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Breaking News Atka Pharma joins Ascendis Health

01 03

(Atka Pharma press release) NEWSLETTER | EDITION 01 - March 2014

index CHD-FA™ News:

02 03

Fulvic acid compared to Carbohydrate Derived Fulvic Acid Toxicity and Safety data

03 04 03

Manufacturing plant receives Certificate of Conformity (FSSC 22000: 2011) US Department of Defence evaluates CHD-FA™ for use in US soldiers’ battle-packs Research Institution focus: Euprotec

Press release

BioBalance™ News:

05 03

Product Focus: BioBalance™ Immunova+ 30’s BioBalance™ stars in upcoming movie Vrou Soek Boer

06 03

New BioBalance™ Immunova display units in time for Winter

07 03

BioBalance™ to get Halaal certificate Medical Schemes and BioBalance™

Atka Pharma News:

08 03

Atka Pharma enters US market New representative: Wouter Stieger (Free State)

Atka Pharma joins the Ascendis Health Group of Companies 1 February 2014 – For immediate release Pretoria - Atka Pharma is proud to announce that it is now part of the fast-growing Ascendis Health Group. Atka Pharma products contain the compound Carbohydrate Derived Fulvic Acid (CHD-FA™). The products are marketed under the fast growing BioBalance trademark owned by the company. It will join well-known brands Nimue, Solal, Sportron, SSN and Evox in Ascendis’s Consumer Brands division. Chief Executive Officer of Atka Pharma, Andre Daly , says, “Very little will change as far as our operational activities are concerned; in fact, it is business as usual with regard to retailers and suppliers. The change will be the multiple opportunities to develop cross product synergies within the group as well as benefiting from the economies of scale.” Atka Pharma produces a wide range of health supplements under the BioBalance™ brand, to manage and maintain a healthy body, including oral health, wound care, urinary tract health, digestive health, feminine health and foot care. The flagship product group, the Immunova+ Range, provides a natural boost to immune system function. Andre Daly concludes, “We are excited about this development as it clearly reflects the confidence that a company like Ascendis Health has in the BioBalance™ brand and the management team. It will allow us to develop a stronger market position and become a leading player in the local and international health and care sector.” For more information on Atka Pharma, please contact ATKA Pharma office on 086 111 55 32 or email info@atkapharma.com.

01 03


CHD-FA™

News

Fulvic acid and Carbohydrate Derived Fulvic Acid (CHD-FA™):

TOXICITY & SAFETY DATA Atka Pharma’s primary concern in marketing CHD-FA™ for human use is the safety of CHD-FA™ and BioBalance™ products. To prove the safety of CHD-FA™ a thorough set of research projects has been completed.

what is the difference? Environmental sources of Fulvic Acid are contaminated with heavy metals and often with herbicide and pesticide residues.

A full set of tests required for certification under the REACH (Registration, Evaluation, Authorisation and Restriction of Chemical Entities) programme in the European Union have been concluded. These tests show that CHD-FA™ is safe and not hazardous to the environment.

CHD-FA™ is manufactured from a pure carbohydrate source in a GMP standard factory using pure water and medical grade oxygen. The manufacturing process and quality controls result in a product that is consistent, pure and conforms to the reference standard time after time. As such CHD-FA™ can be used in a variety of products for medicinal, cosmetic and food use in both humans and animals.

A Phase 1 safety trial in humans with no adverse effects noted at doses that were 6 times the recommended daily dose over extended periods was concluded. Human tests have also been carried out for topical uses of CHD-FA™ e.g. against eczema or rosacea. A wide range of tests have also confirmed the lack of toxicity for ingested or topical use. The safety of CHD-FA™ has been confirmed in all the research to date.

The series of photos, about 10 seconds apart, show candida fungi . Before CHD-FA™ is added researchers add a substance called Propidium Iodide (PI). When candida DNA is exposed to propidium iodide it fluoresces i.e. the red colour. What the slides show is that when they add CHD-FA™ you get an immediate fluorescence. So this implies that the candida cell wall has collapsed exposing the DNA to PI which then fluoresces red i.e. the cell wall of the candida has been destroyed meaning the candida fungi is destroyed.

02

The Food Safety System Certification 22000 (FSSC 22000) is a robust, ISO-based, internationally accepted certification scheme for auditing and certificate for safe international packing standards in the whole supply chain. FSSC 22000 uses the existing standards ISO 22000, ISO 22003 and technical specifications for sector PRPs, which were developed through a wide and open consultation with a large number of related organizations. ISO 22000 certified manufacturers can obtain full Global Food Safety Initiative (GFSI) accepted FSSC 22000 certification by meeting the requirements of technical specifications for sector PRPs and the additional scheme requirements.

How CHD-FA™ works: Research at the School of Dentistry at Glasgow University indicates that CHD-FA™ breaks down the cell wall of disease-causing bacterial and fungal pathogens.

BioBalance™ manufacturing plant Fulvimed receives certificate of conformity.

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Additional early research suggests that CHD-FA™ acts as an entry inhibitor to viruses; in other words viruses are prevented from entering target cells and are therefore unable to replicate.

The Global Food Safety Initiative is a business-driven initiative for the continuous improvement of food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide. GFSI provides a platform for collaboration between some of the world’s leading food safety experts from retailer, manufacturer and food service companies, service providers associated with the food supply chain, international organizations, academia and government. In November 2010, the BioBalance™ manufacturing plant received the FSSC 22000 Certification after a successful audit.

In addition to its well-known anti-microbial properties, CHD-FA™ also offers anti-inflammatory and a powerful antioxidant properties. All BioBalance™ products contain varying amounts of CHD-FA™.

03


News

US DEPARTMENT OF DEFENCE EVALUATES CHD-FA™ FOR USE IN US SOLDIERS’ BATTLE-PACKS Euprotec, a UK-based specialist contract research organisation, is collaborating with the manufacturers of BioBalance™ and the New Jersey Medical School-UMDNJ, following funding from the US Department of Defence, to evaluate CHD-FA™, a topical broad spectrum antimicrobial agent for use in US soldiers’ battle-packs. It is proposed that, when applied to a battlefield wound, the product will prevent a broad range of post-traumatic microbial infections, which could otherwise prove fatal if left untreated. This has the potential to not only save the lives of numerous soldiers but also to revolutionise the treatment of infections following trauma. Carbohydrate Derived - Fulvic Acid (CHDFA™), has a novel mechanism of action with no reservoir of natural resistance. CHD-FA™ demonstrates potent broad spectrum antimicrobial activity against a large range of multidrug resistant Gram positive and Gram negative bacteria such as MRSA, NDM-1 positive E. coli, carbapenemresistant Enterobacteriaceae (CRE), tuberculosis and pathogenic fungi. The DOD contract has been awarded to fund extensive research, in order to accelerate the development of the product for treatment of US soldiers, in a bid to reduce the significant morbidity and mortality caused by traumatic wound infections.

04

BioBalance™

News

Product Focus:

BioBalance™ Immunova tablets (30’s, 90’s)

BioBalance™ stars in the new movie, the romantic Afrikaans comedy, VROU SOEK BOER bied aan

Nico Panagio

Lika Berning

Bok van Blerk

Indications: CHD-FA™ is likely to be particularly suitable for use in soldiers’ battle-packs or first aid situations as it is safe and stable at high temperatures. If successful, the programme signals a significant breakthrough in the prevention of a broad range of difficult to treat infections.

Research Institution Focus: Euprotec About Euprotec: Euprotec is a world-leader in the provision of infectious disease and respiratory biology services.

With a highly relevant and validated portfolio of assays and disease models, underpinned by internationally recognised expertise, the company supports each stage of client anti-infective drug discovery and development programs through to late stage preclinical investigation and clinical proof-ofconcept studies.

Euprotec is based in Manchester (UK) operating out of state of the art laboratory facilities. Many of the research studies on CHD-FA™ have been constructed at Eurotec

May assist in overcoming minor infections and enhancing the immune system.

Ingredients:

Each tablet contains: Carbohydrate Derived Fulvic Acid 147.75mg l-Glutamine 38.55mg Selenium 45µg

Features and benefits: •

Useful in combination with antibiotics simultaneously compliance

the efficacy of older antibiotics which removes the time to improved health

the resistance of older antibiotics which enables cost effectiveness therapy

side effects associated with antibiotics treating the resistence of secondary infections

Covered by medical schemes

BioBalance

‘n Mens se baksels proe altyd beter as jy verlief is…

‘n Maynard Kraak film

Vrou BOER soek

CHD-FA™

WEST FIVE FILMS PRESENTS IN ASSOCIATION WITH COLLECTIVE DREAM STUDIOS AND THE DTI AND IDC AND NFVF AND GFC “VROU SOEK BOER” STARRING LIKA BERNING NICO PANAGIO BOK VAN BLERK MARGA VAN ROOY ALMARIDA REYNECKE ROWAN CLOETE CASTING BY THORSTEN WEDEKIND MUSIC SUPERVISION ADOLF VORSTER JOHN FISHLOCK JOHAN HANEKOM MUSIC COMPOSER KEVIN KRAAK COSTUME DESIGNER BIANCA ERASMUS EDITOR LAYLA SWART PRODUCTION DESIGNER JACKIE LOTZ DIRECTOR OF PHOTOGRAPHY JUSTUS DE JAGER ASSOCIATE PRODUCERS BERNICE PEREIRA DOMINIQUE FOURIE EXECUTIVE PRODUCERS JOHAN REYNECKE LINDA REYNECKE ALMARIDA REYNECKE BASIL FORD KAGISHO BAPELA DANIE HALGRYN RUDI HALGRYN SUPERVISING PRODUCER JOHAN KRUGER STORY BY MAYNARD KRAAK JACOMIEN BEZUIDENHOUT WRITTEN BY JACOMIEN BEZUIDENHOUT PRODUCED & DIRECTED BY MAYNARD KRAAK

The movie launches at a Ster Kinekor theatre near you from 7 March onwards. It stars Lika Berning, Nico Panagio and Bok van Blerk. Atka Pharma is the headline sponsor and the plot of the movie incorporates three or four of the BioBalance™ product range. See if you can spot them. We will be promoting the BioBalance™ Multivitamin range, namely BioBalance™ All-in-One and BioBalance™ Kiddi Tonic in association with the movie.

Win free tickets! the Atka Pharma – BioBalance™ page to enter the competition.

05 03


BioBalance™

News

Some common misconceptions about antibiotics Adapted from Pharmacy Update May-June 2013. Written by Dr. Layla Cassim

Resistance to antibiotics is a growing world-wide problem. It involves existing antibiotics no longer being effective in treating bacterial infections as members of the bacterial species concerned, have developed biochemical mechanisms to “survive” exposure to the particular antibiotic. Given that there are not that many new antibiotics entering the market1, it is thus increasingly difficult to treat these infections, leading to high mortality rates. Examples of highly antibioticresistant bacteria are Methicillin-Resistant Staphylococcus aureas (MRSA) and Multidrug-Resistant gram-negative bacteria, which are both a leading cause of hospital-acquired bacterial infections2.

However, the probiotic cannot be taken at the same time as the antibiotic – which is what many patients do. The reason for this is that taking both the probiotic and antibiotic at the same time can lead to the probiotic being rendered ineffective. So the probiotic should be taken at least two hours before or at least two hours after the antibiotic dose.

There are many factors contributing to antibiotic resistance , but a key one is the irrational use of antibiotics - antibiotics not being used as they should. However the timing when coadministrating with probiotics is also important.

1. Boucher, H.W., G.H., Bradley, J.S., Edwards, J.E., Gilbert, D., Rice, L.B., Scheld, M., Spellberg, B. & Bartlett, J. 2009. ‘Bad bugs, no drugs: no ESKAPE! An update from the infectious diseases Society of America’, Clinical Infectious Diseases, 48 (1): 1-12. 2. World Health Organisation. 2013. Antimicrobial resistance [online]. Geneva: WHO. Available from: http://www.who.iny/mediacentre/factsheets/fs194/ en/index.html [Accessed 9 June 2013].

2

Probiotics, whether in supplement form or in foodstuffs such as yoghurt, are useful when patients are on antibiotics, to counter the gastrointestinal side-effects of certain antibiotics, such as diarrhoea, as well as the risk of vaginal fungal infections.

References:

New BioBalance™ display units in time for Winter 2014 sees the start of our consumer-focussed advertising and promotion. The movie, Vrou Soek Boer, kicks off the campaign in March. This will be followed with the Winter campaign and this year sees the introduction of new display units, display boxes and other in-store material. These in-store promotions will be followed by below-the-line media campaigns and selected print media advertising. This will be supported towards the latter end of the year by other activations.

BioBalance™ to get Halaal certification Our manufacturing facility is undergoing rigorous audits by SANHA to ensure the various raw materials used in the BioBalance™ products are Halaal-friendly. The South African National Halaal Authority (SANHA) is an international, non-profit organisation, representing the Muslim Community on all matters pertaining to the general application of the term Halaal with specific reference to Islamic dietary laws. SANHA’s membership comprises of leading Theological Bodies and leading Professional Organizations of global repute. SANHA has been established as a representative authority, which promotes professionalism and excellence in the certification of Halaal food and other related products.

Medical schemes and the BioBalance™ range Most of the BioBalance™ range of products are covered by the major medical schemes such as GEMS, Discovery, Bonnitas and Fedhealth.

This serves to confirm that our organisation is among the founder members of the World Halaal Council and enjoy international recognition from both Muslim countries and the broader global community. We expect to receive certification shortly.

BioBalance Immune range BioBalance™ Immunova™ for Adults BioBalance™ Immunova™+Tablets (30’s/90’s) BioBalance™ Immunova™ Ready to Take (500 ml) BioBalance™ Immunova™+ Liquid Concentrate (100 ml) BioBalance™ Immunova™ Effervescent (15’s) NEW

An exciting year for the BioBalance™ range!

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07 03


Atka Pharma

News

Testimonial

Atka Pharma enters the US market

Lip Sore Gel

A select range of the BioBalance™ products is now available online in the United States.

I would like to give you some feed back on your Lip Sore Gel: a few weeks ago one of our customers came to me and asked for help with an oral problem. For 10 (yes, TEN) years he had been suffering with a raw and very sensitive inner oral area as well as on his lips. He had been treated by numerous physicians and specialists over the last 10 years with little to no improvement. He was very desperate and I then suggested him to give the Lip Sore Gel a try. One week later he returned and almost hugged me! For the first time in 10 years he now has a normal inner oral area with no discomfort and he could tolerate any type of food and drink. He was so thankful that he even brought me a gift.

For the first time, consumers in the US will have access to the growing BioBalance™ brand and the internationally patented CHD-FA™. CHD-FA™ is a South African invention and up until January 2014, has been available in limited volumes in other parts of the world. The introduction of BioBalance™ into this market, which is one of the largest in the world, marks the beginning of Atka Pharma’s global roll-out strategy.

This was most amazing and I am sure you could share this with your management. Thank you for a wonderful product!

Best wishes Hugo (Pharmacist)

New representative: We welcome Wouter Stieger who joined Atka Pharma in January 2014. He will be responsible for promoting the BioBalance™ products in the Free State. Look out for Wouter. His number is 072 271 8178.

Please contact us: Reg. No: 2007/008216/07 ATKA TRADING 46 (Pty) Ltd T/A ATKA PHARMA A:

Unit 1 Stonehouse 94 Sovereign Drive Route 21 Corporate Park Irene, Gauteng

T: E:

086 111 55 32 www.biobalance.co.za


Atka Pharma - BioBalance Newsletter Vol. 1