Chronological Review
"Dermaportation is the first of a new generation of “coercive” active drug delivery technologies developed by OBJ Limited that “teleport” drugs past the skin’s protective layers. The technology is powerful, yet gentle and represents the first of a new generation of bio-communication delivery systems. As such the market applications are enormous and the value of the technology to drug companies, medical professionals and patients/consumers will be considerable."
"John Baldoni, Ph.D., SVP platform technology and science R&D with GSK, discussed knowledge as becoming a commodity, and he predicts the next therapeutic game changer will come not from drugs, but electrons."
"Moncef Slaoui, chairman of GSK research and development, said bioelectronics was set to be the next big wave in medicine, comparable to the rise in biological therapies over the past 15 years triggered by advances in biotechnology. This is our vision for the next 10 to 20 years," he told Reuters. "In the future, a big chunk of R&D will be doing bioelectronics."
09/02/05 - Reduces Transdermal Drug Delivery Times by 70%
Western Australia Biomedical Research Institute study confirms OBJ’s Dermaportation technology reduces the time to onset of action by up to 70%
10/02/05 - Lodges First Drug Specific Delivery Patent
This is the first of a number of patent applications covering the specific relationship between the proprietary transdermal delivery fields used by OBJ and the molecular structure of a particular drug.
01/03/05 - Demonstrates fine control over drug delivery rates
Researchers find Dermaportation can either accelerate rates of drug delivery by as much as 280% or decrease them to 36%... these promising results represent a significant step forward in drug delivery technology.
10/03/05 - Tests Confirm Time-Based Drug Delivery Capability
This is the first time a drug delivery technology has demonstrated the ability to control a rate of delivery while in place and then to selectively increase or decrease drug bioavailability up to an hour after the patch has been removed.
17/03/05 - Presentation to the 39th Annual Conference ASCC
16/05/05 - Presentation to the Australasian College of Dermatologists
18/05/05 - Dermal Penetration Enhancement by Dermaportation – Preliminary investigations of a novel technology
02/06/05 - Patent published for WO2005049135 - Apparatus for facilitating transdermal delivery of therapeutic substances and method of transdermally delivering therapeutic substances
08/06/05 - Receives approval for Vaccine & Anti-body drug patch trials
Ethics Committee approves clinical trial to investigate the efficacy of Dermaportation drug delivery technology in the development of a Vaccine and Anti-body drug patch, allowing the potential for more people to be immunised using less vaccine to create the same immunological response.
07/07/05 - Smart Patch
OBJ's “smart” patch is believed to be the world's first intelligent solid-state drug patch and embodies the company’s propriety Dermaporation through-the-skin drug delivery technology - the re-usable coin-sized drug patch contains a complete microcomputer system and rechargeable power source and is expected to cost just a few dollars.
20/07/05 - Accelerates Skin Cancer Drug Absorption by 900%
16/08/05 - To Present at World Congresses on Inflammation & Pain
16/09/05 - Results of Study - Transdermal Delivery of Voltaren
16/09/05 - Annual Report 2005
OBJ begins early stage discussions with major pharmaceutical companies with the view to develop customised delivery solutions for a range of problematic or underperforming drugs or compounds. Drs Kay Fei Chan and Chin Joo Goh supported the work in Asia and Dr Maud Eijkenboom has been invaluable in building relationships with European and US based pharmaceutical companies. The Company also acknowledged the contributions of Dr Heather Benson, Dr John Snowden and Dr Andrew Barker for their ongoing support and scientific involvement in the development of OBJ's technology. Dr Chris Quirk has worked tirelessly in all aspects of the Company’s business, both in his capacity as clinical advisor, as a member of the Board of Directors and as a presenter of the Company’s technology at events such as the World Congress on Inflammation. Reducing the time of delivery of a specific drug, and in doing so reducing the time to onset, is a critical factor in deciding the route of delivery of both new and existing drugs. The ability to manage both dosages and time-to-effect is a significant technological achievement.
11/11/05 - Vaccine Patch Matches Injections in 2nd Phase Pilot Study
Final antibody analyses taken 2 weeks following the second or booster vaccination phase shows superior immunological response with OBJ's technology compared to the traditional intra-muscular injection method. The trial involved the administration of GLANVAC (™ Pfizer Australia).
05/12/05 - 100 Fold Increase in Transdermal Delivery of Naltrexone
Independent University studies confirm Dermaportation can increase delivery of Naltrexone by up to 100 times.
06/12/05 - Full Copy of Presentation to Aust Pharmaceutical & Science Assoc
13/12/05 - 75 Fold Increase in Cortisone Delivery Through-the-Skin
Dermaportation successfully delivers Hydrocortisone at rates up to 75 times that achieved by normal passive diffusion. Hydrocortisone is a corticosteroid drug, widely used in sports medicine, dermatology, antiallergy and cosmetic sectors to treat a wide range of disorders including chronic joint pain, arthritis, psoriasis, post trauma scarring, allergic disorders and hormonal disorders. These results achieved with OBJ's technology may avoid many of the common systemic complications and provide a commercially significant alternative to both oral and injections.
09/02/06 - Lodges patent over new energy driven drug delivery process
OBJ technology exploits a number of electrokinetic and thermodynamic principals to create the first wireless active delivery system providing separate control over diffusion and skin permeability. The graph below demonstrates the clear differences between the passive delivery of low concentration drugs and the company’s Dermaportation system. Passive diffusion, even after 4 hours, does not achieve detectable levels through human skin, however Dermaportation shows a strong early energy delivery phase followed by controlled permeability changes to the skin itself.
22/02/06 - Appoints Director of Business Development
Glyn Denison is appointed to the Board of Directors to oversee the commercial and market development activities of the company. Glyn comes with 30 years experience in international business development including 16 years in technology intensive industries, during which time he oversaw annual company revenues rise from a small base to over $450m per annum.
06/04/06 - Drug Delivery Technology to be Presented at Conference
19/04/06 - Drug Delivery Technology Proven in Human Trial
Blinded placebo controlled human pilot study into the effects of the company’s drug delivery technology on the speed of onset of a commercially available Tetracaine local anesthetic represents the first time OBJ's drug delivery technlogy has been demonstrated on live human skin.
26/06/06 - OBJ's Technology Enhances Follicle Drug Delivery
The hair follicle is potentially a useful route for transdermal delivery of drugs as it provides a major entry point for topically applied compounds and has a significant reservoir capacity for drugs that are substantially higher than normal skin. Follicular drug delivery may also provide opportunities for hair therapy and in the treatment of hair follicle disorders such as andogenetic alopecia and hirsutism. Follicular drug delivery is also being explored for its potential in gene therapy and in immunotherapy. This study into follicle delivery was part of a larger research program headed by Professor Michael Roberts and Dr Sheree Cross into the specific effects of Dermaportation on various aspects of drug formulations and applications.
19/09/06 - Dermaportation Demonstrates Lasting Effects
Dermaportation found to increase and maintain the controlled supply of the hormone ESTRADIOL through the skin for at least 8 hours, even though the technology was active for only 2 hours. Other drug delivery techniques require “whole of therapy” contact, which can be undesirable in a number of aspects. Poor adhesion, skin irritation and cosmetic unacceptability are significant problems yet to be resolved by traditional drug delivery patches. By controlling the movement of drug molecules and the skin’s barrier effect as separate processes, OBJ has succeeded in overcoming a number of technical obstacles.
28/09/06 - Annual Report 2006
Exciting scientific accomplishments continued during the period including new capabilities in the ultra-low concentration fields. Drug delivery systems traditionally require quite high concentrations in order to drive the diffusion process through the skin. The Company was able to demonstrate that it was able to work at concentrations of less than 2%, which provides a significant improvement over the curent limitations faced by the drug industry.
The ability to both “turn-on” and “turn-off” the movement of drug through the skin remains an important capability of the OBJ technology and one that will ultimately allow the Company to provide time-of-day delivery across a wide range of drug types and uses.
The Company is also working with Professor Chris Anderson of Linköping University in Sweden where microdialysis techniques and technologies are being applied to track the movement of drugs through living skin under the influences of Dermaportation.
Nature Journal - Cutaneous Microdialysis: Is it Worth the Sweat?
23/11/06 - Announces Power-Less Active Drug Patch
OBJ announced the development of the first power-less active drug patch technology. Traditional patches, such as those used for smoking cessation and hormone replacement, use a drug and adhesive matrix that relies on the slow migration of drug molecules from the matrix into the skin. This has restricted the commercial use of drug patches to simple molecules and low dose applications. OBJ is a leader in non-contact inductive drug delivery systems. The result is a novel biphasic material that captures thermal energy from the body to create an active drug push. Unlike traditional drug patches it does not require the drug-adhesive matrix, and as a result can avoid the drug retention, disposal or adhesion problems currently facing traditional delivery patches. The performance of OBJ's new power-less patch has been in line with the delivery rates being achieved by iontophoresis, the most commonly used form of active transdermal delivery technology on the market today. OBJ has been able to achieve similar delivery rates without the adhesion, electrical contact or battery disposal problems currently facing iontophoresis.
The graph above, shows the drug delivery effect of the new powerless patch when compared
with passive diffusion for the delivery of the local anaesthetic Lidocaine.
The new powerless patch compliments the Dermaportation system which provides re-usable and personal drug delivery solutions for pharmaceutical, animal health and cosmetic applications. While the new drug patch substrate lacks the power and advanced capabilities of OBJ's Dermaportation technology, it does represent the first step towards directed and controlled drug delivery using a passively powered device.
"Traditional transdermal drug delivery patches use a drug and adhesive matrix that relies on the slow migration of drug molecules from the matrix into the skin. This has restricted the commercial use of drug patches to simple molecules and low dose applications. A change in the underlying capabilities of drug patch technology will have a significant impact on this market. As a leader in non-contact inductive drug delivery systems OBJ offers innovative solutions covering both powered and unpowered delivery technology platforms - The company's proprietary ETP material technology is a novel biphasic material which captures thermal energy from the body to create an active drug push. Unlike traditional drug patches it does not require the drug-adhesive matrix, and as a result can avoid the drug retention, disposal or adhesion problems currently facing traditional drug delivery patches. OBJ's technology platforms have been specifically designed to meet the Standard for Environmental Management. These standards were developed in Europe to overcome the environment problems caused by the high levels of drug residues from traditional patches."
"Through-the-skin delivery of drugs, hormones, vitamins, vaccines, anti-bodies and anti-aging molecules provides economic, safety and efficacy benefits to the pharmacology, medical, veterinary and cosmetic industries. Cost reductions are achieved through self administration with a corresponding increase in safety and patient compliance. Side effects can be reduced in many cases by localized delivery and programmed delivery rates. Needle stick injuries and needle disposable problems can be eliminated
while the reduction in the level of skill required for application can significantly reduce total cost of administration."
"The exponential rise in global population puts increasing strain on many aspects of our society, and healthcare is no exception. The dynamics of this increase are important too. For example, the increases in the elderly population will have a significantly disproportionate impact on our healthcare system, driven by a more rapid increase in patient need over the ability of our society to pay. Increasing numbers of patients, at a time when therapy costs are already high, puts strain on the management of disease in an often over-stretched system. Within this system, a number of drivers are being debated, including the trend towards home-based care to offset pressure on hospitals and local surgeries, and the efficiencies offered through better patient and outcome data management. The move towards home-based care raises the prospect of more simplified drug delivery devices, based on two characteristics of this new market. The first is that the prescribers and carers may no longer be doctors, so instruction on use/training should be simple and effective. The second is that the patient themselves or their non-professional carer may be required to administer drugs previously given in a clinic, requiring simple and low-risk mechanisms to ensure safety and efficacy."
07/12/06 - Reduces Time to Onset in Successful Clinical Trial
PhaseII of the company’s human clinical trial for the enhanced transdermal delivery of the local anaesthetic Ametop showed that Dermaportation was able to induce numbness in volunteer subjects within 20 minutes using one fifth of the recommended drug dosage. This represents a significant reduction in both the amount of drug required and the time to onset compared to manufacturers recommended time of 30-45 minutes. At 20 minutes after drug administration, there were also statistically significant differences in the touch sensitivity between active and placebo treatment areas in volunteers. This provides evidence of successful enhanced skin penetration of tetracaine under the influence of Dermaportation. This provided evidence of the in vivo skin penetration enhancement effect of the Dermaportation technology.
09/01/07 - Former Alza Executive Director to Advise OBJ
Dr Ravi Kiron PhD, MBA - one of the world authorities on drug delivery licensing and technology evaluation and former Executive Director of Alza Corp - subsidiary of $200 billion US pharma giant Johnson & Johnson, appointed in consultancy role to assist the growth of OBJ's transdermal drug delivery products and licensing business.
11/01/07 - Dermaportation Study to be published by prestigious journal
11/01/07 - Peer Reviewed: Liquid chromatography assay for 5-aminolevulinic acid: Application
to in vitro assessment of skin penetration via Dermaportation
27/04/07 - 3rd World Congress of Pharmaceutical Sciences
07/05/07 - OBJ Enters into Agreement with GlaxoSmithKline
OBJ signs a short term Feasibility Agreement with GSK for multiple applications in Consumer Healthcare. The arrangement follows a small exploratory study during 2006 to exploit the ability of OBJ's Dermaportation technology for increasing the delivery of a specific drug through the skin.
19/06/07 - Investor Presentation & Update
11/07/07 - Positive Results for Delivery of Therapeutic Peptide
Dermaportation enhances the delivery of a di-peptide (ALA-TRP) through excised human skin. These results demonstrated that the transdermal delivery of ALA-TRP through human epidermis was increased 28-fold with Dermaportation.
Therapeutic peptides are molecules made up of 2-100 amino acids that are highly effective and selective in targeting specific biological processes. Peptides can be used to treat a broad range of diseases including cancer, cardiovascular, infection, metabolic diseases and central nervous system disorders. The market is forecast to expand rapidly reaching US$20B by 2013, as some of the 670 peptides in development enter the market.
Trial Summary| ETP and DP data summary
28/09/07 - OBJ presented scientific posters at the following national and international scientific forums:
• Skin Frontier Conference, Washington, 2007
• 8th World Congress on Inflammation, 2007
• Bio2007, Boston USA
• Journal Chromatography, 2007
• Drug Delivery Partnerships USA, 2007.
28/09/07 - Annual Report 2007
Technology is not an easy sector in times where the market is driven by resources, however health is the cornerstone of quality of life and the Company remains dedicated to delivering the benefit of its work to the global healthcare sector. The Company has conducted initial human and animal pilot studies to provide preliminary evidence of efficacy in-vivo. The energy fields were not perceived by patients and were shown to be painless and well tolerated in pilot human studies. Collaborations with partners that have the clinical development, regulatory and marketing capabilities to successfully develop and commercialise transdermal products will remain central to the Company’s strategy.
Ex-vivo skin diffusion studies
25/10/07 - OBJ Appoints Transdermal Experts To Scientific Advisory Board
OBJ announced that it strengthened its Scientific Advisory Board with the appointments of two transdermal scientists. Dr Michael Roberts and Dr Heather Benson will advise the Company on its optimisation and validation programs for its Dermaportation and ETP delivery platforms.
Scientific Advisory Board profiles
Dr Michael Roberts - BPharm MSc PhD DSc DipTertEd MBA FAIPM
Dr Mike Roberts is a registered pharmacist and leading transdermal scientist with over 35 years experience in transdermal drug delivery. He is NHMRC Senior Principal Research Fellow, Professor and Director of the University of Queensland’s Therapeutic Research Unit at the Princess Alexandra Hospital. He was previously Professor and Chairman of Pharmacy at Otago University (NZ), and prior to this a community and hospital pharmacist. Dr Roberts has extensive academic and industry experience in the commercialisation of transdermal drug delivery technologies and products. He has published over 350 scientific papers covering aspects of transdermal transport, has coedited 3 research books and is a regular international speaker in transdermal delivery. He is also Associate Editor of Skin Pharmacology and Applied Physiology; Member of Editorial Board for J Pharmacokinetics and Pharmacodynamics, Pharmaceutical Research, Clinical Pharmacokinetics, Current Drug Delivery, Drug Metabolism & Pharmacokinetics. He was past president of Australasian Pharmaceutical Science Association (APSA) and was a co-recipient of the Inaugural APSA Achievement award for outstanding achievements in pharmaceutical science in 2004.
Dr Heather Benson - BSc(Hons) PhD (updated 2012)
Heather A.E. Benson has extensive experience in drug delivery with particular focus in transdermal and topical delivery. She is an Associate Professor at Curtin University where she leads the Drug Delivery Research Group. She received the Western Australian Inventor of the Year (Early Stage Category) award in 2008. She is also a scientific advisor to OBJ Ltd., a Perth - based company involved in the development of magnetically enhanced transdermal delivery technologies. Prior to Perth Dr. Benson was at the University of Manitoba, Canada, where she won Canadian Foundation for Innovation funds to establish the Transdermal Research Facility. Before Canada, she was a senior lecturer at the University of Queensland, Australia, where she worked closely with Professor Michael Roberts to establish a highly successful topical and transdermal research group at the university. Heather has a PhD from Queen’s University in Belfast in the area of transdermal delivery and a BSc (Hons) in Pharmacy. She is on the editorial board of Current Drug Delivery and acts as a reviewer for many journals. She is a member of the CRS Australian Chapter Executive Committee and the Australian Peptide Society Conference Organising Committee.
Dr Chris Quirk - MBBS FACD MAAD
Dr Quirk is a leading Australian dermatologist with significant clinical and industry experience in dermatology product development and has conducted numerous trials for international pharmaceutical companies such as Roche, Novartis, 3M and Matrix and has served on advisory boards for Merck, Allergan and Roche, Abbott, Wyeth and Janssen. Dr Quirk has published over 22 scientific papers in dermatology and is a regular presenter at international dermatology conferences. He is a Fellow of the Australasian College of Dermatologists and Member of the American Academy of Dermatology.
07/05/08 - Patent filed for WO2009135246 - Method and apparatus for enhanced transdermal diffusion
05/06/08 - Enhanced Transdermal Delivery of a Dipeptide by Dermaportation
Dermaportation significantly enhanced the transepidermal delivery of Ala-Trp in vitro over an 8-h period when compared with passive diffusion. The dipeptide was shown to beunstable on exposure to human epidermis with an increasing amount of degradation product evident in the receptor phase over the 8-h period. Given the susceptibility of peptides to degradation in the skin, it is essential that they are delivered rapidly across the skin in order to maximize the opportunity for delivery of the native peptide. Dermaportation offers a potential new delivery method for skin delivery of peptides for a range of dermatological and cosmetic applications.
Peer Reviewed Article
Link to paper
08/06/08 - Research in the Facility of Health Sciences
"Together with local biotech company OBJ Limited, the Curtin team is exploring the use of magnetic fields to enhance skin penetration for a range of drugs, including drugs to treat skin conditions, local anaesthetics to treat pain, anti-inflammatory drugs to treat muscle injury and drugs with cosmetic applications such as anti-ageing and acne treatments. A biological evaluation of magnetic technology treatments for the company is underway, and this new approach is demonstrating success for a range of drugs."
08/09/08 - Shareholder Update
The Company signed a research collaboration with the University of Queensland in January 2008 for a $250,000 ARC Linkage Grant titled “Topical peptide delivery for cosmetic and therapeutic benefits”, and plans to investigate the mechanism and feasibility of using the ETP platform for delivery of cosmetic peptides under this collaboration.
Topical peptide delivery for cosmetic and therapeutic benefits - ARC Linkage Program at the University of Queensland from 2008 to 2011
30/09/08 - Annual Report 2008
The Company is at various stages of discussion and assessment with pharmaceutical and drug delivery companies to evaluate the OBJ technology for transdermal delivery. OBJ aims to take advantage of the current interest in active delivery platforms that can provide a transdermal solution for existing drugs going off-patent within the next 4-5 years.
29/10/08 - OBJ Signs Second Agreement
OBJ announced that it had executed a second research collaboration agreement with a global Fast Moving Consumer Goods (FMCG) company to evaluate and optimise its proprietary DP and ETP drug delivery platforms for the transdermal delivery of an undisclosed compound. In December 2007, OBJ executed a research collaboration agreement with the same FMCG company to evaluate the use of both the DP and ETP platforms for up to 2 compounds for over-the-counter (OTC) healthcare applications. The initial feasibility was successfully completed in March 2008. The terms of the agreement and details of the feasibility project were subject to confidentiality; however OBJ received fees of up to US$335,000 for completion of the project. The agreement also deals with future collaboration and licensing rights that may arise following a successful feasibility.
18/12/08 - Shareholder Update
OBJ engaged independent transdermal experts to review the Company’s technology, skin diffusion results and POC program, and provide recommendations to further evaluate, optimize and validate the DP and ETP technologies for transdermal drug delivery.
Professor Brian Barry of Bradford University is an international authority on drug delivery systems, specializing in topical and transdermal delivery including transdermal formulation and skin chemistry with some 400 publications. He has previously served as a member of the Chemistry, Pharmacy and Standards Sub-Committee of the Committee on Safety of Medicines. He acts as adviser on topical and transdermal delivery of drugs to the Medicines Control Agency of the UK and the Food and Drug Administration of the USA. Professor Barry is a Fellow of the Royal Pharmaceutical Society of Great Britain, a Fellow of the Royal Society of Chemistry and a Fellow of the American Association of Pharmaceutical Scientists.
Dr Keith Brain of Cardiff University was formerly head of Drug Delivery and is currently a Reader in Advanced Drug Delivery and Pharmaceutical Analysis at Cardiff University. He is also a founder and Director of An-eX Analytical Services Pty Ltd, one of the UK’s leading transdermal contract research and development laboratories that provides specialist skin services to the pharmaceutical, cosmetics, chemical and agrochemical industries. Dr Brain has broad expertise across dermal and transdermal drug delivery, including prediction of dermal permeation, formulation development and evaluation, bioequivalence, skin penetration enhancement, claim substantiation and risk assessment.
10/03/09 - Electromagnetophoresis: Potential for enhanced skin penetration of drugs and cosmetics
10/03/09 - Electromagnetophoresis: Potential for enhanced skin penetration of peptides
10/03/09 - International Society of Drug Delivery Sciences and Technology 2009
10/03/09 - Skin and Formulation 3rd Symposium & Skin Forum 10th Annual Meeting
17/03/09 - OBJ Data Presentation in France
06/04/09 - Technology Testing Update
In a multi-experiment in vivo study conducted between December 2008 and March 2009 at the Optical + Biomedical Engineering Laboratory (OBEL) Dr Vincent Wallace and his team used Optical Coherence Tomography (OCT) laser technology and skin electrical analysis to monitor changes in epidermal thickness and electrical properties during the application of the cosmetic moisturising compound Urea under occluded and ETP enhanced delivery. In December 2008, the Company commenced work using a number of new models that provided information on how the skin’s microstructures were altered by the Company’s technology and the penetration of certain drugs and compounds.
The highlighted areas show changing epidermal morphology over a 20 minute period, comparing eM-Patch enhanced delivery with passive occlusion. Under eM-Patch enhanced delivery, a 5% urea gel created a downstream bio effect increase in total epidermis thickness of 29 microns compared with 19 microns under occlusion alone.
Additional in vivo study techniques
Hyaluronic Acid (HA) is a humectant and binds to the loosely associated water in the epidermis once it penetrates the stratum corneum. In the study (below) skin capacitance was used to monitor in vivo epidermal hydration over a 60 minute period. The significant reduction in epidermal capacitance achieved by ETP during the period of contact with the skin contrasts with minimal biological effects of HA delivered passively. The reversal of trend shows the rapid reversibility of the ETP effect.
Dermal hydrating and moisturizing products increase skin capacitance by adding to the total non-bound epidermal water. When delivered effectively, they cause a rapid and deep increase in epidermal water reserves. When ETP was tested in vivo using a commercial moisturizing compound, substantial downstream bioeffect differences were observed when compared with passive occlusion alone.
Micro-Relief shows changes in the underlying morphology, similar to that seen in OCT images. These changes are reflected in the skin as visible wrinkle reductions. When ETP was tested using a leading commercial penta-peptide formulation, the change in wrinkle profile improved by an average of 27% when compared with normal topical delivery.
Diamagnetics - Directionality in diffusion
Ingredient molecules diffuse from a product into the skin by random directionless motion of molecules. However, the majority of cosmetic actives are made up of diamagnetic molecules, meaning they are repelled by certain magnetic fields due to the rotational behavior of their paired electrons. ETP is designed to enhance diamagnetic forces to give direction and energy to diffusion, resulting in increased bioavailability and reduced time to onset.
Electo-osmosis - a less torturous Route
Cosmetic products penetrate the stratum corneum via the inter-cellular or torturous route. eM-Patch has field structures that work with body heat (thermodynamics) to open osmotic shunts and appendageal pathways to provide faster onset, reduced lag time and greater control over dermal distribution.
Magneto-Physiochemistry - hygroscopic expressway
ETP temporarily and reversibly alters stratum corneum and epidermal water binding and retention to provide a means of managing the hydrophilic and lipophilic pathways.
Enhanced Transdermal Polymer (ETP)
ETP is a flexible polymer material with embedded magnetic arrays developed by the Company to provide a low-cost powerless active drug delivery capability. ETP can be manufactured as an industrial roll and is designed to replace the passive plastic backing layer in standard drug patch production. ETP is designed to add minimal costs to production but allow greater drug delivery, fast penetration and shorter times to onset in a wide range of applications in the pharmaceutical, dermatology and cosmetic sectors. ETP functions by generating tightly controlled magnetic field gradients that interact with the skin’s microstructures and the drug’s formulation to enhance the time, rate and efficiency of transdermal delivery. Each magnetic field gradient is made up of an array of magnetic elements with the dimensions and orientation acting together to create 3-dimensional field structure. The magnetic gradients generated by ETP can be optimised to suit the delivery requirements of specific drugs and products.
Introducing eM-Patch
Journal of Pharmacy and Pharmacology
Improved sample characterization in terahertz reflection imaging and spectroscopy
08/07/09 - eM-Patch delivers significant improvement in Tooth Whitening
OBJ reported that it has delivered statistically significant improvements in all key tooth whitening measures using the new eM-Patch® Tooth Strip design when compared to the same tooth whitening agent delivered using the standard contact method. Dr Heather Benson of the Curtin University’s School of Pharmacy concluded that eM-Patch® Tooth Strip achieved:
• 49% greater colour change
• 31% greater shift in colour from yellow to the white spectrum
• 40% greater increase in tooth luminosity
The collaboration with Curtin University was part of the eM-Patch® Oral Health Development program which focused on developing disposable, inexpensive tooth wrap products to deliver carbamide peroxide and other beneficial oral health compounds with greater efficiency and at less cost than existing “mouth guard” based products. Tooth enamel, tooth dentin and the plaque films are semi-permeable and are therefore potential areas for commercial development using the Company’s proprietary drug delivery platforms. The collaborative study set out to test the effectiveness of the Company’s eM-Patch® Tooth Strip system as a means of enhancing the penetration of a leading commercial carbamide peroxide gel, a product sold internationally as an over-the-counter product for home tooth whitening. The study investigated the level of enhancement in tooth whitening by eM-Patch® delivered carbamide peroxide compared with the same agent applied in the traditional contact manner.
Changes in tooth colour were determined by examining the percentage of the mean yellow in the digital image histogram. The analysis revealed that the eM-Patch® group achieved a 49% (p= 0.025) greater reduction in yellow content compared to the passive Carbamide peroxide group.
Analysis of the colour spectrum shift for each tooth revealed that the average shift from the yellow spectrum to the white spectrum was 31% greater in the eM-Patch® group than the passive.
Luminosity analysis also showed a statistically significant difference between active and passive within the eM-Patch® group achieving 40% greater increase in luminosity than the passive group.
The Company’s eM-Patch® Oral Health Development Program also includes research and development into the enhanced delivery of desensitising agents for the treatment of sensitive teeth and the potential delivery of anti-microbial compounds through the plaque membrane for effective anti-plaque treatments. The Company is actively engaged with the international oral health industry and is exploring several potential partnering opportunities.
22/07/09 - eM-Patch Permeation Study
The study by Curtin University’s School of Pharmacy, showed that the eM-Patch® technology increased penetration of urea by over 20 fold at the 30 to 40 minute points and by almost 7 fold after one hour of application.
This result is consistent with the 8 fold increase in hydration related measures observed in human volunteers in the previous OCT study.
The combined in vivo – in vitro study demonstrates the ability for the eM-Patch® system to provide greater cosmetic effects earlier and with less time commitment from consumers and the patient, all of which are believed to be important commercial benefits of the eM-Patch® technology.
"The advent of advanced drug delivery devices has arrived, raising the bar for many traditional devices. The companies that recognize this fact, and which focus their innovation accordingly over the next 10 years, will be rewarded with a growing market share by 2020, leading what will become a highly competitive and very lucrative industry." - Cambridge Consultants
12/08/09 - Magnetic Enhanced Delivery Creates Transient Epidermal Pores
200 fold increase of 10 nm gold nanoparticle delivery in human epidermis by magnetic field versus passive delivery
This study may soon prove to be more significant on a couple of counts. As reported in the study, OBJ's Dermaportation was responsible for the formation of transient pores through which the nanoparticles were able to penetrate the skin and that these pores created by Dermaportation must have been larger than the 10nm diameter of the rigid particles under investigation. Whilst we may already understand one of the unique advantages with the Dermaportation technique over other drug delivery technologies is the capability of creating pores during a process where the size, sequence and duration of these generated pores are all controllable, a recent study at UK's leading University, and headed up by Prof. Richard Guy, a world authority on transdermal drug delivery and skin barrier function characterization, was published under the title, Objective assessment of nanoparticle disposition in mammalian skin after topical exposure
Study leader Professor Richard Guy said:
“Previous studies have reached conflicting conclusions over whether nanoparticles can penetrate the skin or not. Using confocal microscopy has allowed us to unambiguously visualise and objectively assess what happens to nanoparticles on an uneven skin surface. Whereas earlier work has suggested that nanoparticles appear to penetrate the skin, our results indicate that they may in fact have simply been deposited into a deep crease within the skin sample. The skin's role is to act as a barrier to potentially dangerous chemicals and to reduce water-loss from the body. Our study shows that it is doing a good job of this."
"So, while an unsuspecting consumer may draw the conclusion that nanoparticles in their skin creams are 'carrying' an active ingredient deep into the skin, our research shows this is patently not the case."
"Many pharmaceutical brands claim that nanoparticles in their products give their creams a 'deep penetrating action'. But scientists at the University of Bath found that such claims are "patently" untrue and that even the tiniest of nanoparticles do not actually penetrate the skin's surface."
While it can be noted that the Gold Nanoparticles under investigation in the Dermaportation study were 10nm in size, the results of Prof. Guy's study once again raises a serious question with the efficacy of pharmaceutical, cosmetic and the many sunscreen products contrary to manufacturers' claims.
Moreover, last month the former Chief Scientist at Acrux, Dr Adam Watkinson has also just published similar findings;
"The penetration of intact particles in the nanometer range (nanoparticles, [NP]) through human skin is a controversial topic, which has attracted much interest from both the pharmaceutical and the personal care industries. Concerns have also been raised about the possible implications that dermal exposure to NP may have for human health, particularly from physical sunblock formulations. Here we use a theoretical approach to determine the feasibility of NP penetration of healthy human skin. The maximum flux of NPs of various dimensions is calculated based on two algorithms that have been developed to model passive diffusion of molecules through skin. The results confirm that NPs are too large to permeate skin by this mechanism. Although components of NPs may dissolve in the skin and measurable amounts have been detected in body fluids, this is not indicative of actual NP transport through the skin. The possible roles for NP formulations in drug permeation enhancement are also considered but are not associated with the penetration of intact NP. - Nanoparticles Do Not Penetrate Human Skin—A Theoretical Perspective
When we are constantly being reminded about the phenominal growth in nanotechnology is expected to lead into virtually every aspect of our lives including, water, defence, food, energy, buildings, consumer products and medicines, these latest findings may add considerable value to companies developing physical enhancement technologies such as OBJ's Dermaportation platform. * Please see article in this post dated 03/05/2013: Big drugmakers think small with nanomedicine deals
30/09/09 - Annual Report 2009
Intellectual Property programmes have continued to mature and focused on developing patentability for the unique combination of patch format, delivery fields and drug ingredients. By doing so, the Company is able to offer the potential of patent protection for each individual product without limiting the scope of the Company’s underlying technologies. In July 2009, the Company announced the results of a collaborative study with Curtin University into Tooth Whitening using the Company’s eM-patch® Tooth Strip design. Results showed statistically significant improvements in all key tooth whitening measures using the new eM-patch® Tooth Strip when compared to the same tooth whitening agent delivered using the standard contact method. OBJ has held a series of discussions with selected international pharmaceutical and cosmetic companies with a view to engaging with the most suitable partners to further develop the selected product applications.
01/10/09 - US Study Results
OBJ advised that it received the final report from Azopharma covering the Company’s research collaboration with a global Fast Moving Consumer Goods (FMCG) company. The report set out the results of an eight-month patch development and evaluation program. The study tested the delivery performance of OBJ’s Dermaportation and ETP technologies in a fully formulated patch format, when compared to an existing Over the Counter (OTC) drug product with significant international sales. In 2008, OBJ advised the market that it had entered into an Agreement with a major international FMCG company to evaluate OBJ’s two main technologies and had engaged the independent Contract Research Organisation (CRO) to undertake the formulation and evaluation phases. Under the terms of the Agreement, OBJ is restricted from disclosing any information relating to the drug tested, the comparative product or the market. However the following graph by Azopharma illustrates the relative performance and the achievement of the FMCG’s objectives.
The Azopharma Report, which remains the property of the FMCG company, stated in the Executive Summary that: “The developed patch system effectively fluxes approximately a 10-fold over the existing product comparatively - The development work to this point justifies proof-of concept of the formulation and technology to proceed further into the pharmaceutical development of a drug product.
04/11/09 - OBJ Enters into Materials Transfer Agreement
OBJ enters into a Materials Transfer Agreement (MTA) with 3M Corporation in the US for the evaluation of the Company’s eM-patch® technologies as an approach to enhance transdermal drug delivery. The Materials Transfer Agreement sets the parameters for an initial testing program to evaluate the performance of the eM-patch® technology in conjunction with 3M drug delivery platforms and proprietary formulations.
Peer Reviewed: Enhanced Skin Permeation of Naltrexone by Pulsed Electromagnetic Fields
28/01/10 - 3M Requests Extension to MTA
OBJ announced on 4 November 2009 that initial evaluations by 3M was expected to be completed by 1 February 2010. The testing undertaken by 3M required an extension of time to the initial agreement. OBJ granted the extension to the Materials Transfer Agreement (MTA) to 3M Corporation to allow for the completion of additional testing.
08/02/10 - Statement of Intent from Global FMCG Company
OBJ received a Statement of Intent from a global FMCG company in regards to an ongoing product development program utilising OBJ’s ETP and DP technologies. The FMCG company permitted OBJ to state that it is continuing to work with a major healthcare company to enhance the delivery of one of their key therapeutic agents. In 2007 OBJ executed a Collaboration Agreement with the same undisclosed FMCG company to explore the use of ETP and DP with two compounds for over-the-counter (OTC) use. This initial program was completed in March 2008 and in December 2008 the Company announced a second and larger technology optimization program, to be conducted in the USA at a facility operated by Azopharma Inc. OBJ received approximately US$335,000 for the program and the outcomes of that program were summarized to the market in October 2009 confirming the Company’s technology achieved the FMCG company’s stated objectives. OBJ continues to work with the FMCG company in the development of a product and the Statement of Intent represented a continuation of that relationship.
18/02/10 - GSK enters into further agreement with OBJ
This Evaluation Agreement involved an evaluation of OBJ’s ETP technology in a non-prescription consumer healthcare application. OBJ first collaborated with GSK in 2006 in an advanced delivery program employing the Company’s Dermaportation technology. This program was further expanded to involve both the Company’s Dermaportation and ETP technologies. This relationship was announced to shareholders in May 2007 following approval of that release by GSK. A further confidential collaboration with GSK was undertaken in 2008 in an undisclosed consumer healthcare field and the current announcement continues the work in that same commercial field. The results, application field and drug used in the current program are, by agreement, to remain confidential.
16/03/10 - Industry Expert to Head International Partnering
OBJ appoints Dr. Kevin Hammond in a new executive role as OBJ’s International Partnering Manager. Dr Hammond has over 30 years experience with some of the world’s leading pharmaceutical, FMCG and cosmetic companies. His principal responsibilities have involved managing the partnering, licensing and new product innovations for companies such as Reckitt Benckiser, Unilever, PZ Cussons, CB Fleet (US) and GSK. Dr Hammond holds a PhD in Physical Biochemistry, a B.Sc. in Biochemistry and is a member of the Editorial Board of the International Journal of Cosmetic Science.
13/05/10 - FIM Technology Platform
FIM® or Field-in-Motion is a format of magnetic micro array film designed to be incorporated into products that are moved during normal consumer rubbing, brushing and wiping actions. The magnetic micro-array captures the energy of this motion, similar to a generator, and redirects that consumer energy to enhance the performance of a wide range of consumer, household and industrial products. The FIM® technology is the subject of a recent international patent filing and forms the basis of an expanding portfolio of field-of-use patent applications. Capturing consumer energy to enhance product performance provides OBJ and its partners with a broader aspect in product development focusing on sustainability and efficient use of resources.
"Utilising the “free” energy of normal consumer action to create more efficient products using fewer chemicals addresses one of the key commercial objectives of OBJ’s international partners."
"The majority of OBJ’s potential partners, including the announced relationships with GSK, 3M, and other FMCG companies, have widely diversified product portfolios across multiple product categories and sectors. The potential for OBJ’s technology platforms to add value and product innovations across multiple product categories, multiple brands and in a wider range of markets increases the appeal of the Company as a long term technology partner."
22/05/10 - GSK pays $135 million for NovaMin technology
"While he cannot speak to GSK's plans for NovaMin's technology, Scott said the pharmaceutical company was attracted to NovaMin's products for dentists, an area where GSK is trying to gain a foothold. A GSK spokeswoman would only confirm that the deal was completed in December 2009. GSK was keeping the deal confidential, but word slowly started leaking out in the local biotech community after the acquisition was mentioned in the company's 2009 annual report."
22/06/10 - Patent filed for US 20120130150 - Apparatus and method of treatment utilizing a varying electromagnetic energization profile
09/08/10 - Shareholder Update
Commercial confidentiality provisions of existing arrangements prohibit the release of details however the Company can report that partnering programs are progressing across the following market sectors:
The pharmaceutical sector is characterised by long lead times and high regulatory barriers. However the potential returns are correspondingly high. As one example, OBJ is working with one of the world’s largest pharmaceutical companies in consumer acceptance testing for a patch version of an existing multi-billion dollar product currently sold internationally. Other programs continue with a number of major pharmaceutical companies across this market sector.
Transdermal drug and technology market, 2010–2017. Source: Kalorama Information
OBJ is working closely with two of the world's foremost cosmetic brands for the design and development of new products involving OBJ's eMpatch and FIM technologies.
OBJ is active in this sector and has a number of international collaboration program discussions underway utilising OBJ’s ETP and FIM technologies. The highly competitive nature of this sector necessitates strict confidentiality on both the target market and the active ingredients used. OBJ is in discussion with five of the world’s largest companies across a variety of applications in consumer healthcare.
The same techniques that allow OBJ to deliver drugs to follicles and minute pores within the skin also give OBJ the tools to modify how liquids and solids interact. Discussions are currently underway with leading international groups to further explore suitable applications in this sector.
INTELLECTUAL PROPERTY: The Company has undertaken a significant expansion of its IP and patent portfolios with the lodgment of six additional "Field of Use" patents covering the major commercial areas of interest to OBJ's partner companies. These are designed to provide OBJ with broad exclusivity and allow the efficient and effective licensing across key markets.
NEW RESEARCH MANAGER: The Company announces the appointment of Dr. Matthew McIldowie as Research Manager. Dr. McIldowie is a bio chemist who will lead the Company’s product research programs in both the biological and non-biological areas.
22/09/10 - Technology Introduction
Indicator film shows the complexity of micro-array fields used to mobilise complex molecules such as Peptides
OBJ has developed a platform of patent protected physical enhancement technologies based on low-cost magnetic micro-arrays that influence the movement and penetration of drugs,
active ingredients and formulations at the molecular level. When a magnetic micro-array is correctly matched to a product’s atomic structure and physical properties it provides a low cost, powerful and chemistry-free method of enhancing product performance.
OBJ harnesses the physical sciences as a new tool to enhance drug delivery and product performance. OBJ uses complex 3-D micro-array and moving magnetic fields to change rates of diffusion independent of concentration and to alter barrier function, wettability and targeting without the need for new chemistry.
KEY TECHNOLOGY CAPABILITIES
• Economics
- Low cost, long shelf-life, single use or re-usable
- Opportunity for reduced active ingredient levels
- Limited regulatory impact
- 100% active surface
• Adaptable Format
- Drug Patches
- Strips and Masks
- Applicators and Devices
• Drug and Ingredient Compatibility
- Lipophilic and hydrophilic molecules
- Charged and uncharged molecules
- Wide range of molecular weights
- Multiple actives and complex formulations
• Engineered Delivery Profiles
- Release and penetration profiling
- Targeted delivery profile (follicular delivery)
• Intellectual Property
- Patent protected platforms
- Market exclusivity
28/09/10 - Strategic Alliance with Global FMCG Company
OBJ executed a Letter of Intent to establish a Strategic Alliance program with one of the world's leading Consumer Products companies for the evaluation of OBJ technologies across multiple product categories. The Letter of Intent for the Strategic Alliance sets out a program of technical evalutions that, if successful, should lead to an initial 5 year Strategic Alliance for the design and development of a wide range of consumer products incorporating OBJ’s micro-array and FIM drug delivery technologies. If agreed developmental objectives and criteria are met, and the FMCG company commercializes products within the field, OBJ will grant a license for each product within the field and receive royalties for a period of 5 years or life of patent, whichever is longer. The Strategic Alliance is a new relationship for the Company and is in addition to the programs and collaborations in the Fast Moving Consumer Goods (FMCG) sector previously announced.
30/09/10 - 2010 Annual Report
3M remains a major collaborator with OBJ, and in additon to offering key fabrication expertise they remain alongside OBJ in exploring potential large opportunities for magnetic array applications. The potential Personal Care applications for magnet arrays has received substantial interest from several FMCG and cosmetic companies, particularly due to the potential to deliver existing cosmetic active ingredients more effectively. Applications in Skin Care have prompted much attention, but interest has now extended to Hair Care, Deodorants, Delipatories , Cosmetic Oral Care, and even Colour Cosmetics. This interest has benefitted in part from the significant growth in devices and applicators entering the Personal Care market. Over the reporting period, the Company has expanded its Intellectual Property and Patent portfolios with the lodgement of seven new “Field of Use” patent applications covering the commercial areas of interest to OBJ’s partner companies and the progression of its foundation patents through to examination in both the USA and Europe. We are encouraged by the strong interest from our targeted partners across all market sectors as the Company moves steadily forward to realizing its potential for product development.
25/10/10 - GSK to Progress FIM Technology
OBJ announced that GlaxoSmithKline informed of its desire to proceed with an FIM™ development program in a major consumer healthcare sector following a sequence of successful technology evaluations. GlaxoSmithKline Consumer Healthcare issued the following statement. - “GlaxoSmithKline Consumer Healthcare (GSK) has reported statistically significant levels of enhancement in an in vitro testing model by the OBJ technology in a global Consumer Healthcare application. These results are the outcomes of the short term evaluation agreement with GSK announced to shareholders on 18th February 2010. GSK and OBJ are now in discussions regarding the next steps of this program which will include a technology integration program and in vivo human efficacy testing to quantify the business opportunity" - The Consumer Healthcare program under discussion will include a design and development stage to build OBJ's FIM™ technology into a common household consumer product. These will then be used in human efficacy studies to demonstrate the level of consumer benefit provided by the FIM™ technology and consumer acceptance testing to determine marketability within the US$29 billion market sector. In May 2007, the Company announced that it had entered into an arrangement with GSK to carry out exploratory studies to investigate the potential of technologies for a range of non-prescription healthcare applications. This relationship was further expanded with focus on a proof-of-concept study commencing in February 2010 and the current announcement is an extension of that program following commercially significant levels of enhancement.
30/11/10 - 2010 AGM Chairmans Address & Presentation
14/12/10 - A ‘‘plug-and-play’’ approach to the preparation of transparent luminescent hybrid materials based on poly(methyl methacrylate), a calix[4]arene cross-linking agent, and terbium ions
"The use of EMF as a skin penetration enhancement technique has received little attention until the recent development by a Perth based company OBJ Ltd, Australia." - Gayathri Krishnan
23/02/11 - Nanoparticles and microparticles for skin drug delivery
05/04/11 - Shareholder Update
GlaxoSmithKline Consumer Healthcare (GSK)
The Company is pleased to report that the relationship between the two Companies is progressing well with plans for first-in-man studies being finalised.
FMCG - Strategic Alliance – Consumer Care Products
The Strategic Alliance with a major international FMCG company announced in September 2010 is progressing across multiple fronts. The broad range of products for which the OBJ technology is being evaluated has required the establishment of a number of new and innovative test models and the recruitment of leading specialists and industry experts familiar with these product categories.
Amongst recent successes has been an independent university study that showed a significant increase in the delivery of a key anti-ageing ingredient through the stratum corneum (upper skin surface) and into the living tissues of the skin. The ability to show enhanced penetration of cosmetic compounds beyond the superficial surface provides a major competitive advantage for cosmetic and FMCG companies.
FMCG – OTC Healthcare
The Company’s collaboration with a second major international FMCG, initially announced in 2009, has progressed through a number of stages of technical evaluation and has more recently been subjected to consumer studies. As a consequence of the response to date, this development program has now moved to being reviewed by FMCG’s international marketing department.
17/05/11 - Collaborative Development Agreement with GSK
OBJ announced that GlaxoSmithKline Consumer Healthcare and the Company entered into an exclusive Collaborative Development Agreement with the objective of developing new consumer products in the field of Oral Health utilizing the Company’s proprietary technologies. GSK and OBJ have collaborated on enhanced oral healthcare developments on similar bases resulting in statistically and commercially significant levels of enhancement.
24/05/11 - Patent Filed for WO2011146978 - Delivery of oral care products
24/05/11 - Patent filed for WO2011146977 - Delivery of hair care products
17/06/11 - Patent filed for WO2011156869 - Delivery of skin care products
"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. - Designing Patent Applications for Field-of-Use Licensing
07/07/11 - Research and knowledge transfer success
Steve Britland from the Centre for Skin Sciences, attracted international research funding to the value of £33,000 in a collaborative development with OBJ Limited of Australia for the development of innovative bioequivalence models for use in specialised areas of transdermal drug delivery research.
16/08/11 - Pain Patch Development Program
OBJ advised that it proceeded with a musculoskeletal pain patch initiative utilising the eMPatch® magnetic micro-array technology with the aim of delivering therapeutic ingredients at the same time as providing biomechanical support. The decision follows an extended period of testing of eM-Patch® magnetic micro-array technology to create new levels of product performance. In 2010, the Company announced its intentions to develop value-added and market ready products utilising its own proprietary technologies for distribution through channel partners. The Company have since expanded its internal development capabilities and engaged the services of a number of leading international experts in formulation chemistry, sensory science and biomedical engineering, and the Company’s established partnering relationships will remain a core aspect of the Company’s commercial plans.
23/08/11 - US Patent Office Allows Dermaportation Patent
OBJ received notification from its patent attorney that the Company’s powered electromagnetic fields drug delivery technology for the USA, has proceeded to allowance. Dermaportation is currently being developed for a number of applications and the allowance is assisting with partnering discussions.
12/09/11 - Patent filed for WO2012031335 - Delivery of fabric care products
27/09/11 - Coty honoured as most innovative company of the year
27/09/11 - 2011 Annual Report
During the reporting period, the Company accepted an invitation to present at the prestigious BioPartnering Conference in London, announced the commencement of consumer studies by a major FMCG company into a key OTC pharmaceutical application, and announced the commencement of the first-in-man clinical study program with GSK following continued successes.
25/10/11 - Global FMCG Company to Secure Access Rights for Beauty Care
OBJ announced the commencement of negotiations with a global FMCG company for a Joint Development Agreement (JDA) with the objective of commercializing new products in the consumer health and beauty fields utilising OBJ’s three core technologies. In September 2010, the Company entered into a Strategic Alliance to explore applications for the Company’s technologies across a wide range of consumer product platforms. The ability of OBJ’s technologies to enhance performance through physical rather than chemical science provides the potential for improved product benefits using less chemicals and at lower costs.
03/11/11 - US Patent Granted
OBJ announced the Dermaportation Patent was issued by the US Patent office, and the granting of the patent enhances the commercial value of the Company’s powered technology as it allows the Company to offer various market licensing options to potential partners in key market sectors.
03/11/11 - The Procter & Gamble Company and Teva Partnership
25/11/11 - AGM Corporate Presentation
Since the close of FY 2011:
– US Patent Granted (Dermaportation technology)
– Commenced negotiations with Global FMCG for JDA
– Commenced multi-product discussions with major US Pharma
– Developed a new Cosmetic Pod based delivery system
– Musculoskeletal project moved to consumer testing in Europe
25/11/11 - AGM Technical Presentation
The structure of the 3-D magnetic fields are designed to match the molecular property of the formulation and film can be cut and incorporated into an almost infinite number of products.
Key aspects of magnetic field:
• Magnetic Fields following the inverse square law – their range and influence is therefore controllable
• Diamagnetics act on electron pairs – Unaffected by charge or lipophilicity
• Magnetic Fields do not interact chemically – Do not affect formulations or chemistry
• Each array is potentially unique and patentable – Providing new or extended IP protection
• Humans have no sensor for magnetic fields – No potential for inducting pain or other adverse reaction.
20/12/11 - Interaction of Nanoscale Particles with the Skin Barrier
26/01/12 - 2012 Drug Delivery Partnerships
The Globalization of
Pharma & Biotech
28/02/12 - Appendix 4D 31 Dec 2011 (Full Copy)
OBJ remains committed to its three-part commercial development program which focuses on partnering with major international pharmaceutical, cosmetic and FMCG companies, developing value added products and processes utilising OBJ’s proprietary design and development of its range of products to be distributed by channel partners. Since receiving notification from the USPTO that its Dermaportation patent had been allowed considerable interest has been received from major cosmetic groups for the Company’s new e-skin product range. The Strategic Alliance program with one of the world's leading Consumer Products companies continues to progress and in October, the OBJ learned that the FMCG company was seeking world-wide exclusive access rights to OBJ’s technologies in the area of a beauty. Negotiations commenced regarding the various financial, developmental and investment commitments to OBJ’s technologies and considerable progress in these negotiations was achieved during the period.
12/04/12 - PPP Conference 2012 - Program
26/04/12 - March 2012 Update
The Company reported that the work with GSK in the field of oral health is proceeding with a view to expanding the scope of the current collaboration to include additional key oral health active ingredients and the relationship with GSK was also expanded to include discussions with GSK Pharmaceutical groups in the US. Micro-needles - The Company has been working with the UQ and Dr Tarl Prow for enhancing microneedle performance with the addition of OBJ’s ETP technology. OBJ’s ETP technology, when integrated into a traditional micro-needle delivery system, showed substantially greater drug delivery than microneedles alone. The results of this work were presented at the 13th International PPP2012 Conference in France during the month by OBJ Director, Dr Chris Quirk, and a number of commercial opportunities are now being explored following the presentation.
Dr Tarl Prow - Profile Synopsis
Over the past few years, my collaborators and I developed microneedle-based drug and vaccine delivery to treat and/or prevent cancers. The development of novel nanolayered microneedles will help us deliver therapeutic/diagnostic nanoparticles to site of interest. Over the last year, I have used edge-cutting non-invasive imaging, such as reflectance confocal microscopy and fluorescence lifetime imaging microscopy, to identify the therapeutics uses for silver nanoparticles by analysing the metabolic effects of skin in volunteers. In addition, I have studied the penetration of quantum dots and nanotoxicology of metal nanoparticles in human skin metabolism using advanced time correlated single photon counting techniques.
18/05/12 - Procter and Gamble Enters Joint Development Agreement
OBJ announced the signing of an exclusive multi-product Joint Development Agreement (JDA) with The Procter and Gamble Company for the development of new products that utilise OBJ’s technologies. P&G is the world’s largest consumer products company providing global market access across 180 countries serving 4.4 billion consumers every day. The two companies commenced collaborations over a year ago as part of P&G’s Connect+Develop open innovation program. Under the JDA, P&G and OBJ will jointly evaluate OBJ’s technologies with products in P&G’s global brand portfolio.
26/07/12 - OBJ places ad with seek.com.au for a New Products Development Manager:
Australia's leading transdermal patch development company seeks an experienced and motivated Market Development Manager to lead the final development stages and manage the international roll-out of a unique platform of sports and consumer pain and injury management products. This new platform of sports and retail medical products will create a new category in the international professional and amateur sports medicine, rehabilitation and injury treatment markets. The products are currently being developed by one of the world’s leading transdermal drug delivery companies in conjunction with international sports medical and formulation experts. The unique selling features and benefits provided by the Australian developed transdermal technology will provide new levels of features, functions and performance beyond the capabilities of existing competitor products.
15/08/12 - Coty partners with LG
"This fall, Coty Korea will kick off its efforts by introducing iconic beauty brand philosophy into the Korean marketplace. Best known for its lines of inspirational beauty products, the philosophy brand will play a key role in the expansion of Coty's portfolio of products, particularly its skin-care structure throughout Asia. The importance of skin care products cannot be overestimated in the Asian marketplace - particularly in Korea, China and Japan, where skin care is valued over color cosmetics by women who are looking for flawless skin."
15/08/12 - Shareholder Update
The relationships fostered with OBJ's partnering companies over many years is leading to a number of potential commercial undertakings as the testing and development process achieves expected levels of performance. ORAL HEALTH: The studies undertaken by the independent Modus Laboratories of the UK demonstrated statistically significant increases in the delivery of key compounds into the tooth enamel in as little as two minutes using a toothbrush-styled applicator incorporating OBJ’s FIM technology. COSMETIC AND SKIN CARE: The Company’s eM-patch, FIM and eSkin systems are currently attracting interest from a number of US and European cosmetic and skin care companies. Current US-based programs with a number of prestige cosmetic brands were expanded following the completion of pre-clinical studies which showed commercially important levels of enhanced delivery of a multi-million dollar peptide based cosmetic agent in partner-funded programs. PHARMACEUTICAL: The Company’s work with one of the world’s largest pharmaceutical companies advanced with the presentation of the results of a recently fully-funded development in the area of analgesics. NEW OBJ DELIVERY DEVICES: The ability to deliver precise volumes of formulations using a single action measured patch opens significant opportunities for OBJ’s technologies. During the period OBJ also partnered with the Centre for Pharmaceutical Engineering Science at Bradford University in UK and an Asian-based multi-national manufacturer for low–cost, high-volume manufacturing, and commercial interest from OBJ’s current partners in these new delivery devices has been encouraging. SURFACE HYGIENE: A testing program is underway by a major UK University following studies which showed significantly greater antiseptic penetration into key microchambers by OBJ’s FIM technology when compared with traditional disinfection methods. The ability to increase the efficacy of disinfectant agents without additional chemical or toxicity effects opens a potentially important non-medical area for OBJ. MICRO-NEEDLES: The Company’s work with the UQ for enhancing the passage of drug from the skin into the viable epidermis following micro-needle application continues following encouraging results and are now being developed into commercially focused opportunities. OBJ’S OWN PATCH PRODUCTS: A number of consumer studies have been completed in the UK to further define the application, and product functionality is being refined in response to consumer sentiment and market strategies. OBJ is using the partner-funded programs to prove-up products and innovations and utilize its resources to broaden its commercial base and reduce sole reliance on the time-frames of its partners.
07/09/12 - WO2013033782 - Method and Device for transdermal delivery of substances (e-Skin)
27/09/12 - 2012 Annual Report
By utilising physical science rather than chemistry, OBJ is able to provide its international partners with cost-effective means of enhancing the performance of a wide range of therapeutic, applications, often to levels not possible using costly formulation chemistry. The Company has been working with a number of the teams at P&G’s Cincinnati facility for some time culminating in a funded multi-product development collaboration with the clear objective of taking OBJ’s technologies to market (in P&G products). OBJ relationship with GSK was further expanded during the period with the inclusion of a new pharmaceutical development program with GlaxoSmithKline’s USA based pharmaceutical group. A funded study program is currently under negotiation and an expansion to the GSK (UK) Oral health program was also initiated. Cosmetics and Skin care also remain a key focus area for the Company and a number of new collaborations were formed during the period. Several existing collaborations were expanded and OBJ's powered technology, known as eSkin, was also expanded to include web based personalised skin care capabilities which have been enthusiastically received by the partners. In response to the growing commercial need for controlled dose/applicator packaging for various drugs, the OBJ laboratory team has developed and prototyped a low cost packaging solution based on deformable microchambers named the “Popper”. These micro-chambers can deliver precise volumes of drug while simultaneously acting as the product applicator. The clever design also allows for the incorporation of OBJ’s FIM technology.
"OBJ works with major international pharmaceutical and FMCG companies to help them develop new products. This is highly secretive work as these are highly competitive sectors, so our partners rarely permit us to announce our progress, as that would alert competitors to where these majors are focusing their product development plans." - Source
"The advice that we have signed a Joint Development Agreement with Proctor and Gamble and the possibilities that may transpire from that arrangement has come about after three years of really hard work. It may not be well appreciated in some quarters just how difficult a task it is to execute an arrangement such as this with one of the world’s major pharmaceutical and skin care company's. And these companies do not enter into such agreements without serious intent... So we are looking forward to the future which is set up after many years of endeavor and as events unfold we will so continue to advise the market." - Source
06/12/12 - P&G Progresses to Clinical Trials
OBJ announced that The Procter and Gamble Company (P&G) has committed to two separate human clinical trials following successful pre-clinical developments conducted as part of the exclusive multi-product Joint Development Agreement (JDA) with OBJ. The commitment to human clinical trials represents a solid investment by P&G and a key milestone for OBJ in the development of consumer products utilising its magnetic micro-array technologies. OBJ’s technical team has been focused on the development and testing of new magnetic microarrays that produce the best possible performance enhancement for two key proprietary molecules used by P&G across a number of their global product platforms. The devices to be used by consumers in the clinical trials were designed and developed by OBJ’s Perth based scientific team, led by Dr Matt McIldowie. The units were manufactured in Singapore to the necessary standard and quality for the trials.
10/12/12 - Dermaportation Patent Allowed
Beauty devices have created a mega category and are transforming the skin care market and consumer behavior, just as the electric toothbrush and the hair iron changed oral care and hair styling. Technology provides new "red carpet" standards of skin care—the wow factor, according to U.S., Chinese and European beauty experts interviewed by Diagonal Reports for the market report. Beauty technology—including cleansing brushes, light-based platforms and skin care systems—has created a huge new market worth billions in U.S. dollars. Year-on-year sales' comparisons are quite meaningless because this market did not even exist a few years ago, but most likely, exponential growth rates will continue for the foreseeable future. Beauty technology devices deliver immediate results especially for core skin care problems such as anti-aging and blemish removal. Technology has democratized beauty outcomes that were previously unaffordable and explains why 70% of women would like to own a new beauty device. Despite the recession, women continue to spend on their facial care. But cost-conscious consumers are doing the math and calculating the need. They justify the price by factoring in the money saved on skin care products, treatments and the time required for visits to the spa or dermatologist. And positive consumer reviews and feedback about immediate results—all now online—also are a major factor in driving strong demand. Technology is now shaping a distinctive beauty culture and expectations. Devices are creating new standards in skin care, and this change will impact demand for all manually applied/removed products skin care products—especially anti-aging creams, skin cleansers and even makeup. - Beauty Devices Creating a New Mega Beauty Category
25/02/13 - Exclusive Collaboration Agreement with Coty Inc.
OBJ announce that it has entered into an Exclusive Collaboration Agreement with Philosophy, a skin care brand of COTY Inc., an emerging leader in beauty. The Agreement details the exploration of possible 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. COTY Inc. is active in 130 countries with manufacturing and 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 recent allowance of the Dermaportation patent by the European Patent Office and the granting of the same patent by the US Patent Office in 2012 are fundamental to the collaboration.
26/02/13 - Coty Teams with Australian Tech Company for Device Manufacture
28/02/13 - Appendix 4D 31 Dec 2012
During the period, The Procter and Gamble Company (P&G) committed to two separate human clinical trials following successful pre-clinical developments conducted as part of the Joint Development Agreement (JDA). 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. 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. The Company continues to make strong progress with all of its partnering activities some of which have reached the clinical trial stage. Work will continue with other partners and in attracting potential new partners in adopting the OBJ technologies within their product ranges. In parallel, the OBJ team is well advanced in its evaluation, testing and development with the first application of its own product aimed at a particular muscular skeletal patch.
14/03/13 - Patent Publication: WO2013033782 - Method and device for transdermal delivery of substances
21/03/13 - European Patent Granted
OBJ receives 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. This process is 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 utilised 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 personalised treatments. These capabilities have been incorporated into the e-Skin® product platform.
"The idea is to use the electrical impulses that form the "language" of the body's nervous system to address a range of diseases, from high blood pressure to breathing problems and, eventually, brain disorders. Moncef Slaoui, chairman of GSK research and development, said bioelectronics was set to be the next big wave in medicine, comparable to the rise in biological therapies over the past 15 years triggered by advances in biotechnology. "This is our vision for the next 10 to 20 years," he told Reuters. "In the future, a big chunk of R&D will be doing bioelectronics." - Source
10/04/13 - Patent Publication: EP 1694408 - Apparatus for facilitating transdermal delivery of therapeutic substances
10/04/13 - Patent Publication: EP 2575950 - Delivery of oral care products
02/05/13 - e-Skin Clinical Trial Units to USA
OBJ announced that it has manufactured and shipped the first clinical trial eSkin™ units to its partner’s Contract Research Organization (CRO) 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. If successful the clinical trial will be a major step forward for the Company in the potential commercial development of its powered drug delivery technology and its web-enabled personalisation capabilities that allow eSkin™ to optimise cosmetic delivery precisely to individual needs via the world wide web using portable devices.
"Most of us look in the mirror every morning, but what if, rather than just seeing your reflection, you also saw a prescription for the products that you should be using that day? And what if your new regime was not only tailored to the weather and your skin type, but also to your genetic make-up, using specially created bespoke molecules expressly designed to even out your skin tone and stop your hair from frizzing? It may sound like science fiction, but this isn’t just some Jetsons-style view of what the beauty industry might look like in the year 2050. It’s technology that is being tested in beauty labs around the world... Genomics — the science of genomes, where differences between gene behaviour in young and old skin can be studied — is also a huge area of interest. Dr Jay Tiesman, a genomic scientist at Procter & Gamble’s Global Technology Division, explains that it’s not about genes being switched on or off: ‘It’s more like a dimmer switch than a light switch, but basically we’ve started to identify which genes get dimmer with age, and which get brighter - The End of Aging
03/05/13 - Big drugmakers think small with nanomedicine deals
16/05/13 - Coty Inc. Wins 2013 Manufacturing Leadership 100 Global Value Chain Award
23/05/13 - Wow factor helping to boost uptake of beauty devices for skin care
21/05/13 - BodyGuard Program Update
OBJ reported that its
musculoskeletal patch development, known internally as BodyGuard, has achieved
several significant milestones in its ongoing development program, and planning
for the overall BodyGuard program is progressing with the first steps in the
industrial design and formulation optimisation now well advanced. The Company is
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. 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 will 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 forthcoming
clinical trials. A shortlist of candidate companies was prepared from the
excellent proposals received. During March, the leading design companies were
interviewed by our Product Development Manager and OBJ is now evaluating the
recommendations to progress this key activity. 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.28/05/13 - Coty continues march into emerging markets
04/06/13 - Gucci Make-Up: Coming Soon
WILL Gucci launch its first beauty collection next year? Reports emerged this morning suggesting that the fashion house is developing a new make-up line, yet a spokesperson for P&G Prestige - with whom Gucci has a fragrance licensing contract - declined to comment when we contacted them today. During Milan Fashion Week, Gucci's catwalk make-up is generally taken care of by Pat McGrath - most recently centring around metallic burgundy eyes offset by nude lips and slicked-back hair. The brand already has several very successful fragrances including Gucci Guilty, Gucci Flora and Gucci Première, whilst Blake Lively and Evan Rachel Wood are both Gucci fragrance ambassadors. If the rumours are true then we predict gloss, a sophisticated palette and some very sleek packaging - this is not a brand to do things by halves.
06/06/13 - Patent Publication: US20130144109 - Delivery of Skin Care Products
"OBJ is the first company to develop low cost micro-array film technology that utilizes 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 commercially significant drugs and peptides used in the pharmaceutical, dermatology, cosmetic and consumer healthcare sectors. Low cost and controlled through-the-skin delivery of drugs, hormones, vitamins, vaccines, antibodies and anti aging molecules has long been the desire of the pharmaceutical industry. It would provide economic, safety and efficacy benefits to the pharmacology, medical, veterinary and cosmetic industries. Side effects could be reduced by localised delivery and programmed delivery rates. Needle stick injuries and needle disposable problems could be eliminated while the reduction in the level of skill required for application could significantly reduce total cost of many health programmes."
11/06/13 - Coup for Coty as new appointment strengthens brand-building
24/06/13 - Skin Forum - Modelling Skin Permeation - 24 June 2013
25/06/13 - Skin Forum 13th Annual Meeting - 25-26 June 2013
OBJ has executed 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 has 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 will 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 these categories, GSK funded a small human pilot study during 2012, the results of which have now led to the first major human efficacy study as set out in the Agreement.
The Clinical EvaluationThe clinical evaluation will be conducted in the UK by GSK’s Oral Healthcare group in Middlesex. The study is expected to commence towards the end of 2013 however the duration, number of subjects and the detailed protocols to be employed in the study are still being planned in preparation of submission for ethical approval.
Next Generation ToothbrushOBJ’s proprietary thin‐film magnetic micro‐arrays are well suited to oral health and toothbrush production as the low cost and flexible design is highly compatible with modern toothbrush production line technologies. The ability to integrate drug delivery technology into a toothbrush at very low additional cost, resulting in a new approach to improved oral hygiene has the potential to go beyond the scope of toothpaste chemistry alone. The low cost, high performance capabilities of OBJ’s toothbrush technology is especially applicable to new growth markets.
01/08/13 - WO/2013/110124 - Delivery Device
The present invention relates to a device for delivering a measured or predetermined dose of an active agent to a dermal or mucosal surface comprising: a deformable chamber comprising at least one dome-shaped member defining a reservoir for an active agent and a porated disc. The porated disc may have magnetophoretic properties; and/or microneedles.
SUMMARY
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 o f 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 bee n 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.
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 these categories, GSK funded a small human pilot study during 2012, the results of which have now led to the first major human efficacy study as set out in the Agreement.
The Clinical EvaluationThe clinical evaluation will be conducted in the UK by GSK’s Oral Healthcare group in Middlesex. The study is expected to commence towards the end of 2013 however the duration, number of subjects and the detailed protocols to be employed in the study are still being planned in preparation of submission for ethical approval.
Next Generation ToothbrushOBJ’s proprietary thin‐film magnetic micro‐arrays are well suited to oral health and toothbrush production as the low cost and flexible design is highly compatible with modern toothbrush production line technologies. The ability to integrate drug delivery technology into a toothbrush at very low additional cost, resulting in a new approach to improved oral hygiene has the potential to go beyond the scope of toothpaste chemistry alone. The low cost, high performance capabilities of OBJ’s toothbrush technology is especially applicable to new growth markets.
01/08/13 - WO/2013/110124 - Delivery Device
The present invention relates to a device for delivering a measured or predetermined dose of an active agent to a dermal or mucosal surface comprising: a deformable chamber comprising at least one dome-shaped member defining a reservoir for an active agent and a porated disc. The porated disc may have magnetophoretic properties; and/or microneedles.
23/09/13 - 2013 Annual Report
REVIEW OF OPERATIONS
SUMMARY
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 o f 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 bee n 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 (above) 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 (above) 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 (Mr George Tsadilas)
BodyGuard
The Company continues with the development of a musculoskeletal patch with the appointment of a full time Manager to facilitate the design, testing and roll-out of the BodyGuard range of products. 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.
10/10/13 - 3rd Annual PODD, Partnership Opportunities in Drug Delivery 2013
"The skin’s role is to act as a barrier to dangerous chemicals and to reduce water loss from the body. Our study shows that it is doing a good job of this." - Professor Richard Guy - Professor of Pharmaceutical Sciences, University of Bath
15/05/14 - Characterization and Inhibition of a Nickel-Alpha-Hydroxyoxime (LIX 63) Salt Precipitate Formed under Proposed Commercial Operating Conditions
Keith Barnard - Research Group Leader at CSIRO Process Science and Engineering
Denis W. Shiers - CSIRO Process Science and Engineering
Matthew McIldowie - OBJ Limited
Brian W. Skelton - Centre for Microscopy, Characterisation and Analysis, M313, UWA
Mark I. Ogden - Department of Chemistry, Curtin University
Tannice M. McCoy - Teck Resources Ltd (Teck are developing an innovative CESL Nickel Technology
22/09/14 - Argonaut Morning Note on OBJ Limited
"There has been little interest in magnetophoresis until recently, when an Australian company, OBJ Ltd., developed a technology described as dermaportation, which applies pulsatile electromagnetic fields to target tissues. Recent work by Krishnan et al. showing that dermaportation caused enhanced naltrexone penetration though human epidermal membranes, but not through silicone membranes, provides evidence to support a direct effect of pulsed magnetic fields on skin." - Prof. Michael Roberts - Australian National Health & Medical Research Council Senior Principal
"Imaging by multiphoton microscopy and fluorescence lifetime imaging (MPM - FLIM) showed that 10-nm gold nanoparticles applied to excised human skin penetrated through the SC into the viable epidermis. Magnetic technologies potentially offer several advantages for penetration enhancement in a commercial setting. Technologies like those being developed by OBJ Ltd require very little energy to generate the electromagnetic fields and could be miniaturized and easily incorporated into skin patches." - Dr Jeffrey E. Grice - Team Leader with the Topical Drug Delivery Group at University of Queensland
"There is a significant market opportunity to develop an effective transdermal delivery system that eliminates the need for needles. OBJ is putting in place an experienced team to pursue this opportunity and I am pleased to be involved in this exciting project." - Prof. Ken Donald - Queensland Commissioner of Medical Safety and Health
"The number of drugs available as marketed transdermal products is limited to those that exhibit the correct physicochemical and pharmacokinetic properties that enable their effective delivery across the skin. In this respect, there are less than 20 drugs that are currently marketed in the US and EU as products that deliver systemic levels of their active ingredients. An analysis of clinical trials conducted in the transdermal sector shows a similar picture with only nine drugs accounting for approximately 80% of all transdermal clinical trials listed on ClinicalTrials.gov. Those drugs for which there are very few transdermal trials listed consist mostly of molecules that are inherently unsuitable for transdermal delivery and serve as a clear warning to drug developers that the science that governs transdermal drug delivery is well reflected by the successes and failures of drugs in development as well as those that make it to the market." - Dr Adam Wilkinson - Storith Consulting UK and Co-editor of Transdermal and Topical Drug Delivery - Principles and Practice 2012
“The clear evidence of electro-osmosis being generated by both the ETP and DP mechanisms need to be taken advantage of...” - Prof. Brian Barry - adviser on Topical and Transdermal Drug Delivery to the EMA and the FDA,
“OBJ’s electromagnetic technology platforms has the potential to enhance the delivery of vaccines through the skin in a painless, safe and patient friendly manner. OBJ has unique transdermal delivery technologies that have the potential to provide significant public health benefits and improve the availability of vaccines to developing countries,” - Prof. Ian Frazer - Director of the Diamantina Institute, UQ
"OBJ's eM-Patch® technology has delivered statistically significant improvements in all key tooth whitening measures in a new Tooth Strip design when compared to the same tooth whitening agent delivered using the standard contact method." - Prof. Heather Benson - Assoc Prof at Curtin University
"OBJ’s physical rather than chemical approach to product performance enhancement may change the balance in established product categories. Its application in the cosmetic, consumer and healthcare markets may offer similar opportunities to those in the pharmaceutical sector. I see my role with OBJ as an opportunity to be part of a highly committed team focused on delivering sustained growth.” - former New Technology & Partnership Licensing Manager for Reckitt Benckiser, Unilever, and GSK - Dr Kevin Hammond
"A testing model by OBJ's technology in a global Consumer Healthcare application has resulted in statistically significant levels of enhancement. OBJ and GSK have agreed to work exclusively together with the objective of developing new products which make use of OBJ’s proprietary Enhanced Transdermal Polymer (ETP) and Field-In-Motion (FIM) technologies in the field of Oral Healthcare. The objective of the Collaboration is to develop and commercially release Oral Healthcare products utilising OBJ’s proprietary technologies..." - Statement issued by GlaxoSmithKline Consumer Healthcare
"OBJ’s technologies are unique in that they utilise the interaction forces generated between molecules and magnetic fields to change the way molecules move into or through the skin and hair follicles. By utilising physical science rather than chemistry, OBJ is able to provide its international partners with cost-effective means of enhancing the performance of a wide range of therapeutic, applications, often to levels not possible using costly formulation chemistry." - OBJ Annual Report 2012
"New therapies that fuse physics, electronics, biology and medicine may upend how the industry thinks about treatment. “Rather than loading the body with drugs with potentially deleterious effects, we’ll have the ability to execute pinpoint interventions using electrons,” - John Baldoni - SVP platform technology and science R&D with GSK
"True innovation is becoming increasingly rare with regulatory barriers and increasing costs leading to more standardised products. OBJ’s physical rather than chemical approach to product performance enhancement may change the balance in established product categories" - Dr Kevin Hammond - former New Technology & Partnership Licensing Manager @ Reckitt Benckiser, Unilever, and GSK.
"GSK and OBJ have collaborated on enhanced oral healthcare developments on similar bases resulting in statistically and commercially significant levels of enhancement." - statement issued by GlaxoSmithKline Consumer Healthcare
"P&G’s partnership with OBJ and our joint commitment of collaboration directly aligns with P&G’s business strategies, working to develop new solutions and innovations that can touch and improve the lives of our consumers all over the world." - Jeffrey Weedman - P&G Vice President of Global Business Development
"I would have thought that anyone would see that this is a considerable volume of activity that has steadily been building over many years and we remain optimistic that some of these opportunities may progress to further stages as we go through the product development and commercialisation cycle. It really is a tremendous range of opportunities." - Glyn Denison - OBJ Director
"OBJ’s technologies are based on physical performance enhancement rather than chemical, and while this offers our products and patents a new way of approaching problems, the relative performance gains provided by technologies can outstrip anything available through formulation chemistry alone." - OBJ AGM 2012
"The next therapeutic game changer will come not from drugs, but electrons." - John Baldoni, SVP platform technology and science R&D with GSK
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Additional Links
OBJ - qualitative analysis 2013
Skin Care: The Powerhouse of Beauty
Beauty devices are creating a new benchmark in facial skin care
Positive or negative? Nanoparticle surface charge affects cell-membrane interactions
Global Trends 2030: Alternative Worlds a publication of the National Intelligence Council
At Home Skin Care Devices Show Huge Growth Potential in 2013
2013 Global Life Sciences Report
Outstanding Transdermal Drug Delivery Paper Award - July 2013
Controlling drug delivery
OBJ's Collaboration Principles
Microneedles
Health Sciences - Prof. Heather Benson
P&G Beauty and Grooming
Top 50 Cosmetic Brands 2013
Industry Collaboration: A new era of open innovation
Transdermal Patches, Microneedles, Neddle-free Injection
Telegraph UK - CyDen signs £250m hair remover deal with P&G
The Future of Peptide Development in the Pharmaceutical Industry
Johnson & Johnson Innovation
Innovating for Everyday Life
Hidden Heroes - The Next Generation of Retail Markets
Dermatologic, Cosmeceutic, and Cosmetic Development
