Honevo®

HoneyLab has conducted and is conducting Phase 2 & 3 clinical trials of our pharmaceutical-grade kanuka honey formulation for a range of common dermatological conditions for which there is a need for proven natural treatments.

Our most developed product is the patent-pending novel formulation, Honevo®, consists of kanuka (Kunzea ericoides) pharmaceutical (sterile) honey combined with a natural stabilizing agent to create temperature and shelf life stability, and to improve the consumer experience.

In terms of its mechanism of action, kanuka medical honey has a number of specific physicochemical properties that contribute to its effectiveness as a dermatological medicine:

• Osmotic effect – honey is a concentrated sugar solution predominantly consisting of the monosaccharides fructose and glucose. Few water molecules are available for micro-organisms and therefore it is a poor environment for their growth

• Hydrogen peroxide – this is slowly released when the honey comes into contact with body fluids and has antiseptic properties

• Acidity – honey is acidic with a pH of 3.2 to 4.5, which makes micro-organism growth difficult

• Antioxidants – contains bioflavonoids and other antioxidants which may contribute to its activity

• Phenolic compounds – these are found in high levels in certain honeys, such as New Zealand kanuka honey, and have been shown to possess potent antibacterial effects.

HoneyLab

HoneyLab is a New Zealand pharmaceutical company that has created a new category in the pharmaceutical OTC space: PharmaNaturals. We undertake laboratory studies and high standard controlled clinical trials of honey, bee venom and other products obtained from bees and their environment. Proven claims based on strong science enable licensing opportunities for partnering pharmaceutical companies, as new products or brand extensions.

HoneyLab has three key platforms: dermatology, pain management and nutrition. We use unique New Zealand raw materials to create new, evidence-based, and natural OTC medicines.

HoneyLab honeylab.co.nz T +61 21 93 92 01

A novel over-the-counter PharmaNatural product for Rosacea & other dermatology conditions

Honevo® has been shown in early studies to be potentially a very effective treatment for a range of common dermatological conditions, including rosacea, cold sores, nappy rash and acne.

Rosacea

The topical therapies with the best evidence of effectiveness for rosacea are metronidazole and azelaic acid, however these are only partially effective and use can be limited by side-effects. There is therefore a need for novel effective therapies that are acceptable to patients. In addition, the pathogenesis of rosacea is incompletely understood, but it was recently discovered that a type IV hypersensitivity reaction to faeces from Desmodex mites deep in the skin may contribute to the disease. This may explain the lack of efficacy of current products. Medical honey has been shown to be effective against mites and has been shown to be particularly effective for deep infections.

HoneyLab have completed phase 2 and phase 3 clinical trials of Honevo® for rosacea. The Phase 3 study has just completed and the design was peer reviewed by the Mayo Clinic (Rochester, MN, USA).

• Parallel group randomised controlled trial withassessor blinding

• Undertaken by 5 trial centres 4 GP centres andMedical Research Institute of NZ

• 138 patients aged 16 or over with a RosaceaSeverity Score (RSS) of ≥2

• Randomised in a 1:1 ratio to Honevo or controlcream, twice daily

• Seen and assessed at start of trial, week 2 andweek 8

The preliminary headline results are positive:

• The result is statistically significant at p <0.05 atboth weeks 2 and 8 weeks

• The ≥2 improvement in RSS is a substantialimprovement

• This means that Honevo® is a proven effectivetreatment for rosacea

• There is evidence that there is both a quick and acontinued positive effect with Honevo®

There are a number of reasons why Honevo® can be a strong selling OTC medicine, including:

1 As an OTC product regulatory approvals are far easier than for prescription medicines

2 There are no known side effects from the use of honey topically3 It can be combined with other active ingredients

to increase efficacy and/or extend patent life4 There is an increasing problem with antibiotic resistance

but honey has multiple methods of action and therefore bacterial resistance is very unlikely

5 Consumers are increasingly demanding natural products instead of synthetic chemicals

6 The raw materials can be sourced in high volumes at consistent biologic levels to fulfill global demand

Platform Indication IN VITRO PHASE I/II PHASE III APPROVAL

Honevo Rosacea

Honevo Nappy Rash

Honevo Cold Sores

Honevo/aciclovir Cold Sores

HoneyLab honeylab.co.nz T +61 21 93 92 01

Market Analysis

In 2013 the global rosacea therapeutics market was estimated to be worth US$1.5 billion and is growing at approximately 3.3% CAGR. This comprises only the prescription market. The average cost of treatment for prescriptions in 2013 was approximately US$87.

The diseased population in 2013 was estimated at 38.4 million with the treatment seeking population around 32.3 million. However only 16.8 million were prescribed therapeutics leaving another 15.5 million treatment seeking afflicted patients available and ready for an OTC alternative with proven clinical efficacy.

The clinical development pipeline for rosacea is not strong due to the significant generic pressure and companies are reluctant to invest in this disease condition.

Market Opportunity

With Metrogel® (metronidazole) and Rosanil® (sodium sulfacetamide and sulfur) being off patent and Finacea Gel® (azelaic acid) coming off patent in 2018, there is an opportunity for a major pharmaceutical brand owner to release a “PharmaNatural” extension to their brand by in-licensing the Honevo® platform technology. This would be a low cost release option with this extension falling into the OTC segment and targeting the 15.5 million currently un-prescribed sufferers.

Additionally, a re-combination of Honevo® with an off patent active ingredient could, following suitable trials conducted by HoneyLab, provide another extension product as a “Plus” category.

Organisation

HoneyLab is a privately held limited liability pharmaceutical research company registered in New Zealand. New Zealand has a first world regulatory environment for clinical research, and is famous for having a clean, green, unpolluted environment.

HoneyLab team is led by Dr. Shaun Holt. He lectures at Victoria University of Wellington on the subjects of natural products and evidence based medicine, has started two clinical trials organizations, has been the Principal Investigator in over 50 clinical trials and has over 120 publications in the medical literature.

He is supported by CEO Laurence Greig. He has led professional groups in addition to personally leading start-ups. He is a Certified Company Director with the NZ Institute of Directors and a Certified Risk and Compliance Management Professional with the International Association of Risk and Compliance Professionals.

The clinical research is conducted in collaboration with the Medical Research Institute of New Zealand (www.mrinz.ac.nz) and the Mayo Clinics’ Complementary and Integrative Medicine Programme (http://www.mayoclinic.org).

Intellectual Property

HoneyLab has a comprehensive IP protection plan including pending patents, trademarking, control of supply of raw ingredients and trade secrets. Honevo® is filed under patent application number US 61/872,799.

Opportunity SoughtHoneyLab is seeking interest from pharmaceutical companies, particularly those with a focus on dermatology and or natural products.

We would welcome approaches in the following areas:

1 Collaboration in the clinical trials programme with an option on the product if successful

2 In-licensing of HoneyLab’s treatments or technologies

3 Distribution of HoneyLab’s trademarked micro-branded products www.honevohoney.com

4 Investment in HoneyLab parent company

ContactLaurence GreigChief Executive, HoneyLab Ltd

E laurence@honeylab.co.nz Skype laurencegreigW www.honeylab.co.nz T +64 21 93 92 01

HoneyLab Ltd

Level 16 Swan Lane WellingtonNew Zealand

honeylab.co.nz