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1
October 2015

AURENA LABORATORIES
2
Aurena started in 2000, with a vision to create a successful international
business and become a strong, creative, posit...
3
Advancing the Art of Purity + Protection
What We Do
•  Full-service contract development and manufacturing
organization ...
4
Commercialisa+on	
  of	
  our	
  range	
  of	
  registered	
  por4olio	
  products	
  
Development	
  and	
  commerciali...
5
•  Cleanroom production areas
•  Tripled warehouse capacity
•  State-of-the-art laboratory spaces
	
  
Features Include:...
6
Technology
Platforms
Current & Future
Products
Manufacturing &
Development
Capabilities
Aurena Core Areas
ABOUT COMPANY
...
7
TECHNOLOGY
PLATFORMS
8
AURENA: Leader in
Bag-On-Valve
Packaging Techology
•  Leader in manufacturing of
final products in bag-on-valve
•  Formul...
9
•  Total separation of product and propellant
•  A bag with superior barrier properties
•  Complete oxygen protection
• ...
10
Unique	
  sprayable	
  petrolatum-­‐based	
  emollients	
  
Saline	
  solu+ons	
  for	
  ENT,	
  Eye	
  Care	
  &	
  Wo...
11
Working With Leading Suppliers
Aurena co-operates with leading bag-on-valve-
component suppliers like Aptar Group, Lind...
12
NEW
In June 2015, Aurena Laboratories announced a
partnership with Lipidor AB to combine Lipidor’s
proprietary AKVANO® ...
13
MANUFACTURING &
DEVELOPMENT
CAPABILITIES
14
Advancing the Art of Purity + Protection
Manufacturing Capabilities
•  Small-scale test filling of new formulations
•  F...
15
Drug-classified products in bag-on-valve packaging
Clinical trial material
Topical sprayable drug product
Products based...
16
Regulatory Compliance
MANUFACTURING & DEVELOPMENT CAPABILITIES
Certified in accordance
with SS-EN ISO
13485:2012.  	
  
...
17
Formulation Development
Regulatory Guidance
Preparation of technical files
for CE-marking
Writing of clinical reports
Wr...
18
CURRENT &
FUTURE PRODUCTS
19
Current Medical Device Products
CURRENT & FUTURE PRODUCTS
20
AURENA CE-mark Available For Brand Owners
•  Wound Cleansing/
Irrigation Sprays
•  Emollient Spray (Skin
Moisturizers)
...
21
Saliva substitute spray
Silicone-based scar gel spray
Liquid bandage spray
Range of NZ Kanuka honey based products: thr...
22
AKVANO® is a novel proprietary drug delivery technology. It represents a
completely new dosage form consisting of water...
23
1st Quarter 
2016
Available in Q1, 2016.
We are now seeking brand owners for distribution agreements:
Non-Drug AKVANO P...
24
Available in Q1, 2016.
We are now seeking brand owners for distribution agreements:
Drug Opportunities with AKVANO
CURR...
25
To date, 73 active substances, of which 45 are APIs, have been
tested successfully in AKVANO, including:
Drug Opportuni...
26
Contact Details
Aurena Laboratories
Fjärrviksvägen 22 653 50
Karlstad Sweden
+46 54 53 11 99
contact@aurenalabs.com
aur...
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About Aurena

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Find out more about Aurena and how we can work with you to revolutionize your products.

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About Aurena

  1. 1. 1 October 2015 AURENA LABORATORIES
  2. 2. 2 Aurena started in 2000, with a vision to create a successful international business and become a strong, creative, positive, and innovative force in the medical device and pharma industry. The company is family-owned by the Hedman’s and based in Karlstad, Sweden. ABOUT AURENA LABORATORIES
  3. 3. 3 Advancing the Art of Purity + Protection What We Do •  Full-service contract development and manufacturing organization (CDMO) specializing in the bag-on-valve aerosol dosage form •  Known for its range of registered medical devices •  Worldwide client base and currently exports products to all continents •  Effective, modern organization with a network of partners offering supporting services •  In 2016, Aurena will also offer cGMP-production of drug- classified products in bag-on-valve
  4. 4. 4 Commercialisa+on  of  our  range  of  registered  por4olio  products   Development  and  commercialisa+on  of  custom  versions  of  our  por4olio   products   Development  and  commercialisa+on  of  new  products  (medical  devices  &   drugs)  suitable  for  the  bag-­‐on-­‐valve  packaging   Development  and  manufacturing  of  products  based  on  the  partnerships   with  Clover  Hill  (Sparkling  Saline)  and  Lipidor  (AKVANO  lipid-­‐based  topical   formula+on  pla4orm)   1   2   3   4   How To Work With Us ABOUT COMPANY We are interested in becoming your strategic partner for development and manufacturing. If you have a project related to the business of Aurena, we are also open to discussing different investment opportunities.
  5. 5. 5 •  Cleanroom production areas •  Tripled warehouse capacity •  State-of-the-art laboratory spaces   Features Include: Expanded facility in Karlstad, Sweden Aurena broke ground for a 4,600 square meter new facility in early August 2015, and is expecting completion in Q2 2016.   The building will be designed to meet the requirements for manufacturing of medical devices and drugs in bag-on-valve packaging. •  Product mixing areas •  Designated area for handling of natural seawater  
  6. 6. 6 Technology Platforms Current & Future Products Manufacturing & Development Capabilities Aurena Core Areas ABOUT COMPANY TECH   PRODUCTS   MANU-­‐   FACTURING  
  7. 7. 7 TECHNOLOGY PLATFORMS
  8. 8. 8 AURENA: Leader in Bag-On-Valve Packaging Techology •  Leader in manufacturing of final products in bag-on-valve •  Formulations for packaging technology can be liquids, creams, ointments, gels or lipid-based •  Aurena offers the first transparent BOV-pack in a PET-aerosol called SprayPET reveal TECHNOLOGY PLATFORMS
  9. 9. 9 •  Total separation of product and propellant •  A bag with superior barrier properties •  Complete oxygen protection •  Many products can be made in a sterile presentation Why Bag-On- Valve for Pharma & Medical Device Products?
  10. 10. 10 Unique  sprayable  petrolatum-­‐based  emollients   Saline  solu+ons  for  ENT,  Eye  Care  &  Wound  Management   Natural  seawater-­‐based  products  for  ENT-­‐products   Silicone-­‐based  wound/skin  formula+ons   Hydrogels     1   2   3   4   5   Formulation Platforms TECHNOLOGY PLATFORMS
  11. 11. 11 Working With Leading Suppliers Aurena co-operates with leading bag-on-valve- component suppliers like Aptar Group, Lindal Group, Coster and PCC BAG-­‐ON-­‐VALVE  
  12. 12. 12 NEW In June 2015, Aurena Laboratories announced a partnership with Lipidor AB to combine Lipidor’s proprietary AKVANO® topical formulation technology with bag-on-valve packaging technology. Together, these two technologies offer new innovative product opportunities for customers across dermatology, wound, burn & skin care. We invite brand owners to start discussions with us. Commercialization of this technology will start Q1 2016. In partnership with Clover Hill we can offer the new proprietary innovation with Sparkling Nasal Spray. Take saline and seawater nasal sprays to the next level. We invite brand owners to start discussions with us. Commercialization of this technology will start Q1 2016. AKVANO – Topical Spray Formulation Technology Clover Hill Healthcare Inc. Sparkling Nasal Spray Q1  2016   NEW Q1  2016   New Strategic Partnerships
  13. 13. 13 MANUFACTURING & DEVELOPMENT CAPABILITIES
  14. 14. 14 Advancing the Art of Purity + Protection Manufacturing Capabilities •  Small-scale test filling of new formulations •  Filling of products for clinical trials •  Filling of products for stability studies •  Commercial production •  Mixing and filling also of flammable products •  Products can be mixed by Aurena or filled from bulk tanks
  15. 15. 15 Drug-classified products in bag-on-valve packaging Clinical trial material Topical sprayable drug product Products based on AKVANO-formulations Flammable sprayable drug products    +    +    +    +    +   Planned cGMP MANUFACTURING & DEVELOPMENT CAPABILITIES Plans for cGMP drug manufacturing during 2016:
  16. 16. 16 Regulatory Compliance MANUFACTURING & DEVELOPMENT CAPABILITIES Certified in accordance with SS-EN ISO 13485:2012.     The sterile saline products are approved and CE-marked in accordance with MDD. AURENA Laboratories is registered by FDA as a Drug Establishment.   AURENA Laboratories is registered by FDA as a Medical Device Establishment. EU-cGMP planned from 2016.
  17. 17. 17 Formulation Development Regulatory Guidance Preparation of technical files for CE-marking Writing of clinical reports Writing of biocompability reports 1   Design and execution of clinical studies (in-vivo and in-vitro) Claim development Biofilm testing Packaging Development 2   3   4   5   6   7   8   9   Product Development Capability MANUFACTURING & DEVELOPMENT CAPABILITIES
  18. 18. 18 CURRENT & FUTURE PRODUCTS
  19. 19. 19 Current Medical Device Products CURRENT & FUTURE PRODUCTS
  20. 20. 20 AURENA CE-mark Available For Brand Owners •  Wound Cleansing/ Irrigation Sprays •  Emollient Spray (Skin Moisturizers) •  Medical Adhesive Remover Sprays •  Skin Barrier Film Sprays •  Burn Gels •  Eye Wash Sprays •  Wound Washes •  Wound & Eye Wash Spray •  Burn Gel •  Sterile Alcohol Sprays •  Saline Nebuliser Solution •  Ear Spray •  Nasal Spray Range •  Throat Spray   Ear, Nose & Throat Wound & Skin Care First Aid Other Products Product Groups CURRENT & FUTURE PRODUCTS
  21. 21. 21 Saliva substitute spray Silicone-based scar gel spray Liquid bandage spray Range of NZ Kanuka honey based products: throat spray, nasal spray & wound spray  +    +    +    +   Medical Devices Under Development CURRENT & FUTURE PRODUCTS Products from Aurena currently in development and will soon be available for brand owners:
  22. 22. 22 AKVANO® is a novel proprietary drug delivery technology. It represents a completely new dosage form consisting of water-free, sprayable liquid formulations in which selected lipids and the active ingredient are dissolved in a volatile solvent. Different lipids and solvents can be selected and combined from a large number of commercially available materials to achieve the desired physicochemical properties and optimize the incorporation and function of active components. AKVANO technology is extremely versatile.  +    +    +   AKVANO Products Under Development CURRENT & FUTURE PRODUCTS
  23. 23. 23 1st Quarter 2016 Available in Q1, 2016. We are now seeking brand owners for distribution agreements: Non-Drug AKVANO Produts Under Development CURRENT & FUTURE PRODUCTS > AKVANO® Foot Spray: anti-bacterial product for diabetic foot treatment. Formulation include urea, and lactic acid in combination with AKVANO® base. AKVANO® Sensitive Skin Spray AKVANO® Emollient Spray AKVANO® Sesame Oil Nasal Spray AKVANO® Skin & Hand Disinfection Spray > > > > Available
  24. 24. 24 Available in Q1, 2016. We are now seeking brand owners for distribution agreements: Drug Opportunities with AKVANO CURRENT & FUTURE PRODUCTS > Lipidor’s psoriasis program (calcipotriol only + calcipotriol- corticosteroid formulations). Product reformulation (enabling patent protection/life cycle management of products with generic active substances with major market presence). Improved product formulation of proprietary API.   > >
  25. 25. 25 To date, 73 active substances, of which 45 are APIs, have been tested successfully in AKVANO, including: Drug Opportunities with AKVANO CURRENT & FUTURE PRODUCTS •  Antibacterial agents (e.g. fusidine) •  Antifungal agents (e.g. terbinafine) •  Corticosteroids (e.g. betamethasone, hydrocortisone and mometasone) •  NSAIDs (e.g. diclofenac) •  Analgesics (e.g. capsaicin) •  Local anesthetics (e.g. lidocaine) •  Antipsoriatic agents (e.g. calcipotriol) •  Anti-alopecia agents (e.g. minoxidil) •  Anti-acne agents (e.g. adapalene) •  Wound healing agents (e.g. dexpantenol) •  Steroid hormones (e.g. estradiol)  
  26. 26. 26 Contact Details Aurena Laboratories Fjärrviksvägen 22 653 50 Karlstad Sweden +46 54 53 11 99 contact@aurenalabs.com aurenalabs.com

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