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Siegfried at a glance
Siegfried
                                  Actives
                                  2_2




            Overview
Siegfried
            Services
            Chemical Development
            Chemical Production
            Compliance
            Standard Products
            Formulation
Siegfried
Overview                                   Actives
                                           2_3

Siegfried Group: Profile
•   Global presence: 4 sites in EU & US

•   >130 years in pharma industry

•   Listed on the Swiss Stock Exchange
    (SWX)

•   Concentration on the development
    and manufacturing of APIs,
    intermediates, and finished dosage
    forms incl. inhalation products

•   Total work force:    approx. 800

•   Annual sales CHF:    > 350 mio

•   >120 commercialized products in last
    40 yrs
Siegfried
Overview                             Actives
                                     2_4


Siegfried Group: Vision


To be a world-class partner in
developing and manufacturing drugs
that improve human life.

A leader in:
• Speed
• Reliability
• Flexibility
Siegfried
Overview                                                  Actives
                                                          2_5


Siegfried Group: Divisions


     Siegfried      Actives      Siegfried       Drug Product
     Development and             Development and
     manufacture of active       production of
     pharmaceutical              finished dosage
     ingredients (API).          forms.
      Exclusives:
      • Custom process and       •   Custom packaged
        method development           products
      • Custom manufacturing     •   Inhalation products
        services                 •   Manufacturing and supply
                                     chain services
      Multi Clients:             •   Regulatory services
      • Supply of generic APIs
      • Opiate APIs
      • Controlled substances
            •DEA license
Siegfried
Overview                                                                                                              Actives
                                                                                                                      2_6


Siegfried Group: Locations




                                                                                                                      Plus various
                                                                                                                      agents
                                                                                                                      around the
                                                                                                                      world




               Siegfried Pharma     Headquarters                 Siegfried UK        Alpine Dragon        Siegfried Shanghai
               Development GmbH     Siegfried Ltd                Branch office       Pharma               Sourcing Office
               Munich, Germany      Siegfried Actives            Stockton, UK        Wuwei, China         Shanghai, China
               Höchstädt, Germany   Siegfried Drug Product
                                    Zofingen, Switzerland
  Siegfried (USA), Inc.                                      Siegfried (Malta) Ltd                   SCI Pharmtech, Inc.
  Pennsville, U.S.A.                                         Malta                                   Taipei, Taiwan
Siegfried
                                  Actives
                                  2_7




            Overview
Siegfried
            Services
            Chemical Development
            Chemical Production
            Compliance
            Standard Products
            Formulation
Siegfried
Services                                                             Actives
                                                                     2_8


Meeting Customer Needs


Service offering         Customer value               Goal

•   Key account and      •   Speed –
    product                  from inquiry to
    management               delivery

•   Project              •   Reliability –
    management               on time, in budget,      Maximize
                             and at expectation       your benefit
•   Supply chain
    management           •   Flexibility –
                             tailored service solu-
•   Regulatory support       tions meet changing
                             needs
•   Quality
    management
Siegfried
Services                                                        Actives
                                                                2_9


Project Management Offering


Project planning    •   Addressing customer requirements
                    •   Target setting and scope definition/tracking


Project execution   •   Dedicated project management (PM)
                    •   Tracking & Communication


Chemical            •   Extensive corporate Expertise
development         •   Scale-up experience of over 500 processes

Team management     •   Cross-functional project teams
                    •   Joint Customer/Siegfried team
Services                                                                     Siegfried
                                                                             Actives
                                                                            2_10

Project Management - Life Cycle

                                         Solid finished dosage forms

                                              Full-scale production*

                                              Kilo lab/pilot plant*

                                    Laboratory development
                         Laboratory feasibility study
              Technical Transfer Package,
             project evaluation & quotation
                                                                      Project
        Confidentiality agreement                                   Management

Customer inquiry
                                          * Location depends on capacity, capability &
                                            regulatory needs
Services                                                                 Siegfried
                                                                         Actives
                                                                         2_11

Project Management - Project Leadership Team
       External role
                                       Customer




                                       BD/Project
  Internal role                            Manager
                    Development                         Purchasing
                                       Project
                                     Leadership
                  Production         Team (PLT)            Quality


                             Pilot Plant        Analytic


                  Point to Point contacts are set at project inception
Siegfried
Services                                  Actives
                                          2_12


Project Management Benefits


•   Single point of contact for project

•   Timely communication

•   Ease of doing business

•   Reliable project delivery

•   Flexibility & speed



“Exceed Customer Expectations”
Siegfried
Services                                                              Actives
                                                                      2_13


Supply Chain Management


Production planning    •   Maintaining flexibility while optimizing
                           efficiency

Manufacturing          •   Multipurpose facilities
                       •   Highly trained personel
                       •   Short cycle times

Inventory management   •   Optimizing availability and working capital
                       •   Managing safety stock
                       •   Purchasing
                       •   Worldwide sourcing of key raw materials with
                           permanent presence in China
Siegfried
                                  Actives
                                  2_14




            Overview
Siegfried
            Services
            Chemical Development
            Chemical Production
            Compliance
            Standard Products
            Formulation
Siegfried
Chemical Development                                                   Actives
                                                                       2_15


Overview

Process development leading to scaleable and robust processes by

•   Process research and development of APIs and key intermediates
•   Evaluation of new synthesis routes
•   Analytical development
•   Process optimization
•   Scale-up and pilot services
•   cGMP compliant small scale production
•   Supporting services: Logistics / In-house safety tests / Quality assurance
Siegfried
Chemical Development                                            Actives
                                                                2_16


Key Technologies – The Siegfried Difference


                  •   High Potency 1.0µg/m3 (OEL 3) in production and
                      pilot plant
                  •   High Potency 0.1µg/m3 (OEL 4) in development
                  •   Cryogenics
                  •   Micro Reactor Technology
                  •   Spray-Drying
                  •   Expertise in Polymorphology & Crystallization
                  •   Process Safety Laboratories
                  •   Small-scale & Pilot cGMP Production
                  •   Analytical Method Development & API Release
                      Testing
Siegfried
Chemical Development                                           Actives
                                                              2_17


Key Expertise

Team                   30 Ph.D. Chemists
                          4 full time Project Managers
                          4 full time Analytical Project Leaders
                       12 Chemical Engineers
                       29 Lab Technicians (3 year apprentice)
                       12 Chemical Operators (3 year apprentice)


Experience         •   Methods validated according to ICH
                       guidelines; >500
                   •   Process evaluation for more than 1900
                       compounds
                   •   Scale up of more than 500 processes
                   •   Ability to run 50 development projects in
                       parallel
Siegfried
Chemical Development                    Actives
                                        2_18


Lab, Kilolab & Pilot Plant
Laboratories:
• 10 laboratories
• 30 Ph.D. chemists
• 83 staff

Kilolab:
• Steel and glass-lined reactors (30-
  60L)
• Temperature range -60oC to 220oC
• Coated centrifuge
• Mettler Reaction Calorimeter (RC1)
• Automated synthesis workstation
• Mettler LabMax with IR for IPC

Pilot plant:
• Steel & glass-lined reactors (250-
  500L)
• Hydrogenation reactor (steel 250L)
• Centrifuge
• Stainless steel paddle dryer 250L
• Alpine & Fitzpatrick mills
Siegfried
Development Building                  Actives
                                      2_19
                                       3.4.5.5

cGMP Wall


•   cGMP wall to separate operating
    room and technical part
•   Minimized cross-contamination
•   Efficient cleaning possible
•   Remote-controlled valves
•   Feed tanks & receivers equipped
    with weight sensors
•   Reactor monitoring by TV
    cameras
Siegfried
MRT at Siegfried                                 Actives
                                                 2_20


Reaction Candidates

Best suited for reactions with the properties:

• Fast, preferred within seconds
• Mixing controlled
• (highly) Exothermic
• Narrow temperature window between
   the desired reactionandside product
  formation
• Safety concerns
• Catching short lived intermediates
Siegfried

MRT at Siegfried                                                  Actives
                                                                  2_21



Capabilities
Materials of Construction            Glass, SS/Hastelloy
Temperature range explored so far:   -60 C to +300 C
Pressure range explored so far:      100 bar
Reactor capacity:                    200 mL/min = 290 L/day = 9
MT/month
Integration into Pilot               done (glass unit)
Integration into Plant               mobile unit for Mfg areas
Siegfried
MRT at Siegfried                                                                                      Actives
                                                                                                      2_22


MRT Reactions
Reaction type                                                     O                                            R

• Aromatic boronic acid                           MgX                                    DCM
                                                                                                                    OMe
• Metalorganic reaction (doubel de-
  protonation)                                              OH O                                               R
                                                                                Cl           O
• Pinacolato-dichloromethylborane                                                        B
                                                  B(OH)2                        Cl           O                      OH
  formation                                                       RO        O

• Demethylation or MeO-Aryl
                                              R                        O                  CONH2                R'
• Nitration of an aromatic system                                                         CONH2          RHN
                                                                                                                        OR

• Epoxide opening with ammonia                    H                                                                 O

• Hetereocyclization (Barbiturate)                                                           O
                                              R                  NH2                                           R'       Cl
• Multi-step sequence; deprotonation,                                                            NH
                                                                                                         RHN
  silylation, alkylation, hydrolysis              NO2             OH                 O       N                      O
                                                                                             H
• a-Alkylation of a carboxylic acid
• O-Nitration of an aromatic alcohol          CO2H         Ary             OH   HO               OH            CO2R
                                                                                (Cl)
• Mono-nitration of an aliphatic diol
• Nitration of an aliphatic alcohol
• Ammonolysis of an ester
                                              CO2H                              HO           ONO2
                                                           Ary         ONO2                                    CONH2
• Oxidation with hydrogen peroxide      Alk                                     (Cl)
Siegfried
MRT at Siegfried                                                                  Actives
                                                                                  2_23

Case Study: DCM-BPin


Reaction Scheme and Paths to By-Products


 Desired Transformation                  O
                                             B O
             LDA                         O                       Li+                     O       Cl
                               Li                  O        O
                                                       B-                                    B
Cl    Cl                  Cl        Cl                          Cl                       O       Cl
                                                   O
                                                       Cl
                                                                                 DCM-BPin


 Side-Reactions

                     carbenes and                          Cl
                     their degradation                                 other un-identified
                                         O         O             Cl    by-products
                     products
                                             B O       B
                                         O         O
Siegfried
MRT at Siegfried                               Actives
                                               2_24


Case Study: DCM-BPin

 100%

  80%

  60%                                Product
                                     Starting Material
  40%                                By-Products

  20%

  0%
        batch -55°C    0°C   -40°C
Siegfried
                                  Actives
                                  2_25




            Overview
Siegfried
            Services
            Chemical Development
            Chemical Production
            Compliance
            Standard Products
            Formulation
Siegfried
Chemical Production                                                        Actives
                                                                           2_26


Chemical Reaction Capabilities

More than 200 chemical reactions possible in-house, with specific expertise in:

•   Alcoholysis, alkoxylation, amidation   •   Hydrogenation with catalyst or
•   Bromination, chlorination                  hydrides
•   Chloromethylation, chlorosulfonation   •   Organometallic reactions
•   Cyanidation, decarboxylation           •   Nitration, Mannich reaction
•   Dehalogenation, diazotation,           •   Phase transfer reaction
    Diels-Alder                            •   Resolution of racemates
•   Epichlorohydrine reaction,             •   Sandmeyer reaction
    formulation
•   Friedel-Crafts, Gattermann, Grignard
Chemical Production                                           Siegfried
                                                              Actives
                                                              2_27

Capabilities & Capacity (1)
Capacity                      Zofingen                     Pennsville
Number of reactors                   120                                  52

Output/year [tons/year]           >1000                              >300

Output range [tons]             0.5 – 500                   0.05 – 150
Range of reactor
                              800 – 5000                    350 – 7600
volumes [litres]

Total reactor volume [m3]            360                              200

Drying capacity [m3]                  25                                  30

                                                           -15 to +165
Temperature range [°C]        -80 to +250
                                            special equipment up to 350
Chemical Production                                                     Siegfried
                                                                        Actives
                                                                        2_28

Capabilities & Capacity (2)
Capacity                                Zofingen                     Pennsville
Pressure range                    1 mbar to 40 bar              1 mbar to 20 bar

Distillation capacity [m3]                      5.5                                  3

Crystallization capacity [m3]                    32                                 40

Solvent distillation [m3]                        22                                  8

Short path distillation                       KD10                                   -
                                 Centifuges, Filter    Centifuges, Filter presses,
Product isolation
                                  presses, Nutch                             Nutch
                                Frewitt Impact Mill,
Mills                                                                  Fitzpatrick
                                 Universal, Sieves
Chemical Production                                     Siegfried
                                                        Actives
                                                       2_29

Pilot and commercial spray dryer

                             Pilot Spray Dryer:

                             •Model - Anhydro PSD 52 CC.
                             •Evaporation rate at max temp =
                             4kg/h water or 20kg/h organic
                             solvents (e.g. acetone)
                             •Max inlet temp = 250 C
Chemical Production                                     Siegfried
                                                        Actives
                                                        2_30

Pilot and commercial spray dryer

                             Commercial Spray Dryer:

                             Model - Anhydro MS 400 CC
                             Water evaporation rate at max

                             temp = 12 kg/hr or 60kg/h organic
                             solvents (e.g. acetone)
                             Max inlet temp = 250 C
Chemical Production                  Siegfried
                                     Actives
                                     2_31
                                      3.5.4.3

Process Technology


Biazzi high pressure reactor

•   2.0 m3 stainless steel reactor
•   Reactions up to 40 bars
•   Catalyst charging vessel
•   Mott filter to remove catalyst
•   Enlarged heat exchange surface
Chemical Production                      Siegfried
                                         Actives
                                         2_32
                                          3.5.4.7

Isolation


Packaging

•   Room classification D
    (<100,000 particles per cubic foot
    air allowed)
•   GMP floors and walls (Terazzo)
    (easy to clean)
•   Personnel / material air lock
Siegfried
                                  Actives
                                  2_33




            Overview
Siegfried
            Services
            Chemical Development
            Chemical Production
            Compliance
            Standard Products
            Formulation
Siegfried
Compliance                                                                      Actives
                                                                                2_34


Quality Management



                            Siegfried Compliance

        Chemical Development, sites Zofingen, Pennsville


        API production, sites Zofingen, Pennsville


        Pharmaceutical Development, sites Zofingen, Munich


         Final dosage forms production, site Malta


     Quality              Quality              Regulatory    Safety, Health &
    Assurance             Control                Affairs      Environment
Compliance                                                          Siegfried
                                                                    Actives
                                                                    2_35

Regulatory Documentation


•   Complete registration files or parts thereof
•   CMC-parts for NDAs/ANDAs
•   Drug master files (DMF type II) for EU or US (currently more than 20 US
    DMFs)
•   Manufacturing documentation for submission and update of IND
•   Certificates of Suitability to the European Pharmacopeia (CEP)
•   Support during registration incl. response to deficiency letters
•   Support after filing with maintenance of the registration documentation
Siegfried
Compliance                                                                                Actives
                                                                                          2_36


Outstanding Track Record
Zofingen                                          Pennsville
Authority   Date        Result                    Authority             Date            Result
RFS         Nov 2002    GMP Certificate           FDA                   May/June 2003   NAI
FDA         June 2003   NAI                       FDA                   Sept 2004       NAI
RHI         Feb 2004    GMP Certificate           FDA                   June 2006       NAI
RHI         Nov 2004    GMP Certificate           FDA                   Dec 2007        NAI
FDA         Aug 2006    NAI                       FDA                   Jan 2008        NAI
RHI         Nov 2006    GMP Certificate           FDA                   Dec 2008        NAI
RHI         Dec 2006    GMP Certificate           FDA                   May 2009        NAI
RHI         Feb 2007    GMP Certificate
RHI         June 2007   GMP Certificate
FDA         Nov 2007    NAI
RHI         June 2007   GMP Certificate
FDA         July 2008   NAI



                          RFS =Regionale FachStelle für Arzneimittel
                          RHI =Regionales Heilmittel-Inspektorat)
                          FDA = Food & Drug Administration
Siegfried
                                  Actives
                                  2_37




            Overview
Siegfried
            Services
            Chemical Development
            Chemical Production
            Compliance
            Standard Products
            Formulation
Siegfried
Multiclients (Standard Products)                                       Actives
                                                                       2_38


Commitment to Controlled Substances Market
•   Product range of over 20 different controlled products
•   Opiate Technology platform for the development of novel APIs with
    customers
•   One out of five NRM import license holders in the U.S.A.
•   Long-term Supply Positions for key Narcotic Raw Materials (NRM)
•   GMP manufacturing sites in Pennsville, U.S.A. and Zofingen, Switzerland
•   Maintain an excellent track record with regulatory authorities such as
    DEA and Swissmedic
Multiclient (Standard Products)                                                           Siegfried
                                                                                          Actives
                                                                                          2_39

Product overview
                    Pain management            Addiction treatment      CNS disorders


 Opiate APIs       Buprenorphine Hydrocodone   Buprenorphine

                   Hydromorphone               Naloxone*

                   Morphine                    Naltrexone*

                   Oxycodone

                   Oxymorphone*


 Nicotine                                      Nicotine

                                               Nicotine bitartrate

                                               New Nicotine products*


 Controlled        Propoxyphene Methadone      Methadone                Butalbital

 substances                                                             Dexmethylphenidate

                                                                        Pentobarbital

                                                                        Phenobarbital

                                                                        Mephobarbital

      * Products in development / validation                            Methylphenidate
Siegfried
                                  Actives
                                  2_40




            Overview
Siegfried
            Services
            Chemical Development
            Chemical Production
            Compliance
            Standard Products
            Formulation
Siegfried
Formulation                                                 Actives
                                                            2_41

Solid Oral Dosage Forms


•   Granules
•   Powder mixtures          With immediate, sustained or
•   Tablets                  modified release profiles
•   Filmcoated tablets
•   Hard gelatine capsules
Siegfried
Formulation                                                      Actives
                                                                 2_42


Capabilities

Analytical and Pharmaceutical Development of all kinds of Solid Oral
Dosage Forms for the EU and US Market

•      Compatibility Studies
•      Small Scale Formulation Work
•      Clinical Trial Batches
•      Analytical Method Development
•      Full GMP validation of analytical methods and manufacturing
       process
•      Tech-transfer and Process Optimization
•      Stability testing according to ICH
•      Source Documents for Registration
Siegfried
Formulation                                                        Actives
                                                                   2_43


Pharmaceutical Development - Technologies

Broad Range of Technologies for Oral Solid Dosage Forms


•       Powder Blending
•       Wet Granulation with High Shear Mixer
•       Fluid Bed Spray Granulation/ Drying
•       Roller compaction
•       One-pot Granulation
•       Pellet Extrusion and Spheronisation
•       Tablet compression
•       Coating (Granules, Pellets, Tablets)
•       Hard Gelatin Capsule Filling (Granules, Powder, Pellets)
Siegfried
Formulation                                                                                Actives
                                                                                           2_44


Pharmaceutical Development - Equipment
Equipment                         Type                           Capacity
Freefall blender                  Turbula blender                200 ml – 10 l
                                  Rhönrad blender                50 / 100 l
Roller compactor (June 07)        Powtec RCC 100x20              50g – 10kg / h
High shear mixer                  Diosna P 1-6/2/4/10/25/50      0.5-50 l
Fluid bed granulator/ drier,      Mini Glatt                     200 ml l
Wurster (Pellets)                 Glatt GCPG 3 / 1               5, 7 l (Wurster 5, 7 l)
                                  Glatt GPCG 15 pro (Q3 2006)    42 l (Wurster 20l)
Oscillating sieve                 Frewitt TC 150                 0.6/0.8/1.0/1.2 mm
                                  Frewitt MF3
Rotating sieve                    Frewitt TC Lab                 0.6/0.8/1.0/1.2 mm
Tabletting machines               Excenter press: Korsch EK0     up to 12‘000 tablets/hour
                                  Rotary press: Fette Perfecta
                                  Rotary press: Korsch XL 100
Hardgelatin capsules filling      Zanasi LZ/64                   up to 4000 capsules /hour
maschine with 100% weight control Sade Weight controller         up to 3000 caps or tabl./ hour
Coater                            Glatt GC 300                   1-3 l
                                  Glatt GMP II                   2l, 9l, 24, 56l
Stirring container                Glatt                          25 l
One-pot granulator                Diosna VAC 50 (10, 25, 50)     10 – 50 l
Extruder                          Nica E140                      0.5 - 2kg/min
Spheronizer                       Nica S 450                     0.4 - 2kg/min
Drying oven (vacuum)              Heraeus VT 6130 M              3- 5 kg
Siegfried
Conclusion                                                    Actives
                                                              2_45


Why Siegfried?

Siegfried Actives is fast:
• From inquiry to delivery

Siegfried Actives is reliable:     •   Ease of doing business
• Custom development services
                                   •   Delivering on promises
• Custom manufacturing services
• Standard API supplies
                                   •   Security of supply
• Regulatory experience            •   Regulatory expertise
                                   •   Optimizing total cost of
Siegfried Actives is flexible:         ownership for you
• Tailored services to best meet
  customer requirements

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Siegfried Exclusive Presentation Final

  • 1. Siegfried at a glance
  • 2. Siegfried Actives 2_2 Overview Siegfried Services Chemical Development Chemical Production Compliance Standard Products Formulation
  • 3. Siegfried Overview Actives 2_3 Siegfried Group: Profile • Global presence: 4 sites in EU & US • >130 years in pharma industry • Listed on the Swiss Stock Exchange (SWX) • Concentration on the development and manufacturing of APIs, intermediates, and finished dosage forms incl. inhalation products • Total work force: approx. 800 • Annual sales CHF: > 350 mio • >120 commercialized products in last 40 yrs
  • 4. Siegfried Overview Actives 2_4 Siegfried Group: Vision To be a world-class partner in developing and manufacturing drugs that improve human life. A leader in: • Speed • Reliability • Flexibility
  • 5. Siegfried Overview Actives 2_5 Siegfried Group: Divisions Siegfried Actives Siegfried Drug Product Development and Development and manufacture of active production of pharmaceutical finished dosage ingredients (API). forms. Exclusives: • Custom process and • Custom packaged method development products • Custom manufacturing • Inhalation products services • Manufacturing and supply chain services Multi Clients: • Regulatory services • Supply of generic APIs • Opiate APIs • Controlled substances •DEA license
  • 6. Siegfried Overview Actives 2_6 Siegfried Group: Locations Plus various agents around the world Siegfried Pharma Headquarters Siegfried UK Alpine Dragon Siegfried Shanghai Development GmbH Siegfried Ltd Branch office Pharma Sourcing Office Munich, Germany Siegfried Actives Stockton, UK Wuwei, China Shanghai, China Höchstädt, Germany Siegfried Drug Product Zofingen, Switzerland Siegfried (USA), Inc. Siegfried (Malta) Ltd SCI Pharmtech, Inc. Pennsville, U.S.A. Malta Taipei, Taiwan
  • 7. Siegfried Actives 2_7 Overview Siegfried Services Chemical Development Chemical Production Compliance Standard Products Formulation
  • 8. Siegfried Services Actives 2_8 Meeting Customer Needs Service offering Customer value Goal • Key account and • Speed – product from inquiry to management delivery • Project • Reliability – management on time, in budget, Maximize and at expectation your benefit • Supply chain management • Flexibility – tailored service solu- • Regulatory support tions meet changing needs • Quality management
  • 9. Siegfried Services Actives 2_9 Project Management Offering Project planning • Addressing customer requirements • Target setting and scope definition/tracking Project execution • Dedicated project management (PM) • Tracking & Communication Chemical • Extensive corporate Expertise development • Scale-up experience of over 500 processes Team management • Cross-functional project teams • Joint Customer/Siegfried team
  • 10. Services Siegfried Actives 2_10 Project Management - Life Cycle Solid finished dosage forms Full-scale production* Kilo lab/pilot plant* Laboratory development Laboratory feasibility study Technical Transfer Package, project evaluation & quotation Project Confidentiality agreement Management Customer inquiry * Location depends on capacity, capability & regulatory needs
  • 11. Services Siegfried Actives 2_11 Project Management - Project Leadership Team External role Customer BD/Project Internal role Manager Development Purchasing Project Leadership Production Team (PLT) Quality Pilot Plant Analytic Point to Point contacts are set at project inception
  • 12. Siegfried Services Actives 2_12 Project Management Benefits • Single point of contact for project • Timely communication • Ease of doing business • Reliable project delivery • Flexibility & speed “Exceed Customer Expectations”
  • 13. Siegfried Services Actives 2_13 Supply Chain Management Production planning • Maintaining flexibility while optimizing efficiency Manufacturing • Multipurpose facilities • Highly trained personel • Short cycle times Inventory management • Optimizing availability and working capital • Managing safety stock • Purchasing • Worldwide sourcing of key raw materials with permanent presence in China
  • 14. Siegfried Actives 2_14 Overview Siegfried Services Chemical Development Chemical Production Compliance Standard Products Formulation
  • 15. Siegfried Chemical Development Actives 2_15 Overview Process development leading to scaleable and robust processes by • Process research and development of APIs and key intermediates • Evaluation of new synthesis routes • Analytical development • Process optimization • Scale-up and pilot services • cGMP compliant small scale production • Supporting services: Logistics / In-house safety tests / Quality assurance
  • 16. Siegfried Chemical Development Actives 2_16 Key Technologies – The Siegfried Difference • High Potency 1.0µg/m3 (OEL 3) in production and pilot plant • High Potency 0.1µg/m3 (OEL 4) in development • Cryogenics • Micro Reactor Technology • Spray-Drying • Expertise in Polymorphology & Crystallization • Process Safety Laboratories • Small-scale & Pilot cGMP Production • Analytical Method Development & API Release Testing
  • 17. Siegfried Chemical Development Actives 2_17 Key Expertise Team 30 Ph.D. Chemists 4 full time Project Managers 4 full time Analytical Project Leaders 12 Chemical Engineers 29 Lab Technicians (3 year apprentice) 12 Chemical Operators (3 year apprentice) Experience • Methods validated according to ICH guidelines; >500 • Process evaluation for more than 1900 compounds • Scale up of more than 500 processes • Ability to run 50 development projects in parallel
  • 18. Siegfried Chemical Development Actives 2_18 Lab, Kilolab & Pilot Plant Laboratories: • 10 laboratories • 30 Ph.D. chemists • 83 staff Kilolab: • Steel and glass-lined reactors (30- 60L) • Temperature range -60oC to 220oC • Coated centrifuge • Mettler Reaction Calorimeter (RC1) • Automated synthesis workstation • Mettler LabMax with IR for IPC Pilot plant: • Steel & glass-lined reactors (250- 500L) • Hydrogenation reactor (steel 250L) • Centrifuge • Stainless steel paddle dryer 250L • Alpine & Fitzpatrick mills
  • 19. Siegfried Development Building Actives 2_19 3.4.5.5 cGMP Wall • cGMP wall to separate operating room and technical part • Minimized cross-contamination • Efficient cleaning possible • Remote-controlled valves • Feed tanks & receivers equipped with weight sensors • Reactor monitoring by TV cameras
  • 20. Siegfried MRT at Siegfried Actives 2_20 Reaction Candidates Best suited for reactions with the properties: • Fast, preferred within seconds • Mixing controlled • (highly) Exothermic • Narrow temperature window between the desired reactionandside product formation • Safety concerns • Catching short lived intermediates
  • 21. Siegfried MRT at Siegfried Actives 2_21 Capabilities Materials of Construction Glass, SS/Hastelloy Temperature range explored so far: -60 C to +300 C Pressure range explored so far: 100 bar Reactor capacity: 200 mL/min = 290 L/day = 9 MT/month Integration into Pilot done (glass unit) Integration into Plant mobile unit for Mfg areas
  • 22. Siegfried MRT at Siegfried Actives 2_22 MRT Reactions Reaction type O R • Aromatic boronic acid MgX DCM OMe • Metalorganic reaction (doubel de- protonation) OH O R Cl O • Pinacolato-dichloromethylborane B B(OH)2 Cl O OH formation RO O • Demethylation or MeO-Aryl R O CONH2 R' • Nitration of an aromatic system CONH2 RHN OR • Epoxide opening with ammonia H O • Hetereocyclization (Barbiturate) O R NH2 R' Cl • Multi-step sequence; deprotonation, NH RHN silylation, alkylation, hydrolysis NO2 OH O N O H • a-Alkylation of a carboxylic acid • O-Nitration of an aromatic alcohol CO2H Ary OH HO OH CO2R (Cl) • Mono-nitration of an aliphatic diol • Nitration of an aliphatic alcohol • Ammonolysis of an ester CO2H HO ONO2 Ary ONO2 CONH2 • Oxidation with hydrogen peroxide Alk (Cl)
  • 23. Siegfried MRT at Siegfried Actives 2_23 Case Study: DCM-BPin Reaction Scheme and Paths to By-Products Desired Transformation O B O LDA O Li+ O Cl Li O O B- B Cl Cl Cl Cl Cl O Cl O Cl DCM-BPin Side-Reactions carbenes and Cl their degradation other un-identified O O Cl by-products products B O B O O
  • 24. Siegfried MRT at Siegfried Actives 2_24 Case Study: DCM-BPin 100% 80% 60% Product Starting Material 40% By-Products 20% 0% batch -55°C 0°C -40°C
  • 25. Siegfried Actives 2_25 Overview Siegfried Services Chemical Development Chemical Production Compliance Standard Products Formulation
  • 26. Siegfried Chemical Production Actives 2_26 Chemical Reaction Capabilities More than 200 chemical reactions possible in-house, with specific expertise in: • Alcoholysis, alkoxylation, amidation • Hydrogenation with catalyst or • Bromination, chlorination hydrides • Chloromethylation, chlorosulfonation • Organometallic reactions • Cyanidation, decarboxylation • Nitration, Mannich reaction • Dehalogenation, diazotation, • Phase transfer reaction Diels-Alder • Resolution of racemates • Epichlorohydrine reaction, • Sandmeyer reaction formulation • Friedel-Crafts, Gattermann, Grignard
  • 27. Chemical Production Siegfried Actives 2_27 Capabilities & Capacity (1) Capacity Zofingen Pennsville Number of reactors 120 52 Output/year [tons/year] >1000 >300 Output range [tons] 0.5 – 500 0.05 – 150 Range of reactor 800 – 5000 350 – 7600 volumes [litres] Total reactor volume [m3] 360 200 Drying capacity [m3] 25 30 -15 to +165 Temperature range [°C] -80 to +250 special equipment up to 350
  • 28. Chemical Production Siegfried Actives 2_28 Capabilities & Capacity (2) Capacity Zofingen Pennsville Pressure range 1 mbar to 40 bar 1 mbar to 20 bar Distillation capacity [m3] 5.5 3 Crystallization capacity [m3] 32 40 Solvent distillation [m3] 22 8 Short path distillation KD10 - Centifuges, Filter Centifuges, Filter presses, Product isolation presses, Nutch Nutch Frewitt Impact Mill, Mills Fitzpatrick Universal, Sieves
  • 29. Chemical Production Siegfried Actives 2_29 Pilot and commercial spray dryer Pilot Spray Dryer: •Model - Anhydro PSD 52 CC. •Evaporation rate at max temp = 4kg/h water or 20kg/h organic solvents (e.g. acetone) •Max inlet temp = 250 C
  • 30. Chemical Production Siegfried Actives 2_30 Pilot and commercial spray dryer Commercial Spray Dryer: Model - Anhydro MS 400 CC Water evaporation rate at max temp = 12 kg/hr or 60kg/h organic solvents (e.g. acetone) Max inlet temp = 250 C
  • 31. Chemical Production Siegfried Actives 2_31 3.5.4.3 Process Technology Biazzi high pressure reactor • 2.0 m3 stainless steel reactor • Reactions up to 40 bars • Catalyst charging vessel • Mott filter to remove catalyst • Enlarged heat exchange surface
  • 32. Chemical Production Siegfried Actives 2_32 3.5.4.7 Isolation Packaging • Room classification D (<100,000 particles per cubic foot air allowed) • GMP floors and walls (Terazzo) (easy to clean) • Personnel / material air lock
  • 33. Siegfried Actives 2_33 Overview Siegfried Services Chemical Development Chemical Production Compliance Standard Products Formulation
  • 34. Siegfried Compliance Actives 2_34 Quality Management Siegfried Compliance Chemical Development, sites Zofingen, Pennsville API production, sites Zofingen, Pennsville Pharmaceutical Development, sites Zofingen, Munich Final dosage forms production, site Malta Quality Quality Regulatory Safety, Health & Assurance Control Affairs Environment
  • 35. Compliance Siegfried Actives 2_35 Regulatory Documentation • Complete registration files or parts thereof • CMC-parts for NDAs/ANDAs • Drug master files (DMF type II) for EU or US (currently more than 20 US DMFs) • Manufacturing documentation for submission and update of IND • Certificates of Suitability to the European Pharmacopeia (CEP) • Support during registration incl. response to deficiency letters • Support after filing with maintenance of the registration documentation
  • 36. Siegfried Compliance Actives 2_36 Outstanding Track Record Zofingen Pennsville Authority Date Result Authority Date Result RFS Nov 2002 GMP Certificate FDA May/June 2003 NAI FDA June 2003 NAI FDA Sept 2004 NAI RHI Feb 2004 GMP Certificate FDA June 2006 NAI RHI Nov 2004 GMP Certificate FDA Dec 2007 NAI FDA Aug 2006 NAI FDA Jan 2008 NAI RHI Nov 2006 GMP Certificate FDA Dec 2008 NAI RHI Dec 2006 GMP Certificate FDA May 2009 NAI RHI Feb 2007 GMP Certificate RHI June 2007 GMP Certificate FDA Nov 2007 NAI RHI June 2007 GMP Certificate FDA July 2008 NAI RFS =Regionale FachStelle für Arzneimittel RHI =Regionales Heilmittel-Inspektorat) FDA = Food & Drug Administration
  • 37. Siegfried Actives 2_37 Overview Siegfried Services Chemical Development Chemical Production Compliance Standard Products Formulation
  • 38. Siegfried Multiclients (Standard Products) Actives 2_38 Commitment to Controlled Substances Market • Product range of over 20 different controlled products • Opiate Technology platform for the development of novel APIs with customers • One out of five NRM import license holders in the U.S.A. • Long-term Supply Positions for key Narcotic Raw Materials (NRM) • GMP manufacturing sites in Pennsville, U.S.A. and Zofingen, Switzerland • Maintain an excellent track record with regulatory authorities such as DEA and Swissmedic
  • 39. Multiclient (Standard Products) Siegfried Actives 2_39 Product overview Pain management Addiction treatment CNS disorders Opiate APIs Buprenorphine Hydrocodone Buprenorphine Hydromorphone Naloxone* Morphine Naltrexone* Oxycodone Oxymorphone* Nicotine Nicotine Nicotine bitartrate New Nicotine products* Controlled Propoxyphene Methadone Methadone Butalbital substances Dexmethylphenidate Pentobarbital Phenobarbital Mephobarbital * Products in development / validation Methylphenidate
  • 40. Siegfried Actives 2_40 Overview Siegfried Services Chemical Development Chemical Production Compliance Standard Products Formulation
  • 41. Siegfried Formulation Actives 2_41 Solid Oral Dosage Forms • Granules • Powder mixtures With immediate, sustained or • Tablets modified release profiles • Filmcoated tablets • Hard gelatine capsules
  • 42. Siegfried Formulation Actives 2_42 Capabilities Analytical and Pharmaceutical Development of all kinds of Solid Oral Dosage Forms for the EU and US Market • Compatibility Studies • Small Scale Formulation Work • Clinical Trial Batches • Analytical Method Development • Full GMP validation of analytical methods and manufacturing process • Tech-transfer and Process Optimization • Stability testing according to ICH • Source Documents for Registration
  • 43. Siegfried Formulation Actives 2_43 Pharmaceutical Development - Technologies Broad Range of Technologies for Oral Solid Dosage Forms • Powder Blending • Wet Granulation with High Shear Mixer • Fluid Bed Spray Granulation/ Drying • Roller compaction • One-pot Granulation • Pellet Extrusion and Spheronisation • Tablet compression • Coating (Granules, Pellets, Tablets) • Hard Gelatin Capsule Filling (Granules, Powder, Pellets)
  • 44. Siegfried Formulation Actives 2_44 Pharmaceutical Development - Equipment Equipment Type Capacity Freefall blender Turbula blender 200 ml – 10 l Rhönrad blender 50 / 100 l Roller compactor (June 07) Powtec RCC 100x20 50g – 10kg / h High shear mixer Diosna P 1-6/2/4/10/25/50 0.5-50 l Fluid bed granulator/ drier, Mini Glatt 200 ml l Wurster (Pellets) Glatt GCPG 3 / 1 5, 7 l (Wurster 5, 7 l) Glatt GPCG 15 pro (Q3 2006) 42 l (Wurster 20l) Oscillating sieve Frewitt TC 150 0.6/0.8/1.0/1.2 mm Frewitt MF3 Rotating sieve Frewitt TC Lab 0.6/0.8/1.0/1.2 mm Tabletting machines Excenter press: Korsch EK0 up to 12‘000 tablets/hour Rotary press: Fette Perfecta Rotary press: Korsch XL 100 Hardgelatin capsules filling Zanasi LZ/64 up to 4000 capsules /hour maschine with 100% weight control Sade Weight controller up to 3000 caps or tabl./ hour Coater Glatt GC 300 1-3 l Glatt GMP II 2l, 9l, 24, 56l Stirring container Glatt 25 l One-pot granulator Diosna VAC 50 (10, 25, 50) 10 – 50 l Extruder Nica E140 0.5 - 2kg/min Spheronizer Nica S 450 0.4 - 2kg/min Drying oven (vacuum) Heraeus VT 6130 M 3- 5 kg
  • 45. Siegfried Conclusion Actives 2_45 Why Siegfried? Siegfried Actives is fast: • From inquiry to delivery Siegfried Actives is reliable: • Ease of doing business • Custom development services • Delivering on promises • Custom manufacturing services • Standard API supplies • Security of supply • Regulatory experience • Regulatory expertise • Optimizing total cost of Siegfried Actives is flexible: ownership for you • Tailored services to best meet customer requirements