Sunday 8 April 2012

OBJ Limited - Qualitative Analysis

Disclosure: Stock Held
Sentiment: LT Buy
  OBJ Limited

The following might be helpful for conducting qualitative analysis as a method for putting a value on OBJ Limited (ASX:OBJ)


Products & Pipeline

"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."

OBJ currently offers three separate technology platforms to suit a broad range of medical, consumer, household and consumer needs.

eM-Patch A film based micro-array technology ideal for patches, masks, dressings and other topical applications. The magnetic micro-array film replaces the traditional plastic backing layer imparting new levels of product performance with minimal cost impact. The magnetic field gradients required to interact with each active ingredient and the barrier function of the target biology are programmed into the film during manufacture.








Field in Motion (FIM)

A magnetic micro-array film that is integrated into brushes, applicators and wipes captures the energy of motion of normal usage behaviour and redirects this to achieve new levels of product performance. Structures within the micro-array are developed to enhance delivery of active ingredients and to focus these at structures and pathways such as epidermal pores, follicles and dentine tubules. Well suited to brushes, scrubs, wipes, applicators and various products where consumer movement and manipulation from part of normal usage patterns.

Dermaportation


A precision delivery system generating precise time varying magnetic fields by an onboard micro-processor. Designed for applications where repeat applications, extended usage and multi-formulation requirements make a powered reusable device the best solution. Able to be implemented as a power-patch, a wand, an instrument or an iPod-like device, Dermaportation is well suited to many professional and retail applications where repeat delivery of consumables or the targeted delivery of actives is beneficial.
 



Summary
 
OBJ’s technologies are the first to meet the tough economic, environmental
and usability needs of the wider consumer goods markets, featuring;

Economics
- Low cost, Good shelf-life, Single use or Re-usable
- Opportunity for reduced active levels
- Exhaustible reservoir potential
Adaptable Format
- Patches, strips, wipes, applicators, and devices
Active Compatibility
- Wide range of molecules and compounds (inc. peptides, nanoparticles)
- Chemically non-invasive
Engineered Delivery Profiles
- Release and Penetration Speed
- Overall delivery profile
- Depth of penetration
Intellectual Property
- Proprietary technology platform
- Opportunities for application specific patents.


Key Events for FY 2011

July – December 2010
- Dr Kevin Hammond joined to accelerate International Partner Programs
- Dr Matt McIldowie joined to expand product development and testing
- Company expanded its commercial focus onto Consumer Goods
- Large FMCG issues Letter of Intent for Strategic Alliance
- GSK enters Collaborative development to explore FIM™ in Oral Health

January – June 2011
- GSK Collaboration moves to human studies following early successes
- Strategic Alliance technical evaluations progress to multiple product groups
- UK FMCG commences consumer testing of patch product concept
- Company expands UK partnering presence

November 2011: Since the close of FY 2011
– US Patent Granted (Dermaportation technology)
– Commenced multi-product discussions with major US Pharma
– Developed a new Cosmetic Pod based delivery system
– Musculoskeletal project moved to consumer testing in Europe

In OBJ's 2011 AGM Presentation, two additional prospective partner companies have engaged in collaboration discussions with OBJ - A UK FMCG company  commenced consumer testing of a patch product, and multi-product discussions commenced with a major US Pharmaceutical company.

Here's a list of the top 10 (US) Pharmaceutical / Health companies in order of revenue:
1. Johnson & Johnson
2. Pfizer
3. Abbott Laboratories
4. Merck & Co
5. Eli Lilly
6. Bristol-Myers Squib
7. Wyeth
8. Amgen
9. Genetech
10. Baxter


LINKS

www.obj.com.au
2010 Annual Report
2010 AGM Presentation
2011 Annual Report
Corporate Presentation 2011
Technical Presentation 2011
eM-patch Cosmetic Booklet
ETP & eM-patch Summary Results
ETP & DP data summary
OBJ Technology and Introduction Booklet
OBJs Collabortion Principles
Mechanisms of Action
Dipeptide Publication full version
Epidermal Pore Formation by Magnetic Fields
Urea
Enhanced Skin Permeation of Naltrexone
Liquid chromatography assay for 5-aminolevulinic acid
HPLC ASSAY FOR 5 – AMINOLEVULINIC ACID


OBJ - Intellectual Property

* Apparatus for Facilitating Transdermal Delivery of Therapeutic Substances and Method of Transdermally Delivering Therapeutic Substances
APPARATUS FOR FACILITATING TRANSDERMAL DELIVERY OF THERAPEUTIC SUBSTANCES AND METHOD OF TRANSDERMALLY DELIVERING THERAPEUTIC SUBSTANCES 
USA – Granted
EU Examiners Response
PCT Examiners Response

* An Apparatus and Method of Treatment Utilizing a Varying Electromagnetic Energisation Profile
'An apparatus and method of treatment utilizing a varying electromagnetic energisation profile
PCT-Exam requested

* Method and Apparatus for Enhanced Transdermal Diffusion
Method and Apparatus for Enhanced Diffusion
European Patent Convention-Exam requested
Japan - Exam requested
USA - Filed

* Delivery of Skin Care Products – PCT Application filed
Delivery of Skin Care Products
* Delivery of Hair Care Products – PCT Application filed
Delivery of Hair Care Products
* Delivery of Oral Care Products - PCT -Application filed
Delivery of Oral Care Products
* Delivery of Fabric Care Products -PCT Application filed
Delivery of Fabric Care Products
* Method and Device for Transdermal Delivery of Substances
Provisional Application - Filed

 OBJ – Sept 2005
“Your Company is in early stage discussion with major pharmaceutical companies with the view to developing customized delivery solutions for a range of problematic or underperforming drugs or compounds. The Company is active in raising the level of awareness in the general pharmaceutical community of the Company’s successes. Drs Kay Fei CHAN and Chin Joo GOH have been supporting this work in Asia and Dr Maud Eijkenboom has been invaluable in building relationship with European and US based pharmaceutical companies.”

The following patents are not assigned to OBJ Limited or International Scientific Pty Ltd

Inventors: Jeffrey David Edwards (Claremont, AU) Chin Joo Goh (Singapore, SG) Kay Fei Chan (Singapore, SG)
Assignees: Global Energy Medicine Pty Ltd
IPC8 Class: AA61N200FI
USPC Class: 600 13
Class name: Surgery magnetic field applied to body for therapy electromagnetic coil
Publication date: 2010-10-14
Patent application number: 20100261947
VIVO STIMULATION OF CELLULAR MATERIAL 
WIPO Vivo Stimulation of Cellular Material 
WO2002076850 - Secure Transport Container 
(WO1987004851) PROXIMITY SENSING DEVICE 
(WO2002060311) PHYSIOLOGICALLY ACTIVE BRACING
(WO1996011723) DEVICES AND METHODS FOR IMPLEMENTATION OF PULSED ELECTROMAGNETIC FIELD THERAPY 



OBJ - Research & Development



Dermaportation of ALA hydrochloride through human epidermis



Sarika Namjoshi, Rima Caccetta, Jeffrey Edwards, Heather A.E. Benson

The purpose of the present study was to develop a reverse-phase high performance liquid chromatographic (HPLC) assay for quantifying 5-aminolevulinic acid (ALA). The assay was applied to study the skin permeation of ALA and the influence of a novel skin penetration enhancement technology. Separation was achieved utilizing a Phenomenex Jupiter C18 column following fluorescence derivatization with fluorescamine. The assay was linear (r2 > 0.99) with a minimum limit of quantitation of 400 ng/mL. The inter- and intraday variation was 1.6 and 0.9% at the lower end of the linear range and 1.5 and 1.9% at the upper end, respectively. The HPLC assay and fluorescence derivatization procedure is sensitive, simple, rapid, accurate and reproducible and offers advantages with regard to stability of ALA in comparison to other fluorescence derivatization methods. Results from the preliminary skin permeation study demonstrated substantial skin penetration of ALA only when applied with Dermaportation as a skin penetration enhancement device.





2008-2011: - Collaboration with University of Queensland - Michael Roberts
Title:Topical peptide delivery for cosmetic and therapeutic benefits
Fundors: Australian Research Council, OBJ Limited

Abstract:This project aims to define rules governing the delivery of peptides (especially those derived from milk) to the different layers of the epidermis using different formulations and certain delivery devices.

The Significance of the work is that, although milk has been acknowledged as a good nutrient and is used in skin care formulations, a systematic study of the benefits of milk on the skin has not been carried out. This project will define the distribution patterns of milk peptides in terms of both the properties of the peptides and the delivery systems used. Source

2011: Collaborative and RKT Centre Successes - Bradford University / Steve Britland

Ex-Bayer and J&J Scientist joins OBJ Dec 2004
Lignocaine & Prilocaine Study February 2005
OBJ announces first inductive coin-sized drug patch July 2005
Novartis - Voltaren Emulgel Study results Sept 2005
Pfizer - GLANVAC preliminary Vaccine results Oct 2005
100 fold increase for TDD of NALTREXONE Dec 2005
75 fold increase in CORTISONE Dec 2005
TDD technology proven in HUMAN TRIAL April 2006
OBJ’S TECHNOLOGY ENCHASES FOLLICLE DRUG DELIVERY June 2006
OBJ demonstrates lasting effects of the hormone ESTRADIOL Sept 2006
OBJ ANNOUNCES POWER-LESS ACTIVE DRUG PATCH Nov 2006
Successful human clinical trial of Smith & Nephews AMETOP Dec 2006
DERMAPORTATION STUDY TO BE PUBLISHED BY PRESTIGIOUS PEER REVIEW JOURNAL Jan 2007
FORMER ALZA EXECUTIVE DIRECTOR TO ADVISE OBJ’S BUSINESS AND LICENSING DEVELOPMENTS IN NORTH AMERICA February 2008
OBJ Limited is pleased to announce that Dr Ravi Kiron PhD, MBA, one of the authorities on drug delivery licensing and technology evaluation and former - Executive Director of ALZA Corporation, a division of the $200 billion US pharmaceutical company Johnson & Johnson, will advise OBJ on a consultancy basis to assist the growth of its transdermal drug delivery products and licensing business.
Enters into Agreement with GlaxoSmithKline May 2007
POSITIVE RESULTS FOR DELIVERY OF
THERAPEUTIC PEPTIDE July 2007
OBJ SIGNS SECOND AGREEMENT WITH GLOBAL FMCG COMPANY Oct 2008
OBJ DATA PRESENTED AT MAJOR INTERNATIONAL CONFERENCE March 2009
TECHNOLOGY TESTING UPDATE INCLUDING RECENT IN VIVO UNIVERSITY STUDY April 2009 RESULTS
eM-PATCH® DELIVERS SIGNIFICANT
IMPROVEMENT IN TOOTH WHITENING July 2009
Em-Patch Cosmetic Results Confirmed by In Vitro Permeation Study July 2009
US STUDY RESULTS 01 October 2009
OBJ advised that it has now received the final report from Azopharma covering the Company’s research collaboration with a global Fast Moving Consumer Goods company. The report by Azopharma Contract Services Inc, a GLP/GMP accredited mcontract research organisation in Miami Florida, sets 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.  OBJ is restricted from disclosing any information relating to the drug tested, the comparative product or the market. However 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.”
US STUDY RESULTS Oct 2009
OBJ ENTERS INTO MATERIALS TRANSFER AGREEMENT with 3M - Nov 2009
STATEMENT OF INTENT FROM MAJOR INTERNATIONAL FMCG COMPANY Feb 2010
GlaxoSmithKline enters into further Agreement with OBJ Feb 2010
INDUSTRY EXPERT TO HEAD INTERNATIONAL PARTNERING March 2010
FIM® TECHNOLOGY PLATFORM EXPANDS MARKET REACH May 2010
September 28 - Strategic Alliance with Global FMCG Company
October 25 - GSK TO PROGRESS FIM TECHNOLOGY
"GSK reported statistically significant levels of enhancement in an in vitro testing model by the OBJ technology in a global Consumer Healthcare application. 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"
GLAXOSMITHKLINE AND OBJ IN COLLABORATION TO DEVELOP NEW ORAL HEALTH PRODUCTS - May 2011
OBJ Limited is pleased to announce that GlaxoSmithKline Consumer Healthcare (GSK) and the Company have 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.Oral Health is a major commercial sector with global markets both in the consumer and professional areas. The consumer sector of the market is currently valued at approximately US$29 billion pa. GSK is a major participant in this sector with over 20 products marketed globally, with Sensodyne, Aquafresh, Biotene and Polident being the most familiar.
Collaborative Development Agreement  
Biotech Daily
Pain Patch Development Program - August 2011
OBJ is pleased to advise that it is proceeding with a development program aimed at creating a range of next generation patch products directed at common musculoskeletal pain. The decision by the Board to target musculoskeletal pain follows an extended period of testing of eM-Patch® magnetic micro-array technology to create new levels of product performance.
An international consumer concept and market research program initiated by the Company was recently completed which supports the Board’s strategy.
Patch Development Program

US Patent Office Allows Dermaportation Patent

2011 Annual Report 

GLOBAL FMCG COMPANY TO SECURE ACCESS RIGHTS FOR BEAUTY CARE - October 2011
OBJ Limited is pleased to announce that a global FMCG company has commenced negotiations with the Company for a Joint Development Agreement (JDA) for the development and commercialisation of 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 with a global FMCG company to explore applications for the Company’s technologies across a wide range of consumer product platforms. The results of this work were recently presented to the FMCG company by Mr Edwards, the Company’s Technical Director, and Dr Kevin Hammond, the Company’s International Partnering Manager. The results met the FMCG company’s success criteria and the parties have now moved into negotiations for the establishment of a JDA in the Beauty Care field.
Global FMCG Company to Secure Access Rights for Beauty Care

US Patent Granted


Half Year ReportLate in 2011, the Company reported that the previously announced Strategic Alliance program with
one of the world's leading Consumer Products companies had further progressed following
successful technical evaluations. In October, the Company 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 by the FMCG company to OBJ’s technologies and considerable progress in these
negotiations was achieved during the period.
 
Technology Development
During the period, the Company was rewarded by positive results in its technology development programs in surface hygiene. Data provided through the Company’s close working relationship with Bradford University in the UK, has supported an expansion of this work.






The Company’s work with microneedles was also expanded during the period with the receipt of the first positive results of enhanced drug delivery when used in conjunction with microneedles. This has led to the development of new Intellectual Property and the development of a number of new product forms that utilise this combination of technologies.

Outlook
The Company has made substantial progress during the period in its key interest areas of
technology utilisation, international partnering and moving towards the development of its own products. The recent FMCG negotiations, expansion of collaborations with major international groups and strong consumer research to OBJ’s product plans should result in an exciting and expansive 2012.

February 2012 - Appendix 4D Half Year

April 2012 - Shareholder Update






PROCTER & GAMBLE ENTERS JOINT DEVELOPMENT AGREEMENT

OBJ Limited (ASX: OBJ) is pleased to announce that it has signed an exclusive mult‐product Joint Development Agreement (JDA) with The Procter and Gamble Company (P&G) to investigate the development for new products that utilise OBJ’s magnetic enhanced delivery technologies.
P&G is the world’s largest consumer products company with a brand portfolio of over 300 household names – from Gillette to Duracell, Olay to Cover Girl. P&G provides globalmarket access across 180 countries and serves some 4.4 billion consumers daily. P&G’s annual turnover is about $US83 billion/annum. The two companies began collaborations over a year ago as part of P&G’s Connect+Develop open innovation program. The signing of the JDA comes after extensive evaluations aimed at identifying commercially viable opportunities for OBJ’s unique  technologies. Under the JDA, P&G and OBJ will jointly evaluate the application of OBJ’s micro-array technologies with products in P&G's global brand portfolio.


P&G announced:
“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,” said Jeff Weedman, P&G Vice President of
Global Business Development.






The signing of the JDA follows the successful completion of a series of proof of principle
studies where P&G and OBJ focused on determining the most suitable commercial opportunities for OBJ’s unique technology.

OBJ Director Mr Glyn Denison commented on the signing of the JDA:
“The JDA is a significant milestone in the Company’s progression from technology
development to commercial application. Having the world’s largest consumer company as
our consumer product development partner is an exciting development and working in high
volume consumer applications plays to the strength of OBJ’s technologies and expertise.
We warmly welcome the collaboration with Procter & Gamble and congratulate the
technical and marketing team for this achievement.Procter & Gamble Enters Joint Development Agreement 



Collaborating or co-author Scientists: - Past and Present

Dr Matthew McIldowie - OBJ Research Manager
Dr Mark A Spackman - School of Biomedical, Biomolecular and Chemical Sciences UWA
Prof Matthew Piggott - School of Biomedical, Biomolecular and Chemical Sciences UWA
Dr Vincent P Wallace - Electronic and Computer Engineering UWA
Dr Rima Cacetta - Curtin University WA
Dr Yan Chen - Curtin Health Innovation Research Institute WA
Gareth L Nealon - School of Biomedical and Chemical Sciences - UWA
Gayathri Krishnan - Curtin Health Innovation Research Institute WA
Mr Bill Hoeneveld - Product Development at A.D. Engineering International
Mr Mike Boddy - Curtin University WA
Ms Sarika Namjoshi - Western Australian Biomedical Research Institute WA
Dr Jonathon Brotchie - Toronto Western Research Institute - Canada
Dr Tom H Johnston - University Health Network, Toronto, Ontario, Canada
Dr Susan H Fox - University of Nottingham – UK
Dr Steve Britland – Bradford University UK
Prof Brian Barry – Bradford University UK
Prof Keith Brain – Cardiff University UK & Boots UK
Prof John Gordon - University of Birmingham UK
Prof Chris Anderson – Linkoping Univesity - Sweden
Dr Christoper R Driscoll - Department of Chemistry - Curtin University
Dr David H Brown - Nanochemistry Research Institute - Curtin University
Dr Brian W Skelton - Nanochemistry Research Institute - Curtin University
Dr Allan H White - School of Biomedical, Biomolecular and Chemical Sciences, UWA & Institute of Science - Strasbourg, France
Prof Mark Ogden - Director of Nanochemistry Research Institute at Curtin University
Dr Maud Eijkenboom - EX-Bayer, Johnson & Johnson & Novartis Senior Scientist
Prof Michael Roberts – Director - Therapeutic Research Unit - University of Queensland
Dr Ravi Kiron - Ex-Director of ALZA Corp (Johnson & Johnson) and Pfizer
Dr Lucio van Rooijen - Ex-Bayer and Novartis Senior Scientist
Dr Jeffrey Grice - University of Queensland
Dr Tarl Prow - University of Queensland
Dr Richard Parsons - University of Queensland
Prof Heather AE Benson - Curtin University WA
Dr Michael N Gandy – School of Biomedical, Biomolecular and Chemical Sciences UWA


Management

Mr Jeffrey Edwards
Jeffrey Edwards has over 20 years experience in managing new technological innovations. He is experienced in production, intellectual property, regulatory affairs and quality systems. He is an award winning technology developer, and has worked with a number of leading international medical and biomedical companies, including Global Energy Medicine Pty Ltd (therapeutics) and CollTech Australia Limited (biomaterials). During the past three years, Mr Edwards has not held a directorship in any other listed companies.

Mr Glyn Denison
Glyn Denison is a qualified professional engineer and operates his own business consultancy advising companies in their development internationally. Mr Denison was one of the founders of the ERG Group and held several senior executive positions over the period from 1987 to 2003. These positions included President of the Americas for the ERG fare collection business and the New Business Development Director for ERG Transit. Prior to ERG, Mr Denison held several commercial positions with Bunnings Forest Products (now part of the Wesfarmers Group).

Dr Christopher Quirk
Christopher Quirk is an Australian dermatologist who has been a teaching hospital consultant for 27 years 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. He has published 22 papers in international journals and has presented at the World Congress of Dermatology in Paris and the World Congress on Cancers of the Skin in Seville. During the past three years, Dr Quirk has also served as a director of the following other listed companies:
* Pharmanet Group Limited

Dr. Kevin Hammond
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’s wealth of experience in new technology applications and technology acquisition for major industry leading companies provides a unique insight into commercial partnering and licensing opportunities with potential partners.
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.


OBJ - Partnerships


P&G is a global, publicly traded Fortune 500 company, and the largest consumer packaged goods company in the world.

P&G’s work is driven by a Purpose of providing branded products and services of superior quality and value to improve the lives of the world’s consumers now and for generations to come. P&G’s growth strategy, inspired by our Purpose, is to touch and improve more consumers’ lives in more parts of the world, more completely.

HQ: Cincinnati, OH
Operations in: About 80 countries
Sales: $82.6 Billion (2011)
Established: 1837

Brands

50 Leadership Brands, which are among the world's best known household names and which account for 90% of P&G sales and more than 90% of profits. Leadership Brands include 24 Billion-Dollar Brands (each generating more than $1 billion in annual sales).

Four billion times a day, P&G brands touch the lives of people around the world.
Consistently one of the world’s top advertisers, investing more than $8 billion in 2010.
P&G has one of the largest and strongest portfolios of trusted brands, including Pampers, Tide, Ariel, Always, Pantene, Bounty, Pringles, Charmin, Downy, Iams, Crest and Olay.




Olay: World's Most Valuable Beauty Brand

Olay was named the Top Beauty Brand for 2012 in the recently released BrandFinance® Top 50 Beauty Brands report. First published in 2011, the Brand Finance Top 50 Beauty Brands is released annually and is the first publicly available study analysing the financial value of the world’s top beauty brands.
“Procter & Gamble should be rightly proud of their well established and impressive beauty brand, Olay,” said David Haigh, CEO of Brand Finance. “For a brand which demands consumers to ‘Challenge what’s possible’ so too has Olay challenged the expectations of the beauty industry and it is no surprise that this multi-billion-dollar brand is the outright global leader in beauty brands this year.”

Brand Finance PLC, the world’s leading independent brand valuation consultancy firm, evaluates all publicly listed beauty companies to determine the Top 50 Most Valuable Beauty Brands. The valuation is based on a number of financial metrics such as market demand, intangible assets and perpetuity of growth. Based on the data collected by their international team of analysts, they determined that in 2012, Olay is the Most Valuable Beauty Brand. This is the second year in a row Olay has earned the number one spot on the list. See the full list.
“On Olay, we try to be at the forefront of innovation, with new ingredients and technologies that really transform the skin, so it’s a true honour to be recognized for this and ranked as the world’s top beauty brand,” said Michael Kuremsky, P&G’s Global Vice President and General Manager of Skin Care, on the Top 50 Beauty Brands. “This year also marks Olay’s 60th anniversary, so we are grateful that millions of women around the world continue to trust Olay for their skin care needs.”
Pantene also earned a spot in the Top 50 on the list.
“Approaching the London 2012 Games, P&G seeks to maintain its brand awareness not only through sponsoring the American gymnast, Alicia Sacramone, as their beauty brands ambassador, but the brand has also secured an impressive Worldwide Partnership with the International Olympic Committee,” according to the press release issued by Brand Finance, which is headquartered in London.

 
Links

www.pgbeautygroomingscience.com
www.scienceinthebox.com
www.pgperspectives.com
www.pgbioscience.com
www.pg.com
22nd World Congress of Dermatology 
P&G Newsletter - August 2012


Announcements

Strategic Alliance with Global FMCG Company
Global FMCG Company to Secure Access Rights for Beauty Care
Procter and Gamble Enters Joint Development Agreement









3M at a Glance




Western Australian Biomedical Research Institute

Staff at WABRI collaborate with a wide variety of research and industry groups. Key collaborations have included:
  • Lions Eye Institute
  • Walter and Eliza Hall Institute
  • University of Western Australia
  • PathCentre WA
  • Westmead Millennium Institute
  • Prince of Wales Hospital
  • Clinical Cell Culture
  • OBJ
  • HeartLink
  • Pharmanet
  • Boron Molecular
  • Neon Antibiotics
  • NeuMedix
  • Regenera












Krishnan, Gayathri
Title Skin penetration enhancement techniques
Degree Ph.D.
Date 2011
Abstract Transdermal drug delivery is an effective alternative to conventional oral and injectable drug delivery routes. It offers painless and convenient once daily or even once weekly dosing for a variety of clinical indications. The major limitation to successful transdermal drug delivery is the efficient barrier properties of the skin. Significant research efforts have been focused on developing strategies to overcome these barrier properties. These strategies include the use of physical and chemical penetration enhancers. Physical skin penetration enhancers use an external energy source to alter the barrier properties of the skin. The current research focuses on some of these physical skin penetration enhancers on a range of drug molecules and peptides.
The first technology investigated was Dermaportation that utilised pulsed electromagnetic energy. This technology enhanced the epidermal permeation of naltrexone in vitro as compared to passive diffusion. A 5-fold increase in naltrexone permeation was observed during Dermaportation application when compared to passive administration. Multiphoton tomography-fluorescence life-time imaging microscopy (MPT-FLIM) analysis of the permeation of gold nanoparticles in the presence of Dermaportation revealed increased penetration across ex vivo human skin. These results demonstrated that the channels created by dermaportation must be larger than the 10 nm diameter of the applied nanoparticles.
The second technology investigated was an unpowered magnetic film array technology (ETP), which utilised unpowered magnetic energy. Chapter 3 presents enhanced epidermal permeation of urea with ETP. A 4-fold increase in urea penetration was observed across human epidermis in the in vitro permeation study. Optical resonance tomography was used to visualise the changes in epidermal thickness due to urea permeation as an indication of increased hydration. The results revealed an increase in epidermal thickness at 30 min, to 16% for ETP induced urea permeation as compared to 3% with urea from occlusion. These results further substantiated our previous findings that magnetic energy creates hydrophilic diffusion channels or pores in the skin.
The third technology investigated was low-frequency sonophoresis that utilises cavitation bubbles as a force to create channels for drug delivery in the skin. Chapter 4 presents enhanced human skin permeation of 5-aminolevuleninic acid in vitro and curcumin dye in vivo with low-frequency sonophoresis. Two different sources of ultrasound devices that generated low-frequency sonophoresis were investigated. MPT-FLIM analysis was utilised to investigate the effects of sonophoresis on human skin in vivo. This revealed that there was substantial disturbance in the epidermal cells due to cavitation by sonophoresis. Permeation of curcumin was found in the deeper layers of the epidermal membrane with 55 kHz sonophoresis and was confined to the more superficial layers of skin with 21 kHz sonophoresis. Permeation of 5-aminolevuleninic acid across human skin increased significantly when compared to passive permeation.
The fourth technology investigated in this research was iontophoresis which utilises a small electric current to drive charged and uncharged molecules across the skin. Chapter 5 presents enhanced epidermal permeation of a range of model therapeutic and cosmetic peptides. Various key parameters such as pH, concentration and presence of counterions and co-ions that are essential for effective iontophoretic delivery of these peptides were investigated. The iontophoretic delivery of 5- aminolevulenic acid revealed a 15-fold enhancement when compared to passive diffusion. For dipeptide (Ala-Trp) the mean cumulative amount increased iontophoretic delivery from 0.4±0.4, 0.1μg/cm2 to 16.0±8.8, 3.6μg/cm2 (Mean±SD, SEM) was observed when the donor pH was reduced from 7.4 to 5.5. The corresponding current intensity (0.38mA/cm2) normalised flux was 36.1±19.5, 11.2μg/(mA.h) for iontophoretic Ala-Trp. For the tetrapeptide (Ala-Ala-Pro-Val) the mean cumulative amount that permeation with 2h iontophoresis was 350.4±45.9, 15.3μg/cm2 (Mean±SD, SEM) compared to zero passive permeation. A 4-fold increase in acetyl hexapeptide-3 delivery occurred with iontophoresis compared with passive application. In addition it was observed that lowering of donor solution pH and the presence of counterions and co-ions reduced the iontophoretic delivery of acetylhexapeptide-3. Iontophoresis provided a significant enhancement factor for the decapeptide, triptorelin acetate with a 16-fold increase in epidermal permeation compared with passive permeation. The iontophoretic permeation was concentration dependent with mean cumulative amounts of 48±28, 14 μg/cm2 (Mean±SD, SEM) achieved with 9 mM concentration of triptorelin acetate.
Overall the technologies investigated in this research work presented enhanced permeation of drug molecules and peptides. In addition MPT-FLIM was demonstrated to be an efficient visualisation tool for permeation within the skin. This research demonstrates the effectiveness of physical skin permeation enhancement techniques and extends our understanding of these technologies.
Subjects skin penetration, transdermal drug delivery, physical skin penetration enhancers, chemical skin penetration enhancers
Supervisor Dr Heather Benson
Department Curtin University, School of Pharmacy












School of Biomedical Sciences














Partnerships

INTERNAL

REGIONAL

NATIONAL

INTERNATIONAL


"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."





Financial Resources
Jun 2012 - $3,696,000
Dec 2011 - $3,827,999
Jun 2011 - $4,483,519
Dec 2010 - $5,326,997


Headline Highlights

 In October, the Company learned that the FMCG company was seeking world-wide exclusive access rights to OBJ’s technologies in the area of a beauty.


"seeking world-wide exclusive access rights to OBJ’s technologies"

 "in discussion with five of the world’s largest Consumer Healthcare companies across a variety of applications"
"currently working closely with two of the world's foremost cosmetic brands

 "OBJ is working with one of the worlds largest pharmaceutical companies in consumer acceptance testing for a patch version of an existing multi-billion dollar product currently sold internationally"

















Negotiations commenced regarding the various financial, developmental and investment commitments by the FMCG company to OBJ’s technologies and considerable progress in these negotiations was achieved during the period.

"FMCG initial 5 year Strategic Alliance for the design and development of a wide range of consumer products"

 "Global FMCG Company to Secure Access Rights"


"GSK has reported statistically significant levels of enhancement in testing"

 "commences multi-product discussions with major US Pharma"
"3M remains a major collaborator with OBJ"
"an exciting and expansive 2012"
"expanded its IP and Patent portfolios 7 new FOU patent applications covering the commercial areas of interest to OBJs partner companies"



The advent of advanced drug delivery devices has arrived, raising the bar for many traditional devices. The companies that recognise 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.
Click for this Drug Delivery Report

"The market for drugs delivered transdermally was valued at $5.6bn in 2009 with the majority of these sales being accrued by products utilizing first generation patch technologies. Innovative technologies that are able to deliver drugs with a broader spectrum of characteristics are poised to revolutionize the transdermal drug delivery market and drive significant growth"
click here for source



Pharmaceuticals & Biotech Industry Global Report — 2011

Patent cliff
During the next five-year period, the revenues of drugs having patents that will expire are about $89.5 billion USD, the majority of them small molecules.

In 2011 the world’s biggest selling drug, Lipitor, went off protection. Other drugs that lost protection in 2011 were Plavix, which is used to inhibit blood clots; Actos, which treats diabetes; and Seroquel and Zyprexa, two drugs that treat schizophrenia and bipolar disorder. Revenues hammered by patent cliffs can only partially be compensated by newly launched products, e.g. in indications such as osteoporosis, respiratory illnesses, thrombosis, multiple sclerosis and cancer.

Patent cliffs' impact depends on many factors. The speed and degree of sales erosion when falling down patent cliff are not equal across countries, prescription setting, and therapy area and formulation type. On average, small molecule originals in the US witnessed the most severe sales erosion on patent expiry. In some countries, off-protection products don’t even get generic competition, particularly if the original’s sales are relatively small.

After the US, sales erosion due to patent cliff was next highest in the UK, Germany and France, and was the lowest in Australia, Italy, Russia, Spain and Japan. Originals did not see massive drops in sales upon patent expiry in China, since they often were exposed to generic competition from the outset.

Price cuts and reimbursement restrictions continue to limit growth

Governments around the world are grappling to arrive at solutions for health account deficits. Political pressures have increased during the past economic crisis. Actions mainly address treatments for nonlethal indications with large patient numbers and decreasing profit margins.

"OBJ is the first company in the world 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." ~ (13/08/2010 - Shareholder Update)


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. These clear commercial benefits may only be achievable if the skin’s natural barrier effect can be overcome. OBJ is the first company to create a broad spectrum through-the skin delivery system that is kind to the skin, completely reversible, yet can handle drugs range from the small difficult molecules up to the largest and most complex proteins and anti-bodies. OBJ manages an extensive IP portfolio and prosecutes patent applications throughout the world. ~ (07/12/2006 - OBJ Reduces Time To Onset in Double Blind Human Clinical Trial)

Move to emerging markets — a major growth driver

The dynamic and high-potential pharmerging markets offer tremendous opportunities for drug manufacturers. Big Pharma’s drive into a group of high potential pharmerging markets has continued to gather momentum. Collectively, these markets have been steadily gaining share at the expense of the US and top five European countries (France, Germany, Italy, UK and Spain), accounting for close to 34 percent of global growth.

Eight pharmerging countries are amongst the top 20 world pharmaceutical markets, and China is likely to become one of the “top three” in the near future. This forces pharma companies to adapt their historically grown launch plans.

As of today, their performance in the pharmerging region has been mixed. A few high-profile pharmaceutical companies have been able to gain a foothold, with some of them having notable success. Recent strategic moves include Abbott’s acquisition of Piramal Healthcare in India — a deal that could potentially make the US giant the top player in this country; GSK’s and Lilly’s announcements to double revenue in emerging markets by 2015; Pfizer’s discount-card system in Russia, offering drug price cuts of up to 50 percent; and the purchase of Medley, Brazil’s third-largest pharmaceutical company by Sanofi Aventis. Those pharma companies that fail to enter pharmerging countries run the risk of leaving significant untapped revenue potential on the top-line.

Positive developments in the pharmerging markets, such as greater government investment in healthcare, increasing demand for drugs to treat diseases and strengthening of regulatory and IP requirements, enable global players to launch their products in pharmerging markets: The time lag of drug launch between the first global launch and the first entry into a pharmerging market has halved in the past decade from 2.5 years to 1.25 years. Among all pharmerging markets, Brazil is a preferred destination for drug launch.

Low Productivity of R&D Pipelines

Despite a number of special efforts to bring pharma R&D back to higher productivity levels, the pace of innovation remains anemic: The long-term average is merely one new remedy drug a year per company. Despite R&D spending at a high of 18 percent of revenues, Big Pharma’s R&D productivity declined by 20 percent between 2001 and 2007.

As pipelines dry out, many companies have started to experiment with new R&D models. For example, GlaxoSmithKline has restructured its R&D centers to emulate biotech R&D culture. The company hopes to replicate an entrepreneurial culture in a large pharma organization. Eli Lilly acquired ImClone to source innovation from outside the company and then left it as a stand-alone unit operating independently, much as Roche did extremely successfully with Genentech. Pfizer and GSK broke down corporate barriers to share intellectual property and assets to develop new drugs for diseases such as HIV.

Several pharma companies are partnering with leading academic institutions to promote innovation from basic research. Broadly, to raise innovation returns back to the level that prevailed in the era of blockbusters, pharma companies need transformational change.

"During the period, the Company has focused on a number of technical and development relationships with major universities in both Australia and UK. This has added substantially to the technical scope available to the Company’s R&D and partnering programs. The trend towards utilising specialised centres of excellence around the world as a means of expanding the Company’s technical capabilities is expected to continue."

Medical differentiation is a must

As most single-cause conditions with large patient relevant populations in mature and emerging markets can be addressed today by generic drugs, pharma companies will need a higher degree of medical differentiation to successfully introduce new products into the market. A showcase is Genentech in oncology. In the 1990s, the pipeline for cancer treatments got crowded with pharma companies developing ever newer chemotherapies with little therapeutic difference.

Instead of becoming a "me too," Genentech concentrated on changing the way cancer is treated. With the help of PDL’s humanization technology, it developed treatments based on humanized monoclonal antibodies—a technology that most pharma companies considered too complicated. The company’s researchers focused on understanding tumor biology and set goals to take patient outcomes to a new level. With this, Genentech gained market leadership along with being able to price its therapies several times higher than pharma’s marginally improved options.

In today’s market, differentiation is more important than ever. Big Pharma’s customers increasingly are payers (very often government units) and patients who care about two criteria: health outcomes and affordability.

OBJ is pleased to announce that Elsevier, the world’s leading publisher of peer reviewed science and health information, has notified the Company that the study into Dermaportation enhanced delivery of 5-ALA has been accepted for international publication in the prestigious Journal of Chromatography.

The Journal of Chromatography is a leading publication in the field of drug discovery and provides a scientific forum for the publication of original research on all aspects of fundamental applied science. The scope of the journal includes chromatography, electromigration and other multi-dimensional techniques.

The study titled "Liquid chromatography assay for 5 aminolevulinic acid: application to in vitro assessment of skin penetration via Dermaportation" will be published later in the year through Elsevier, which serves more than 30 million scientists, students, and health and information professionals worldwide.

Dermaportation increased the rate of transdermal diffusion of the anti-cancer drug 5-aminolevulinic acid or 5-ALA by almost 900%. ~ 07/01/2007 - Dermaportation Study to be published in prestigious peer review journal

OBJ Limited has been invited to present at the 7th World Congress on Inflammation in late August. This follows OBJ’s invitation to present at the World Congress on Pain in the same month.

Dr Chris Quirk and Mr Jeffrey Edwards will present the OBJ ‘smart’ drug-patch delivery system and the commercial opportunities resulting from the technology at the BioPartnership session of the 7th World Congress on Inflammation.

Recent independent University results achieved by OBJ’s through-skin drug patch technology in the field of anaesthetics will be presented by Dr Heather Benson, for the first time to an international audience as a poster presentation at the 11th World Congress on Pain.

These invitations follow the company’s announcements that its Dermaportation smart drug-patch technology which was shown to increase the through-the-skin delivery of a range of commercially and medically important drugs including a 900% increase in the delivery of the anti-cancer drug 5-aminolevulinic acid, an increase of 600% in caffeine delivery and a reduction in the time taken to deliver local anaesthetics by 70%. ~ 16/08/2005 - OBJ to present at the World Congress on Inflammation and the World Congress on Pain

Biosimilars – an emerging opportunity

The US market represents the greatest opportunity for the emerging biosimilars industry, and is forecast to constitute nearly 90 percent of the seven major market biosimilars volume market in 2014. The size of the US market, combined with typically high generic substitution that characterizes it, makes it an attractive prospect for potential biosimilars players. However, how fast this market can develop, and how many players can participate, depends on the biosimilars approval pathway.

Through 2015, biologic drugs worth more than $80 billion USD in global sales will lose patent protection, presenting a major opportunity. Given this potential, Big Pharma companies are poised to enter the biosimilars market. Even the larger generics players are in danger of being overtaken by the originator drug companies, with Merck & Co., AstraZeneca and Eli Lilly all looking to carve out a share for themselves in the biosimilars market.


2011: Steve Britland, Centre for Skin Sciences, University of Bradford collaborative development with OBJ Limited of Australia for the development of innovative bioequivalence models for use in specialised areas of transdermal drug delivery research.

OBJ Limited
2011: Collaborative and RKT Centre Successes
Pharmaceuticals & Biotech Industry Global Report — 2011
Corporate Presentation
Technical Presentation
eM-Patch Cosmetics Booklet
CANCER CHANGING THE CONVERSATION 2012
Pfizer Development Pipeline - 2012
Dermatologic,Cosmeceutic, and Cosmetic Development 


Information presented in this post has been obtained from the internet through publicly available sources. The opinion of the author is in no way to be considered as investment advice. The author may be holding a position in the stock being discussed, but will always endeavor to disclose such information. The author makes no representation or warranty as to the accuracy of information posted on this site, and always encourages the reader to follow up and further research any information which may be obtained from here for the purpose of forming ones investment decisions


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