Rising to the Pharma Challenge

Introduction to CPS

(Custom Pharmaceutical Services)

For LinkedIn

Christian Jones

European Sales & Business Development Manager

30-Aug-11 1

Corporate Overview

Custom Pharmaceutical Services (CPS) Overview

API – Development Capabilities

API – Commercial Manufacturing

Dosage Form Capabilities

Project Execution

Content

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Corporate Overview

Purpose: “Providing affordable and innovative medicines for healthier lives” Strategy: Leverage industry-leading science & technology, product offering, and customer service with execution excellence to provide affordable and innovative medicines for healthier lives.

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$1.7 BN

Size Business Mix

Product Portfolio

Infra structure

Business Mix

•Pharma Services & Active Ingredients contributing 1/3rd of revenues

•Global Generics contributing balance 2/3rd

•Proprietary products business in incubation mode

Size

•FY11 ~ $1.7 Billion in revenues

Product Portfolio

•100+ APIs, 150+ Finished Dosages

•2 biosimilars launched in India

•69 ANDAs pending approval

•200+ DMFs filed globally

•8 biosimilars in development

•Over 200 projects under development

People & Infrastructure

•14,000+ employees; ~ 2,000 in in international workforce

•20 Billion units in finished dosage manufacturing capacities

•16 manufacturing facilities (9 Chemicals, 6 Finished Dosages & 1 Biologics)

Dr. Reddy’s Today

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Our Businesses

Pharmaceutical Services and Active Ingredients

• Active Pharmaceutical Ingredients

• Custom Pharmaceutical Services (CPS)

Global

Generics

• NA

• EU (Germany, UK)

• India, Russia, Ukraine/CIS & Venezuela

Proprietary Products

• Biologics

• Specialty Pharmaceuticals

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Built the foundations for a strong business. Moved up the value chain. Strengthened capabilities.

Achieved scale and global presence. Growth aided by acquisitions.

The Last Decade: Achieved Scale and Global Presence

183 234

338 380

463 447

546

1,510

1,250

1,365

1,563

1,700

0

200

400

600

800

1000

1200

1400

1600

1800

FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 FY08 FY09 FY10 FY11

FY00 FY02 FY04 FY06 FY08 FY10

37 50

121 94

75

26

68

379

243

285 351 369

EBITDA ($ Mn)

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Strong Product Development Platform

Strong and Growing Pipeline

Segment Pipeline

Total Filings

Pending ANDAs

126 (including partnered ANDAs)

69 (including partnered ANDAs)

US DMFs

EU DMFs

176

78

European Products

(pending registration)

>60

Dossiers

(Rest Of the World)

150+ pending registration

Specialty (US

Dermatology)

3 ready to market products +

several others in development

Biologics 8 in development

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Track Record 2010 Agreement for acquisition of GSK’s Penicillin Facility (USA)

2009 Partnership deal with GSK in emerging markets

2008 Acquisition of BASF facility at Shreveport, US

2008 Aquisiton of Dowpharma Small Molecules business associated with Dow’s Mirfield and Cambridge, UK Sites

2007 World’s first biosimilar monoclonal anti-body ,Reditux (rituximab) launched

2007 Fastest Indian Pharma Company to cross $1billion in annual revenue

2006 1st Indian manufacturing company to be Sarbanes-Oxley certified

2006 1st authorized generic deal with multinational pharma

2006 Key acquisition betapharm (Germany)

2005 Key acquisition “Falcon” (Mexico)

2001 1st Indian pharma company to be listed on the New York Stock Exchange

1997 1st Indian company to out-license an NCE to a multinational pharma

1993

1997

2001

2005

2006

2007

2008

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Care for Environment and Society

• Customer: FDA approved, Product safety (Pharmcovigilance) • Suppliers: Vikreta- B2B portal,GBS • Corporate Governance

Core Purpose

Business Operations

Communities

Society • Dr.Reddy’s Foundation – Livelihoods & Education

• Patient Assistance Programs & DRHFE

• Employee Engagement- Volunteer Program & Power of Ten

• Employees: Policies / Talent Mgmt Board / Leadership dev/ BPE

To help people lead healthier lives through Access & Affordability

• Environment: ISO 14001 & OHSAS 18001certified facilities;

Zero Liquid Discharge & SHE technologies

• Community Development– Health/Education/Livelihoods/Employability

Triple Bottom Line Approach…

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Achievements

Dun & Bradstreet American Express Corporate Awards 2007

Best Corporate Social Responsibility Initiative 2007 BSE - India

Pharma Excellence Awards 2006-07 for sustained Growth The Indian Express

Asia-Pacific HRM Congress 2007 Global HR Excellence Award for Innovative HR Practices

Aon-Hewitt 25 best Employers in India 2011 Business Leader in the Pharmaceutical Sector

Forbes 2010 Asia Fab 50 companies 2011 First time featured on the list

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Overview – Custom Pharmaceutical Services

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Background

39%

One of the largest Custom Pharma businesses from India

End-to-end capabilities

Discovery

Chemistry

Clinical

Development

Commercial

Launch

Process

Development

Process

Development

Kilolab quantities

Intermediates

APIs &

Dosage Supplies for clinical trials

Intermediates

APIs &

Commercial drug product

3 dedicated R&D facilities (2 in Hyderabad

and 1 in Cambridge)

Broad Client Base:

Large Pharma – 10+

Mid Sized Pharma – 5+

Emerging Pharma and Biotech – 30+

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Custom Pharmaceutical Services

To be the preferred supplier of APIs, Intermediates and

Formulations to ‘Innovators’ worldwide

Delivering cost-effective and cGMP compliant products and services

Managing intellectual property consistent with Global standards

Emphasizing safety, health and environment

Speed

Competitive Pricing

cGMP

Innovation

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Technology Development Centre commissioned

Acquired Roche’s Facility in Mexico.

70 110

800

Focus on API Development and scale up

Integrated offer of services with Dosage Form Development and Supplies

Offer contract Development & Manufacture of Niche API’s (High Potent - Cytotoxic, Hormonal etc)

Manpower

Services

Initiated contracts with Big Pharma Business

Expanded customer base to about 30 with several repeat business

History

Acquired Dow Pharma’s technology platforms and facility in the UK, BASF Dosage site in the US.

950

Offer niche technology solutions in complex Chiral molecules, PEG’s, Peptides, prostaglandins, carbohydrates

2003 2004 2005 2006-7 2008-10

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Custom Pharmaceutical Services

North America

Europe

Sales & Marketing

Manufacturing

Technology Dev. Centers

Asia Pacific

Pilot Plant

R&D

Chemical Plants

Hyderabad, India

Cambridge, UK

Hyderabad, India

Mirfield, UK

Hyderabad, India

Cuernavaca, Mexico

Mirfield, UK

Formulation Plants

Hyderabad, India

Custom Pharmaceutical Services A Global Organization

Louisiana, USA

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CPS Value Proposition

Technology: ► Chiral Capabilities – Chemo and Bio Catalysis ► PEGylation Technology ► Continuous Processing ► Steroid and HPAI capabilities ► Carbohydrate Chemistry (Ex.Fondaparinux) ► Traditional Chemistry ► Peptide, Prostaglandins & Oligo building blocks

Manufacturing & Security of Supply: ► Extensive, flexible capacity ► Geographical versatility -India/UK/Mexico ► Large portfolio of DMF’s available off the shelf ► More than 100 tech transfers of Innovator projects ► Competent technical staff ► Dedicated project management teams through

product life cycle

Cost-effective: ► Geographic advantage ► Fit-to-purpose scale of production ► Global supply chain

Track Record & Quality: ► Large base of customers with several repeat business ► High quality products and services ► Corporate philosophy supports global markets ► cGMP compliant, USFDA inspected facilities ► ISO 27001 certification (IP and Documentation standard)

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API – Product Development Capabilities

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Technology Development Center (Hyderabad, IN)

Dedicated R&D facility for CPS with ~300 chemists and engineers

Kilo Lab / Pilot Plant with about 10,000 sq ft

Class 100,000 clean room

Discovery Chemistry & Process R&D

21 Chemistry Labs

5 Analytical Labs

Class 100, 000 Cytotoxic suite

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Analytical Capabilities

Method development and validation

Impurity profile: Established expertise in isolation, identification and

characterization

Certified, qualified and validated equipment: DSC/TG, GC/LC-MS, LC-MS-

MS, powder XRD, single crystal XRD, NMR, LC-NMR, FT-IR, CHN analyzer

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Chemocatalysis • Technologies with utility in large scale manufacturing • World leader in asymmetric hydrogenation • Other capabilities for fine chemical applications such as

• Achiral • Asymmetric hydro-formylation

Biocatalysis • Discovery and development of Industrial biocatalysts and their application in bio-catalytic manufacture of fine chemical intermediates • In-house culture collection of more than 2000 microorganisms in 96 well plate format

Complex Synthesis • Have experience of more than 120 customer projects over the last 12 years • Capability to develop efficient processes to manufacture complex target molecules including

• Sugars • Prostoglandin analogues • Oxa-prostoglandins

Technology Development Center (Cambridge, UK)

Mirfield

Cambridge

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Activated PEG Offering

► mPEG-X

–Linear architecture

–Molecular Weights: 5, 10, 20, 30, 40, 60 kDa

–Narrow polydispersity

–Low levels of difunctional PEG: < 1-5% depending on MW

► Functional Groups

–p-nitrophenyl carbonate

–propionaldehyde

–Maleimide

–Amine

► Custom PEGs

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API – Commercial Manufacturing Capabilities

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API Production Facilities - India

Six commercial production units – All inspected by USFDA

Six Pilot Plants, Two Kilo Labs

Over 2 million liters of reaction volume

Over 500 GL and SS reactors that can handle temperature range

of –75 to 300 oC

Operations fully integrated through SAP

and global supply chain practices

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Highly Potent API Production Blocks - India

Contained Blocks 1&2:

► Fully contained cGMP compliant facility

► Range of reactor capacity – 63 L to 630 L, 250 L to 2000 L

► Occupational Exposure Limits (OEL) 0.2µg/m3 for 8 h TWA

► Containment practiced through Air Handling, Pressure Zoning, Isolators

and Personal Protective Equipment

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API Manufacturing Network: India

Miryalguda

Hyderabad

Vizag

CTO I – 1985

CTO II – 1986

CTO III – 1995

CTO IV – 1984 CTO V – 1987

CTO VI – 1990

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Regulatory Experience

Type Number

USDMF 176

EDMF 78

CEP 22

Canada 51

Japan 18

Korea 23

China 14

Turkey 12

Singapore 5

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USFDA Inspections

Unit Date

Unit IV November 1987

Unit IV March 1996

Unit V March 1997

Unit I & IV June 1999

Unit II, III & VI February 2000

Unit V November 2000

Unit IV November 2002

Unit Date

Unit II & III March 2003

Unit VI May 2004

Unit V March 2005

Unit I & II

Nov 2005

Unit III & IV March 2007

Unit VI April 2008

Unit I & Unit 5 Feb 2009

Unit III September 2010

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API Production Facilities – Cuernavaca, Mexico

Mexico City

Cuernavaca

USA

Guatemala

Belize

Toluca

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Quality Centre

Production

Utilities

Warehouses

Tank Farm Incinerator

Main Offices

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API Production Facilities – Cuernavaca, Mexico

Installed production capacity : 3350 MT

7 Reactor Bays with reactor volume ranging from 100L to 20KL

1000L and 3000L Cryogenic reactors capable of -110 oC

20 Steroidal API’s and several Steroid Intermediates currently produced

Unit audited by FDA

125 Multi-disciplinary professionals

• 25 post-graduates (Ph.D. and Masters)

• 100 graduates (chemists, engineers, accountants)

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Product Lines - Mexico Facility

Naproxen:

• 32 Years of experience in producing Naproxen

• Installed capacities: Naproxen & Naproxen Sodium – 1000+ TPA History of

Supplying of Naproxen globally including USA, EU and Japan

• Inspected & approved by USFDA

Steroids:

• Expertise in development of NCE steroids

• Dedicated, refurbished bay at a cost of ~ $29 M

• 3 Flexible manufacturing trains

• Containment for Offloading & Milling

• Class 100,000

• More than 20 DMF’s,

80% on exclusive basis on behalf of customers 31

Dosage Form Capabilities

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• Preformulation

• Analytical and Bioanalytical Development

• Formulation Development

• Pilot Scale-up

• Clinical Trial (CT) Supplies Manufacturing

• Commercial Scale Contract Manufacturing

Analytical Development

Preformulation Development

Formulation Development

CT Manufacturing

Commercial Manufacturing

Preclinical Clinical Supply Market Launch

Seamless Formulation Services Covering the Entire Product Development Chain

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NCE Product Development - Capabilities

Preformulation Studies: Solution stability studies

Chemical Physical properties

Solid-state characterization

Solubility and reactivity and forced degradation studies

Formulation Development; Formulation development for safety assessment studies

Prototype formulations for clinical evaluation

Process development

Formulations for comparator studies

Commercial formulation development

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NCE Product Development - Capabilities

Clinical Trials Supplies Manufacturing and Packaging: Process optimisation, scale-up and technology transfer

Clinical trials supplies manufacturing and release testing

NDA stability and registration batches

CMC documentation for IND submission

Analytical Development: Method development and validation

Cleaning method development and validation

Dissolution and drug release profiling

Forced degradation studies

Specification development

Stability studies per ICH guidelines

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Clinical Trial (CT) Supplies Manufacturing

cGMP Manufacturing of CT supplies for Phase I, II and III.

Scales of 1/100, 1/10 and 1 in similar equipment.

Seamless scale-up and technology transfer to commercial site.

Drug product supplies for comparator trials (DB encapsulation).

Packaging for clinical studies, comparator trials and commercial supplies.

IND and NDA support documentation.

Experienced Product Development teams

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Product Registration Support

Support Includes:

Manufacturing, packaging and release testing of registration

batches

Stability studies per ICH guidelines and monitoring

Process validation plan, protocol and validation reports

Documentation:

• CMC for IND and NDA

• Technical reports

Experienced PAI teams

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NCE Product Development - Experience

Rapid prototyping for “quick” first time in human (FTIH) studies

Clinical product development integrating formula, process and analytical development minimizing costly reformulation

o Solubilization Technology;

Nanoparticulate Formulations

Cyclodextrin-based Formulations

o Injectables:

Small volume parenterals

Lyophilization

o Cytotoxic Product Development;

IV

Oral

o CMC for Regulatory Submission

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Product Development Capabilities

New Drug Delivery Systems

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Apart from standard oral solid dose formulations, specialized

technology platforms and IP have been developed to target:

Delivery of drugs with tailored release profile

Combination product with multiple incompatible DS

Combination product with sequential release

Solubility, dissolution and bioavailability

enhancement

Taste masking and stabilization

Drug Delivery Technologies

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Novel Drug Delivery Systems (NDDS) - Capabilities

• Explore drug delivery approaches for life cycle management

(LCM) to enhance therapeutic outcome and improve patient

compliance.

• Delivery System Based:

• Gastro-Retentive Systems

• Colon Specific Drug Delivery systems

• Small Drug particles

• Solid-Lipid particles

• Orally Disintegrating Tablets

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Technologies practiced at Dr Reddy’s…..

Pellets/ beads

Gastro-retentive

Zein Coating

Muco-adhesive

Combination product

Liquid API in solid dosage form

Nanotechnology

Cyclodextrin Complexes

ODT

Ion exchange resins

Ultra sound particle sizing

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Dosage Forms Commercial Manufacturing Sites

Hyderabad Vyzag

Yanam

• FTO 1 - Bollaram, Hyderabad

• FTO 2 - Bachupalli, Hyderabad

• FTO 3 - Bachupalli, Hyderabad including R/D and pilot plant

• FTO 4 - Yanam

• FTO 5 - Recently divested

• FTO 6 - Baddi (started up April 1 2006)

• FTO 7 - Vishakapatanam ~800km from

Hyderabad (Vyzag)

Baddi

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Main site for the development and manufacturing of standard oral dosage forms and specialized dosage forms

Modular concept - All batches follow linear

flow movement and one product at a time

Total of 11 modular manufacturing suites: •9 Modules for Tablet Manufacturing ~ 4’750 mn units/year

•2 Modules for Hard Gelatin Capsules Manufacturing ~ 650 mn units/year

•3 Pilot Plants (10 suites + 2 pkg)

Integrated development services

FTO-3 Capabilities

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Processes and Equipments: Fully aligned from Laboratory to Pilot Scale

100 mL – 5 Ltr / hrBuchi / HemrajSpray DryerSpray Drying

200 – 2000 vialsVertisLyophilizerLyophilization

5 K/hr – 40 K/hrPAMTamp Filling MachineCapsule Filling

1 Ltr – 125 LtrGlattFluid Bed (Wurster)

Coater

500 g – 30 kg / lotGansonsSide Vented PansCoatings (Tablets

and Pellets)

150 g – 35 kgGlattDrug Layering

1 kg – 2.5 kgFuji PaudelSpheroidizer

1 kg/hr – 20 kg/hrFuji PaudelExtruderPelletization

8 – 20 StationCadmachRotary Compression

PressCompression

1 Ltr – 425 LtrAdamsDouble Cone and

OctagonalBlending

1 Ltr – 125 LtrGlattFluid Bed

100 mL – 250 LtrKevinHigh ShearGranulation

100 mL – 2 LtrNetzsch

Labstar

Bead MillSolubilization

CapacityMakeEquipmentProcess

100 mL – 5 Ltr / hrBuchi / HemrajSpray DryerSpray Drying

200 – 2000 vialsVertisLyophilizerLyophilization

5 K/hr – 40 K/hrPAMTamp Filling MachineCapsule Filling

1 Ltr – 125 LtrGlattFluid Bed (Wurster)

Coater

500 g – 30 kg / lotGansonsSide Vented PansCoatings (Tablets

and Pellets)

150 g – 35 kgGlattDrug Layering

1 kg – 2.5 kgFuji PaudelSpheroidizer

1 kg/hr – 20 kg/hrFuji PaudelExtruderPelletization

8 – 20 StationCadmachRotary Compression

PressCompression

1 Ltr – 425 LtrAdamsDouble Cone and

OctagonalBlending

1 Ltr – 125 LtrGlattFluid Bed

100 mL – 250 LtrKevinHigh ShearGranulation

100 mL – 2 LtrNetzsch

Labstar

Bead MillSolubilization

CapacityMakeEquipmentProcess

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Different batch sizes (20 kg – 1800 kg)

Granulation (low and high shear, FBP)

Aqueous-based

Solvent-based (x-proof)

Blending (60 L to 5000 L)

Compression: Sejong, Cadmach, Manesty (8 – 75

stations), bi-layer- tablets

Coating: Accela-cota equivalent (24’’ up to 66” from

15 kg – 450 kg)

Fluidized Bed Coating (125 to 500 Liters)

Aqueous coating (Functional and non-functional

coating)

Organic solvent-based coatings

Granulation, Blending and Tablet Manufacturing Capabilities

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• Different Batch Size

• Bead Manufacturing (Pelletization or non

pareil seeds, dry powder loading).

• Fluid Bed Drying (15 kg – 300 kg)

• Blending (60 L – 5000 L)

• Coating (24’’ up to 66” from 15 kg – 450 kg)

• Encapsulation tamping and dosator - from

40 K/hour up to 120 K/hour

Capsule Manufacturing

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Conversion of dosage forms to finished packs of

HDPE Bottles, Blisters (PVC/Alu, PVC-PVdC/Alu,

Alu-Alu, including cold form, PVC/ACLAR or

Aluminium Pouches

Total of 10 Lines

4 Bottle Lines

6 Blister-cartonators

Dosage Forms Primary Packaging

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Automated equipment designed and constructed as

per cGMP requirements

BossPack (Aus), Swiftpack(UK), Countec (Korea)

BQS, BP-602, Cartonator (IMA)

Dosage Form Secondary Packaging Capabilities

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Highly Potent Formulation Facility

• Will comply with USFDA and MHRA requirements

• Containment practiced through Air Handling, Pressure Zoning,

Isolators and Personal Protective Equipment

• Three modules for

• Hormonal Tablets – 40 mn units/yr

• Cyto Capsules – 15 mn units/yr

• Cyto Injectable (Liquid/Lyophilized) – 3 mn units/yr

• Being commissioned

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Project Execution

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Well Knit Support Structure

Process & Formulation R&D

Production

QA QC

Supply Chain Management

Regulatory Affairs

Planning Project Management

Capacity & Infrastructure

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Confidentiality

• Global Standards practiced for Confidential Disclosure Agreements

• IP ownership and rights clearly defined at project initiation

• Complete data protection for customers. Firewalls within various Project Teams

• Non disclosure and confidentiality agreement executed by all employees

• ISO 27001:2005 certified for information security management

©

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R&D Support for R&D Work

350 Chemists and Engineers across 3

centers

Access to Kilo-Labs for piloting

Multiple Analytical Labs for process

research support

DSC/TG, GC/LC-MS, LC-MS-MS,

powder XRD, single crystal XRD, NMR,

LC-NMR, FT-IR, CHN analyzer, ICP-MS

CHEMISTRY

Preformulation

Analytical & Bioanalytical

development

Formulation development

Pilot scale-up

LC-MS/MS, Prep-HPLC, Capillary-HPLC,

GC, FTIR, NIR, p-XRD, Photo Stability

Chamber , Dissolution Apparatus (Type

I, II, III & IV)

FORMULATION

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Project Path – Functional Involvement

R&D

Feasibility Optimization Hazop Studies Lab Validation Piloting Trial Production Comm. Production

AR&D

PE

QC

QA

MFG

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Communication Process

Project manager is single point of contact

Communication between functional departments of CPS & clients

Regular e-mail updates & periodic progress reports

Use of web-based communication channels like Groove

Weekly / Fortnightly teleconferences & videoconferences

Face to face meetings

Proactive communication of deviations for joint problem solving

Campaign reports

Reduces re-work leading to better control on cost, quality and time

Establishes strong customer orientation

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Service Orientation

Niche Capabilities

Assets (Dossiers, DMFs, IP,

Manufacturing)

Life Cycle Mgmt

Portfolio Mgmt

Tech-Transfer

Niche Offerings

Uniquely Positioned to meet pharma challenges…

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CPS uniquely poised to meet pharma challenges…

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…By leveraging organizational strengths

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CPS Group in Dr. Reddy’s – A Summary

• Wide experience and use of several Technology solutions

• Breadth of experience in process R&D, scale-up and commercial contract

manufacturing

• Intellectual property managed as per global standards

• Well-trained man power, quality systems and excellent infrastructure

• Well-versed with API & Formulation development, scale up, technology transfer,

Regulatory requirements and CMC Documentation needs

Our Value Proposition: Excellent speed and cost advantage without compromising quality

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For more information or to discuss your specific interest please contact: Christian Jones European Sales and Business Development Manager Dr Reddy’s CPS ChiroTech Technology Limited, 410 Cambridge Science Park, Cambridge, UK CB4 0PE T:+44(0)1223 728 030 M:+44(0)7827 157 247 E: cjones@drreddys.com

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