ASX:TIS
www.tissuetherapies.com
Tissue Therapies Limited: ASX:TIS Company Announcements
I was asked recently on a public forum to offer my opinion on Tissue Therapies Limited so I have copied some of my reply to begin this post.
Posted: 30/01/12
Stock Price (at time of posting): $0.355c
Sentiment: LT Buy
Disclosure: No Stock Held
I am not currently holding TIS, however from what I understand of this company to date, it certainly appears to pass my qualitative analysis test and comes in under-valued at the current level - leaving one important question remaining for any prospective new investor?
When can we expect to see a reversal in the technical down trend? I'm not a technical analyst and very rarely do I use charting for investing in biotech micro-caps so I'd prefer to leave the technical assessment to others, however many respected international market experts are predicting 2012 will see some tremendous gains across this sector, so for those interested in TIS it may certainly be wise to mark June 2012 down in your diary for the European commercial launch of VitroGro.
The advanced wound care landscape is massive and to a degree this can already be witnessed with the successful growth of major commercial players like Smith & Nephew, Systagenix and Convatec which specialise in the field, and we can also find the billion dollar generating retail giants like Johnson & Johnson and 3M who are consistantly reporting increased sales growth figures for the wound care market.
I like Tissue Therapies CEO Dr Mercer who's wealth of experience and expertise would no doubt be a valuable asset to TIS. Among other impressive credentials the good CEO held former Senior Management positions with Smith & Nephew who's business model serves as an inspiration to its competitors.
One of the more positive points to note with Tissue Therapies is the consistency of positive data returned in all studies for VitroGro, and more importantly, a strong consistency in data have been mirrored in the human clinical trials.
Some points worth highlighting imo:
* Engaging the services of world renoun wound care experts, notably Prof Keith Harding from the prestigeous Cardiff University to supervise trials - A class act.
* There are multiple target applications for VitroGro which significantly increases the value of the IP
* Great Scientific Advisory Board and very close business partnership ties with one of Australia's leading institutions in wound care at the QUT - home of VitroGro inventor, Prof Zee Upton
* The science is heavily supported with years of peer reviewed, published scientific papers
* Very strong supporting data for human trials
* Director buying last month (December) on market @ 41.5c ps
* Technology addresses a significant unmet need
* Partnerships with Quintiles and Movianto not to be underestimated - Although not a household name within Australia they are both global corporations in their own right.
* Commercial launch planned towards the end of Q2/2012
The following abstract has been copied from a white paper authored by Michael Arlotto, who is the Senior Vice President of Corporate Development for Tissue Therapies partner, Quintiles... and his words are spot on imo...
"The biopharmaceutical industry is at a critical point of considerable change. Faced with mounting pressure to move drug candidates through the development cycle more quickly, companies are also trying to navigate the substantial risk involved in pursuing a growing portfolio of products – and the current paradigm is clearly not tenable. To successfully increase shareholder value, mitigate risk, and improve clinical execution, biopharmaceutical companies must explore alliances that meet the needs of the New Health and produce medicines that speak to the needs of the entire constellation of stakeholders. By bringing more, non-traditional parties into strategic alliances with an eye toward reimbursement realities, the industry will accelerate innovation, experience a healthier return on investment, and provide better patient outcomes – thus securing its vital role in the global healthcare ecosystem."
The New Health Alliance
Critical to any type of partnership is a
clearly defined vision and a perfect alignment of objectives among partners. The
primary shift in the evolving biopharma partnership, however, is that a New
Health alliance must include the entire constellation of stakeholders for
optimal success. Naturally, a base financial arrangement still remains between
the two partners, but the development process is driven by market access
realities, comparative effectiveness assessments against the current standard of
care, and an improvement in real-world patient outcomes. In light of this shift,
biopharma alliances must now balance the needs of all players by establishing a
structure through which true innovation can be fostered. How this balance is
manifested, and to what degree health outcome improvement is considered
throughout development, will be the critical drivers of success.
For a New Health alliance to be realized fully, four elements must be present:
For a New Health alliance to be realized fully, four elements must be present:
(1) Convergence among biopharma’s clinical and commercial functions,
(2) proper and effective alliance management capabilities,
(3) an alternative financial structure which shares both risk and reward, and
(4) a global network of nimble providers who can take an asset any stage, for any function, to help drive the development of a new product.
Biopharmaceutical companies are entering into a New Health landscape where the rules are changing on all fronts. With new rules, new models are needed. A new model is needed for discovery. A new model is needed for clinical research. A new model is needed for commercialization. And a new model is needed to ally with partners. Further, the conversation surrounding biopharmaceutical development has shifted. No longer just about producing and commercializing medicines, the dialogue is now about demonstrating real-world outcomes and value. To demonstrate the value of its products to the entire constellation of stakeholders, biopharma must crystallize its deal-making abilities and back into clinical trial design with more emphasis on market access and reimbursement realities.
Although not to be compared directly with VitroGro ECM as they both provide for different applications but Smith & Nephew only this month have released the new pocket Pico which introduces a new generation of negative pressure wound therapy technology.
Introducing PICO™ - An entirely new way to deliver
TIS already have a former Divisional General Manager of Smith & Nephew sitting in their corner with CEO Dr Mercer and one could almost guarantee that Dr Mercer is still in contact with some of his former Smith & Nephew collegues... I'm sure if you take a closer look at Smith & Nephew's Advisory Board Members you may be surprised with what you find ...
Smith & Nephew Science Advisory Board
Posted: 02/04/12
Stock Price (at time of posting): 44c
Sentiment: LT Buy
Disclosure: No Stock Held
Shire's, Dermagraft, for diabetic foot ulcers, generated sales of $105m in only six months from June 2011 to December 2011, which is not too bad considering the technology is not new, so this might present a more realistic initial 6-12 month sales target for VitroGro's introduction to the market - albeit, a rather conservative one some here will agree.
Dermagraft was originally developed by a New York company, Marrow-Tech back in the 1980's which later changed its name to Advanced Tissue Sciences and went bankrupt after pouring $100m dollars into developing the technology only to have the FDA fail to grant marketing approval to sell the product in the US. All the company's assets were sold to Smith & Nephew for a song, who later sold Dermagraft to Advanced Biohealing who in turn went on to commercialize it in the US with the FDA's blessing in 2007.
Advanced Biohealing recorded revenue of $147 million in Dermagraft sales for 2010 before being acquired last year by Irish company, Shire for $750m dollars.
Dermagraft is a transdermal patch product with a human-derived composition as apposed to VitroGro being a synthetic topical solution.
Fyi, the FDA compiled a draft assessment of 31 skin substitute products recently which concluded a low level of clinical evidence across a broad range which imo leaves a gaping hole in the market for a product like VitroGro, which is already backed by solid scientific data...
FDA efficacy assessment - Skin Substitute products - December 2011
"Only five of the 31 skin substitute products identified for this report were examined in RCTs. Results from one skin substitute cannot be extrapolated to other skin substitutes nor can results from studies of diabetic foot ulcers be extrapolated to venous leg ulcers. Therefore, the actual clinical evidence for the efficacy of skin substitutes in the treatment of chronic wounds is very limited.
In most of the included studies, treatment efficacy was judged by the number of wounds healed after 12 weeks of treatment or at some point shortly after 12 weeks. All studies defined healing as full epithelialization of the wound with no drainage. Based on this outcome the majority of studies reported significantly more healed wounds in the skin substitute patients. However, this outcome may be over stating the value of skin substitutes since half of the control therapies was simple gauze dressings. Other outcomes not directly related to wound healing such as amputation, hospitalization, return to function, and pain relief, were poorly reported.
Apligraf/Graftskin is a living cell bi-layered skin substitute derived from bovine type 1 collagen and human fibroblasts and keratinocytes derived from neonatal foreskins. Based on the percentage of wounds closed at 12 weeks, Apligraf/Graftskin was significantly better in all three studies. In the two studies of diabetic foot ulcers the control dressings were a non-adherent gauze dressing (healing rate at 12 weeks was 52% vs. 26%) and saline-moistened gauze (healing rate at 12 weeks was 56% vs. 38%). The third study compared Apligraf to an Unna boot for treated venous leg ulcers. The rate of wounds healed at 6 months was 63% for Apligraf and 49% for the Unna boot. The median time to wound closure was significantly shorter in the Apligraf group (61 days vs. 181 days).
Skin Substitutes for Treating Chronic Wounds - FDA Draft - Dec 2011
As I'm sure many long term Tissue Therapy investors can relate to, one of the risk factors associated to holding biotech stocks like TIS is that the timing factor in regards to research and development combined with the long drawn out regulatory process we must learn to endure is measured in years rather than months like the drilling campaigns of our exploration mining stocks, however the rewards offered in proportion can be significantly higher, especially in very strong areas of biomedical research where there exists a high degree of incidence in global population.
Tissue Therapies at its current MCap of $75m and CE approval for launch of VitroGro into the massive European market just around the corner is now offering a significant opportunity for investors and whilst I can understand and respect the frustrations expressed by some holders for a lack of PR activity to target the wider investment community, I do believe that management of a small company with limited resources like TIS need to remain 100% focused on the commercial enterprise for achieving its corporate goals and profit maximisation for all shareholders.
___________________________________________________________________________________
Tissue Therapies: Qualitative Analysis
abdm
Tissue Therapies Limited is an Australian company developing biomedical technologies for wound healing, tissue and various cell culture applications.
VitroGro®
VitroGro® ECM is a biomimetic scaffold that is sterile, acellular and flowable (designed to be applied to the surface of wounds).
•
It is an artificially created matrix protein designed from polypeptide sequences that normally provide attachment sites in healthy skin that guide cells during normal wound healing.
•
In chronic (non-healing) wounds, skin cells are deprived of these attachment sites because the extracellular matrix (ECM) is degraded.
•
VitroGro® ECM restores normal wound healing by replacing the degraded ECM with a scaffold containing the attachment sites that guide skin cell attachment, proliferation and migration (the essential processes of normal wound healing).
•
VitroGro® ECM is a temporary matrix that is designed to be replaced through the normal process of tissue restoration and turnover.
•
VitroGro® ECM consistently and conveniently restores healing in chronic ulcers that have failed to respond to current expert care.
•
Expert health economics modelling indicates that VitroGro® ECM offers the opportunity for substantially more cost effective treatment of wounds compared to the current standard of care.
•
It is an artificially created matrix protein designed from polypeptide sequences that normally provide attachment sites in healthy skin that guide cells during normal wound healing.
•
In chronic (non-healing) wounds, skin cells are deprived of these attachment sites because the extracellular matrix (ECM) is degraded.
•
VitroGro® ECM restores normal wound healing by replacing the degraded ECM with a scaffold containing the attachment sites that guide skin cell attachment, proliferation and migration (the essential processes of normal wound healing).
•
VitroGro® ECM is a temporary matrix that is designed to be replaced through the normal process of tissue restoration and turnover.
•
VitroGro® ECM consistently and conveniently restores healing in chronic ulcers that have failed to respond to current expert care.
•
Expert health economics modelling indicates that VitroGro® ECM offers the opportunity for substantially more cost effective treatment of wounds compared to the current standard of care.
The extra-cellular matrix is the connective tissue that surrounds and supports our cells. During wound healing the extracellular matrix acts as a scaffold within the wound providing a structure on which cells can attach and migrate in order to repair injured tissue.
VitroGro® provides a temporary scaffold on which wound cells can attach and migrate. This is important in chronic wounds where healing needs to commence from the edges of the wound. Once wound cells have adhered to a temporary VitroGro® matrix they can repair injured tissue and restore balance by producing a new extracellular matrix.
Patents
WO2002024219 - GROWTH FACTOR COMPLEX
WO2004069871 - GROWTH FACTOR COMPLEXES AND MODULATION OF CELL MIGRATION AND GROWTH
WO2005012508 - SKIN REGENERATION SYSTEM
WO2008148174 - WOUND REPAIR COMPOSITION AND METHOD
WO2009029983 - A FEEDER CELL-FREE CULTURE MEDIUM AND SYSTEM
WO2010105302 - TARGETS FOR GROWTH FACTOR SIGNALLING AND METHODS OF THERAPY
WO2011063477 - FIBRONECTIN: GROWTH FACTOR CHIMERAS
WO2011150470 - VITRONECTIN:KERATINOCYTE GROWTH FACTOR CHIMERAS
WO2004069871 - GROWTH FACTOR COMPLEXES AND MODULATION OF CELL MIGRATION AND GROWTH
WO2005012508 - SKIN REGENERATION SYSTEM
WO2008148174 - WOUND REPAIR COMPOSITION AND METHOD
WO2009029983 - A FEEDER CELL-FREE CULTURE MEDIUM AND SYSTEM
WO2010105302 - TARGETS FOR GROWTH FACTOR SIGNALLING AND METHODS OF THERAPY
WO2011063477 - FIBRONECTIN: GROWTH FACTOR CHIMERAS
WO2011150470 - VITRONECTIN:KERATINOCYTE GROWTH FACTOR CHIMERAS
Partnerships
Professor Zee Upton
Date: 19 July 2011
A wound-healing invention developed at the Queensland University of Technology (QUT) has produced remarkable results in an international human trial. The multi-centre study of VitroGro® found 92 per cent of the patients taking part in the trial were partially or completely healed in 12 weeks. The average treatment time that patients' venous ulcers had not responded to expert care before VitroGro® treatment was 37 months.
VitroGro® is a liquid that is applied using a needle-less syringe and is dribbled over the wound. The protein in the liquid is extremely sticky and so very quickly adheres to the wound bed, offering a revolutionary new treatment.
The invention could prove to be a massive boost for sufferers of chronic wounds - many of them diabetic - who often have limbs amputated as a result of wounds that won't heal.
The clinical trial - led by the world-renowned Cardiff University Wound Healing Clinic in conjunction with the QUT Wound Clinic in Brisbane - evaluated VitroGro® in the treatment of venous leg ulcer patients who had not responded to compression therapy, which is the current standard of care. Out of a total of 53 patients recruited for the study, 24 patients have been evaluated so far. Eight patients' ulcers have completely healed and two have achieved more than 98 per cent healing.
The average reduction in wound size was 65 per cent, with no adverse events related to VitroGro® reported.
"We're very excited by these results as it's a new formulation, which is going to be extremely cost effective to the consumer," said Professor Zee Upton from QUT's Institute of Health and Biomedical Innovation who is also the technical founder and consulting Chief Scientific Officer for Tissue Therapies Limited - a biotechnology company developing VitroGro®.
"There's nothing else like it in the market in terms of approach, outcome or cost effectiveness.
"For conditions like venous ulcers where the biology of healing is aberrant, VitroGro® provides critical adhesion for cells by forming a scaffold they can attach to and migrate upon. It creates a favourable environment for healing and this is something that has been missing from conventional wound care."
The preliminary data confirms the results of earlier Australian and Canadian human trials by showing VitroGro® restarts or accelerates healing of chronic venous ulcers that don't respond to expert care, reducing the ulcer size as well as improving wound characteristics and reducing pain.
"Patients have also reported that their pain has improved, which is important as these wounds are often quite painful and people in the trials have been living with them for years - in one case, 30 years," Professor Upton said.
"Nurses have also been impressed by the visible and consistent performance of VitroGro®, particularly the visible and quick improvement seen in challenging cases combined with ease of use and pain reduction.
Chronic wounds affect hundreds of thousands of Australians, particularly older Australians and people in Indigenous communities.
"These wounds are painful and debilitating, resulting in extreme reductions in the quality-of-life of sufferers across months, years and potentially decades.
"For many patients living with chronic non-healing wounds, amputation of an affected limb is the only option."
Professor Upton said VitroGro® was biologically inspired and was developed to emulate the way nature repaired wounds. The results position VitroGro® well for approval and planned first sales in Australia and Europe in the second quarter of 2012. Trials are also expected to commence in the United States early next year.
Media Contact: Katrina Blowers, QUT Media Officer
VitroGro® is a liquid that is applied using a needle-less syringe and is dribbled over the wound. The protein in the liquid is extremely sticky and so very quickly adheres to the wound bed, offering a revolutionary new treatment.
The invention could prove to be a massive boost for sufferers of chronic wounds - many of them diabetic - who often have limbs amputated as a result of wounds that won't heal.
The clinical trial - led by the world-renowned Cardiff University Wound Healing Clinic in conjunction with the QUT Wound Clinic in Brisbane - evaluated VitroGro® in the treatment of venous leg ulcer patients who had not responded to compression therapy, which is the current standard of care. Out of a total of 53 patients recruited for the study, 24 patients have been evaluated so far. Eight patients' ulcers have completely healed and two have achieved more than 98 per cent healing.
The average reduction in wound size was 65 per cent, with no adverse events related to VitroGro® reported.
"We're very excited by these results as it's a new formulation, which is going to be extremely cost effective to the consumer," said Professor Zee Upton from QUT's Institute of Health and Biomedical Innovation who is also the technical founder and consulting Chief Scientific Officer for Tissue Therapies Limited - a biotechnology company developing VitroGro®.
"There's nothing else like it in the market in terms of approach, outcome or cost effectiveness.
"For conditions like venous ulcers where the biology of healing is aberrant, VitroGro® provides critical adhesion for cells by forming a scaffold they can attach to and migrate upon. It creates a favourable environment for healing and this is something that has been missing from conventional wound care."
The preliminary data confirms the results of earlier Australian and Canadian human trials by showing VitroGro® restarts or accelerates healing of chronic venous ulcers that don't respond to expert care, reducing the ulcer size as well as improving wound characteristics and reducing pain.
"Patients have also reported that their pain has improved, which is important as these wounds are often quite painful and people in the trials have been living with them for years - in one case, 30 years," Professor Upton said.
"Nurses have also been impressed by the visible and consistent performance of VitroGro®, particularly the visible and quick improvement seen in challenging cases combined with ease of use and pain reduction.
Chronic wounds affect hundreds of thousands of Australians, particularly older Australians and people in Indigenous communities.
"These wounds are painful and debilitating, resulting in extreme reductions in the quality-of-life of sufferers across months, years and potentially decades.
"For many patients living with chronic non-healing wounds, amputation of an affected limb is the only option."
Professor Upton said VitroGro® was biologically inspired and was developed to emulate the way nature repaired wounds. The results position VitroGro® well for approval and planned first sales in Australia and Europe in the second quarter of 2012. Trials are also expected to commence in the United States early next year.
Media Contact: Katrina Blowers, QUT Media Officer
Ian Eckersley, QUT Media Manager
Content sourced from QUT News Web Service.
Lime Associates is the only UK consultancy firm that specialises in bringing best practice purchasing and supply chain solutions exclusively to medical and health technology companies. They get great results by working closely with clients’ teams to build long term relationships and provide sustainable benefits in terms of cost, value and customer service. Their list of clients include companies like Chester, Genzyme and Smith & Nephew
Catalent is the leading provider of advanced technologies, and development, manufacturing, and packaging solutions for pharmaceutical, biotechnology, and consumer healthcare companies. Covering nearly 100 countries, the company applies its local market expertise and technical creativity to advance treatments, change markets, and enhance patient outcomes. Catalent employs over 9,000 at 20+ facilities worldwide.
Movianto is part of the Celesio Group which is active in 27 countries worldwide, employs approximately 47,000 people and generated revenue of more than 23 billion euros in 2011
The Movianto Group is committed to being the preferred European contract logistics service provider to the pharmaceutical, biotechnology and healthcare industry. Offering outsourcing services along the supply chain such as warehousing, transportation, cold chain logistics as well as re-packaging and re-labelling, Movianto’s international clients benefit from a pan-European network, the broad range of healthcare logistics services, the know-how of the local markets and uncompromising quality standards.
Movianto Group has expanded rapidly over the last few years. More than 1,700 healthcare experts are managing over 275,000 pallet places spread over a network of wholly owned subsidiaries in 14 European countries. They provide a full range of innovative logistics and distribution services to store and deliver the goods for the pharmaceutical industry and beyond. Today the Movianto Group is represented in: Austria, Belgium, Czech Republic, Denmark, France, Germany, Ireland, Netherlands, Portugal, Slovenia, Slovakia, Spain, Switzerland and the United Kingdom.
Quintiles is the only fully integrated bio and pharmaceutical services provider offering clinical, commercial, consulting and capital solutions. More than 20,000 Quintiles employees in 60 countries helped develop or commercialize all of 2010’s top 50 best-selling products or compounds. This Capital brochure reviews how Quintiles helps biopharma allies maximize the value of assets, reduce risk, accelerate outcomes and increase rewards.
Download PDF
New challenges and opportunities arise almost daily in pharmaceutical marketing. And no matter the size of your organization, finding a partner to help you navigate new territory and capitalize on untapped potential is critical to long-term success.
With capabilities far surpassing those of traditional contract sales providers, Quintiles has the infrastructure, experience and experts to help you launch, nurture and extend the value of your products.
Quintiles can help you accomplish these goals and more:
- Increase market penetration and sales.
- Positively impact patient compliance through various educational services.
- Lower risk and maximize value during product commercialization.
- Reveal your product's value to regulators, payers, providers and patients.
- Reach key stakeholders with highly strategic communications.
- Make “go/no go” decisions throughout the entire product development lifecycle.
Contact us about providing you with specialized commercial solutions.
- Sales Solutions
- We can identify ways to balance your resourcing, in single or multiple markets, as your portfolio needs adjust to your product pipeline, regulatory approvals and market fluctuations.
- Clinical Educators & Nurse Advisors
- As an independent intermediary, Quintiles can act as your ally in developing and implementing value-based programs for all stakeholders.
- Medical Science Liaisons
- MSLs from Quintiles are highly experienced Pharm.D., M.D., D.D. or Ph.D. professionals who have a deep understanding of the local healthcare environment.
- Market Access Implementation
- We help you identify outcome and pricing requirements to best present your product’s unique value to regulators, payers, providers and patients. Learn more.
- Medical Communications
- Deliver scientific communications that compel your target audiences to act.
- Late Phase
- Keep communication flowing throughout the product lifecycle by accessing our lifecycle safety resources.
- Brand Solutions
- We will work with you to truly understand your product, market, customer base and competitors, and create tailored commercial solutions which are designed to maximize your commercial success.
- Patient-Centric Solutions
- Quintiles provides our pharma clients with ‘real life’ outcomes, supports patient relationships with medical professionals and helps patients enjoy healthier lives through education and adherence.
- Product Solutions
- Comprehensive commercial solutions which harness our extensive clinical and commercial expertise & resources, tailoring them to your needs to help optimize the success of your innovative products throughout development and commercialization
- Locations Worldwide
- We span virtually every therapeutic area, every type of product and every key pharmaceutical market.
Why customers choose Quintiles for commercial
solutions
Identify value: Quintiles draws on experience
and data in stakeholder assessment, sales and marketing, which helps us to
identify outcome and pricing requirements
to demonstrate unique value. We create commercial solutions that consistently achieve quality results.
* To help support your brand’s commercial initiatives, Quintiles has developed strong relationships with key gatekeepers in local markets worldwide, including opinion leaders, physicians and patients
* To help shape your strategies, Quintiles has more than 300 medical doctors and approximately 400 PhDs on staff, working in all major therapeutic areas
Promote value: Quintiles has managed hundreds of sales teams in primary and specialty care in 30+ countries. Drawing on three decades of experience, market insights, and outcomes research, we help create the best product profiles, then plan and create multi-channel campaigns to deliver the right value messages to the right stakeholders at the right time. The results are impressive.
* We’ve helped launch 30 of the world’s top-selling drugs. We’ve helped market 21 of the top 30 best-selling oncology products in 2008 and more than half of the “breakthrough” products introduced in the last 12 years
to demonstrate unique value. We create commercial solutions that consistently achieve quality results.
* To help support your brand’s commercial initiatives, Quintiles has developed strong relationships with key gatekeepers in local markets worldwide, including opinion leaders, physicians and patients
* To help shape your strategies, Quintiles has more than 300 medical doctors and approximately 400 PhDs on staff, working in all major therapeutic areas
Promote value: Quintiles has managed hundreds of sales teams in primary and specialty care in 30+ countries. Drawing on three decades of experience, market insights, and outcomes research, we help create the best product profiles, then plan and create multi-channel campaigns to deliver the right value messages to the right stakeholders at the right time. The results are impressive.
* We’ve helped launch 30 of the world’s top-selling drugs. We’ve helped market 21 of the top 30 best-selling oncology products in 2008 and more than half of the “breakthrough” products introduced in the last 12 years
Quintiles - navigating the new health
R&D
Clinical data from difficult-to-treat venous ulcer patients treated with
VitroGro® ECM for 12 weeks show:* 34% were completely healed.
* 43% were more than 90% healed.
* 82% were improved ie. were partially or completely healed.
* Average reduction in venous ulcer area was 56%.
* Average ulcer size at the start of the trial was 7.2 cm2.
* Average time the treated ulcers had not responded to expert care prior to VitroGro® ECM treatment was 36 months.
* Average age of the patients in this study was 74 years.
* Treatment twice per week was no more effective than once per week.
* No adverse events related to VitroGro® ECM have been reported after a total of more than 750 uses of the VitroGro® ECM device.
* Expert health economics modelling indicates that VitroGro® ECM offers the opportunity for more cost effective treatment of wounds than the current standard of care.
* 43% were more than 90% healed.
* 82% were improved ie. were partially or completely healed.
* Average reduction in venous ulcer area was 56%.
* Average ulcer size at the start of the trial was 7.2 cm2.
* Average time the treated ulcers had not responded to expert care prior to VitroGro® ECM treatment was 36 months.
* Average age of the patients in this study was 74 years.
* Treatment twice per week was no more effective than once per week.
* No adverse events related to VitroGro® ECM have been reported after a total of more than 750 uses of the VitroGro® ECM device.
* Expert health economics modelling indicates that VitroGro® ECM offers the opportunity for more cost effective treatment of wounds than the current standard of care.
Prof. Keith Harding Interview - 2011
Keith Harding: "I have been around this subject for nearly 30 years.
I have seen a lot of new products come and go. The one thing that was impressive
both from the preclinical data and the early clinical studies is that in the
clinical studies particularly, there seemed to be a greater consistency of
response in the patients that were exposed to this product, far more consistent
than I’ve seen with other biological therapies that I personally have been
involved in trialling or evidence that I have reviewed in other
capacities."
Keith Harding - Interview TranscriptProfessor Keith Harding is the Director of the
Wound Healing Research Unit and Professor of Rehabilitation Medicine at Cardiff
University in Wales and is widely acknowledged as the foremost international
researcher / clinician into wound healing, with particular emphasis on chronic
wounds. He is an Advisor to the Board of Tissue Therapies and is overseeing the
current EU venous ulcer human trial of VitroGro®.
Q: You must get many requests to trial or endorse new treatments. What made you take VitroGro seriously and get involved more closely with its development?
Keith Harding: "The problem with wound healing is that it has been around for many, many centuries. There have been many attempts over recent years to come up with solutions to the problem of non-healing wounds.
Unfortunately many of the early attempts at novel and new therapies for this particular problem have suffered from a lack of good basic science to underpin the product and many of those products have arrived and failed.
The one thing that I have found impressive in working with Tissue Therapies is that they seem to have commitment to understanding the science and managing the development of the product in a structured way that doesn’t go anywhere unless the science is there to support the data."
Q: So what is your perspective on the VitroGro trials?
Keith Harding: "I have been around this subject for nearly 30 years. I have seen a lot of new products come and go. The one thing that was impressive both from the preclinical data and the early clinical studies is that in the clinical studies particularly, there seemed to be a greater consistency of response in the patients that were exposed to this product, far more consistent than I’ve seen with other biological therapies that I personally have been involved in trialling or evidence that I have reviewed in other capacities."
Q: Keith, Tissue Therapies is a very small company in comparison with well known pharmaceutical giants, what will its next steps need to be if VitroGro fulfills its early promise and where do you see the company’s future?
Keith Harding: "Although Tissue Therapies is a small company compared to many of the larger players in this area, the one thing that is impressive is that Tissue Therapies seem to have a genuine interest, focus and passion in trying to provide a sound basis and evaluation of the product that they have. My hope - and I’m not a spokesperson for Tissue Therapies - is that they will continue that focus, they will continue that passion, and I would anticipate that the success of VitroGro will be significant, but I would also hope that it will be the first generation of a series of biologically based therapies that may be developed by this company as it goes forward, and I would expect that because of the complexity of the customer base that the company will have to deal with, is that they would probably be talking to major companies and developing a partnership arrangement so they will have enough bodies on the ground, enough sales staff to go out and provide the education and training for clinicians who may be seeing patients with wounds."
Prof Keith Harding - publications
Q: You must get many requests to trial or endorse new treatments. What made you take VitroGro seriously and get involved more closely with its development?
Keith Harding: "The problem with wound healing is that it has been around for many, many centuries. There have been many attempts over recent years to come up with solutions to the problem of non-healing wounds.
Unfortunately many of the early attempts at novel and new therapies for this particular problem have suffered from a lack of good basic science to underpin the product and many of those products have arrived and failed.
The one thing that I have found impressive in working with Tissue Therapies is that they seem to have commitment to understanding the science and managing the development of the product in a structured way that doesn’t go anywhere unless the science is there to support the data."
Q: So what is your perspective on the VitroGro trials?
Keith Harding: "I have been around this subject for nearly 30 years. I have seen a lot of new products come and go. The one thing that was impressive both from the preclinical data and the early clinical studies is that in the clinical studies particularly, there seemed to be a greater consistency of response in the patients that were exposed to this product, far more consistent than I’ve seen with other biological therapies that I personally have been involved in trialling or evidence that I have reviewed in other capacities."
Q: Keith, Tissue Therapies is a very small company in comparison with well known pharmaceutical giants, what will its next steps need to be if VitroGro fulfills its early promise and where do you see the company’s future?
Keith Harding: "Although Tissue Therapies is a small company compared to many of the larger players in this area, the one thing that is impressive is that Tissue Therapies seem to have a genuine interest, focus and passion in trying to provide a sound basis and evaluation of the product that they have. My hope - and I’m not a spokesperson for Tissue Therapies - is that they will continue that focus, they will continue that passion, and I would anticipate that the success of VitroGro will be significant, but I would also hope that it will be the first generation of a series of biologically based therapies that may be developed by this company as it goes forward, and I would expect that because of the complexity of the customer base that the company will have to deal with, is that they would probably be talking to major companies and developing a partnership arrangement so they will have enough bodies on the ground, enough sales staff to go out and provide the education and training for clinicians who may be seeing patients with wounds."
Prof Keith Harding - publications
CEO - Steve Mercer
Management
STEVEN MERCER :: CHIEF EXECUTIVE OFFICER
B.Med.Sc, MB, BS, FAIM, FAICD
Tissue Therapies Limited boosted its commercial progress with the appointment of Dr Steven Mercer as Chief Executive during mid September 2004.
Dr Mercer has significant medical and commercial experience, most recently as Managing Director of Mercy Tissue Engineering, a successful tissue engineering company with commercial operations in Melbourne and Singapore. He brings considerable international expertise to Tissue Therapies following a successful career with multinational companies, including six years with Smith & Nephew as General Manager, Smith & Nephew Surgical, and seven years previously as a health industry specialist with IBM.
In addition to Dr Mercer's extensive commercial experience in healthcare and biotechnology, he is a Registered Medical Practitioner (Australia and USA) and a former Surgical Registrar.
Dr Mercer provides an ideal mix of skills and commercial relationships to refine and implement the Company's strategy in commercialising biomedical technologies for wound healing and tissue and cell culture. His commercial achievements with large international companies and smaller innovative biotechnology companies provide a portfolio of skills in new product development and sales and marketing that are a major asset for the Company in achieving its commercial objectives for the VitroGro platform via licensing, distribution and sales.
Among his commercial achievements, Dr Mercer managed the commercialisation of the first Therapeutic Goods Administration (TGA) approved Australian human cell biotechnology laboratory, including securing the licensing of living cell implants for human use, and managing rapid growth in sales and profit derived from the facility.
Dr Mercer also successfully grew Smith & Nephew Surgical in terms of sales per employee, profit per employee and market share during his career with the company.
NIGEL JOHNSON :: OPERATIONS MANAGER
B.App.Sc (Med&AppBiotech)Tissue Therapies added further strength to its operational capabilities during late September 2004 with the appointment of Mr Nigel Johnson.
Mr Johnson was recruited from the Australian Red Cross Blood Service (ARCBS) where he was responsible for operational and regulatory activities at the ARCBS Skin Bank. Mr Johnson is a member of the ARCBS – Queensland University of Technology (QUT) Skin Culture Research Committee, focusing on research to speed and improve recovery from burns. Among other duties, he also represented ARCBS at the Transplantation Clinical Advisory Committee (TCAC) for Queensland Health, and the TCAC Tissue Banking Sub-Committee. Mr Johnson also works within the Tissue BioRegeneration and Integration Program at QUT on research to better manage commercialisation and manufacture in tissue engineering and biological product characterisation.
Mr Johnson was previously employed by Queensland Health where he was responsible for operational and quality activities at the Queensland Bone Bank, Princess Alexandra Hospital.
ZEE UPTON :: CONSULTING CHIEF SCIENTIFIC OFFICERB.Sc (Adelaide), B.Sc. Hons (Biochemistry, Adelaide), Ph.D. (Biochemistry, Adelaide)
Professor Zee Upton is a biochemist, an inventor and a tissue engineer who is nationally and internationally renowned for her research in growth factors, extracellular matrix proteins and wound repair.
She is a Queensland University of Technology (QUT) Research Professor and Leader of the Cells & Tissue Domain within the Institute of Health and Biomedical Innovation, and Head of the Cell & Molecular Biosciences Discipline within the QUT Faculty of Science & Technology.
Since the award of her PhD in Biochemistry in 1994 she has developed a significant record of innovative and quality scientific research that has yielded more then $15 million in research funding from both competitive grant schemes and industry; more than 70 peer reviewed scientific publications; the establishment of new, innovative, interdisciplinary, collaborative research projects; 9 patent applications; the receipt of many awards including the 2010 ASBMB Beckman Coulter Discovery Award, the 2009 Women in Technology Biotech Outstanding Achievement Award, and the 2004 Queensland Smart State – Smart Women Award; and the establishment and listing of a biotechnology company, Tissue Therapies Ltd, on the ASX.
Most recently Professor Upton led the successful bid for $28 million of Australian Government funding to establish the Wound Management Innovation Cooperative Research Centre.
ROGER CLARKE :: CHAIRMAN
Mr Clarke has over 30 years commercial experience, principally in the investment banking industry, with responsibilities in fund management, banking and corporate finance, and involvement in a significant number of initial public offerings, capital raisings and corporate transactions.
He is Chairman of the Board of Advice of RBS Morgans and is past or present Chairman of mulitiple companies including Pipe Netwoks Ltd, MTA Insurance Ltd, Trojan Equity Ltd, Maverick Drilling and Exploration Ltd and White Sands Petroleum Ltd. Mr Clarke holds a Bachelor of Commerce and is a Chartered Accountant.
KEITH HARDING :: CLINICAL ADVISOR TO THE BOARD
MB, MRCGP, FRCS
Professor Harding graduated in medicine from the University of Birmingham. He is trained in general surgery and in family medicine and has a longstanding interest in wound healing. As Clinical Director of the Wound Healing Research Unit, he is currently Head of the Department of Surgery and Professor of Rehabilitation Medicine (Wound Healing).
He specialises in treating patients with wound healing problems and has authored over 250 publications and written a number of text books on wound healing that are widely considered to be definitive clinical reference books.
Professor Harding was the First President of the European Pressure Ulcer Advisory Panel, First Recorder of the European Wound Management Association and is currently President of the European Tissue Repair Society.
As well as conducting his own research, Professor Harding has managed a large number of large wound treatment clinical trials for large international companies and is often invited to lecture on wound management at scientific and clinical meetings.
MEL BRIDGES :: NON-EXECUTIVE DIRECTOR
BSc (Chemistry), FAICD
Mr Bridges has extensive experience as a CEO and Company Director in healthcare, agricultural technology, drug development, pathology, diagnostics and medical devices.
Has successfully raised in excess of $300M investment capital in the healthcare/biotech sector and been directly involved in over $1B in merger and acquisition and related transactions.
Mr Bridges is current or past Chairman of Alchemia Limited and ImpediMed Limited, Director of Benitec Limited, Campbell Brothers Limited and Genera Biosystems Limited.
DR CHERRELL HIRST AO :: NON-EXECUTIVE DIRECTOR
MBBS, BEd Studies, FAICD, PhD (Honorary, QUT, Griffith and Southern Cross Universities)
Dr Hirst has had a distinguished clinical career in the detection and treatment of breast cancer and extensive and respected achievements as Director and Chair of multiple commercial, government and not-for-profit organisations.
She is Deputy Chair and CEO (part time) of Queensland Biocapital Funds and a Director of Medibank Private Limited, Avant Mutual Group, Avant Insurance Limited, Impedimed Limited and Xenome Limited.
ROBERT BAXTER :: SCIENTIFIC ADVISOR TO THE BOARDPhD (Biochemistry, Sydney), DSc (Sydney), FAACB, FAA
Professor Baxter is Director of the Kolling Institute of Medical Research at the Royal North Shore Hospital in Sydney and a professor in the departments of Medicine and Molecular & Microbial Biosciences at the University of Sydney.
Professor Baxter is a leading expert in proteins that regulate cell growth and metabolism, the insulin-like growth factors (IGFs) and their binding proteins.
These are essential for normal body growth but are also important in the abnormal growth of some cancers. He was the first to identify several of these proteins and to devise methods of measuring them.
At the Kolling Institute, Professor Baxter is Head of the Hormones & Cancer Group which is among the leading groups internationally studying the endocrinology and cell biology of the IGFs and their binding proteins. Professor Baxter has led successful R&D programs involving the application of IGFs in diagnostic tests, critical illness, pregnancy, nonpancreatic tumour hypoglycaemia, cancer cell biology and cell signalling, cancer cell apoptosis, and the use of serum and tissue proteomics in understanding cellular mechanisms of cancer and identifying new biomarkers for diagnostic development.
Professor Baxter has authored more than twenty book chapters, and over 250 refereed papers. He is on the Executive Committee of the International Society for IGF Research, was awarded the prestigious Ramaciotti Medal for Excellence in Biomedical Research in 2002, and was elected as a Fellow of the Australian Academy of Science in 2004.
Nine reasons to look at Tissue Therapies
By Bell Potter's Biotech expert, Stuart Roberts - April 2012..
The market for diabetic and venous ulcers is large.
In the US alone there are an estimated 3 million people with diabetic ulcers and another 1.4 million with venous ulcers. These undertreated patient populations are growing rapidly due to an ageing
population and the high incidence of diabetes in the population. We see other markets are being similarly sized or larger in terms of prevalence.
The data for VitroGro has been superb.
In its European registration trial, out of 44 difficult-to-treat venous ulcer patients, 34% had complete healing and another 43% had >90% healing at 12 weeks. In total 82% were completely or partially healed. The average reduction in ulcer area was 56%. Previously these ulcers had not responded
to an average 36 months of ‘standard of care’ treatment. VitroGro’s superb numbers are likely to attract significant commercial interest once the product is approved for sale in Europe.
VitroGro is about to launch in Europe.
Tissue Therapies have filed for CE Mark approval for the sale of VitroGro, expected to be granted in Q2/2012. The product will be marketed in Europe under a ‘sales partnership’ with Quintiles, a large US company (US$3.2bn pa in revenue) which often provides contract sales force services for pharma companies. This partnership will allow effective mid-double digit royalty to Tissue Therapies.
There is potential for a future licensing deal on VitroGro.
The Quintiles deal allows some flexibility on future licensing arrangements for Europe as well as the US and we expect that the current sales arrangement bolsters the chance for a strong US licensing featuring upfronts and milestone payments.
US approval for VitroGro is expected by 2015.
In the US two clinical trials are expected to initiate during 2012 – one in venous ulcers (270-300 patients) and one in diabetic ulcers (380 patients) – putting the product on track for FDA approval in 2015. Obviously the US market will be a key one for VitroGro given the large US patient populations and favourable product pricing.
There is a pipeline of opportunities for VitroGro.
After the ulcer dressing opportunity, there is also the potential for Tissue Therapies to gain usage of VitroGro in burns, as a surgical wound application, and for sunburn management. All these could considerably enlarge the VictroGro ‘franchise’ but are at an early stage.
Tissue Therapies has good management.
CEO Dr Steven Mercer has a good strategic understanding of the wound care business, having been a mid-level executive with market leader Smith & Nephew for many years. He has guided Tissue
Therapies through early pre-clinical and then clinical work since joining the company in 2004. We think he has the commercial smarts to take VitroGro further forward.
The Quintiles deal has created a buying opportunity.
Tissues Therapies stock was marked down following the November 2011 announcement of the Quintiles partnership. The arrangement with Quintiles, which featured no formal licensing but
basically represents Tissue Therapies hiring Quintiles’ sales force, puzzled many followers of the company, who were expecting a conventional deal for VitroGro with upfronts, milestones and royalties. We think this has created a buying opportunity.
Tissue Therapies is undervalued on our numbers.
We value Tissue Therapies at $0.95 per share base case and $1.40 per share optimistic case using a DCF valuation of VitroGro, diluted for a future A$20m equity raising that would fund US trials of the product and European commercialisation. Our target price of $1.20 per share sits at around the midpoint of our DCF range. We expect that EMA approval followed by the Quintiles launch can lead to a re-rating of Tissue Therapies to our target price.
Communication
Information presented in this post has been obtained 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 for the purpose of forming ones own investment decisions
No comments:
Post a Comment