Euticals. Group Company Profile

Transcription

1 Euticals Group Company Profile

2 Agenda Company Profile Group Overview Historical Milestones Board of Directors Product & Services Key Figures Key Customers Key Technologies

3 Euticals R&D R&D Centers Chorisis Euticals Manufacturing Sites QA & QC DMF Statistics & CEP EDQM Sustainable facilities

4 Group Overview Established in 1984, Euticals is a Chemical Company focused on the development and manufacturing of Active Pharmaceutical Ingredients (APIs), Customs Synthesis products and Fine Chemicals. Euticals is a privately owned company controlled by Private Financial Investors. 4

5 Historical Milestones Our Start EUTICALS Prime European Therapeutics SpA Spin-off of Istituto Chemioterapico Italiano ACQUISITION Acquisition by Carinelli Family ACQUISITION Prochisa SpA Norpharma s Rozzano plant ACQUISITION Pro. Bio.Sint. SpA

6 PRIVATE S INVESTORS GROUP Mandarin C.P. and Poli Family ACQUISITION Poli Industria Chimica SpA ACQUISITION Archimica PRIVATE S INVESTORS GROUP CLESSIDRA Mandarin C.P. PEP IDEA TODAY Today Euticals Group is one of the leading players in the Pharmaceutical & Fine Chemicals Industry with a global scale production and diversified manufacturing plants. 6

7 Board of Directors CEO M. Fine R&D OPERATIONS & SUPPLY CHAIN GLOBAL QUALITY & REGULATORY CFO GLOBAL HR GLOBAL MKTG, SALES & BD GLOBAL PROJECTS CS & CMO M. Villa M.Fabris L. Fournel M. De Bernardi C. Majocchi G. Fabotti T. Pallotta D. Hanoch S. Hancock J. Kaus 7

8 Products and Services Our Offer API MANUFACTURING CUSTOM SYNTHESIS CONTRACT MANUFACTURING FINE CHEMICALS Extensive product portfolio with more than 200 APIs covering multiple therapeutic areas Euticals has the skill and experience to meet a wide range of outsourcing needs including: process development, scale-up, validation, and rapid volume escalation Supporting our customers from non-gmp to full cgmp synthesis and chemical manufacturing services, from production of early stage clinical trial materials to postlaunch commercial manufacturing Broad technological expertise including: boronic acids, prostaglandin precursors, organometallics, cross couplings, enzymatic chemistry and high performance reagents 8

9 Key Figures Turnover by Business Offering * APIs and Intermediates 64% Custom Synthesis 7% Contract Manufacturing 13% Fine Chemicals 16% 9 (*) data

10 Key Figures * Financial Strengths Extensive Portfolio Technologies Leader R&D Capabilities Global Presence Quality More than 215 Mln EUR Turnover Over 200 Products 9 Multipurpose facilities 61 Skilled Chemists Over 70 Countries Served More than 90 Audits per year Market Leader on 10 APIs 12 Dedicated Production lines 3 Pilot Plants 6 R&D Centers More than 600 Customers 10 (*) data

11 Key Figures Turnover by Area * US & Canada 25% LATAM 6% TOP 5 EU 21% Rest of EU 22% MENA 2% Rest of World 10% India 8% China 3% Japan 3% WORLD 0% 100% 11 (*) data

12 Key Customers Number of Products and Projects Mln EUR Turnover ,0 6,0 9,0 12,0 15,0 18,0 21,0 24,0 Customer 1 Customer 2 Customer 3 Customer 4 Customer 5 Customer 6 Customer 7 Customer 8 Customer 9 Customer 10 Customer 11 Customer 12 Customer 13 Customer 14 Customer 15 Customer 16 Customer 17 Customer 18 Customer 19 Customer 20 12

13 Key Technologies Monobactams Sterile APIs Fermentation Controlled Substances (US) Manufacturer of Aztreonam, both Oral APIs and Sterile Dedicated plant Involved in new Monobactams developments Dedicated plant Sterilization via aseptic filtration and crystallization Ergots Alkaloids and Immunosuppressant Absorption/Silica Gel/Ion Exchange Chromatography 4 DEA manufacturing areas for total capacity of 180 m 3 Research and export registration for schedules I, II and V Organometallics Heterocycles Enzymatic Chemistry Other Capabilities Lithiation Nicotinic Acid derivatives Lipase applications Cryogenic Chemistry Boronic Acids Piperazines Chiral Cyclopentenol acetates Hydrogenation Tri-F Methyl Pyridines Grignard Naphthyridines Furans Alcohol Dehydrogenase (ADH) applications Steroids Curares X-Coupling C-O Couplings Indoles Triazoles Pyrimidine Preparative HPLC purifications stationery phases Green Chemistry (Amides preparation) 13

14 Euticals R&D Our Strong Scientific Expertise Network Services & Support: 5 Internal Centers Crossed functions and multidisciplinary approach International Partnership Collaboration with international CRO Project feasibility, Definition of New Synthetic Routes Development and Optimization of chemical Processes for New Generic API or NCE for Phase I II III devoted to Clinical Trials Scale-up Universities Looking for Innovation Analytical Methods Development and Validation 1 Affiliate Center State of the Art analysis research center Isolation and Characterization of impurities Regulatory Support 14

15 5 Internal + 1 Affiliate Development Centers R&D Centers Chemical Lab Analytical Lab TOTAL Springfield MISSOURI Bon- Encontre FR Origgio IT Frankfurt DE Rozzano IT USA France Germany 17 xx 17 Italy TOTAL Total 61 highly skilled chemists are focused on: API development Analytical development Process development and scale-up Process stewardship & improvement 15 (xx) Not accounted as R&D FTE

16 Chorisis Analysis: cgmp Development and validation of HPLC/GC analytical methods (DoE based) Special analyses (post- pre-column derivatization) Selective/universal detection (MS, ELSD, fluorimeter, LS,Viscometer) Size Exclusion Chromatography Purification: Development and optimization of industrial Large scale preparative HPLC Downstream process optimization (fermentation /extraction / synthesis) Impurities isolation and characterization: Impurity profile characterization Isolation & purification Unknown impurities reference standards preparation Synthesis: Development of new APIs/ intermediates synthetic pathways Optimization by DoE of single / multiple synthetic steps Development of continuous flow chemistry Synthesis of Pure Reference Standards Chorisis is a Contract Research Organization, founded in 1986, owned entirely by Euticals, as separate legal entity, since July Mission: supply development and optimization analytical, preparative and industrial purification service. Chorisis is located in Insubrias Bio Park of Gerenzano (formerly Dow-Lepetit Research Center) CHORISIS Gerenzano 16

17 Euticals Manufacturing Sites cgmp Plants: USA France Italy 17

18 ITALY ORIGGIO 2014: AIFA - FDA - PMDA 2013: OHSAS Hydrogenation & Tetracyclines ROZZANO V.A. 2016: FDA 2015: AIFA Monobactams Varese IT Rozzano IT Origgio IT Lodi IT 18 ROZZANO Q.de S. 2015: FDA - PMDA - OHSAS : AIFA 2011: ANVISA Fermentation & Semi Synthesis VARESE 2015: FDA - PMDA 2014: AIFA 2013: KFDA Oncology LODI 2014: AIFA - FDA 2012: PMDA 2011: KFDA Large Volumes & Oral Anticancer Last inspection dates See details on ppt plants

19 France Tonneins FR Bon-Encontre FR TONNEINS 2015: ANSM 2014: FDA ISO 9001, 14001, Aseptic Filtration & Crystallization BON-ENCONTRE 2014: FDA 2013: ANSM ISO 9001, 14001, Organometallic & Cryogenic Chemistry 19 Last inspection dates See details on ppt plants

20 Frankfurt Frankfurt DE Frankfurt 2015: ISO : ISO 9001 Boronic Acids & T3P Reagent 20 Last inspection dates See details on ppt plants

21 US Springfield MISSOURI Springfield 2014: FDA (since) 2005: DEA License Distillation Large Volumes 21 Last inspection dates See details on ppt plants

22 QA & QC ITALY GERMANY USA FRANCE People Specialty People Specialty People Specialty People Specialty QA 19 QC 52 GMP and Qualification Compliance Chemical, Microbiological and Fermentation Analysis QA 1 QC 0 ISO Certification and HSE Outsourced QA 3 Overall 100 Quality Assurance 27 Quality Control 73 QC 8 GMP and Qualification Compliance HPLC, UPLC and GC QA 4 QC 13 Sterile Manufacture and ISO Certification HPLC, GC, Titration, Endotoxins, Particle Counting, Microbial and Sterility tests 22

23 DMF Statistics & CEP AIFA FDA ANSM PMDA EDQM KFDA ANVISA More than 90 Customers Audits per year 8 Customers Audits every month (on average at our facilities) 23

24 DMF Statistics & CEP FILED EU 400 USA 66 Australia 11 Bangladesh 9 Euticals has exemplary commitment to quality. Our multiple cgmp facilities across Europe and the USA are audited by all relevant regulatory authorities and by our customers on a regular basis with excellent track record and no critical observations. Canada China India Japan Korea Malaysia Mexico Russia South Africa Taiwan CEP

25 EDQM- Certificate of Suitability (CEP) PRODUCT Rozzano Q.de S. Origgio Varese Lodi Bon-Encontre CEP NUMBER Niflumic Acid R0-CEP Hexetidine R1-CEP Hydroxyurea R1-CEP Chlortalidone Unmilled, Milled, Micronized R1-CEP Flutamide Unmilled, Milled R1-CEP Minocycline Hydrochloride Dihydrate R1-CEP Propofol R1-CEP Ribavirin R0-CEP Dihydroergocristine Mesylate R0-CEP Dihydroergotamine Mesylate R1-CEP Ergotamine Tartrate R0-CEP Pancuronuim Bromide R1-CEP Ticlopidine Hydrochloride R1-CEP Bromocriptine Mesylate R1-CEP Ciclosporin R1-CEP Cytarabine R0-CEP Fludarabine Phosphate R1-CEP

26 Sustainable Facilities Italian Safety Regulations (D.Lgs. 81/08) Pressure Equipment (PED 97/23/EC and ASME) Risk of Explosion (99/92/EC, [ATEX 137], 94/9/EC [ATEX 100], DSEAR2002 and COMAH. Regulations 1999 and updating; Environment Protection (European Directive 96/61/CE, D.Lgs.59 /05, D.Lgs. 152/06, Clean Air and Water Act, NPDES and POTW) Big and Relevant Risk (D. Lgs. 334/99 and updating) 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 26

27 Thanks Disclaimer 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.