"something that we learnt I suppose last year as we were allowed deeper and deeper into these multi-billion dollar companies we really did realise that OBJ’s technical strength was actually quite significantly superior to their own and these are the big companies in the world" ~ Jeff Edwards
25/02/13 - EXCLUSIVE COLLABORATION AGREEMENT EXECUTED WITH MAJOR COSMETIC AND FRAGRANCE COMPANY
To kick off 2013 OBJ surprised holders with the announcement that it had entered into an Exclusive Collaboration Agreement with Philosophy, a skin care brand of COTY Inc., an emerging leader in beauty. The Agreement detailed the exploration of future development and manufacture of OBJ's patented eSkin system. COTY Inc. markets a portfolio of widely known brands in fragrance, color cosmetics, and skin and body care products and is active in 130 countries with manufacturing, research and development centres spread across a number of locations internationally. Philosophy was acquired by COTY Inc. in 2010 as its prestige skincare brand and now ranks in the top 10 skincare brands worldwide. The Agreement defines the terms upon which OBJ and Philosophy will collaborate to develop, program and manufacture eSkin systems with the proprietary delivery fields necessary to control a number of key ingredients used widely by Philosophy. The granting of the Dermaportation patent by the European Patent Office and the US Patent Office in 2012 are fundamental to the collaboration. The more recent filings of patent applications with the US and European patent offices over a number of key innovations that make up the eSkin system, add significantly to the overall strength of the eSkin IP.
28/02/13 - 4D - REVIEW OF OPERATIONS
OBJ provided an update on the technical and commercial progress of the Company for the half- year ended 31 December 2012. The major focus for the period involved the progression of a number of the Company’s International Partnering relationships from technology development and evaluation to consumer focused clinical efficacy trials. The Company’s developments in the musculoskeletal patch area progressed with continued strong consumer research results and further refinement of the Company’s propriety formulations technologies.
Proctor & Gamble During the period, The Procter and Gamble Company had committed to two separate human clinical trials following successful pre-clinical developments conducted as part of the Joint Development Agreement. A number of consumer focused devices containing the OBJ FIM technology were developed and fabricated in preparation for the consumer efficacy studies to be conducted by P&G during 2013.
GlaxoSmithKline During the period, the Company’s work with GlaxoSmithKline progressed with the successful completion of a number of evaluations and developments in the Oral Healthcare field.
International Collaborations International collaborations during the period included the successful completion of initial evaluations for the delivery of a widely used topical analgesic compound on behalf of a major international pharmaceutical company. Discussions with a global Top 10 Cosmetic company continued. Those discussions had advanced to programs of evaluation using the Company’s proprietary eSkin delivery technology.
21/03/13 - PATENT PORTFOLIO GROWS WITH GRANTING OF EUROPEAN PATENT
OBJ announced that it had received notice from the European Patent office of the granting of European Patent EP1694408 protecting the Company’s powered magnetic delivery technology, known as Dermaportation. The Company previously announced in December 2012 that this patent had been allowed and that the full granting of that Patent in Europe was subject to translation and filing in each of the member countries. The company advised that this process was now complete and the Patent titled Apparatus for the Facilitating Transdermal Delivery of Therapeutic Substances is now in full effect. Dermaportation was the first of the Company’s three platform drug delivery technologies now being utilized across various international collaborations, partnerships and product development programs. Dermaportation employs a micro-processor controlled magnetic enhancement system that has sufficient computing power to provide a number of additional consumer focused value-added capabilities such as web programmability, smart-phone connectivity and personalized treatments. These capabilities have been incorporated into the e-Skin® product platform. e-Skin® was the subject of a Collaboration Development Agreement with one of the world’s largest multi-national cosmetic and fragrance companies announced to shareholders on 25 February 2013. The granting of the European Patent, in addition to the already granted US Patent, further strengthens the commercial value of the powered drug delivery technology.
OBJ offers a portfolio of proprietary technologies and supports partners by providing IP protected market exclusivity, expertise in magnetic array design, feasibility and efficacy and claims testing, engineering and production. OBJ is the first company to develop low-cost micro-array film technology that utilises diamagnetic repulsion, induced permeation and energy redirection to offer a new way of managing the speed, depth of penetration and delivery of active ingredients in a wide range of pharmaceutical and consumer products.
02/05/13 - ESKIN CLINICAL TRIAL UNITS SHIPPED TO THE USA
OBJ announced that it had manufactured and shipped the first clinical trial eSkin™ units to its partner’s Contract Research Organization in the US. The shipment was part of the Exclusive Collaboration Agreement involving the Company’s proprietary eSkin™ technology, announced to the market on 25th February 2013. The clinical trial units were developed by the Company in consultation with its partner’s scientific teams in the USA and Europe and will be evaluated in an independent clinical efficacy study in the USA.
The clinical trial will serve to prove up efficacy in humans for marketing claims and, subject to success in the clinical trial, as a pre-cursor to potential licensing, supply and global distribution. eSkin™ incorporates OBJ’s patented Dermaportation powered transdermal delivery technology that has been shown to enhance the delivery of key anti-aging and skincare ingredients deeper and more effectively into the skin. The clinical trial is designed to demonstrate consumer perceivable levels of performance improvement including more rapid reduction of fine lines and wrinkles in comparison with the commercial formulation applied by hand. The use of an independent CRO validates the data generated to then be potentially used commercially throughout the world. If successful the clinical trial will be a major step forward for the Company in the commercial development of its powered drug delivery technology and web-enabled personalization capabilities that allow eSkin™ to optimize cosmetic delivery precisely to individual needs via the world wide web using portable devices.
21/05/13 - BODYGUARD PROGRAM UPDATE
OBJ reported that its musculoskeletal patch development, known internally as bodyguard, had achieved several significant milestones in its ongoing development program. Planning for the overall bodyguard program was progressing with the first steps in the industrial design and formulation optimization well advanced. Further assessment of the positioning of the product in its selected market sector had been completed and reconfirmed the initial positioning selected. The Company said that it was not aware of any active patch in the market today that is able to provide the benefits offered by the bodyguard series application. It is intended that the bodyguard series of products will ultimately be designed for application to various body joints. OBJ’s Product Development Manager for the overall management of bodyguard products was also appointed to his position during the last quarter of 2012.
In late 2012 the Company invited several major international design houses with sports and medical design experience to tender for the design and prototype production of BodyGuard’s first family of products for the treatment of various joint, ligament, tendon and cartilage injuries and degenerative conditions. The selected tenderer would be required to prepare alternative designs for the first product, material selection and testing and prepare a number of prototype products that can then be used in clinical trials. The successful design house will be responsible for the key elements relating to look, feel and manufacturing form for the first family of BodyGuard products.
Recent in vitro human skin penetration studies of OBJ’s Lubricen™ formulation, in conjunction with the new specially designed magnetic microarray, achieved through-the-skin delivery rates significantly greater than Europe’s leading topical joint pain product. OBJ’s proprietary Lubricen™ formulation, which was designed to increase joint, tendon and ligament lubrication by mimicking natural synovial fluid aggrecans, was developed by OBJ’s scientific team in conjunction with Professor Adrian Davis of the London School of Pharmacy, one of the leading topical formulation specialists.
Independent research confirmed the widespread discomfort experienced by many people who undertake regular exercise and by people who suffer osteoporosis particularly as they get older. The Bodyguard active patches are intended to provide localised relief to patients rather than the common systemic applications used today. Clinical testing of the BodyGuard patches to demonstrate functional capabilities and superior performance was being planned through a number of leading Sport Science, Exercise and Health campuses in both Australia and Europe. Clinical testing will commence following the completion of pre-production prototype development. The Company said it will undertake this development program bringing each of the BodyGuard applications to a production stage by selecting the most efficient method of distribution through established brands.
26/06/13 - Underwriting of Options Expiring 30 June 2013
Following the efforts of Novus Capital which terminated the Underwriting Agreement after claiming that the Boston Marathon bombing had a materially adverse effect on the Company OBJ executed an Underwriting Agreement to see the Company’s Listed Options expiring on 30 June 2013 be fully underwritten, providing an additional $731,000 to the Company. Baker Young Stockbrokers was appointed Lead Manager and Underwriter to the Option Underwriting. Participation in the Underwriting was significantly oversubscribed and participants were scaled back following strong support from both existing Top 20 Shareholders and new Institutional Investors. Director Glyn Denison commented: “the strong support from the investment community for the underwriting highlights the potential of OBJ as it progresses its various programs. The underwriting ensures that the Company will have the necessary funds to continue to advance those programs. We thank our supportive shareholders and welcome new ones to what will be a very exciting 12 months for OBJ.”
16/07/13 - GSK ORAL HEALTHCARE MOVES TO CLINICAL EVALUATION
OBJ announced the execution of a Clinical Evaluation and Exclusivity Agreement with GlaxoSmithKline Consumer Healthcare in preparation for a human clinical trial in the field of Oral Healthcare. Under the Agreement OBJ granted GSK an exclusive right to conduct the study and to negotiate future licensing terms and conditions in consideration for GSK funding the clinical trial plus OBJ’s costs and expenses in supporting the trial. The study would be the largest undertaken in the area of oral healthcare using OBJ’s FIM™ technology.
GSK approved the following statement:
“OBJ and GSK have executed a Clinical Evaluation and Exclusivity Agreement which contains the terms and conditions under which OBJ and GSK have agreed to work exclusively together for GSK to evaluate OBJ’s FIM microarray technology with the objective of performing an in vivo study in humans and once the results of the study become available, GSK will discuss with OBJ potential further agreements for the development of OBJ’s proprietary technologies in the field of oral healthcare. GSK will conduct the human study and OBJ will support GSK by providing the OBJ Technology and technical support as requested by GSK from time to time”
OBJ and GSK have been working together for over 5 years in the development of new toothbrush technology based on OBJ’s Field-in-Motion (FIM™) technology. As part of this collaboration, OBJ developed specific magnetic microarrays for the three major commercial tooth care areas of anticaries (decay), hyper-sensitivity (sensitive teeth) and remineralisation (re-hardening). Following significant success in independent third party studies in all of these categories, GSK funded a human pilot study during 2012, the results of which led to the first major human efficacy study as set out in the Agreement.
There is little doubt that GSK and OBJ are working on something with the potential to disrupt an entire manual toothbrush market. In this paper published in November 2013 there is talk about how the roles of fluoride and metal ions may facilitate the development of systems to accelerate and enhance the delivery of fluoride using only a fraction of the amount of toothpaste currently recommended by the dental profession - GSK recently securing 'First Right To Negotiate' makes no secret of the fact that there is significant interest for OBJ's technology platforms in Oral Health.
27/08/13 - 4E APPENDIX to 30 June 2013 During the period, the Company gained momentum across a number of activities with partnering companies as well as furthering its own product development.
Procter and Gamble Engaging with Procter and Gamble on a regular basis resulted in wide-ranging discussions with various product groups to determine the most suitable commercial targets for OBJ’s technologies. Three clinical trials commenced using OBJ’s technologies in applications for P&G’s product lines. This is a significant series of human clinical trials for establishing the claims to be available to P&G in the event that OBJ’s technologies are incorporated into P&G’s product lines.
GlaxoSmithKline (UK) During the same period, the Company reported continuing successes in the Oral Health field in its exclusive collaboration with GlaxoSmithKline in the caries (tooth decay) field. The Company agreed with GSK to undertake a series of human trials in the UK using OBJ’s technology in oral health applications.
Coty The Company announced testing of applications for the dermaportation technology with Coty cosmetic applications. The Company also gained patent protection for dermaportation in both the European and US regions during the period.
Other Collaborations The Company also advised that it was maintaining a close working relationship with a number of major collaborative partners across the cosmetic, analgesic and pharmaceutical fields.
Internal Products Strategy The BodyGuard musculoskeletal joint pain and disability patch development program progressed rapidly throughout the period. Now resourced with a dedicated development team and supported by the commissioning of a major design house for industry design, the primary focus was on clinical trials scheduled for late 2013. It is the intention of the Company to undertake the development of its own series of products utilising established distribution partners and brands to market these products.
23/09/13 - 2013 ANNUAL REPORT
During the year, OBJ executed an agreement with Procter & Gamble to undertake human clinical studies with three P&G product applications. These series of clinical studies are undertaken for establishing the claims to be available to Procter and Gamble in the event that OBJ’s technologies are incorporated into P&G’s future product lines. In addition, during the year the Company announced testing of applications for the dermaportation technology with Coty cosmetic applications. The Company also gained patent protection for dermaportation which was being evaluated by Coty in both the European and US regions. The Company also reported continuing successes in the Oral Health field in its exclusive collaboration with GlaxoSmithKline in the caries (tooth decay) field. The Company agreed with GSK to undertake a series of human trials in the UK using OBJ’s technology in oral health applications. Cosmetics and skin care remain a key focus for the Company as it provides a broad set of market applications for products that incorporate OBJ’s technologies and likely to be a shorter route to market than the traditional pharmaceutical market sector. The Company maintains its development program across many pharmaceutical applications with targeted partnering firms. OBJ is moving forward with the testing and development of specific market applications for its technologies as it moves from being principally a technology R&D entity to a product development company. At the same time, work was well advanced with the Company’s own musculoskeletal and pain patch development that should see OBJ for the first time able to reach its market under its own timetable. I would like to take this opportunity of thanking our shareholders in supporting the Company as we transition OBJ into a more development orientated business. A great deal has been achieved this year in that transition phase. I would like to particularly thank my fellow Directors for their regular discussions and advice over many years. ~ Glyn Denison
REVIEW OF OPERATIONS SUMMARY - Jeffrey Edwards
"OBJ’s technologies are now at the fore front of new product developments across a number of main-stream commercial sectors and with a number of the world’s leading companies"
The 2013 financial year has been one of consolidation and progress for the Company on many fronts as its technologies are increasingly being accepted by global brand leaders as the next generation in product innovation. OBJ’s technologies are now at the fore front of new product developments across a number of main-stream commercial sectors and with a number of the world’s leading companies.
The transition from Research and Development to Product Innovation has been an exciting and rewarding journey for all areas of the Company. The Company’s focus on Consumer Healthcare, Oral Health, Skin Care and its own internal developments in joint pain management has yielded positive progress. During the period, all of the major reported projects have progressed and the Directors are pleased to provide the following summary of partnering activities together with our own product development, marketing initiatives and technical developments.
While the Company has a number of international partnering programs in various stages, the relationships with Procter & Gamble (P&G), GlaxoSmithKline (GSK) and Coty are particularly important initiatives.
PROCTER AND GAMBLE In 2012, the Company announced it had executed an exclusive Joint Development Agreement (JDA) with P&G, the world’s largest consumer products company. During the 2013 financial year, this collaboration led to the development of a number of custom magnetic micro-arrays designed to enhance the time to onset and level of performance of several key P&G ingredients used across multiple consumer products. Early successes in evaluation programs encouraged a rapid move to the design and development of consumer relevant prototypes for clinical trialing. These study programs are progressing and are expected to conclude by the end of 2013.
GLAXOSMITHKLINE CONSUMER HEALTHCARE - ORAL HEALTH In early 2012, the Company reported continuing success in the enhanced delivery of active ingredients employed by the oral healthcare industry in a joint development program with GSK Consumer Healthcare Group in the UK. Early successes encouraged GSK to fund the first in-mouth human pilot study which was conducted in early 2013. As a result of these early studies, the focus has moved to the development of new toothbrush technology incorporating OBJ’s technologies that could facilitate broader clinical evaluations. The Board is pleased to report that this challenging program has been successfully completed by the Company’s R&D group and that GSK and OBJ will now move forward into a clinical study using OBJ’s technology. This program will initially explore enhanced fluoride delivery using OBJ’s technology. There are also two additional key areas where OBJ’s FIM technology has been previously shown to be effective. The image (below) shows one of the Company’s internal developments that incorporate FIM magnetic micro-array elements into a standard toothbrush format.
GSK PHARMACEUTICALS (USA) - TOPICAL ANALGESICS The Company’s early work with GSK Analgesics in the USA continued during the period with the successful completion of a PHASE I study program to explore the impact on delivery of the OBJ technology on a number of proprietary formulations developed by GSK. Discussions and negotiations for a PHASE II optimisation program are currently at the planning stage. The image (below) shows the Company’s “Super Tube” measured dose applicator which is well suited to the controlled application of various therapeutic products and is under consideration by a number of potential partnering companies.
COTY - PHILOSOPHY - PRESTIGE SKINCARE During the period, the Company announced its collaboration with the Coty Group’s prestige cosmetic skincare company Philosophy. That collaboration is based around the Company’s powered technology and the e-Skin platform that includes an e-commerce component. Progress with Coty has been rapid with the Company designing and manufacturing a customer skincare device for clinical trialing and COTY commissioning a third-party contract research organisation to conduct a clinical study. Early indicative results have been encouraging and the Company is now working with Coty to develop a new “Wand” format incorporating Coty’s desired commercial attributes.
The image (above) sets out one format in which the e-Skin system could be deployed.
A number of other parties have also expressed an interest in various products based on the powered and e-Skin technology platforms.
OBJ’s PRODUCTS GROUP REPORT - George Tsadilas
"... has successfully shown enhanced delivery of key aggrecan at rates greater than leading European brands."
A thorough market appraisal has been conducted of the first product for the application to the knee and a business model has been developed for implementation. The appraisal indicated that a significant global opportunity exists for a knee patch in three target segments:
• Athletes; • Middle aged active people; and • Osteoarthritis sufferers
A design house has been engaged to design and develop a number of product prototypes in order to conduct product efficacy testing, clinical trials and consumer research. OBJ’s laboratory has been responsible for the formulation development in conjunction with the London School of Pharmacy which has successfully shown enhanced delivery of key aggrecan at rates greater than leading European brands. The intention is for the Company to develop a full commercial offering package before seeking branded companies to distribute the product.
INTERNATIONAL PARTNERING REPORT - Dr Kevin Hammond
"These commitments to undertake clinical trials are very positive intentions to consider OBJ’s technologies across a variety of applications."
The past twelve months has seen the Company move into a far more dynamic phase in partnering activities. Earlier efforts focused on consolidating collaborations, extending the technology portfolio, and delivering proof of principle data. These have now culminated in significant developments with partners in the FMCG Cosmetic and Personal Care sectors. Two key partners, P&G and Coty, have committed to clinical evaluation studies. As recently announced, GSK has now committed to significant clinical studies in the oral health care sector. OBJ is working closely and continuously alongside partners in all these studies. These commitments to undertake clinical trials are very positive intentions to consider OBJ’s technologies across a variety of applications. Partnering activities in the pharmaceutical sector have also continued positively. Safety and regulatory factors inevitably necessitate a cautious pace. Internally, significant progress has also been made on the BodyGuard program. This has not detracted from our ongoing partnering activities. OBJ identified a gap in the musculoskeletal injuries market and the opportunity to exploit it with its unique technology.
TECHNOLOGY DEVELOPMENT REPORT - Dr Matthew Mclldowie
"In response to the need for rapid development of production quality Dermaportation and FIM based units, OBJ acquired in-house 3D modeling and 3D printing capabilities."
The OBJ technical team has had a successful year. The primary focus has been the evolution of OBJ’s Dermaportation and FIM technology platforms into consumer focused commercial products. The high quality data produced in the laboratory for the P&G “Proof of Principle” assessment program of in vitro and in vivo work in 2012 has resulted in the advancement of the collaboration to the clinical trial stage. Design and development of the clinical trial units was undertaken in-house, demonstrating OBJ’s ability to provide expertise from technology development through to pre-production in support of partnering clients. In response to the need for rapid development of production quality Dermaportation and FIM based units, OBJ acquired in-house 3D modeling and 3D printing capabilities. This additional capability has accelerated the design process significantly and allowed OBJ to quickly tailor devices to the specifications that FMCG partners require. An extensive program of formulation design and testing in support of the BodyGuard series of products was initiated in early 2013. This has already resulted in significant positive data obtained in vitro with regard to the through-skin delivery of OBJ’s Lubricen™ formulation. The formulation testing program is ongoing, and OBJ looks forward to further enhancements being achieved with the cooperation of its Australian design partners.
28/11/13 - PATENT PORTFOLIO UPDATE
OBJ advised that its wholly-owned subsidiary, International Scientific Pty Ltd has lodged an Australian Provisional Patent Application entitled “Method and Apparatus for Increased Partitioning of Agents into the Stratum Corneum”. This third magnetic enhanced delivery technology by OBJ is known as Enhanced Partitioning and Penetration System or “EPPS”. The new technology utilises synchronized time varying magnetic fields in unison with microvibrational energy to increase the rate of ingredient partitioning from a formulation and increases diffusion into the upper skin layers (stratum corneum) that are the primary target for cosmetic and skin care products.
OBJ’s E-Skin technology patent has now been lodged internationally as a final specification under the Patent Cooperation Treaty (PCT).
Patent applications should be organized and drafted with a long-term objective that carefully considers the multiple possibilities, and opportunities, of field-of-use licensing. This is particularly the case in the pharmaceutical, biochemical, and chemical disciplines, as inventions can have multiple applications that are sometimes impossible to foresee. Technology managers must, therefore, focus strategically, not only on the basic idea of an invention but broadly, in order to consider the various ways such an invention might be put into more widespread and more profitable use. Therefore, the more details, examples and alternatives that are thought through and then disclosed in the patent application, the greater the opportunity for future divisional or continuation applications, as well as future claims that can be exclusively (field-of-use) licensed. By making all of the institution’s licenses, in effect, field-of-use licenses, the technology manager retains the ability to take a possible future use and license it to someone else, maximizing the benefits of the inventions and generating higher royalties for the institution. - IP Handbook
28/11/13 - 2013 AGM PRESENTATION
UNAUTHORISED 2013 AGM PRESENTATION
2013 OBJ AGM – Jeffrey Edwards - Transcript ~ originally posted by Gbr
We are involved in a lot of projects, we could spend hours on each one and product development and technology platform, etc, however I have prepared really a highlight, presentation, so you really need to focus down on the key aspects on what the company has been doing in the last year and from that you should be able to project what is going to happen in the future.
The big issue for OBJ, or where we find ourselves this year is up until 2013 we were really a technology development company in many aspects, we were working with partners to get an understanding of how our technology platforms could be incorporated into products and provide commercially relevant solutions for them thus generating revenues. 2013 has really seen quite a significant shift from what is effectively R&D, into working with our Partners to develop solutions. And these are market focused solutions, we have gone beyond the technology platforms and we are now in the solutions business, hand in hand with some of the largest companies in the world. We still remain absolutely focused in the cosmetic & skincare area - these are clearly areas that we can bring a great deal of value add, a lot of our commercial business is focused on that. Consumer Health care is another area that we are focused on because we now have the ability to create solutions to problems rather than technology alone we have grown our strength and our capability in that area through the year and in Oral Healthcare - Oral Healthcare started approximately 3 years ago I suppose as a very broad concept of “wow wouldn’t it be great if”, we’ve now gone beyond all of that we have covered so many ex vivo and first in human studies as we’ve announced there is a major human clinical study to be conducted in the UK, just showing how much progress we’ve made on Oral Healthcare - we will touch on that in a minute.
Pharmaceuticals
Where we are still keeping relatively away from long term deeply expensive pharmaceuticals activities we quite like what’s with OTC (Over-the-counter) - OTC short gestation period large volume, the big end of town in the very heavy weight pharmaceuticals is still an area that we will hold back on in preference to rapid to market higher turnover consumer based products. So that’s really where we are it’s really absolutely consistent with the story we gave last year and the year before and in fact there is an absolute sequential program that we have moved through where we have achieved every one of the goals that we have set ourselves with every one of our clients. I will now touch on each of those I think will be interesting.
Proctor & Gamble
Clearly P&G are foremost on every one’s mind. P&G are the world’s largest consumer company, you virtually cannot open your kitchen cupboard or your bathroom cupboard without being inundated with P&G products they have over 2000 of the world’s biggest selling sku’s. Our relationship with P&G is in an exclusive area within their Beauty & Grooming group and that is divided into 7 sub categories and we’re working with those - skincare clearly being the foremost one that we’re moving forward with. We have completed the first of 3 clinical studies and in fact the most important of those with P&G. Before you ask, no I can’t tell you what the outcomes of those are because the clinical results are not OBJ’s property, however the outcomes are being sufficiently engaging for them that we are now moving - that we have now moved forward into negotiations regarding possible product development for the first application of OBJ’s technologies across P&G’s product range. I hope to be able to expand on that in coming announcements shortly.
Coty – philosophy
The next one that was quite recently was the Coty – philosophy program, the philosophy clinical program that was a very large one in the U.S is now complete, again the results are not ours, I can’t share it with you, however I think that you can clearly see that the results have been sufficiently engaging and encouraging that we are now have moved forward and philosophy and OBJ are currently in negotiations for a development program which will lead on to a licensing agreement, from there, relatively advanced on those sections, so those 2 major clinical events that we announced earlier in the year have achieved everything that OBJ wished to and have been sufficiently encouraging that we are now engaged with these major parties on how you now turn those into products.
Oral Healthcare
As I have just mentioned earlier your Oral Health, Oral Health is potentially a very big area for us because the technology lends its self so easily to the toothbrush business there have been no major changes in toothbrush, manual toothbrush technology in probably the last 40 years this will be the very first, we have done multiple ex vivo studies, we have done first in mouth pilot studies, all of those have been encouraging the whole length and have encouraged GSK to commit to a rather large human clinical [?] study, as Glyn said we had expected that to commenced by now, but there are hold ups with the English ethics groups but they are just temporary things we expect to go on that any day now. We are very enthusiastic about this space it’s really where OBJ’s technology can change people’s lives we may have mentioned before, 1% improvement in fluoride uptake in teeth will save 1,000,000 children’s teeth in Australia alone so we think the level of enhancement we get starts to make serious social impact.
GSK Pharmaceuticals
GSK Pharmaceuticals, this is a development that has moved quite rapidly for us it is an OTC pharmaceutical area we previously announced that we were working with them on a phase 1 optimisation program where we are applying OBJ’s technology to an existing GSK formulation, they were having some trouble competing in the market with the performance of their product so they came to OBJ, we have now completed that phase 1 program and that is now moving forward to negotiations and expansion into a much larger phase 2 development program with GSK. A very convenient one because GSK is moving that division out of the U.S and into south east Asia much closer to our home ground, it means that I won’t have to spend quite so much time on aeroplanes in the future which I think is great. So that is another one area that we are moving very, very forward with.
BodyGuard Program
Our own products the BodyGuard, George will be doing a separate presentation on this but really 2013 has seen a massive movement forward on that we are very excited about that one I think that you will share that enthusiasm once George has finished, I will try not to steal any of his thunder, but this is very serious clinical program under the supervision of a guy, Professor Tony Wright, we are making this a world class event and George will tell you exactly where we are and why we are so excited about those thing’s.
Other Events
Other events during the year, there the primary ones that everybody’s mind was on, Coty, P&G, GSK, GSK & our own product. Just other things so that you can get a sense of how we have grown through the year we have now appointed a new Operations Manager, now that we have moved into the solutions business essential that we have the resources, the capability the in-house to be able to satisfy our partner’s manufacturing capabilities, spent most of last night on a phone call to an overseas company trying to work out things, logistics of producing products with OBJ’s technology so we are seriously growing our strengths in these commercial steps areas. Again we have really grown our test models and expertise because of our ability to influence partners, something that we learnt I suppose, last year as we were allowed deeper and deeper into these multi-million dollar companies we really did realise that OBJ’s technical strength was actually quite significantly superior to their own and these are the big companies in the world at this stage, we are now being asked to support those development programs, much stronger, because we can offer a speed of results and a capability that’s beyond the vast majority of our partners now, so we moved not only the technology, but the development steps, all chargeable development steps so we can turn our lab from a research centre into a profit centre so we have grown that strength and capability through the year quite extensively. But in-spite of all those things if you look at our expenditure we have been able to maintain that irrespective of our growth we are still considered one of the most conservative expenditure companies, we are very careful about what we do with your money because we believe that it is a valuable and finite resource, we waste nothing.
And of course the recent capital raising with Dirk (Baker & Young) and the help of our loyal supporters have now really put the company in a position where it has vision, capital resources to now really drive these areas home, especially with such exciting projects as George has a level of support, where getting from our partners again keeping in mind that all of our partner activities are fully funded, yet they put up the cheques. The days of us investing in partner activities are gone - it’s now joint funded they're paying the bills and that really changes the economics, dynamics so we can focus on how we turn that into strong and sustainable cash flow, so we can grow the value that under pins the work of OBJ. So in a nutshell, that’s what we have done with your company during 2013, it’s been a terribly exciting period and I think there is some very near term stuff that I think that you will be very happy with that we will be very very keen to announce as soon as we possibly can.
13/12/13 - FIRST BODYGUARD TRIAL SUCCESS
OBJ advised that the first product trial of its BodyGuard Knee patch has exceeded expectations and improved knee functionality in 94% of volunteers in a two week, Aggregated Locomotor Function (ALF) study. The study, designed by Professor Tony Wright, combined 6 knee intensive challenges. The program was developed to evaluate the effect of the Bodyguard patch technology and OBJ’s Lubricen formulation on healthy male volunteers following two weeks of daily use of the BodyGuard patch. Improvement in performance in the timed challenges of the ALF program resulted in 16 out of 17 participants showing substantial improvements in their aggregated times. The distance challenges resulted in substantial gains in 12 of the 17 participants over the two week treatment period. The overall performance improvement following two weeks of patch use across all participants and all challenges was 14% which Professor Wright has indicated as being clinically important.
Improving knee function is a major unmet medical need with incidence of age and injury related joint deficiency now affecting 1 in 5 people in the developed world. Loss of knee function through injury, overuse or degeneration is known to increase the likelihood of Osteoarthritis. The goal of the BodyGuard project is to develop a new form of transdermal patch that can hydrate and lubricate the articular surfaces of joints, potentially reversing the effect of joint ageing and degeneration. In addition to the ALF program, the study also utilised thermal imaging before and after exercise to determine whether the patch altered localised tissue trauma during intensive exercise. A Knee Injury/Osteoarthritis Outcome Score (KOOS) questionnaire and a daily participant diary were also part of the study and will be used to determine participant perceptions and usage experiences, all of which will be used to further refine the next phase of trials.
As a result of the success of this first trial, the Company plans to undertake a larger independent clinical trial during 2014. A number of Australian and international scientific and sporting clinical centres are under consideration. The outcomes of such a clinical trial would then underpin the Company’s business planning, partnering and distribution discussions.
BodyGuard was established by OBJ to utilise its low cost magnetic microarray drug delivery technology in a new form of transdermal patch designed to limit joint ageing and to restore healthy joint function. By combining OBJ’s drug delivery technology and Lubricen formulation with the patch’s physical kinesiology, proprioception and tendon stabilisation properties, a unique and highly advanced joint treatment product platform will be created. The product would create a new and potentially unique category for the treatment of joint injury, joint ageing and osteoarthritis.
The Company plans to commercialise the BodyGuard range of products through distribution and branded supply relationships with established global brand leaders across the sporting, life-style and osteoarthritis sectors. The Company is currently exploring new patch designs for other major joints of the body and new formulations for performance enhancement, injury recovery and pain management.
13/12/13 - APPOINTMENT OF LICENSING SPECIALIST
OBJ announced that it has secured the services of Dr. Steve Meller, recently retired Chief Innovation Catalyst at P&G based in Cincinnati to assist in negotiations of partnering and Licensing for the use of OBJ's technologies. Dr. Meller was born and raised in South Australia and obtained his B.Sc., BSc. (Hons.), and PhD from the University of Adelaide. Dr. Meller’s first career was as a research scientist in Neuroscience at the University of Adelaide, The University of Iowa and The University of Cincinnati. Subsequently Dr. Meller joined Procter and Gamble where he has had close to 20 years experience in Senior Health, Innovation and Sustainability leadership roles and worked extensively across 6 continents. Dr. Meller now runs a specialty consulting company from San Francisco and Silicon Valley, works extensively in the US Venture Capital Industry and sits on a number of Advisory Boards. Dr Meller will work closely with OBJ in future negotiations and discussions with Global FMCG and Pharmaceutical companies and advice on further opportunities for OBJ’s technologies.
16/12/13 - GSK PHARMACEUTICALS PROGRESSES TO SECOND PHASE
OBJ advised that it has executed a second Analgesic Study Agreement with GlaxoSmithKline (USA) following the successful completion of the Phase I program. GSK has authorized the following statement:
"GlaxoSmithKline (USA) has entered into a Phase II Analgesic Study Agreement with OBJ following the successful completion of a Phase 1 program conducted during 2012. The Agreement sets out a development program of the design and optimization of magnetic micro-arrays specifically for GSK proprietary formulations".
In 2012, OBJ and GSK Pharmaceuticals of New Jersey USA, entered into a Phase I Development Agreement designed to determine the effectiveness of OBJ’s Field-in-Motion applicator technology on the ex-vivo transdermal delivery of a number of GSK proprietary analgesic formulations against competitor products. Following completion of the Phase I program, technical discussions commenced on a Phase II Study Agreement and were concluded with GSK’s Analgesics Group now located in Singapore.
28/02/14 - APPENDIX 4D - REVIEW OF OPERATIONS
The Company’s primary focus during the period remained on four major international partnering programs including progressing the Company’s own BodyGuard project
Procter and Gamble The highlight of the period was the completion of the first human clinical efficacy study conducted in China. The 80 person study sought to evaluate the efficacy of OBJ’s non-powered Wand technology on a range of industry standard cosmetic indices using high resolution imagery, expert dermatology evaluations and consumer perception data. Negotiations are underway for the Company’s first Product Development and an expansion of the work programs into a number of new categories.
GlaxoSmithKline - Oral Health Following repeated successes in ex-vivo evaluations in the oral health field and success in an initial human pilot study, GSK’s Oral Healthcare group in the UK, committed to a human clinical efficacy study into the enhanced delivery of fluoride. OBJ’s technical team worked closely with GSK scientists during the period to develop the new toothbrush-styled technology with GSK now undertaking ethics approval as part of the study.
COTY- Philosophy Cosmetic Collaborations The highlight of the Coty collaborations was the completion of the large human clinical efficacy study conducted in the USA during the reporting period. This clinical study sought to evaluate the effect of OBJ’s powered Dermaportation technology on key cosmetic anti-ageing outcomes using both expert assessment and consumer perceptions. The outcomes of this study resulted in negotiations for a Product Development and those discussions have commenced.
GSK (Pharmaceuticals) - Analgesics In 2013, the Company successfully concluded the Phase I analgesics development and evaluation with GSK Analgesics in Parsippany, New Jersey. During the period, the Analgesics group relocated from New Jersey to Singapore and subsequent discussions resulted in the execution of a Phase II Development Agreement which was announced to the market in December 2013.
BodyGuard The Company’s BodyGuard musculoskeletal patch project took a major step forward during the reporting period with the successful completion of the first product efficacy study on humans with pre¬existing knee conditions. The study, designed by Professor Tony Wright, explored the level of joint anti¬ageing and restorative potential of the BodyGuard patch, in response to two weeks of daily use. Results showed an average improvement of 14% across a range of common but challenging physical exercises. These encouraging results are now being used to plan a larger clinical program that will underpin the Company’s marketing and patenting programs.
Technology and Intellectual Property During the period, the Company announced the lodgment of patent filings covering the Company’s new Enhanced Partitioning and Penetration System (EPPS). This new system utilises synchronized micro¬vibration with diamagnetic enhanced delivery. The combination has been shown to be of specific benefit in various locally acting topical formulations and a number of potential partners are currently being targeted.
Business Development Business development activities were at a high level during the period, with a number of new opportunities being explored with various potential partners. During the period, the Company reported that Dr Steve Meller had joined OBJ's team to assist with negotiations and finalising of various product and licensing agreements with existing and new partners. Dr Meller’s experience includes over 19 years with Procter & Gamble and now works extensively in the US Venture Capital Industry.
"During the period, the Company reported that Dr Steve Meller had joined OBJ's team to assist with negotiations and finalising of various product and licensing agreements with existing and new partners."
"it’s been a terribly exciting period and I think there is some very near term stuff that you will be very happy with that we will be very very keen to announce as soon as we possibly can." ~ Jeff Edwards
OBJ Price at posting:
4.6¢ Sentiment: LT Buy Disclosure: Held
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