The following may be helpful to any new investors of OBJ - It's based on a qualitative analysis as a method for putting a value on biotechnology stocks. (I'm sure I've posted one on the OBJ thread before but had no luck locating it)
I wouldn't expect to see much excitement across our markets today with it being a public holiday in a couple of States, but I do expect we'll see some increased volume again this week. There is significant upside presenting itself with OBJ in the very short, medium and long term right now. Imho.
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Putting numbers on a biotech firm when sizing up a biotech company's strategic and financial health, analysis often relies heavily on qualitative analysis rather than quantitative, financial methods of valuation. Here are a few non-numerical items to consider when analyzing biotech companies.
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Products and Pipeline
Naturally, a biotech company's product portfolio and research pipeline are the lifeblood of its success. That means you need to take a close look at the company's key products and the features of its biotechnology. Ideally, the company should be developing a technology platform with multiple – rather than single – treatment opportunities. Importantly, the company should be working on a large number of products that target diseases with large patient populations.
Watch out for biotech firms developing products for big treatment areas – such as cancer, and cardiovascular diseases and central nervous system disorders – where potential return in investment is greatest. Stay clear of companies developing "me-too" treatments for disease areas that already well served by existing technologies in the market.
At the same time, find out where the company's products are situated in the development pipeline. The later the product's stage of clinical development, the greater the chances of regulatory approval, market launch and commercial success.
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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.
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
Providing all that colour didn't just blind you, this is where we have every good reason to be very bullish on OBJ in the very short term imo.
Whilst many of us have been distracted with the anticipated news regarding the licensing rights and JDA negotiations with a global FMCG company we have neglected some other major news which may potentially result in OBJ holders being served up a smorgasbord of delights within a very short space of time:
As listed above from our AGM Presentation last November OBJ not only advised of a global FMCG company progressing to multiple products and the GSK development collaboration moved to human studies and another UK FMCG company had commenced consumer testing of a patch product but they also advised that multi-product discussions had commenced with a major US Pharmaceutical company.
A major US Pharmaceutical company? Just out of interest 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
Although similar disclaimers are made by many of the big Pharma's the following is provided in Pfizers Development Pipeline presentation publicly released last week which I've also linked at the bottom of this post:
"As some programs are still confidential, some candidates may not be identified in this list. With a view to expanding the transparency of our pipeline, Pfizer is including new indications or enhancements, which target unmet medical need or represent significant commercial opportunities."
In regards to a qualitative analysis of OBJ's products and pipeline I believe, given the crazy sp and tiny MC it's fair to accept that they have a few coals in the fire.
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Patents
A biotech company's technology and products might have great potential, but does the company possess patents to protect its technology? By giving the biotech company exclusive rights to its technology, patent protection increases the value of the technology and the company. The company can pursue R&D and commercial development with less fear of competitors "stealing" or infringing on their technology. Most importantly, patents can attract royalties-paying commercial partners with the financial clout to fund R&D, clinical trials, product development and marketing.
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OBJ - Intellectual Property
* 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
PCT-Exam requested
* Method and Apparatus for Enhanced Transdermal Diffusion
European Patent Convention-Exam requested
Japan - Exam requested
USA - Filed
* Delivery of Skin Care Products – PCT Application filed
* Delivery of Hair Care Products – PCT Application filed
* Delivery of Oral Care Products - PCT -Application filed
* Delivery of Fabric Care Products -PCT Application filed
* Method and Device for Transdermal Delivery of Substances
Provisional Application - Filed
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R&D
Does the company have a track record of productive research and development? Mature biotech companies spend about a fifth of total revenue on R&D, while early-stage biotech ventures typically spend well in excess of hundred percent of revenues on R&D. Not surprisingly, the outcome of R&D spending can vary wildly, especially for early stage biotech ventures.
A key factor in success is the ability to develop cost-effective drugs that represent breakthrough therapies. R&D that delivers similar results to those already on the market is less likely to translate into successful products. Look for companies with R&D programs focused on diseases that aren't currently well-treated.
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OBJ - Research & Development
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.
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.
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.
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
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Management
Talent and experience of management is critical for long term success. Ideally, the biotech company should be run by executives who have developed and commercialized treatments before. It's a good idea to look for management teams with a track record of meeting publicly-stated goals and development milestones. Meanwhile, be wary of companies that regularly miss their targets. Executives must have an excellent understanding of the clinical and commercial development process, appreciate the costs involved, and have a record of putting company's resources into projects that offer high returns on investment.
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OBJ 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.
* Dr John Moursounidis
Former Head of Scientific Affairs at Boots Healthcare, and former Divisional Head at the world's largest Global FMCG company, Procter & Gamble, Dr John Moursounidis was/is engaged as a consultant for OBJ's Product Development Program
* (It has been alleged that Mr Denison when queried advised that Dr Moursounidis was only contracted as a consultant to OBJ from October - January - I question whether any confidential obligations prevent him from saying otherwise. Imo)
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Partnerships
These days, biotech companies can rarely succeed alone. Given the big costs of drug development, a biotech company will be held back from reaching its full potential unless it can find partners to help fund clinical trials and commercialization. So, it's important to find out if the company has secured promising collaborations and licensing partnerships.Look for partners that show lasting commitment – remember, the biotech product development process can be a very long and expensive one. Also, keep an eye on deal terms as they offer a reliable indication of value that the market gives to the technology. A good licensing partnership agreement will include not only a generous royalty rate on future sales but also healthy upfront payments plus milestone payments for achieving development targets.
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OBJ - Partnerships
With the exception of one internal pain patch development program announced to the market in August 2011 all OBJ's research and development projects have and continue to be partner funded from the very early stage.
This imo is a significant endorsement for our technology from our partner companies. Although confidentiality agreements restrict much of the agreement detail we can confirm the following three entities in terms of commencement date of funded programs:
GlaxoSmithKline since 2006
FMCG#1 since 2006
FMCG#2 since 2009/2010
It's quite extraordinary given how many programs have expanded and progressed over recent years to think that OBJ haven't required to raise any capital since 2009. This imo is another very promising indication which the market have neglected to factor in. The following point in relation to Financial Resources clarifies this further.
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Financial Resources
Finally, it's important to know whether the company is well-financed. After all, funding is the fuel of the biotech industry. Without funding, a biotech company will be forced to cut back on R&D, and clinical and commercial activities – reducing its chances of maximizing return on investment.It's reassuring to see enough cash on the balance sheet to cover expenses for at least a year or two. A solid cash position means that the company can strike up favorable partnerships without having to accept the first deal on offer. Of course, the hope is that the biotech company won't have to rely on external financing and cash reserves to keep R&D and commercial development going and will eventually be able to run profitably from high margin revenues.
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OBJ - Financial Resources
Dec 2011 - $3,827,999
Jun 2011 - $4,483,519
Dec 2010 - $5,326,997
At the increased cash burn rate witnessed over this past 12 months since commencement of our internally funded pain patch program I calculate we have another 2.5 years left in the bank, but it would surprise me to see that holding topped up as a result of a near term licensing agreement and/or milestone payment(s)
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The Bottom Line
It's almost impossible for the average investor to grasp the science that underlies biotech companies and their development projects. Given that biotech businesses typically have scant financial records, quantitative analysis represents a big challenge for investors, too. That said, looking at the key qualitative drivers of biotech value – namely a promising product pipeline, patents, good management, durable partnerships and access to funds – offers a good first step in sizing up biotech potential.
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OBJ - Bottom Line
The bottom Line is... OBJ is about to get re-rated imho!... and the writing's on the wall...
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February 2012: Technical and Commercial progress update to December 2011
The US granted patent for the Dermaportation or powered technology device has subsequently resulted in considerable interest from major cosmetic groups for the Company’s new e-skin product range. The potential market exclusivity provided by the US patent has considerably strengthened market interest.
Late 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.
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"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
"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"
"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"
"considerable progress in these
negotiations was achieved"
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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
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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)
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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.
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- "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."
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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.
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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
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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.
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2007: OBJ Demonstrated preliminary evidence of bioequivalence for transdermal vaccine delivery
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.
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
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The qualitative analysis article was written by Ben McClure from Investopedia and Bay of Thermi Limited.
"Ben is the director of Bay of Thermi Limited, an independent research and consulting firm that specializes in preparing early stage ventures for new investment and the marketplace. He works with a wide range of clients in the North America, Europe and Latin America. Ben was a highly-rated European equities analyst at London-based Old Mutual Securities, and led new venture development at a major technology commercialization consulting group in Canada. He started his career as writer/analyst at the Economist Group. Mr. McClure graduated from the University of Alberta's School of Business with an MBA.
Ben's hard and fast investing philosophy is that the herd is always wrong, but heck, if it pays, there's nothing wrong with being a sheep.
Bay of Thermi - Ben McClure
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