presentation jan 2011 new

26
Custom Manufacturing Capabilities for Specialty Chemicals and APIs ChemPacific Business Model: From USA Research to Production in China Some call it the best of both worlds, we call it, The Best of One World.

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ChemPacific Corporation

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Page 1: Presentation Jan 2011 New

Custom Manufacturing Capabilities for

Specialty Chemicals and APIs

ChemPacific Business Model: From USA Research

to Production in China

Some call it the best of both worlds,

we call it, The Best of One World.

Page 2: Presentation Jan 2011 New

A Maryland Corp.---Growth History

1995founded

in

NJ, USA

1999

ChemPacific China

Operation in

HangZhou

1999

Moved to

Baltimore

MD, USA

2002

Baltimore Site

Successful FDA

Inspection

2005

Baltimore Site

Successful FDA

Inspection

2007

3rd Successful FDA

Inspection

10 DMFs

2000-2004

Manufacture

of >

100 custom

products

2008 - 2010

China Operations

FDA Inspected

100 employees

2005

US-China

Quality

Transfer

Page 3: Presentation Jan 2011 New

ChemPacific Offers

R&D- Contract and Custom

Lab Work Done in USA & China

Custom Manufacturing

Process Development and

Scale-Up

Page 4: Presentation Jan 2011 New

R&D Contract and CustomUnique Projects for Hard to Find Molecules

High Levels and Effective Communications with Researchers

CDAs Processed Quickly

Secure Protection of IP

Highly Effective Production Capability with IP Security

FTE Capability in US and/or China

Page 5: Presentation Jan 2011 New

Custom ManufacturingStarting with Customer Process or Just a Structure

We Perform Process Development Beyond the Package Given

Development Work Mainly Done in US

APIs Currently In Production in US (15 DMFs)

Scale-Up to Commercial Quantities in our 100%-Owned China Facility

Low Cost, High quality, reliability and IP Security

Page 6: Presentation Jan 2011 New

Process Research and Development

Novel Synthetic Route Selection

Process Optimization and Scale up

Manufacturing of Specialty Chemicals and APIs

cGMP Synthesis

Kilo-Scale for Clinical Trials

Large-Scale Manufacturing in China

Chemistry Capabilities: Process Research

and Manufacturing

Page 7: Presentation Jan 2011 New

UNIQUE BUSINESS MODEL

From US Research to China Production

US Facility

Process

Research

Small Scale

Production up

to 50kgs

China Facility

Cost Effective

Production/Scale

up to to 100 mt

Page 8: Presentation Jan 2011 New

Leveraging Manufacturing Excellence in China

Raw Material Sourcing Partners

Access to Low Cost Labor and large pool of highly educated talents

Effective Management of IP Security/Position

US Quality and Systems

Management Backgrounds Include Pharma Industry

Exceptional Experience Meeting FDA Regulations

Effective Management of Confidentiality/IP Security

Reputable US-Based Corporation Offering Stability, Consistency

and Reliability

Competitive AdvantageValue to our customers- Low Cost with Superb Product Quality

Page 9: Presentation Jan 2011 New

Specialty Chemicals- R&D & Manufacturing Excellence

A. Staffed R&D Organic and Organometallic expertise

- Organic Synthesis expertise leverages with our pharmaceutical total

synthesis capabilities, strength and experience

- Various Reactor sizes from R&D to kilo-lab and commercial-scale reactors

- Newly added Organometallic expertise to expand our services and product

offering to specialty chemicals industry

- Offering High Quality Products is our major strength and core value

- Speed, Consistency/Reliability and Cost Effectiveness are the value we

provide to our customers

B. Academic Reach and Collaboration

- Collaboration programs with major Universities in the USA and in China

Page 10: Presentation Jan 2011 New

Specialty Chemical Capability- Per-fluorinated Aromatics

A. Per-fluorinated Benzene

B. Per-fluorinated Naphthalene

Octachloro

NaphthaleneOctafluoro Naphthalene

Page 11: Presentation Jan 2011 New

Specialty Chemical Capability- 2-bromo-indene

Functionization of 2-Br-Indene

Br

OH

Br-H2O

p-TSA

Commercial Scale

2-R-Indene2-Br-Indene

Page 12: Presentation Jan 2011 New

ChemPacific Products-

2-Br-Indene2-R-Indene

Requirement- Organometallic Chemistry Expertise

Page 13: Presentation Jan 2011 New

Specialty Chemical Capability- Suzuki Coupling Organics

1. RLi handling capability (Organometallic Chemistry Expertise)

2. Low temperature reaction and handling capabilities

Page 14: Presentation Jan 2011 New

Generic API-Case#1–Pentostatin

NH

NN

N

OH

OOH

OH

DMF No. 18235

Name: Nipent /Pentostatin

•Market: Anti-tumor Pharmaceutical

•Prior API Process: Fermentation

ChemPacific Process: Total Synthesis of 12 steps

US Research-China Production:China: Supply of Advanced Intermediate;

Baltimore: API Manufacture/DMF Submission

Summary:

•ChemPacific Developed the First Chemical Process for API

•ChemPacific Owns the Pentostatin Process Patent

•US-China Synergy Made the Cost Manageable for this

Complex Project

Page 15: Presentation Jan 2011 New

Norepinephrine Bitartrate

Generic API-Case#2-Norepinephrine Bitartrate

Name: Norepinephrine Bitartrate

Market: Anti-Epileptic Pharmaceutical

ChemPacific Process: Improved Process

US Research-China Production:China: Supply of GMP Advanced Intermediate

Baltimore: API Manufacture/ DMF submission

Summary:

•US Sole Producer

•US’s First DMF of the cGMP process

•China’s Low Cost Sourcing Coupled with US Expertise Made

this an Economic Success

Page 16: Presentation Jan 2011 New

China Production-Case#3

Name: 3,4,5-TricarboxylicAcid-

1-Aminobenzene

Market: Specialty Electronic

Material

US Research-China Production:

Baltimore: Process Development

China: 3-step Custom Manufacture

15,000 kg/Y

CO2HHO2C

NH2

CO2H

Page 17: Presentation Jan 2011 New

China Production-Case#4

Name: p-(4-Formylcyclohexyl) Benzonitrile

Market: Specialty Electronic Material

US Research-China Production:

Baltimore: Process Development

China: 5-step Reaction Sequence for Single

Customer

R

O

OH

CN

200 kg

Page 18: Presentation Jan 2011 New

China Production-Case#5Name: 2,3-Difluorophenylacetic Acid

Market: Specialty Electronic Material

US Research-China Production:

Baltimore: Process Development

China: 3-step Reaction Sequence for a

Single Customer

F

F OH

O

F

F F

1000 kg

Page 19: Presentation Jan 2011 New

Baltimore, USA OperationFDA Inspected Lab & Kilo-Scale Production

Total Staff of 35 including 12 Ph.D s

North America Technical Center

Global Headquarters

Page 20: Presentation Jan 2011 New

• 12,000 square foot laboratory space

• 50 L Glass reaction vessel

• 2 L Parr reactors, pressure vessels up to 2000 PSI

• Example of Analytical Instruments

» GC

» GC-MS

» IR, UV/VIS

» NMR

» Polarimeter

» HPLC

» LC-MS

» Prep HPLC

Facilities and Equipment

--R & D Lab Baltimore, MD

Page 21: Presentation Jan 2011 New

China OperationZhejiang ChemPacific at Zhapu

100% Subsidiary of US ChemPacific

Over 100 Employees

Page 22: Presentation Jan 2011 New

Facilities and Equipment Zhapu, China Manufacturing

Plant

ChemPacific Zhapu (2005)

Located in a Modern Industrial Park

11 Acre Site (Expandable to 18 Acres)

Capable of Handling Complex Projects

Multi-Purpose Equipment Up to 5000 L

-78°C Reactor (300 L)

Up to 1000 PSI H2 reactor (300 L)

High Vacuum/Thin Film Distillation

Large-Scale Column Chromatography

Up to 100 MT scale

Page 23: Presentation Jan 2011 New
Page 24: Presentation Jan 2011 New

Management TeamRebecca Chiu

CEO/President/QA

MS Pfizer

Novartis

Chen Zhou

COO/US Op

Ph.D. U. Of Maine

Tony Liang

VP/US Op/China Op

MBA

MS

Novartis

Warren Wang

Senior Director

Global QC/QA

Ph.D. Shire

Pharmaceuticals

James Havlin

VP/Sales

MBA E. Kodak

Mallinckrodt

Peter Wu

Dir. QC

Ph.D. UMBC

Maureen Zhang

Sales Manager

MBA Copeland Refrigeration

Emerson Electric

Page 25: Presentation Jan 2011 New

SUMMARY

Low-Cost Manufacturing in ChinaRaw Material Sourcing with Controls

Efficient Asset Infrastructure

Continued Low-Cost Labor Structure

US-Based Corporate Quality & Systems

IP Security and FDA/cGMP Experience

Proven Track RecordOver 1000 Lab-Scale Projects and Over 100 Large-Scale Projects PerformedSeamless Technology TransfersCapable of Total Product Development

Page 26: Presentation Jan 2011 New

Some call it the best of both worlds;

we call it, The Best of One World.

CHEMPACIFIC

6200 Freeport Centre

Baltimore, MD 21224

PH 410.633.5771

FX 410.633.5808

www.chempacific.com