Biotec Pharmacon has a committed and active shareholder community and some shareholders are frequently in direct contact with the management. An open and proactive approach towards investor relations are one of the company’s key priorities.
In order to give information to all shareholders, Biotec Pharmacon will expand its IR services with a routine where questions asked from shareholders where the answers may be of general interest, will be published on a dedicated Q&A section on www.biotec.no. All questions will be anonymised. For practical reasons, the Q&A section on the website will be split into three segments. One named «Woulgan facts», one named «Woulgan commercial», and one named «Other areas». Note that this information is an expanded service related to information not deemed to influence the company’s share price and therefore on top of the Stock exchange publications filed through the Oslo Stock Exchange news distribution system.
Latest update as of January 4th 2017.
- What is Woulgan® Biogel?
- What is the active substance?
- Has Woulgan® Biogel been approved?
- What are the main advantages and disadvantages of class III, rule 13?
- Are the effects documented?
- Does Biotec Pharmacon have patent protection and other IPR for SBG?
- Are you considering other formulations of Woulgan®/SBG?
- What are the main indications for Woulgan® Biogel?
- How do the effects compare with other products on the market for these indications?
- Is Woulgan® Biogel available in the market?
- Where can Woulgan® Biogel be purchased after approval?
What is Woulgan®?
Woulgan® is a bioactive wound gel primarily for use on hard to heal ulcers and wounds. The product contains water, glycerol, carboxymethylcellulose (CMC), and Soluble Beta-Glucan (SBG) as the bioactive substance. Woulgan® Biogel is a class III, rule 13 medical device, where SBG is the medicinal substance. › Return to top
What is the active substance?
The active substance in Woulgan is the Soluble Beta-Glucan (SBG). SBG is an immunomodulatory compound that would act on white blood cells, like macrophages, in the wound bed to promote more rapid healing of the wound. › Return to top
Has Woulgan® been approved?
Yes, Woulgan® has been CE market as a medical device in class III under rule 13. › Return to top
What are the main advantages and disadvantages of class III, rule 13?
The most important advantage is that this classification will allow claims related to the wound healing effect of SBG in the product which will distinguish it from the typical hydrogels and other wound management products. The classification is demanding since it includes a medicinal substance needing a quality documentation as a drug. › Return to top
Are the effects documented?
Yes, the effects of Woulgan® are well documented in preclinical models, where also the ancillary medicinal effects of the SBG component have been investigated and documented. In addition the active ingredient, SBG, has been documented in several clinical trials. › Return to top
Does Biotec Pharmacon have patent protection and other IPR for SBG?
Yes, the company has a number of patents covering SBG and the Woulgan® product › Return to top
Are you considering other formulations of Woulgan®/SBG?
Yes, we are working on additional formats. › Return to top
What are the main indications for Woulgan® ?
The product is intended for use at all hard to heal wounds like diabetic ulcer, pressure ulcers, leg ulcers and burns. › Return to top
How do the effects compare with other products on the market for these indications?
We expect the effect will be better than the standard hydrogels typically used for these indications. › Return to top
Is Woulgan® available in the market?
Where can Woulgan® be purchased after approval?
It is free to be sold in most countries in Europe which are members of the CE mark system. › Return to top
- How is the German reimbursement system applicable to Woulgan®? (04.01.2017)
- What does German law and SHI mean for reimbursement of Woulgan®? (04.01.2017)
- How is the market reacting to the quality of Woulgan’s documentation? (08.09.2016)
- When will you receive UK Drug tariff? Biotec has previously said that it would take 6-8 months after the application was submitted in Dec 2015? (08.09.2016)
- Do you expect earlier revenues in Germany than in the UK? (16.06.2016)
- Why did you only sign a one year agreement with ROGG? (16.06.2016)
- Why have Biotec spent more than 8 months to reach a distribution agreement in Germany? (08.05.2016)
- Have Biotec met and critical problems related to an agreement in Germany? (08.05.2016)
- In a recent news broadcast, it was stated that there are currently no effective treatments for diabetic foot ulcers. Why was not Woulgan mentioned? (19.01.2016)
- How effective is Woulgan? (19.01.2016)
- Will Biotec pursue other potential target areas for SBG? (22.12.2015)
- What is the distribution split between Navamedic and Biotec? (22.12.2015)
- When will Biotec see first sales in Scandinavia? (22.12.2015)
- What is “sufficient” KOL support? (22.12.2015)
- Will you apply for reimbursement in Norway/Scandinavia? (22.12.2015)
- Does Biotec have any sales targets for 2016? (22.12.2015)
- Which study was published under clinicaltrials.gov on 12 Dec. 2015? (22.12.2015)
- Why are you comparing Woulgan to Intrasite in this study? (22.12.2015)
- What is needed for “early” commercial sales in the different markets? (26.11.2015)
- Do you need more clinical studies before sending a UK reimbursement Application?(26.11.2015)
- Will Biotec postpone potential distributor agreements in Germany until reimbursement in UK is approved? (26.11.2015)
- Where is Biotec prioritising its efforts? (26.11.2015)
- When will you sign the next distributor agreement? (26.11.2015)
- Will the reimbursement process in the UK delay a launch in UK? (26.11.2015)
- Have you applied for reimbursement in the UK? After the application is delivered, when can you expect approval? (26.11.2015)
- Have you applied for reimbursement in Germany? (26.11.2015)
- Can you say anything about the “Surgical wounds” study conducted by Teres Tromsø? (26.11.2015)
- How does a “best possible business partner model for Woulgan” look like?
- When will you enter USA?
- How will you price Woulgan?
- What is health economics and why is it important?
- Are you planning further studies with Woulgan®?
- Will Woulgan® be reimbursed?
- How big is the market opportunity for Woulgan®?
- How will revenues and earnings be split between Biotec Pharmacon and its partners?
- How will you distribute Woulgan® in the market?
- Will Biotec Pharmacon sell products or only receive royalties?
- Does Biotec Pharmacon have the necessary resources to market and distribute Woulgan®?
- Is it expected that the production capacity of Woulgan will be a bottleneck?
- Why did you and Smith & Nephew want this evaluation study when you have considerable documentation?
- Why did the process with Smith & Nephew take so long and why did you end it?
- Who ended the process between Biotec and Smith & Nephew?
- What is the value Smith & Nephew put on Woulgan?
- Will Biotec receive all of the results for the study?
- Will the evaluation study be made public?
German law governs a Statutory Health Insurance (SHI) scheme via Sozialgesetzbuch V (SGB V). According to § 27 SGB V, SHI-insured persons are entitled to a medical intervention if this intervention is necessary to diagnose a disease, cure it, prevent its worsening, or alleviate its symptoms (in particular among other products/treatments: Drugs, bandages and dressings). With Woulgan® being listed as a dressing in the German “Lauer Taxe” in 2016 it is, in principle, refundable in all of Germany. SHI-insured persons are entitled to have a treatment reimbursed (§ 12 SGB V) if it is judged to be: sufficient, effective, economical, and necessary. Any of the 160 sick funds (Krankenkassen) in Germany have room for interpretation if a product like Woulgan® will be reimbursed.
In Germany, each doctor/physician has a specific budget for prescriptions of pharmaceuticals (dressings fall under the pharmaceutical budget) and if this is exceeded by 15% they are subject to an official inquiry and an obligatory consultation by the sick funds. In this case the doctor/physician can claim praxis specialties (e.g. a high number of chronic or diabetes patients). If the doctors/physicians exceed their budget by 25% the sick funds might claim back the reimbursed money. Then the doctor/physician needs to justify the medical necessity for the treatment (e.g. with innovative dressings) by complete documentation of each single patient treated. Also, if an expensive product is being used and the sick fund is not convinced about its effect, such a product may be refused from further reimbursement by this particular sick fund in a particular region. › Return to top
Following the positive confirmation of reimbursement from one of the largest German sick funds in two of the largest regions, it has been reported that the product has also been reimbursed by additional sick funds in additional regions. However, the number of Woulgan® tubes used are still too low to spark many questions from the sick funds. When the use of Woulgan® increases, the doctors’ experience with the product and their ability to demonstrate its therapeutic effect for individual patients, will determine how widely Woulgan® will be used in Germany. › Return to top
Woulgan’s documentation is stronger than the vast majority of evidence available in Wound Care. Biotec continues to produce and use evidence in 2 ways; first to persuade clinicians to try Woulgan and experience its effectiveness for themselves before they then use the new product in their practice. Second, more structured evidence such as a local case series is used in combination with Biotec’s Phase II study to produce an economic model when Biotec and partners gain market access (national reimbursement and listing on a local formulary or tender). Such studies are often being published and being used in the general support of Woulgan as they consistently confirm Woulgan’s effectiveness in reactivating stalled wounds. Additionally these experiences further build Biotec’s insights with the product, helping the company guide users in the best use of Woulgan products in their clinical practice. › Return to top
When will you receive UK Drug Tariff? Biotec has previously said that it would take 6-8 months after the application was submitted in Dec. 2015
Based on historical experience Biotec expected a 6-8 month process. While the application continues to make good progress, 2 points have become clear; first the NHS prescription services are learning about SBG and how it works as they review Biotec’s application which adds time to the process. Second, the department is working to a longer time due to a backlog of applications. This delayed when they first picked it up to late March and also slows the speed at which they can proceed. Biotec has had two rounds of questions and answers with the NHS, submitting the latest response at the end of July and currently awaits the next NHS response. › Return to top
It is early yet, but we expect shorter time from we appoint the distributor until we see the first sale in Germany compared to UK. This is due to different reimbursement systems in the two countries. › Return to top
It was a practical approach reflecting that both sides like gain experience with the product in Germany before we make a longer term agreement. Both parties have an intention to prolong the agreement after the first year. › Return to top
Germany is a different and more complex market compared to a lot of the other Europeans markets. All of the regions act independently and has their own local rules and regulations. As with the other European markets where Biotec has signed a distributor, main focus is to establish a partnership with a company that is willing to spend time and effort into this unique product. Biotec is currently in discussion with several companies (ref Q1 presentation) and has published an outlook to close one or more distribution agreements in Germany during 2016. In parallel with partner activities is Biotec working on reimbursement in the different regions. › Return to top
Biotec has not met any critical problems relating to an agreement in Germany › Return to top
In a recent news broadcast, it was stated that there are currently no effective treatments for diabetic foot ulcers. Why was not Woulgan mentioned?
Biotec was unaware of this story before it was broadcasted. Consequently, we were not in a position to inform about Woulgan, its effectiveness and our key selling points. Biotec and our distributor Navamedic are working closely to contact key opinion leaders (KOL’s) and Health Care Professionals (HCP’s) in Norway to position Woulgan as an effective treatment for diabetic ulcers. We expect awareness levels to increase gradually during 2016 as we are increasing our market activities towards KOLs, institutions, organizations, end-users and key stakeholders like relevant media and journalists. Increasing the awareness and positioning of Woulgan as an effective treatment for diabetic ulcers is currently at the core for Biotec, and will continue to be going forward. › Return to top
Studies and evaluations of Woulgan document improved healing during the treatment period, with less pain and improved comfort compared to other therapies.
Woulgan is classified as a CE marked, class III medical device, not as a pharmaceutical drug. The product is approved for sale in Europe and there are no requirements for additional studies to sell the product.
Biotec will not enter into a large pharmaceutical randomized double-blind and placebo-controlled clinical trial. Such trials represent a significant cost that would not be substantiated for a classified medical device.
Following the approval of Woulgan in 2014, a number of trials and evaluations have been performed to examine its effect:
- A Norwegian study carried out by health professionals amongst 60 patients across the country. The results of the study were presented at a conference hosted by the European Wound Management Association in London in 2015 and Biotec’s Q4 2014 presentation.
- An evaluation study by Smith & Nephew, in which patients in 10 locations across the UK and Germany tested the product. The results were made public in Biotec’s Q2 2015 presentation. Preliminary results were also published during the Wounds UK Conference in 2014
- A Post-Market Clinical Follow-Up study is currently taking place. This study includes 80 patients with diabetic foot wounds. Results from this study are expected in 2017
- A series of case studies are currently underway in the UK to further evaluate and document the effect of Woulgan
Biotec has a strategy of positioning Woulgan as a premium priced product targeting stalled wounds in the professional wound care market. The documentation and product opportunities provides a solid platform for Biotec, and marketing and sale of Woulgan will be our key priority going forward. › Return to top
Yes, Biotec is open for cooperations relating to different use of SBG, but will not pursue any standalone projects at the present. › Return to top
Biotec will not comment on specific details, but Biotec’s share is somewhat more than 50 percent of net sales. › Return to top
We expect to see first sales in Scandinavia during first half of 2016. › Return to top
Sufficient support means that in a given region we see that the support is sufficient to obtain clinical use of the product. › Return to top
The Scandinavian market is different from the UK and German market as there is no “Medical Device” reimbursement in place. The markets are regulated through tender processes.› Return to top
Biotec will not publish any sales targets for 2016. › Return to top
This is the Post Market Clinical Study (PMCF) required from Woulgan’s CE-approval. › Return to top
The study requires a well established gel comparator arm, and Intrasite is one of the most frequently used gels for wound care. › Return to top
Biotec needs local case studies. We need local KOL’s opinion and experience on how to best utilise Woulgan. Biotec is working with KOL’s in Norway, UK and somewhat in Germany. This work will be extended when we sign a distributor in Scandinavia and Germany. › Return to top
Biotec has substantial documentation from the phase II study that will form the basis for health economics and a UK reimbursement application. Biotec with its external experts does not see the need for additional studies before an application is sent.› Return to top
Will Biotec postpone potential distributor agreements in Germany until reimbursement in UK is approved?
No, these are two separate tasks that run independently of each other. › Return to top
Biotec’s main goals going forward are; secure KOL support in the UK, apply for reimbursement in the UK and secure distribution partners in focus regions (Germany and Scandinavia). › Return to top
When will you sign the next distributor agreement?
Biotec will not commit to any specific timeline but the Company is in discussions with potential partners in several regions. It’s all about commitment and execution. › Return to top
Will the reimbursement process in UK delay a launch in UK?
Not necessarily. Biotec and H&R Healthcare are working in close collaboration to secure KOL (key opinion leader) support in order to make official launch in the UK a success. › Return to top
Have you applied for reimbursement in the UK? After the application is delivered, when can you expect approval?
Biotec is together with H&R Healthcare in the process of submitting approval for reimbursement in the UK. Bioetc expetcs governmental processing time of around 6 months before final approval is ready. › Return to top
Have you applied for reimbursement in Germany?
No, but Biotec is preparing its strategic options. Reimbursement in Germany needs to be conducted in conjunction with a potential partner. Biotec will not apply for reimbursement on a stand-alone basis. › Return to top
Can you say anything about the “Surgical wounds” study conducted by Volvat Tromsø (previously Teres)?
This is a study conducted by Volvat to see if Woulgan has cosmetic effects on surgical wounds. This is a limited study with few patients. Biotec does not have any expectations for this survey as this area is outside of Woulgan’s targeted areas.
The study was closed for new patients on 01.11.2015. Results from the study are expected 6-12 months after closure. Publication of results is decided by investigator. › Return to top
How does a “best possible business partner model for Woulgan” look like?
It is all about focus, commitment and execution, not about size. › Return to top
When will you enter USA?
The process of figuring out the right path has started, but it will take time to position the product in a favorable reimbursement classification. › Return to top
How will you price Woulgan?
This will be decided in conjunction with our partners. › Return to top
What is health economics and why is it important?
Most European health authorities are using what is called Health Economic calculation as an important tool to consider the value of a product. For wound care it means that all costs related to a treatment are put into a detailed evaluation calculation and compared with typical standard of care. For example, a home care done by a nurse they will include calculations of hourly costs, driving for saved or extra visits, cost of secondary dressing and of course the cost of our product to mention some of the most important factors. The total cost of the wound until healing will be measured. The basis for the calculation will have to be supported by studies and other documentation. If such a health economic calculation is in favor to the product, heath authorities will be likely to adopt it. › Return to top
Are you planning further studies with Woulgan® Biogel after approval?
Yes, a post market follow up study started in Q3 2015. › Return to top
Will Woulgan® be reimbursed?
In many European countries hospitals and wound clinics will not be dependent on reimbursement. In these segments you will also find many of the opinion leaders that are important for references. These segments will therefore be the place to start selling Woulgan® Biogel while the reimbursement processes, which are national processes, will go in parallel. › Return to top
How big is the market opportunity for Woulgan®?
It is a huge market. The European market for such products are USD 1.8 bn growing around 6% per annum. › Return to top
How will revenues and earnings be split between Biotec Pharmacon and its partners?
That will be decided in a commercial agreement to follow later. › Return to top
How will you distribute Woulgan® in the market?
We will enter into distribution agreements with companies we believe are well positioned to succeed with the products. › Return to top
Will Biotec Pharmacon sell products or only receive royalties?
Biotec Pharmacon will be responsible for the production of the Woulgan® product. Thus our revenues will be based on a transfer price. › Return to top
Does Biotec Pharmacon have the necessary resources to market and distribute Woulgan®?
We are step-by-step building our commercial resources and competence. Until recently, the focus has been mostly scientific, clinical and business development, but we are building the marketing and product management capabilities in order to be a competent partner to our distributors. › Return to top
Is it expected that the production capacity of Woulgan will be a bottleneck?
The capacity of Sanochemia is sufficient for a long time and we also have a contingency manufacturer that may be used. › Return to top
Why did you and Smith & Nephew want this evaluation study when you have considerable documentation?
Wound care is a market where the doctors and nurses often make up their own opinion about a product. This means that products with favorable documentation still has failed in the market because the users don’t like them. A clinical trial is a very controlled process conducted in isolation and is not necessary representative to have the product is experienced in routine clinical setting. An evaluation study is much more representative as the sites are given the product and asked to use it the way they think is best. An important factor in wound care different from many other disease areas is that how a wound reacts to different treatments is very visible to the health care professionals. They thus tend to make up their own mind as to what kind of products they prefer to use. So health care professional’s perception of the Woulgan product is essential in order for us to predict the products’s commercial potential. › Return to top
Why did the process with Smith & Nephew take so long and why did you end it?
The study was delayed three months as announced in November 2014. It was finalized at the end of first quarter 2015. Then the data collection took time. Following this process, Smith & Nephew made different scenario business cases, which they discussed internally. Such processes take time in a large company like Smith & Nephew. During this process, it became clear that Smith & Nephew would not be able to give us the long-term commitment we felt needed to enter into a long-term exclusive agreement with them. › Return to top
Who ended the process between Biotec and Smith & Nephew?
It was an outcome clear to both companies and the conclusion ended a long, constructive and friendly process between our companies. › Return to top
What is the value Smith & Nephew put on Woulgan?
This information has not been released to Biotec. › Return to top
Will Biotec receive all of the results for the study?
Yes, Biotec will receive all of the results from the evaluation study. › Return to top
Will the evaluation study be made public?
The results from the S&N study were presented in the Q2 2015 presentation. › Return to top
- Which goals do you have for ArcticZymes (26.11.2015)
- Will defferred taxes be part of your Balance for 2015? (26.11.2015)
Which goals do you have for ArcticZymes?
ArcticZymes with its enzyme business is one of the Group’s key areas. Focus is to establish a consistent top line growth together with net positive results. › Return to top
Will defferred taxes be part of your Balance in 2015?
This is not decided. A decision regarding deferred taxes will be taken in conjunction with the auditor. › Return to top