about aurena
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October 2015
AURENA LABORATORIES
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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
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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
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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)
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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.
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• 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
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Technology Platforms
Current & Future Products
Manufacturing & Development Capabilities
Aurena Core Areas ABOUT COMPANY
TECH
PRODUCTS
MANU-‐ FACTURING
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TECHNOLOGY PLATFORMS
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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
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• 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?
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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
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Formulation Platforms TECHNOLOGY PLATFORMS
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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
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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
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MANUFACTURING & DEVELOPMENT CAPABILITIES
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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
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Drug-classified products in bag-on-valve packaging
Clinical trial material
Topical sprayable drug product
Products based on AKVANO-formulations
Flammable sprayable drug products
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Planned cGMP MANUFACTURING & DEVELOPMENT CAPABILITIES
Plans for cGMP drug manufacturing during 2016:
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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.
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Formulation Development
Regulatory Guidance
Preparation of technical files for CE-marking
Writing of clinical reports
Writing of biocompability reports
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Claim development
Biofilm testing
Packaging Development
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Product Development Capability MANUFACTURING & DEVELOPMENT CAPABILITIES
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CURRENT & FUTURE PRODUCTS
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Current Medical Device Products CURRENT & FUTURE PRODUCTS
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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
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Saliva substitute spray
Silicone-based scar gel spray
Liquid bandage spray
Range of NZ Kanuka honey based products: throat spray, nasal spray & wound spray
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Medical Devices Under Development CURRENT & FUTURE PRODUCTS
Products from Aurena currently in development and will soon be available for brand owners:
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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.
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AKVANO Products Under Development CURRENT & FUTURE PRODUCTS
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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
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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
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Available
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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.
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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)
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Contact Details Aurena Laboratories
Fjärrviksvägen 22 653 50
Karlstad Sweden
+46 54 53 11 99
aurenalabs.com