Oral mucositis is a serious and very painful condition that can occur in connection with various types of cancer treatment. Swelling and sores in the mouth plague the patient, making it difficult to eat and in some cases may lead to the need to discontinue the current cancer treatment.
A Danish medical team at Hvidovre Hospital in Copenhagen has developed a lozenge that is based on the proven local anesthetic drug bupivacaine, which is currently used in epidural block during childbirth. In 2014, it purchased Moberg Pharma the rights to the lozenge, which now goes by the name BupiZengeNow the project is being spun off to be continued by a dedicated team of its own. OncoZenge.
Lack of sufficiently effective drugs
The standard treatment for pain in oral mucositis today is various forms of pain-relieving mouthwashes and systemic pain relief. According to the company, current treatments do not provide sufficient relief, especially in more severe forms of the disease.
During development, the tablet has undergone Phase I and Phase II studies with good results. BupiZenge has been compared to current standard treatment including morphine, with results showing a 50 percent better effect in terms of pain relief in the mouth. In addition, few and tolerable side effects have been noted.
Focusing initially on Europe
OncoZenge estimates the global market potential at between USD 200 and 400 million per year. The strategy is to first register BupiZenge for marketing in Europe, where it is currently working on study design in collaboration with several medical and regulatory experts. The goal is to start a Phase III study in 2022 and to be able to present topline data in 2023.
At the same time, discussions will be held with partners regarding registration, complementary development and commercialization in other prioritized markets.
Carry out a new share issue and stock market listing
In order to accelerate the project and achieve market approval, Moberg Pharma has just completed a Lex Asea spin-off of its subsidiary OncoZenge, whose shares were listed on the Nasdaq First North Growth Market on February 12. In connection with the listing, SEK 60 million is now being raised via a rights issue to finance the final development stage before the market launch of the lozenge.
CEO comments
BioStock has contacted OncoZenge's CEO Pirkko Tamsen to find out more about the company and the ongoing new share issue.
Pirkko Tamsen, would you like to start by telling us a little about yourself and your professional background?
– I have a research background and many years of experience in drug development from both large and small companies. The first ten years at Astra and Kabi were instructive and it gave me a taste for more when the international clinical studies we worked on led to success in the market. I have been CEO of a clinical CRO company and SME company that has been in the same phase that OncoZenge is in now. It feels extremely meaningful to lead a company that wants to improve the living conditions of cancer patients and where there is a clear demand in the market.
There are already various forms of pain-relieving products for oral mucositis on the market today. Could you tell us more about what the market looks like?
– Oral mucositis is considered the most serious side effect of chemotherapy and radiation therapy. The treatments available are inadequate to manage the pain in the mouth and throat associated with oral mucositis. The pain affects the patient severely as it hurts the mouth, making it difficult to eat, swallow, and speak.
– Today, various types of mouthwashes containing lidocaine or morphine and common painkillers such as paracetamol are used. There are a multitude of products and medical gels that are intended to protect the oral mucosa and which are also intended to reduce pain, but when the pain increases significantly, patients are given morphine and may even be forced to be hospitalized. There is nothing on the market today that is effective enough against local pain.
You have strong results behind you as you now take the final development step before market approval. What are your hopes for the product and what it can bring to healthcare?
– OncoZenge's vision is to radically improve the quality of life for cancer patients with oral pain and thereby reduce healthcare costs, for example by ensuring that patients do not need to be hospitalized or interrupt their treatment.
– Our goal is to make BupiZenge a leading medicine for pain in the mouth and throat. We are primarily targeting pain from oral mucositis that affects cancer patients during treatment. There are also other uses for more potent pain relief in the mouth. In addition to making a difference for patients and for healthcare, we want to create long-term value for our shareholders.
What interest have you seen around BupiZenge so far?
– We see strong interest with immediate positive reactions from doctors, experts and even patients in studies that pain in oral mucositis is a serious problem. In market research in Germany and Italy, 83% of prescribing doctors preferred BupiZenge.
Your strategy is to start with market registration in Europe and then follow up with other priority markets. Can you tell us more about your strategy for taking BupiZenge to market globally?
– In general, we will sell through partners. Among other things, we will continue and resume contacts that Moberg Pharma has had previously, with companies that are interested in commercializing BupiZenge in their specific markets, but have not been able to invest in the Phase III program.
– Oral Mukosit is an interesting indication in that it is possible to reach the clinics that treat these patients with a relatively small sales force, so it is also possible for us to build our own presence in one or more key markets. After evaluating the different markets and dialogue with partners, we will make decisions about which markets may be relevant for our own sales.
Operationally, you are currently strengthening the team. How is that work progressing?
– We have made great progress and now have a strong team in place with solid expertise in, among other things, medical, financial, regulatory and manufacturing issues. We usually bring in experts on a consulting basis, which gives us access to all the experience we need without having to pay for full-time services.
You are currently conducting a rights issue following the spin-off and listing. What will the issue proceeds be used for?
– The fully guaranteed rights issue will provide OncoZenge with approximately SEK 60 million excluding issue costs. The money will primarily be used for a registration-based clinical phase III study for BupiZenge. The issue is guaranteed by strong investors including Linc AB, John Fällström and the Östersjöstiftelsen.
What milestones can we look forward to from OncoZenge in the near future?
– The most important thing this year is the preparations for the Phase III study, which will take place in several stages. We will finalize the study design in collaboration with leading experts, discuss the study with regulatory authorities and then submit the application to start the study.
Looking a little further ahead, where do you see OncoZenge in five years?
– In five years, BupiZenge will have a leading position in the oral pain relief market and will be launched in many markets in close collaboration with distributors and partners. When we have succeeded in this, patients around the world will receive important pain relief and we will create value for our shareholders.
The content of BioStock's news and analysis is independent, but BioStock's operations are to some extent financed by companies in the industry. This post refers to a company from which BioStock has received funding.