Euticals Group Presentation -...

LEADING TO THE BEST PATHWAY

COMPANY PROFILE

The Pharmaceutical & Fine Chemical Company

1984 1995 2001 2002 2007 2008 2010 2011 2012

EUTICALS

Acquisition of

Prochisa Spa

and Norpharma’s

Rozzano plant

EUTICALS

Acquisition of

Diaspa Spa and

Pro.Bio.Sint. Spa

Mandarin Capital

Partners and Poli family

EUTICALS

Acquisition

of Poli

EUTICALS

Acquisition of

40% shares of

Pharmintraco

EUTICALS

Acquisition of

Archimica EUTICALS

Acquisition of

30% shares of

Tianma Tianji

EUTICALS

Prime European

Therapeuticals Spa

(«Euticals»)

Spinn-off of Istituto

Chemioterapico Italiano

(1948)

Acquisition by Carinelli family

CLESSIDRA

Mandarin C.P.

PEP

IDEA

2

Historical Milestones

EUTICALS

Divesting of Diaspa’s

assets

Established in 1984, Euticals is a chemical company focused

on Active Pharmaceutical Ingredients (“API’s”), Custom

Synthesis, Fine Chemicals and other pharmaceutical

products.

Euticals is a privately owned company controlled by Private

Financial Investors.

Today Euticals Group is one of the leading players in the

Pharmaceutical & Fine Chemicals Industry with a global

scale and diversified production in 11 manufacturing plants.

3

Group Overview

8 Plants FDA Approved! 4

Global Scale Production

A GLO-CAL business approach;

Expanding our API capabilities;

Strengthening our position through innovative products and technologies;

Expanding in the Pharmerging markets;

Integrating vertically forward with finished dosage forms;

Entering in the Biotechnology arena with regard to oligonucleotides,

peptides, biosimilars, monoclonal conjugates and bio betters;

Be the One stop shop for the Pharma Industry.

Continuity & Discipline in our Strategic agenda

5

A Unique Strategy

6

Our Vision

To become an innovative technologies engine without parallel in our

industry and in the pursue of excellence in everything we do,

for a powerful and outstanding growth path

Customer centric marketing and sales model;

Commitment in searching and supporting innovative solutions;

Fast throughput of projects thanks to properly planned development labs and

production capacity;

Sustainable development and project stewardship at all process development

stages, at minimum risk exposure for all of our customers;

Competitive prices for our products and services made in sustainable facilities

of superior quality and meeting unparallel customer service requirements.

In the pursue of Excellence

7

Our Value Proposition

API MANUFACTURING A broad product portfolio of more than 200 APIs covering all therapeutic areas like

Oncology, Cardiology, Gastroenterology, Neurology, and Gynecology among others.

CUSTOM SYNTHESIS With facilities in different geographies supporting clients in their regulatory and

strategic development challenges.

CONTRACT MANUFACTURING Reliable, cost effective, quality and timely management of small and large scale

manufacturing of APIs and advance intermediates and starting materials for clinical

trials and commercial products.

FINE CHEMICALS Broad technological expertise with offerings from boronic acids to prostaglandin

precursors, organometalic, cross coupling and enzymatic chemistry. Offering of

high performance reagents like T3P and special Iodine compounds.

FINISHED DOSAGE FORMS Forward integration in high potency oncology injectables in lyo and liquid forms.

A formidable capacity of 2 000 c.m.,

1 100 c.m. of which Glass Lined

A sustainable Business Model

8

Products and Services Offering

Sales Growth

The secret of enduring success

A remarkable expansion through organic and inorganic growth

Sales by Product Group

9

0

100

200

300

400

2008 2009 2010 2011 2012 2016 E

Euticals Poli Archimica

€ mln

Sales Growth

A Global Player with Glo-cal Mindset

10

200 and more Products

to 754 Customers

in 73 Countries

Sales Spread by Geography

Expertly designed to drive your business

11

19%

5%

19%

6%

22%

29%

Central Nervous System

Immunosuppressant

Antinfectives

Cardiovascular

Reagent/Intermediate

Other Areas

Therapeutic categories of Product Portfolio and R&D pipeline

Selected Customers

A market leader and global player in API and intermediates for branded (innovators)

and Generic Pharma

12

EUTICALS CURRENT CUSTOMER COVERAGE 2011 Global Pharma Market data (USD 880 Billion)

100% on Top 10 (40% of WW Market)



Early Clinical Material

Development and Production

(PC,CT-I&II)

Clinical Material Development and

Production

(CT-II & III)

Commercial Supply of RM, RSM, RI and API’s

ACCESS TO EUTICALS TECHNOLOGY PLATFORMS AND RESOURCES

SPEED FLEXIBILITY QUALITY RELIABILITY CONTINUOUS IMPROVEMENT

Expertise in the implementation of cost efficient processes

13

Our Custom Manufacturing Services

YOUR

REQUEST

Marketing Manager

OUR

PROPOSAL

Multidisciplinary Team Experts,

(Quality, EH&S, Legal, Sourcing, Process and Analytical Development)

Most Appropriate Technology Fit,

Plant/Site Selection

Technical Team &

Proposal Returned within 10 business days

14

Our Custom and Contract Manufacturing Services

Project Management

®T3P – Propane phosphonic Acid

Anhydride

Boronic Acids, Biaryls,

Grignards and Organolithiums

Sterile APIs

DEA Controlled Compounds

Nitrations and Other

Hazardous Chemistries

(Cyanide, POCl3,

Nitration, Br2, I2, DMS,

Hydrazine, etc.)

HP APIs for orals & Injectables

Creating and Supporting the difference

Mono bactams/Tetracyclines

Oncology lyo and liquid Injectable Forms

“chiral” technologies

Heterocycles and Oxa acids

15

Biotherapeutic Spores

Our Core Technologies and Product Classes

Effective methodology for controlling stereochemistry, and regeosellectivity;

• Reducing the number of steps and;

• Avoiding side products;

• In shorter processing times;

• Increased number of reactions types.

C-C couplings like Suzuki, Sonogashira, Kumada and Buchwald reactions;

Possibility of running specific reactions using boronic intermediates, lithiated

compounds and high selectivity reactions.

Our core technology platform

16

Low Temperature Chemistry

Rozzano, IT

Bon-Encontre,FR Frankfurt,DE Springfield, Missouri

Origgio, IT

Total 55 highly skilled chemists, 21 with PhD are focused on:

API development;

Analytical development;

Process development and scale-up;

Process stewardship & improvement;

Solid State Chemistry;

New technologies.

17

R&D – Where and Who we are …

The partner of choice

18

R&D Orientation to Innovation

Solid State Chemistry

Solvates/Hydrates;

Polymorphs;

Micro-crystallization and continuous counter crystallization;

Co-precipitates;

Co-crystals (US FDA guidance for the industry);

Salts;

Analogs/Adducts;

Technologies

Nanotechnology. Nano-particles & Nano-crystals;

Purification Technologies like preparative chromatography, column

chromatography, ion exchange chromatography, reverse phase chromatography.

Enzymatic Transglycosylation and Phosphorylation/Dephosphorylation reactions;

Fermentation and product isolation technologies.

Peptides Solid/Solution phase chemistry;

Biosimilars, Monoclonal Conjugates and Bio Betters;

Antisense Oligonucleotides.

The Strategic Partner in a changing API Industry

19

Our Growth Biotechnologies

New growth engines

Certified Quality System

Inspections by Regulatory Agencies: Domestic sites: AIFA – FDA

International sites: ANSM (AFSSAPS) - FDA – MHRA

French sites ANSM (November 2012)

GMP Certificates issued to all sites: According to ICHQ7A and Eudralex Vol 4 Part II.

FDA latest inspections: Domestic sites:

LODI (September 2011), No 483;

ROZZANO - Quinto de Stampi (October 2011);

VARESE (September 2012), No 483;

ROZZANO - Valle Ambrosia (November 2012)

International sites: SPRINGFIELD (January 2012), No 483

• Korean FDA inspection: LODI, CASALETTO (October 2011)

PMDA Japan: VARESE, ROZZANO, LODI

ANVISA: ROZZANO - Quinto de Stampi (July 2011)

ISO 9001-2000: France, UK and Germany sites

20

cGMP Compliance 2011-2012

21

Customer audits 2012

72 Customer Audits

Six (6) customer audits a month at our facilities

• DIAPHARM • DOPPEL • FRESENIUS KABI • GALENYSIS • GILEAD • GIF • GRINDEX • GLAXO • INDENA • INTAS • IWAKI • JANSSEN • KLOKE • KOASHOJI • LACER • LUPIN • JELFA • MAYOLY LABS • MERCK SPAIN • MERCK • MIDAS • MYLAN • NIPRO • NORGINE PHARMA

• NOVARTIS • NOVAGALI • NOSTRUM • PAR • PARI PHARMA • PENN • PFIZER • RAFA • RANBAXY • RATIOPHARM • RIVOPHARM • ROCHE • SALEM LABORATOIRES • SANDOZ • SANOFI AVENTIS • SCHERING PLOUGH • STADA • TAKATA • TEVA TAYIO • TUBILUX • URGO • UCB • VALFARMA • VIROPHARMA

• ABBOTT • ABC PHARMA • ABIOGEN • ACTAVIS • ALCON USA • ALCON SPAIN • ALKEM • ALLERGAN • AMDIPHARM • ANGELINI • ASTRA ZENECA • AUROBINDO • BACHEM • BMS • BOHERINGER • BENVENUE • BEDFORD • BLUE INSPECTION • CADILA ZYIDUS • CID • CELGENE • CIPLA • CRISTALIA • DAICHI

Site Number

Bromocriptine Mesilate Rozzano R1-CEP 2000-151

Chlortalidone, and milled, Micron. Origgio R1-CEP 2001-020

Ciclosporin Rozzano R1-CEP 1999-034

Cytarabine Varese R1-CEP 2000-048

Dihydroergocristine Mesilate Rozzano R1-CEP 2000-073

Dihydroergotamine Mesilate Rozzano R1-CEP 2000-183

Ergotamine Tartrate Rozzano R0-CEP 2008-291

Fludarabine Phosphate Varese R0-CEP 2009-282

Flutamide, and milled Origgio R1-CEP 2000-049

Hexetidine Bon Encontre R0-CEP 2005-238

Hydroxycarbamide Lodi R1-CEP 2003-120

Minocycline Hydrochloride Origgio R1-CEP 2007-107

Pancuronuim Bromide Rozzano R1-CEP 2005-120

Propofol Origgio R1-CEP 2001-267

Ribavirin Origgio R0-CEP 2007-182

Ticlopidine Hydrochloride Rozzano R1-CEP 2001-414

EU 431

USA 69

Australia 11

Bangladesh 9

Canada 14

China 8

India 12

Japan 13

Korea 2

Malaysia 1

Mexico 3

New Zealand 4

Russia 2

South Africa 2

Taiwan 4

Vietnam 1

DMF Statistics

22

DMF status and EDQM Certificate of Suitability CEP (Dec. 2012)

Total CEPs 16, and 5 in preparation

Euticals is in compliance with the most stringent directives and guidelines related to

Environmental, workplace safety, handling, storage, transportation of hazardous

substances, toxic gases, packaging and labeling regulations applied in Europe and

in the US;

Italian Safety regulations: Dlgs. 81/08;

Risk of explosion: 99/92/EC (ATEX 137) and 94/9/EC (ATEX 100), DSEAR2002

and COMAH Regulations 1999 and updating;

Big and relevant Risk: D. Lgs. 334/99 and updating;

Pressure Equipment: PED 97/23/EC and ASME;

Environment protection: European Directive 96/61/CE, D.Lgs.59 /05, D.Lgs.

152/06, Clean Air and water Act, NPDES and POTW.

23

Sustainable Facilities

24

Environmental Sustainability Program

Euticals aspires in leading the path for environmental sustainability, setting goals for

sustainable growth.

Environmental sustainability is core part of our strategic direction aiming not only at

the protection of the environment but also in the efficient use of natural resources.

We are constantly seeking for more environmentally responsible and safe solutions:

Capturing new Technology and Innovation;

Renewable Energy;

Reduction in energy consumption;

Reducing water consumption;

Reducing Carbon footprint.

All sites performance shows improvement in all green chemistry indicators:

Mass Efficiency, %: Mass of products x 100/ mass of materials input

2009: 5%, 2011: 8,4%

Effective mass yield, %: Mass of products x 100/ mass of toxic reagents input

2009: 30,3%, 2011: 36,7%

E factor: total waste (Kg)/Kg of product produced

2009: 63, 2011: 56

Our World Class Facilities

WORLD CLASS FACILITIES

LEADING TO THE BEST PATHWAY

The Pharmaceutical & Fine Chemical Company

Plant: Chemical Plant;

Quality: cGMP, latest FDA inspection September 2011

Latest Italian Regulatory Agency (AIFA) October 2011

Korean Agency September 2011;

APIs: Oxcarbazepine, Hydroxyurea, Capecitabine, Mianserin,

Sucralfate, Choline Alfoscerate, etc;

Technologies: Pyridine reactions and Fluorinations;

Total Capacity: 110 m3, 25 Reactors from 500 to 8’000 L, SS & GL;

Total Surface: 22’700 sq.m;

Covered Surface: 10’100 sq.m.

26

Lodi - Italy


Quality: cGMP, latest AIFA Inspection Nov. 2009

Korean Agency October 2011;

APIs: Chlortalidone, Mononucleotides, Omega-3, Diacerein,

Ribavirine, etc;

Technology: Hydrogenation, Cr Oxidations, Bromination, Grignard, etc;.

Total Capacity: 120 m3, 27 Reactors from 1’000 to 12’500 L, SS & GL;


Covered Surface: 8,000 sq.m.

27

Casaletto Lodigiano - Italy

Plant: Chemical and Fermentation Plant;

Quality: cGMP, latest FDA inspection 2011, latest AIFA inspection

2011, latest ANVISA inspection 2011;

APIs: Steroids/Hormones, Ergot Alkaloids, Central Nervous System,

Immunosuppressant, Neuromuscular Blocking Agents, etc;

Technology: Hydrogenation, Microbiology, Fermentation, Synthesis;

Total Capacity: Fermentation: 180 m3;

Synthesis: 60 m3, Reactors from 50 to 6’000 L, SS & GL;

Total Surface: 20,716 sq.m;

Covered Surface: 8,239 sq.m.

28

Rozzano Quinto de Stampi - Italy

Plant: Chemical Plant and R&D Laboratories

Quality: cGMP, latest FDA inspection 2011

latest AIFA inspection February 2012

APIs: Aztreonam and other Monobactams

Technology: Hydrogenation, Wittig chemistry, Friedel-Craft, High temp.

Total Capacity: 15 m3, 9 Reactors from 300 to 3’000 L, SS / GL

Total Surface: 3’350 sq.m

Covered Surface: 1’830 sq.m

29

Rozzano Valleambrosia - Italy

Plant: Chemical, Enzymatic and Biotech;

Quality: cGMP, latest FDA inspection September 2006

latest AIFA inspection October 2011;

APIs: Citicoline, Nucleotides, Gemcitabine, Bendamustine,

Fludarabine, Cytarabine, Vidarabine and custom

fermentation;

Technology: Transglycosylation, Enzymatic Phosphorylation;

Total Capacity: 50 m3, 12 Reactors from 700 to 10’000 L, SS & GL;


Covered Surface: 3’000 sq.m.

30

Varese - Italy

Plant: Chemical and Solvent recovery Plant;

Quality: cGMP, latest FDA inspection May 20;

APIs: Minocycline, Propofol, Chlortalidone, Ribavirine,

Fexofenadine, Terazosine, Flutamide;

Technology: Hydrogenation, Organometallics, Cryogenic reactions,

Boronic Acid;

Total Capacity: 550 m3, 85 Reactors;

High pressure Hydrogenation from 5 to 15 m3;

Total Surface: 163.000 sq.m;

Covered Surface: 30.000 sq.m.

31

Origgio - Italy


Quality: cGMP, latest ANSM (AFSSAPS) inspection 2011;

APIs: Niflumic Acid, Morniflumate, Hexetidine, Cibenzoline, etc;

Technology: Bulk sterile manufacturing, Organometallic & cryogenic

chemistry, Bromination, Hydrogenation;

Total Capacity: Sterile: 180L GL;

140 m3, 52 Reactors from 1’600 to 6’000L, SS / GL;



32

Bon Encontre - France


Quality: cGMP, Latest FDA inspection 2010;

latest ANSM (AFSSAPS) inspection Nov 2007;

APIs: Aztreonam sterile, L arginine sterile,

Acetyl Salicylate of D,L Lysine sterile;

Technology: Sterile Manufacturing, Oxidation, Chlorination;

Total Capacity: Sterile Facility: from 600 to 1’600L, SS / GL;

80 m3, 20 Reactors from 1’000 to 8’000L GL / SS;



33

Tonneins - France


Quality: ISO 9001;

APIs: Custom Synthesis production and Contract manufacturing;

Technology: Cryogenic & Organometallic reactions; Chiral Synthesis,

T3P & T3P Application, Phosphorous Organics Oxa Acids

Air Oxidations, Distillations;

Total Capacity: 48 m3, SS / GLReactors from 50 to 3’000 L, 100C to

+180C, 2 mbar;

Distillation columns up to 2,5 m3 & 100 theoretical plates;



34

Frankfurt - Germany


Quality: cGMP, latest FDA inspection 2008; latest MHRA

inspection January 2011; latest BSI inspection

March 2012;

APIs: ISMN, ISDN, 5-Fluorocytosine, Salicylates, Carbimazole;

Specialty Chemicals: Methyl iodide, Di-iodomethane, API intermediates;

Technology: Nitration Esterification, Halogenation, Handling and use of

Hazardous chemicals (ie. Fuming Nitric Acid, Dimethyl

Sulphate, Isobutylene, per acids);

Total Capacity: 82 m3, Reactors SS/GL;



35

Sandycroft – United Kingdom


Quality: cGMP, latest FDA inspection January 2012,

DEA controlled substances license since 2005;

APIs: Methylphenidate HCl, Dexmethylphenidate HCl, Omega-3,

Tapentadol HCl, Choline Fenofibrate, Lacosamide, etc;

Technology: Organometallics, Cryogenic, Chiral epoxides,

Controlled substances;

Total Capacity: 574 m3, Reactors SS/GL/Hastelloy;



36

Springfield - USA

This presentation has been prepared by Euticals SpA. The information contained in

this presentation has not been independently verified and no independent evaluation

or appraisal of Euticals has been undertaken.

Neither Euticals nor recipients nor their respective officers, directors, employees and

agents make any representation or warranty, expressed or implied, as to the

accuracy or completeness of this presentation or any statement made herein, or any

other written or oral communications transmitted to the recipient in connection

herewith.

This presentation does not constitute an offer or an invitation to acquire Euticals or

constitute the basis of or form any part of any contract which may be concluded for

a potential transaction.

The contents of this presentation are subject to the Confidentiality Agreement

entered into with Euticals.

38

Disclaimer

Euticals Group Presentation -...

Documents

Transcript of Euticals Group Presentation -...