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 October 23rd 2017.
- What is Woulgan® Biogel?
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.× close
- 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.× close
- Has Woulgan® been approved?
Yes, Woulgan® has been CE market as a medical device in class III under rule 13.× close
- 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.× close
- 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.× close
- 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.× close
- Are you considering other formulations of Woulgan®/SBG?
Yes, we are working on additional formats.× close
- 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.× close
- 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.× close
- Is Woulgan® available in the market?
The product has not yet generally been launched but is available via our web shop.× close
- 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.× close
- Is the Post Market Clinical Follow-up (PMCF) study an efficacy study?
The PMCF was required by the Competent Authority, MHRA, to demonstrate safety and usefulness of Woulgan Gel during the CE-approval process. The study is not powered to demonstrate superior efficacy towards the comparator, although complete healing is one of the endpoints.× close
- What does Drug Tariff listing mean
The UK drug tariff decides which products (drugs and devices) will be paid for under the UK’s prescription system. It also determines at which price products will be reimbursed. Being listed on the Drug Tariff means a Doctor or nurse can prescribe Woulgan and the cost of the product will be reimbursed without the patient needing to pay out of their own pocket.× close
- How is the market reacting to the quality of Woulgan’s documentation?
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.× close
- 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.× close
- Do you expect earlier revenues in Germany than in the UK?
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.× close
- Why did you only sign a one year agreement with ROGG?
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.× close
- Why have Biotec spent more than eight months to reach a distribution agreement in Germany?
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.× close
- Have Biotec met any critical problems related to an agreement in Germany?
Biotec has not met any critical problems relating to an agreement in Germany.× close
- 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.× close
- How effective is Woulgan?
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.× close
- Will Biotec pursue other potential target areas for SBG?
Yes, Biotec is open for cooperations relating to different use of SBG, but will not pursue any standalone projects at the present.× close
- What is the distribution split between Navamedic and Biotec?
Biotec will not comment on specific details, but Biotec’s share is somewhat more than 50 percent of net sales.× close
- When will Biotec see first sales in Scandinavia?
We expect to see first sales in Scandinavia during first half of 2016.× close
- What is “sufficient” KOL support?
Sufficient support means that in a given region we see that the support is sufficient to obtain clinical use of the product.× close
- Will you apply for reimbursement in Norway/Scandinavia?
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.× close
- Will Biotec publish any sales targets for 2016?
Biotec will not publish any sales targets for 2016.× close
- Which study was published under clinicaltrials.gov on 12 Dec. 2015?
This is the Post Market Clinical Study (PMCF) required from Woulgan’s CE-approval.× close
- Why are you comparing Woulgan to Intrasite in this study?
The study requires a well established gel comparator arm, and Intrasite is one of the most frequently used gels for wound care.× close
- What is needed for “early” commercial sales in the different markets?
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.× close
- Do you need more clinical studies before sending a UK reimbursement application?
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.× close
- 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.× close
- Where is Biotec prioritising its efforts?
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).× close
- 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.× close
- 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.× close
- 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.× close
- 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.× close
- 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.× close
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.
- How does a “best possible business partner model for Woulgan” look like?
It is all about focus, commitment and execution, not about size.× close
- 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.× close
- How will you price Woulgan?
This will be decided in conjunction with our partners.× close
- 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.× close
- Are you planning further studies with Woulgan® Biogel after approval?
Yes, a post market follow up study started in Q3 2015.× close
- 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.× close
- 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.× close
- How will revenues and earnings be split between Biotec Pharmacon and its partners?
That will be decided in a commercial agreement to follow later.× close
- 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.× close
- 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.× close
- 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.× close
- 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.× close
- 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.× close
- 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.× close
- 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.× close
- What is the value Smith & Nephew put on Woulgan?
This information has not been released to Biotec.× close
- Will Biotec receive all of the results for the study?
Yes, Biotec will receive all of the results from the evaluation study.× close
- Will the evaluation study be made public?
The results from the S&N study were presented in the Q2 2015 presentation.× close
- What does German law and SHI mean for reimbursement of Woulgan®?
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.× close
- How is the German reimbursement system applicable to Woulgan®?
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.× close
- 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.× close
- Will defferred taxes be part of your Balance for 2015?
This is not decided. A decision regarding deferred taxes will be taken in conjunction with the auditor.× close