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HoneyLab (NZ) Company Introduction
1. 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
2. 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 with
assessor blinding
• Undertaken by 5 trial centres 4 GP centres and
Medical Research Institute of NZ
• 138 patients aged 16 or over with a Rosacea
Severity Score (RSS) of ≥2
• Randomised in a 1:1 ratio to Honevo or control
cream, twice daily
• Seen and assessed at start of trial, week 2 and
week 8
The preliminary headline results are positive:
• The result is statistically significant at p <0.05 at
both weeks 2 and 8 weeks
• The ≥2 improvement in RSS is a substantial
improvement
• This means that Honevo®
is a proven effective
treatment for rosacea
• There is evidence that there is both a quick and a
continued 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 topically
3 It can be combined with other active ingredients
to increase efficacy and/or extend patent life
4 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
3. 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 Sought
HoneyLab 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
Contact
Laurence Greig
Chief Executive, HoneyLab Ltd
E laurence@honeylab.co.nz
Skype laurencegreig
W www.honeylab.co.nz
T +64 21 93 92 01