1. 1
RECIPHARM
DEVELOPMENT SERVICES
TURNING MOLECULES INTO PRODUCTS
May 2015

2. RECIPHARM GROUP KEY FACTS
• Contract development and manufacture
‒ API and drug product
• Established in 1995
• Since 2007 primarily a CDMO
• 2014 Revenue SEK 3.3 bn (approx. €340m)
• About 2200 employees
• Traded at the NASDAQ OMX Stockholm since April 2014
• >400 products in >100 markets
• 2 development facilities in Sweden and France
• 14 commercial manufacturing facilities:
‒ Sweden (4), France (2), UK (1), Germany (1), Portugal (2) Italy
(3)and Spain (1)
2

3. SITES ACROSS EUROPE
322 June 2016
Italy
LAINATE (Milano)
● Lyophilised sterile beta lactam antibiotics
MASATE (Milano)
● Lyophilisates
● Liquid fills
PADERNO DUGNANO (Milano)
● API development
● API manufacturing
Portugal
QUELUZ (Lisbon)
● Solids
● Liquids
● Semi-solid
● Some development
ODIVELAS (Lisbon)
● Solids
● Liquids
● Semi-solids
● Steriles
● Some development
Sweden
JORDBRO, HQ
HÖGANÄS
● Solids (granulates &
powders)
KARLSKOGA
● Semi-solids
SOLNA
● Development
Services
STOCKHOLM
● Solids
STRÄNGNÄS
● Beta lactams
(solid forms and
dry syrups)
UK
ASHTON
● Solids
● Semi-solids
● Inhalors
Germany
WASSERBURG
● Lyophilisates
● Steriles
France
FONTAINE
● Solids
MONTS
● Steriles
PESSAC
● Development
Services
Spain
PARETS
● Solids
● Semi-solids
● Liquids

4. RECIPHARM AB
4
CEO
Thomas Eldered
Manufacturing
Services, COO and
Executive VP
*Kjell Johansson
Operations
Development,
VP
*Magnus Renck
Business Management,
VP
*Kenth Berg
Development &
Technology,
Executive VP
*Carl-Johan Spak
Corporate
Development,
Executive VP
*Mark Quick
Human Resources,
VP
*Jonas Lejontand
Executive Assistant
Gunilla Rydquist
Legal, Company
Lawyer
Erik Domines
Financial, Control &
Investor Relations,
CFO & Executive VP
*Björn Westberg
* Group Management Team

5. DEVELOPMENT & TECHNOLOGY
Development &
Technology
Carl-Johan Spak
Recipharm
Pessac SA
Stéphane Guisado
Recipharm
Pharmaceutical
Development AB
Maria Lundberg
Recipharm
Pharmaceutical
Products AB
Johan Åkerblom
Recipharm
Venture Fund
Carl-Johan Spak
Sales
Torkel Gren
5

6. RECIPHARM PHARMACEUTICAL DEVELOPMENT
SERVICES
• Development unit within Recipharm group since 1995
• Two dedicated development sites
‒ Pessac, France, ~110 employees
‒ Solna, Sweden, ~45 employees
‒ Special development at some commercial sites
• Relatively small sites focused on development
‒ flexibility & speed
• Collaboration with 14 commercial manufacturing sites
• Extensive experience of development of drug products for
clinical trials and market
Large enough to deliver
Small enough to be fast and flexible

7. PHARMACEUTICAL DEVELOPMENT SERVICES
7
API development
Raw and packaging material
selection and sourcing
Formulation development
and drug delivery
Analytical method
development and validation
Clinical supply
Phase I and BE clinical trials
(through partner)
Stability studies
Regulatory services
22 June 2016
Project management Scale up and technology
transfer

8. SEAMLESS COORDINATED DEVELOPMENT SERVICES
• Recipharm offers a complete package of drug development services from
molecule to product
• API development (Milan)
• Drug Product development (Pessac and Solna)
• Phase I and BE clinical trials (through partner, CTC Uppsala, Sweden)
• Tech transfer to commercial manufacture
• RECIPHARM – THE PHARMACEUTICAL DEVELOPMENT ONE STOP SHOP
‒ With the option to buy just one piece
8
API
Drug
Product
Clinical Trial
Commercial
Manufacture

9. CUSTOMER DISTRIBUTION
FOR SOLNA SITE
Small R&D
Big Pharma
Small and midsize
pharma
Other

10. 10
API DEVELOPMENT

11. API DEVELOPMENT CAPABILITIES
• GMP manufacture of Active Pharmaceutical Ingredients
• Development of chemical processes and analytical methods up to
registration on a global basis (EU, US, Japan, etc…)
• Most types of substances can be manufactured
‒ No cytostatics hormones and betalactam antibiotics
• Our plant can produce batch size from 1 g to 400 kg
• GMP kilo lab dedicated to small volume API (1 gr/ 1 kg)
• GMP Pilot (up to 5-10 kg)
• Commercial manufacturing available (up to 400kg)
• Technical transfer capabilities
• Approved for human and veterinary applications
• APIs support for all clinical phases
• Site in Paderno Dugnano, close to Milan , Italy.

12. 12
DRUG PRODUCT DEVELOPMENT

13. ALL COMMON DOSAGE FORMS
Dosage form
Phase 1 Phase 2 Phase 3 Commercial
Tablets and
powder1
Yes Yes Yes Yes
Capsules2 Yes Yes Yes Yes
Coated beads Yes Yes Yes Yes
Semisolids Yes Yes Yes Yes
Oral liquids Yes Yes Yes Yes
Steriles Yes Yes Yes Yes
1Immediate-release tablets, coated tablets, enteric-coated tablets, sustained release tablets,
tablets with active substance(s) in different layers
2Coated or non-coated
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14. Special formulations
• Coated pellets
‒ for extended or delayed release
• Effervescent tablets
• Ophthalmic products
• Minitablets
• Metal coordinated
pharmaceuticals
• Parenteral polymers
14
Drug substances with special
requirements
• Controlled substances
• Beta-lactam antibiotics
‒ In collaboration with
manufacturing site
• Hormones
‒ In collaboration with
manufacturing site
SPECIAL CAPABILITIES

15. STATE OF THE ART PELLET DEVELOPMENT AND
MANUFACTURE
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• 1000 + 700 m2 with excellent equipment
• Batch size: 400 g – 150 kg
• Water or organic solvents
• Long experience in developing products for
clinical trials and the market
From US Patent 6,770,295

16. EFFERVESCENT TABLETS
• Offers a practical solution for high dose drugs that are
difficult to swallow
• Suitable especially for OTC products
• Developed and manufactured in Lisbon, Portugal
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17. OPHTHALMIC PRODUCTS
• Product for administration to the eye is an important niche
market
‒ The global ophthalmic therapeutic market > $15 billion
‒ Glaucoma is the most important indication
• Sterility often in combination with viscous products may be
challenging
• Existing projects
‒ Development in Solna, manufacturing Karlskoga
‒ Developed and manufactured in Lisbon Portugal
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18. MINITABLETS
• 3 mm or less
• Individualized dosing
‒ Optimal effect
‒ Less side effects
• Easy to swallow
• Convenient to use
• Can be combined with dosing device
19

19. METAL COORDINATED PHARMACEUTICALS
• Patentable entity created by
coordinating metal to known active
molecules
• Improved pharmacokinetic
properties through choice of metals
and adjuvants
• Different metals and ligands offer
great flexibility
• Potentially expedited regulatory
review
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CH3
S
CH3
O
CH3
S
CH3
O
R
O
O
R
O
N
H2
O
Mg
N
H2
Ligand

20. METAL CORDINATION CAN IMPROVE DIFFERENT
CHARACTERISTICS OF AN ACTIVE MOLECULE
• Improved water solubility
• Improved lipid solubility
• Improved and less variable bioavailability
• Controlled Release
• Targeted delivery
• Accelerated onset of action
• Increased bioadhesion
• Compatible with current formulation, delivery and targeting
technologies
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21. METAL COORDINATION IS A POWERFUL TOOL IN
PRODUCT DEVELOPMENT
• Improve the characteristics of new active molecules
‒ Better products
‒ Can be the difference between success and failure for a new
molecule with poor PK characteristics
‒ Improved patent protection
• Develop new products from known molecules
‒ Distinct therapeutic advantages
‒ Lower costs and less risk than developing new molecules
‒ Exclusivity through efficient patent protection
• Synthonics and Recipharm will collaborate in applying metal
coordination in the development of your product!
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22. POLYMERS FOR PARENTERAL APPLICATIONS
• New polymers offer opportunities in parenteral and local
drug delivery
‒ E.g. depot effect
• Pyrogen-free low bioburden polymers for sterile
applications are being provided
23

23. RECIPHARM SOLNA
• Located in Solna (Stockholm area) Sweden
• Fully compliant GMP Pharmaceutical Development Facilities
‒ EU approved
• Dedicated development facility in two floors (3,000 m2)
‒ GMP classified area: 500 m2
‒ Class B + Class C: 150 m2
• Flexible facility
• Development of most type of dosage forms
• Analytical development, QC lab, stability studies
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24. RECIPHARM PESSAC
• Located in Pessac (Bordeaux area, France)
• Fully compliant GMP Pharmaceutical Development and
Manufacturing Facilities
‒ FDA approved
‒ EU approved
• 45,000m² site with 9,700m² of production and development
space:
• State of art spray-coating equipment
• Analytical and microbiological laboratory
• QC lab and stability studies
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25. 26
CLINICAL TRIALS

26. RECIPHARM COLLABORATION WITH CTC FOR EFFICIENT
PHASE I TRIALS
• Through our collaboration with CTC Clinical Trial Consultants
AB we can offer benefits to customers
‒ simpler
‒ faster
‒ less costly
‒ more information can retrieved by adaptive design
• Benefits of carefully coordinating the work
‒ manufacture clinical trial material
‒ planning, performing and evaluating the clinical trial
‒ easy and smooth
‒ we take full responsibility for the coordination of all the work needed
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27. 28
COMMERCIAL MANUFACTURE

28. MANUFACTURING SITES
2922 June 2016
Italy
LAINATE (Milano)
● Lyophilised sterile beta lactam antibiotics
MASATE (Milano)
● Lyophilisates
● Liquid fills
PADERNO DUGNANO (Milano)
● API finished dose form manufacturing
Portugal
QUELUZ (Lisbon)
● Solids
● Liquids
● Semi-solids
ODIVELAS (Lisbon)
● Solids
● Liquids
● Semi-solids
● Steriles
Sweden
HÖGANÄS
● Solids (granulates &
powders)
KARLSKOGA
● Semi-solids
STOCKHOLM
● Solids
STRÄNGNÄS
● Beta lactams
(solid forms and
dry syrups)
UK
ASHTON
● Solids
● Semi-solids
● Inhalors
Germany
WASSERBURG
● Lyophilisates
● Steriles
France
FONTAINE
● Solids
MONTS
● Steriles
Pessac
● Coated pellets
Spain
PARETS
● Solids
● Semi-solids
● Liquids

29. DEVELOPMENT WITH COMMERCIAL MANUFACTURE IN
MIND
• Access to excellent experts in large scale manufacture during
the entire development
• Methods are developed in order to work well on large scale
equipment
• Efficient Tech Transfer
‒ Seamless tech transfer to our own manufacturing sites
‒ Our expertise allows smooth tech transfer to third parties
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30. PROJECT MODEL
• An experienced project manager follows the project from
quotation to delivery
‒ Overall responsible for meeting project goal
‒ The project manager is the main contact point for customer
• Effective communication
‒ Frequent status update meetings - frequency and meeting
forms are adapted to customer needs
‒ Customer is informed promptly if there are changes
• Project plan
‒ Agreed with customer, usually at face-to-face meeting
‒ Management meets weekly to track progress and solve any
resource issues in the projects
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31. SUMMARY
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A complete set of development services
From idea to commercial product
We are LARGE enough to deliver
SMALL enough to be fast and flexible

32. THANK YOU!
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