29
November 2011

Core Rx Presentation

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Page 1: Core Rx Presentation

November 2011

Page 2: Core Rx Presentation

CoreRx, Inc OverviewOur Core Business

CoreRx, Inc. is a Dosage Form Development company specializing in formulation development, analytical development and clinical/(niche) commercial manufacturing of various dosage forms

• Drug Characterization

• Preformulation

• Formulation Development • Analytical Development

• Clinical Trial Materials/(Niche) commercial Manufacturing

Page 3: Core Rx Presentation

Our Core Focus

• Complete client satisfaction

• Highest quality science

• Consistent and effective communications

• Strong timeline management

• Full attention to client goals at all levels

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Why CoreRx?• People and Expertise

It all boils down to people and trust..

• CommunicationEffective, Scientist-to-Scientist communication is the cornerstone to every CoreRx™ project’s success.

• FlexibilityCoreRx™ scientists, management, and systems ensure flexibility and agility, allowing for direction changes without inflexible systems and bureaucratic hassles.

• SpeedCoreRx™ understands that developing innovative solutions for improved patient care, combined with the bottom line, revenues and profitability, are tied to getting your product on the market as quickly as possible.

• Quality systemsDocumentation, quality, and operational systems are a necessity in a GLP/cGMP environment. Quality & timeliness must go hand in hand.

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Why CoreRx…?

• Oh yes… and Location

Page 6: Core Rx Presentation

Executive/Scientific Team• Todd R. Daviau, Ph.D. President/CEO

– 25+ years of pharmaceutical experience – Vice President of the Analytical for MDS Pharma Services– Nova Pharmaceuticals (Scios Pharmaceuticals)– Guilford Pharmaceuticals

• Brian McMillan, VP - Product Development– 20+ years of experience in pharmaceutical formulation

development– MDS Pharma Services– Bausch and Lomb Pharmaceuticals– Roxane Laboratories

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Executive/Scientific Team

• Mark J. Licarde, VP - Manufacturing– 28+ years in pharmaceutical manufacturing – MDS Pharma Services – Mylan Pharmaceuticals– Bristol Myers Squibb

• Jim Davis, M.S., VP - Analytical Services– 15+ years of analytical chemistry experience– MDS Pharma Services– Bausch and Lomb

Page 8: Core Rx Presentation

History

• Founded in 2006

• Started with 5 employees

• Now at 26 employees

• Grown from 3300 sq. ft. to over 10,000 sq ft.

• New 35,000 sq ft. facility purchased in December 2010 – now undergoing a $5 million facility expansion

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New 2012 CoreRx Facility Overview

• Approximately 35,000 square feet• 19 Manufacturing suites13 cGMP – including 1 for cytotoxic projects6 Non-GMP – formulation development

• Manufacturing capacity – up to ~500kg• Expanded laboratory space:•Formulation Development•cGMP Manufacturing•Stability storage testing•Analytical

•R&D•cGMP

 

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Convenient Location

Tampa, Florida<10 minutes to Tampa Airport (TPA)

cGMP Compliant

FDA/FL DOH Registered

DEA LicensedSchedule II - V

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And In 2012: Convenient Location

Clearwater, Florida~15 minutes to Tampa Airport (TPA)

cGMP Compliant

FDA/FL DOH Registered

DEA LicensedSchedule II - V

Insert new map

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New Location – Facility Layout

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Core Competencies

• Preformulation Services– Drug substance characterization

• Analytical Services– Method Development and Validation

• Formulation Development– Liquids, Semi-solids and Solids

• Manufacturing, Packaging & Labeling– API in Capsule or in Bottle– Liquids, Semi-solids and Solids– Matching Placebo manufacture– Blinding of reference product (over-encapsulation)

• Stability Program Management– ICH or customized stability parameters

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Additional Capabilities

• CoreRx is committed to adding innovation where we see a client need– API in capsule/bottle services

• Xcelodose ®• Quantos®

– Multi-layer tablet (up to 3 layers)• FlexiTab ®

– Liquid in capsule services– Multi-particulate capsules

• CoreRx licensed with DEA– Controlled substances (II – V)

• Overencapsulation services – comparator or “blinding” studies

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Project Management/Logistics

• Project Manager is assigned to manage:– Project planning and Execution– Team leadership with integration of technical– Manage all CoreRx-Client communications

• Project Teams are made up of subject matter experts which represent their respective disciplines:– Project Management/Logistics– Analytical Chemistry– Formulation Development– Manufacturing– Quality Assurance

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Introducing SuiteViewTM…

The first of it’s kind Client Communication System

• Cameras in Formulation & Manufacturing– Real-time video feed– Remote/IP access

• Password controlled– Two way communication

• Reduce travel time/costs

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SERVICES

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Preformulation

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Preformulation CharacterizationSolid and/or Solution Characterization can be Conducted

Utilizing the Following Instrumentation/Procedures:• Thermal evaluation

• DSC, TGA, Hot-stage microscope• FTIR• X-ray Diffraction• Particle size/morphology• Polarized microscopy• Moisture content

• KF, moisture analyzer• Moisture sorption profile• pH solubility • Partition coefficient• Photostability• Intrinsic dissolution

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Analytical Services

Experienced Professionals in Analytical Chemistry• Method Development, Qualification and Validation

• HPLC, uPLC, Dissolution, etc.

• Raw Material Testing (select)• Stability Sample Analysis• Dissolution Testing• Chiral Analysis• Cleaning Analysis/Verification• CMC Technical Packages

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Analytical Services

• Analytical Support for Formulation Development

• Stability and QC Release Testing• API/Reference Standard Characterization• Isolation and Identification of Impurities• Physical Chemistry

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Formulation Services

• Solids• Tablets, Capsules, Modified Release, Coatings

• Semi-Solids• Creams, Gels, Ointments, lotions, etc.

• Dispersed Systems• Emulsions & Suspensions

• Liquids• Oral, Ophthalmic, Parenteral

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Formulation Services

Solid Oral Capabilities• API in Bottle/Capsule• Excipient Compatibility• Oral Drug Delivery

• Tablets, Capsules, Powders, Pellets, Mini-Tablets• Solutions, Suspensions, Emulsions, Powders for Reconstitution

• Solid Dispersions• Lipid Formulation Delivery for Poorly Soluble/Bioavailable

APIs• Multi-Phasic, Extended and/or Delayed Release Drug

Delivery• Highly Potent Compounds

Page 24: Core Rx Presentation

Contract Manufacturing Services

• Manufacturing– API in Capsule/Bottles– Tablets, Capsules, Pellets, Mini-Tablets– Liquid in Capsule

• Solutions, Suspensions, Emulsions

• Over-Encapsulation, Reference Product Blinding

• Packaging & Labeling

• Other Services– Matching Placebo Manufacturing– Technology Transfer

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Faster to Clinic with Xcelodose ® or Quantos®

• Manufacturing– Advanced neat drug dosing directly into capsule or

bottle– Decreases lab to clinic development– Decreases API requirements– Decrease risk of stability– Minimizes API waste

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Stability• ICH Conditions

– 25oC/60%RH, 30oC/65%RH, 40oC/75%RH– Custom conditions also available

• Protocol design• Report generation• Stability software management system

– SLIM

• Sample analysis• Secure storage

Page 27: Core Rx Presentation

Why CoreRx

• Quality First Focus– Numerous audits reinforcing compliance

• Responsiveness– Flexible manufacturing model– Unique project management team structure with client-

centric focus– Cross training program for employees

• Technology– Investment in new equipment and expertise as they

become available

• Expertise– Ability to attract top-level talent with high-level benefits

package

• Reliability– Leveraging our company’s size to your advantage

Page 28: Core Rx Presentation

Choose CoreRx

The projects we work on may change....

 our values won't...

 quality, reliability, value,

integrity

Page 29: Core Rx Presentation

www.corerxpharma.com