«Woulgan® biogel – an advanced wound healing product I. Executive Summary Biotec Pharmacon (“the Company”) develops wound treatment ...»
The present wound treatment formulation developed by Biotec Pharmacon as the product Woulgan® biogel focuses basically on treatment of diabetic ulcers. Diabetic ulcers occur on the feet and are a major complication of diabetes caused by two factors. Diabetic patients may suffer from peripheral nerve damage as a result of higher than usual blood sugar levels. This nerve damage means patients may not know if they injure their feet, and such injuries may develop into ulcers. In addition, diabetics have an increased risk of atherosclerotic disease, which can reduce blood flow to the arteries in the legs and blood supply to the feet. Skin with a poor blood supply does not heal as well, meaning diabetics may find their wounds take longer to heal, which may also lead to them becoming ulcerated. While most diabetic foot ulcers do respond to treatment, infection can occur and more serious problems can develop such as gangrene which, in extreme cases, may lead to amputation.
There is also a high reoccurrence rate for diabetic ulcers.
According to a World Health Organization Report, the prevalence of diabetes for all age-groups worldwide is estimated to rise from 2.8% in 2000 to 4.4% in 2030, with the total number of people with diabetes projected to increase from 171 million in 2000 to 366 million in 2030. The International Diabetes Federation has even higher estimates, estimating there were 285 million people with diabetes globally in 2009 and that the total number will exceed 435 million in 2030 if current rates of growth continue unchecked. The most important demographic change to diabetes prevalence across the world appears to be the increase in the proportion of people aged 65 years or over. In addition, rising levels of obesity are a major factor in the increase in the number of people with Type II diabetes.
With the numbers of patients with diabetes increasing, there is a corresponding rise in the number of diabetic ulcers requiring treatment, leading to strong demand for advanced wound care products in the future. Developed world studies have estimated that 15% of people with diabetes will ultimately have diabetic foot ulcers, with an annual incidence in at least 2.2% of people with diabetes, according to a Lancet article published in 2005.
According to the National Diabetes Factsheet 2007, produced by the Department of Health and Human Services at the US Center of Disease Control and Prevention, there were approximately 23.7 million people with diabetes in the US in 2007, which amounted to 7.8% of the total population. The total prevalence of diabetes increased by 13.5% from 2005 to 2007. In 2007, the total annual economic cost of diabetes in the US was US$174 billion. Medical expenditure totaled US$116 billion and comprised US$27 billion for diabetes care, US$58 billion for chronic diabetes-related complications and US$31 billion for excess general medical costs.
Copyright 2012; Biotec Pharmacon ASA Non-confidential product overview Woulgan® biogel 8 Based on estimates that 15% of people with diabetes will develop a diabetic foot ulcer in their lifetime, this represents 3.6 million ulcers in the US alone. Over 60% of non-traumatic lower-limb amputations occurred in people with diabetes and, in 2004, approximately 71,000 such amputations were performed in people with diabetes. There is therefore definitely a need to develop improved diabetic ulcer treatments that can reduce the amputation rate.
The wound care market comprises two main sectors: traditional dressings that operate in a dry environment, basically protecting the wound from some external contaminants and soaking up some fluids; and advanced wound care products, which are designed to provide a therapeutic effect that actively aids wound healing. Traditional products are used widely by healthcare professionals and consumers, while advanced wound care products are generally professional-use products. Traditional wound care dressings consist mainly of low technology gauze-based dressings such as woven and non-woven sponges, conforming bandages and non-adherent bandages. While traditional dry dressings are useful for uncomplicated and superficial wounds, they are not effective for more complicated cases such as chronic wounds and other hard-to-heal wounds such as diabetic ulcers.
Advanced wound care products better address these types of wounds. The advanced wound care market is extremely diverse and includes an array of competing technologies such as moist wound dressings (hydrogels, hydrocolloids, alginates, foams and transparent films); biological products such as growth factors, skin substitutes and tissue-engineered products; and wound healing devices that deliver therapies such as negative pressure wound therapy (NPWT), oxygen therapy, electrical stimulation and ultrasound to promote wound healing.
The Professional Wound Care Market Forecast and its Growth for these different wound healing
products can be summarized in Figure 4 below:
The overall field of wound treatment comprises a large number of different product and applications as defined above. Competition is very high. Nevertheless, in niche fields like treatment of diabetic ulcers, there are only a few products on the market. These products include the Rx/growth factor Regranex which is black-boxed (cancerogenic) as well as class-II medical devices like hydrogels, silvercontaining products or the like. At present there are only a very few number of class-III medical device products available.
Woulgan® biogel differs from these products in the following way:
1. Safety: The product is completely safe. No SAEs were observed in any of the clinical study conducted
2. The product is highly documented in preclinical and clinical settings
3. The product is significantly more effective compared to the golden standards in the industry
4. Woulgan® biogel is a low cost (low COGs)/high margin product
5. Woulgan® biogel is covered by broad IP with prospective patent protection until 2031
6. The product is intended to be classified as a class 3, rule 13 medical device
7. Customer preference due to faster healing time and convenience of product application
8. Strong reimbursement arguments due to significantly reduced number of patient visits to physicians and reduced numbers of amputations
VI. Intellectual Property
Woulgan® biogel and the ingredient SBG are patent protected. This includes a patent family covering the use of Biotec beta glucans for wound treatment. Expiry of those patents is in 2020. Further 3 new patent families were filed in Q4 2010 covering the process of production and certain compositions of old and new SBG-variants. Expiry of those patents is in 2031. The trademark Woulgan® itself is also registered in Norway and further trademark applications are pending in several major countries amongst others in Europe (CTM), USA, The Russian Federation, Australia, China, Japan and South Korea. SBG is also a registered Community Trademark.
VII. Present developments and future outlook
The Company has finalized the preparation of the final product (a prototype is available for evaluation).
Intended filing of the technical dossier in Q2 2012.
The first large scale batches have been produced.
Discussions are ongoing with potential partners that can help the Company to a successful market launch and penetration.
A clinical trial is planned for use as a marketing tool.
Follow-up products are under development (second generation product and different modes of application).
Copyright 2012; Biotec Pharmacon ASA Non-confidential product overview Woulgan® biogel