use laboratory grade material for dispensing head selection, filling process evaluation, capsule compatibility, or to fill powder into capsule (PIC) for preclinical studies.

Stability

• ICH conditions

• Protocol design

• Report generation

• Stability software management system

• Sample analysis

• Secure storage area

Enhanced Expertise, Improved Production Times

Expanded Roller Compaction Capabilities> Micromeritics AccuPyc II 1340 Gas Pycnometer> Micromeritics GeoPyc 1360 Envelope and T.A.P. Density Analyzer

Expanded Encapsulation Capabilities> MG Futura – capsule filling for powder and pellets> LCI multi-granulator MG-55 (extruder)> QJ-230T marumerizer (spheronizer)> Wurster insert (bottom spray) for Glatt GPCG-3 fluid bed processor

New Fully-Automated Packaging Line (including ink-jet coding)> For primary bottling of tablets and capsules

Clinical Packaging Services

Primary packaging Filling of API into bottles (AIB) Filling of API into capsules (AIC) Powder filling into sachet/pouch Blister packaging including cold form aluminum blisters Card/wallet sealing Bottle packaging

Labeling and assembly services Multi-language booklet labeling Open label / double blind labeling, disclosure envelopes Randomization services Patient kit assembly

Warehousing and distribution cGMP warehousing of clinical supplies Storage and handling of schedule II-V products Global site distribution and tracking

Package engineering and design Tooling, card/wallet (CR) and patient kits

Global procurement of comparator medications Supported with product pedigree documents

Four Phase Facility Expansion

Phase 1: Laurel Expansion – Complete> Expands formulation development capacity, Increases speed

Phase 2: Laurel Expansion – Complete> Expands analytical and formulation development capacity,

Increases speed> Expands manufacturing and packaging capabilities

Phase 3: Laurel Expansion – Complete> Renovation and expansion of the existing cGMP

manufacturing/packaging area

Phase 4: Grace Facility Expansion – Complete> Purpose-built expansion of new primary and secondary clinical

packaging facility

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Unique Advantage

Market Leading Expertise

Performance Culture

Sound Management

Recognized formulation development expertise

Proven expertise with low dose formulations

Streamlined equipment from experimental to GMP

API sparing strategies minimize waste

Scheduling flexibility, FTE programs

Disciplined project management

No double-booking, 99% on-time completion record

Quality systems ensure safe handling of cytotoxic / potent compounds

Conservative financial management

Diversified client mix

Minimal employee turnover, retained project knowledge

Ability to attract and retain top talent

Choose Xcelience

Quality-First Focus. Expertise. Flexibility.

Partnership

Thank you!

For more information please contact:

Sharon BurgessEmail: sharon.burgess@xcelience.comPhone: 603-226-4060Cell: 603-731-3691Fax: 603-415-3330