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Ann: MEETING: PIL: AGM Address from the Chairman,

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    • Release Date: 29/05/14 17:08
    • Summary: MEETING: PIL: AGM Address from the Chairman, CEO and Principal Scientist
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    					PIL
    29/05/2014 15:08
    MEETING
    
    REL: 1508 HRS Promisia Integrative Limited
    
    MEETING: PIL: AGM Address from the Chairman, CEO and Principal Scientist
    
    CHAIRMAN'S ADDRESS
    It is almost a year ago, to the day, that I addressed my first Annual General
    Meeting as your incoming Chairman.
    Suffice to say this Company is a very different one in a great many respects
    than was the case a year ago.
    With the backing and input of the Board, management has chartered an exciting
    new course to become a global leader in developing and marketing unique and
    safe therapeutic natural products. These products will employ validated
    scientific methodology gathered by robust, evidence-based data.
    
    The comprehensive 2013 annual report bears witness to this new course and the
    commitment the board has to raising governance standards such that we meet
    best practice as befitting an NZX listed entity.
    
    We have made two key management appointments being Mr. Charlie Daily, the
    Company's Chief Executive Officer and Dr. Sheena Hunt the Company's Principal
    Scientist. In no small way the Company's progress to date is because of
    Charlie's and Sheena's efforts.
    We also welcomed businessman Tom Brankin to the board and we look forward to
    his contribution particularly his knowledge of agronomy and the healthcare
    industry.
    
    The Company has raised in excess of $680,000 through placements and the early
    exercise of options.
    
    We have a new name and branding strategy the benefits of which are beginning
    to flow through. I will let Charlie and Sheena provide more background to the
    Company's strategic thrust and positioning.
    
    We have been successful in receiving two research grants from Callaghan
    Innovation, a government entity. The application process for these research
    grants is long and complex and it is a testament to the hard work of the
    management team that both grant applications were successful.
    
    I thank my Co-Directors for their considerable personal commitment to the
    company during the year and look forward with the help of our management team
    to executing on the Company's strategic direction.
    
    CHIEF EXECUTIVE'S ADDRESS
    
    It has been just over a year since I took over as CEO of the company.  When I
    took over it was blessed with a game changing extract that was being marketed
    as a dietary supplement for assisting with joint support to alleviate
    symptoms associated with arthritis.  Anecdotal feedback was overwhelmingly
    positive.  Unfortunately, anecdotal feedback can only help with word of mouth
    marketing.  Healthcare professionals require published robust results from
    scientific based studies and trials before they will endorse or recommend a
    product for a therapeutic benefit.  The other interesting observation is that
    not only did our product lack the scientific validity, but the industry as a
    whole is also lacking the application of such scientific validity.  We are
    determined to develop a significant point of difference between the products
    we will market in the future and the competition.
    
    Direction
    
    Throughout the past year our company has made some made some big steps in
    becoming a company that is focused in developing and marketing unique
    therapeutic natural products with proven safety and efficacy based on robust
    research.  One of the key steps in guiding us in this direction was the
    appointment of Principal Scientist, Dr Sheena Hunt in September of last year.
     Dr Hunt brings over 20 years' experience in scientific research.
    We are currently carrying out laboratory-based in vitro testing of our
    extract in collaboration with Trinity Bioactives an independent laboratory in
    Upper Hutt, specialising in testing the bioactivity of natural products.
    Preliminary results are extremely positive and have well exceeded our early
    expectations. The laboratory testing was 40% funded by the Crown through a
    grant from Callaghan Innovation.  It is important to know that the results
    will remain the IP of Promisia Integrative.  We have recently received
    another grant from Callaghan Innovation to fund 40% of a double-blind,
    placebo controlled trial at Dunedin Hospital.  Again, this trial is with our
    unique extract and will therefore provide more IP for Arthrem(TM).  Dr Hunt
    will shortly provide more insight on the early results from the in vitro
    testing, the design of the clinical trial and future research plans.
    
    Brand
    
    Along with our new scientific approach we have re-branded our company. Our
    new name, Promisia Integrative represents a strong association with science
    and it also has ties to the plant we are working with, Artemisia.
    
    Our advertising agency has put together an engaging campaign to support our
    rebranding which includes new packaging for our product Arthrem(TM), in store
    pharmacy promotional material, a New Zealand Medsafe compliant Arthrem(TM)
    website along with a brand new corporate Promisia Integrative website. In
    conjunction with our branding and advertising, releases from validated
    scientific research will also bolster product awareness.
    
    Competitive Advantage
    
    Our Arthrem(TM) brand is becoming well established in New Zealand as a
    preferred product for joint support.  The more validated research which is
    carried out on our product the more we will differentiate ourselves.
    The competitive advantage for our current product Arthrem,(TM) is based on an
    established agricultural growing program combined with a unique
    diffusion-based, high pressure, low temperature extraction process. This in
    turn is backed by years of unique validated research relevant to our
    particular extract.
    In conjunction with our competitive advantage we also maintain significant
    quantities of our unique extract.   Testing by our Swiss laboratory has shown
    that our extract has at least a 5 year shelf life before there is any
    appreciable degradation.
    
    Sales
    
    Sales for Arthrem(TM) in New Zealand, have seen steady growth since April of
    last year.  We have an outstanding working relationship with our New Zealand
    pharmacy distributer, Pharmabroker.  Their sales team understand our product
    and there are some specific pharmacies in New Zealand that have had real
    success in selling our product.  A grass roots approach with pharmacies by
    giving out samples to known customers who suffer from arthritis has been the
    most sustainable way of building up product awareness. We have also been
    using radio as another stimulus, targeting the over 55 age bracket.
    
    The market here in New Zealand is a great test market. But it has never been
    our intention to focus on New Zealand as the breadwinner for Promisia. The
    proposition of selling our product overseas is what enticed me into taking on
    this role and also investing my own money into the company.
    
    As many are aware, I am now based in the US.  Unlike the New Zealand market,
    the pharmacies in the US are controlled by the big players such as Walgreens,
    CVS and Rite-aid.  Finding a distribution arrangement similar to the one here
    in New Zealand simply doesn't exist.  Instead we are focussing on a program
    that will market directly to the consumer.  I am working on establishing
    relationships with reputable spokespeople from the Healthcare profession in
    the US.  This exercise will work on the backbone of our scientific research.
    Press releases of our scientific results will need to go through the proper
    channels to gain the best validated exposure. In conjunction with the
    business model exercise we are also building an ecommerce website that will
    be US FDA compliant. Along with our online presence we are negotiating terms
    for distribution through healthcare professionals, such as Chiropractors,
    Doctors of Osteopathy and Naturopaths. Integrative medicine in the US appears
    more established than here in NZ. .   The key to our success there will be
    how we position ourselves.  With the research program that our Principal
    Scientist Dr Hunt is overseeing, the Company is confident that 2015 will
    produce some impressive sales figures.
    
    As well as the US, we will be working to establish our brand in Australia in
    the middle of 2015.  Unlike New Zealand and the US, Australia has a third
    category for healthcare products called listed complementary medicine. As a
    dietary supplement in the US and New Zealand, we are limited as to the
    therapeutic claims we can make.  Once we have results from trials and
    scientific studies, we will register our product as a listed complementary
    medicine with the Australian Therapeutic Goods Administration. With this
    registration and the trial results showing statistical significance, we will
    be able to make claims in Australia such as "Treatment for Arthritis."
    
    Goals for the next 12 months
    
    Along with growing our sales, Promisia Integrative will also be focusing on
    the development of some new product formulation.  There is definitely a
    demand for a topical cream that could be used for inflammation of joints and
    sore muscles.  Along with product development we will be striving to develop
    more valuable IP.  The ongoing scientific research is already leading to some
    inventive ideas which would ultimately create unique patentable formulations.
    
    Our growing program in Tanzania improves each year.  Tom Brankin, one of our
    company directors, is helping with establishing an innovative growing program
    here in NZ.  The goal is to constantly develop a unique agricultural regime
    for growing Artemisia annua.
    
    Share Purchase Plan
    
    We currently have an SPP in the market and we are pleased with progress to
    date. We have extended the SPP by a further two weeks.
    
    Concluding Remarks
    
    Overall, I'm very pleased with the prospects for growing this company. The
    board of directors fully understands and endorses our direction, and the
    growth potential is substantial.   I look forward to reporting to the
    shareholders on our progress over the next 12 months.
    
    PRINCIPAL SCIENTIST'S ADDRESS
    
    I have thoroughly enjoyed the last 8 months at Promisia. I'd like to thank
    Charlie and the board for their support while I develop a comprehensive
    scientific programme for the company.
    
    When I started at Promisia, while we had a very exciting product,
    Arthrem(TM), there was a lack of any scientific data regarding its efficacy
    or safety. Such evidence- based data is crucial if we want to gain the
    confidence of consumers, the trust and endorsement of healthcare
    professionals and to differentiate our product from the numerous untried and
    untested supplements on the market.
    
    There are three main questions we need to answer in order to give us the
    information that we need: "does it work?", "is it safe?" and "how does it
    work?" The questions, "Does it work" and "is it safe" can only be answered by
    conducting a well-
    designed, ethically approved clinical trial. We have a clinical trial
    underway and I will discuss that in a moment. We can answer the question,
    "how does it work" by conducting in vitro (laboratory) tests.
    
    In vitro testing
    
    Inflammation is how the immune system in our bodies deals with injury or
    infection - the aim of inflammation is to remove the harmful stimulus and to
    initiate healing. White blood cells release chemicals that protect us from
    infection or injury. Normally this system works well and keeps us safe. But
    the inflammatory response can sometimes be excessive and inflammation can
    become chronic.
    
    To test for inflammation in vitro we can look at white blood cells - the
    cells that normally release the chemicals (or inflammatory mediators) to
    protect the body. In a laboratory, it is possible to activate white blood
    cells to simulate an inflammatory situation. Stimulating the cells causes
    them to produce inflammatory markers. These markers can then be measured with
    and without a test substance, so that you can see whether or not there is any
    anti-inflammatory effect. While you can't directly extrapolate what is
    happening in a test tube to what happens in a human body. If you look at in
    vitro results in tandem with clinical trial results then it is possible to
    get a sense of whether and how a product works.
    
    So far, in collaboration with Trinity Bioactives, we have investigated the
    effect of our extract on three inflammatory mediators: tumour necrosis factor
    ? (TNF-?); nitric oxide and COX-2. These chemicals are all involved in the
    inflammatory pathway, and while they are necessary for our bodies to heal
    damage and fight infection, when they are produced inappropriately or in
    excess they can cause problems.
    Excitingly, the extract in our product Arthrem(TM) has shown potent
    anti-inflammatory activity in all three assays in vitro. Interestingly in all
    three assays, the pure single compound artemisinin (which was originally
    assumed to be the only active compound in the plant extract) is not as active
    on its own as when it is in the crude plant extract. This is great news for
    us as it means that it is our unique plant extract that possesses the
    activity, not a single compound that could potentially be copied.
    
    While the in vitro results indicate that the plant extract in Arthrem(TM)
    capsules has potential anti-inflammatory activity, only a clinical trial will
    show us how well Arthrem(TM) works in the human body.
    
    Clinical trial
    
    We have just started a clinical trial at Dunedin Hospital with consultant
    rheumatologist, Dr Simon Stebbings, as the principal investigator. The trial
    will investigate Arthrem(TM) as a complementary therapy in patients with hip
    and knee osteoarthritis. The trial will assess patients' pain, stiffness and
    functionality over a 12 week period. The trial will be randomised,
    placebo-controlled and double-blind (which means neither the patient nor
    their doctor will know which treatment that has been allocated to them). We
    designed the trial in conjunction with Dr Stebbings and a highly qualified
    biostatistician to ensure that it is statistically sound and scientifically
    robust. The trial will compare two doses of Athrem(TM) with a placebo group.
    We are also going to look at long-term safety. After the 12 week double-blind
    portion of the trial, patients will be given the option to continue taking
    Arthrem(TM) for an additional 6 months (all patients will take the same dose
    during the long-term safety follow-up). During this time safety will be
    monitored to to allow us to collect much needed long- term safety data. The
    trial has been approved by NZ Health and Disability Research Ethics
    Committees and is listed with the Australia and New Zealand Clinical Trials
    Registry.  We aim to publish the results of the 12 week study after the data
    analysis for that part of the study, with a follow up publication on the
    safety results 6 months later. It is these publications in peer-reviewed
    journals that will give the product the credibility it needs to differentiate
    it from other dietary supplements.
    Product development
    
    As Charlie mentioned we are in the process of exploring other products. In
    terms of osteoarthritis we have met with formulations chemists to design a
    gel and/or a rub for sore joints and muscles. We believe that our extract has
    other bioactive properties and we are looking into further product
    development.
    
    Concluding remarks
    
    I am extremely excited about what the next 12 months holds for us in terms of
    results and publication of our first clinical trial, the continuation of the
    scientific programme and the development of new products.
    
    ENDS
    End CA:00251027 For:PIL    Type:MEETING    Time:2014-05-29 15:08:53
    				
 
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