This material has been prepared for marketing purposes and is not and shall not be considered to constitute a prospectus under applicable laws and regulations. The full terms and conditions of the rights issue and further information about the company have been set out in a prospectus which was published and published on mobergpharma.se on August 14, 2023.
Moberg Pharma is a specialist pharmaceutical company that has made a name for itself with its nail fungus treatments. Now the company is about to launch its next generation product, the nail fungus drug MOB-015The product is applied to the nail, which allows the active substance to terbinafine is transported through the nail in high concentration. This leads to an effective treatment without the risk of the harmful side effects that come with the terbinafine tablets available on the market and which constitute today's standard treatment.
Strong results for MOB-015
Moberg Pharma has strong results from two phase III studies with over 800 patients. They showed that 76 percent of patients achieved mycological healing, i.e. became fungus-free. This can be compared to other topical treatments, which have shown healing rates of between 30 and 54 percent.
Based on these results, Moberg Pharma's product was recommended for marketing approval in 13 European countries. The first national approvals have already been obtained in Ireland and Sweden, and other countries are expected to approve the drug in the coming months.
Launch takes place in two stages
Moberg Pharma is planning a two-stage launch of its product MOB-015. First, the company will launch in its home market in Scandinavia in collaboration with AlldermaThey were previously responsible for the Nordic launch of Moberg Pharma's first generation nail fungus product, Naloxone. Stage two of the launch will be a pan-European rollout together with the partner BayerThe company has chosen to do so as it currently has limited supplies of the active ingredient terbinafine. Additional manufacturers of terbinafine are expected to be added before stage two of the launch.
The pan-European launch is planned to take place once the company receives the results of the Phase III study currently underway in North America. The company expects to receive topline results in the first quarter of 2025 – results that Moberg Pharma hopes will further strengthen the marketing message.
CEO comments
To finance the continued development and launch of MOB-015, Moberg Pharma is now conducting a rights issue of approximately SEK 100 million. BioStock contacted the CEO Anna Ljung to find out more about the launch and further development.
You have divided the launch into two parts, starting in Scandinavia. What are your expectations for that part of the launch?
– A launch in our home market allows us to gain valuable insights into consumer behavior, collect patient feedback and provide user data that supports direct sales without a prescription or conversion to over-the-counter status in more countries. The launch in Scandinavia will take place in collaboration with our partner Allderma, which is run by the people responsible for the successful Nordic launch of Moberg Pharma's first generation nail fungus product, Nalox.
– When Nalox was launched in Sweden, the product quickly became the market leader and expanded the existing market by 400%. It is enormously valuable for us to be able to repeat this successful collaboration ahead of the launch of MOB-015, a drug with significantly greater potential.
– It is also a great advantage for us to be directly involved in an early launch ahead of continued launches with our partners.
For the launch in Europe, the focus is on securing access to terbinafine, where you are looking for new suppliers. Where do you stand today?
– Phase two of the launch will be a pan-European rollout together with our partner Bayer, the world leader in over-the-counter products for fungal treatment under the Canesten brand. This will take place once we have the results from the ongoing Phase III study in North America. We have chosen to do so because the study has the potential to further strengthen the product’s marketing claims.
– Timing is also driven by our need to secure sufficient API (active pharmaceutical ingredient) for a pan-European launch. In connection with the approval, it emerged that only one of our two suppliers of the active substance terbinafine was approved, and this supplier will cease production of terbinafine later this year. We therefore have limited access to terbinafine in the near future.
– We expect to be able to include the second API supplier after approval. In addition, we are looking for an additional API supplier and have identified several potential candidates to initiate discussions and secure a long-term supply of terbinafine.
An important milestone going forward is the results from your US phase III study. Can you tell us a little about why you are conducting this study, given that you already have good results from previous phase III studies?
– There is a dual purpose to the study, both to enable market approval in the US, the largest market for nail fungus, and to strengthen the product's clinical evidence and marketing claims globally, including a shorter treatment period.
– The requirements for studies for approval of a new drug differ between the EU and the US. For approval in the US, we need two phase III studies that show superiority compared to vehicle (placebo).
– We already have one of these studies in place from the previously conducted North American study. The European phase III study that we conducted compared MOB-015 against ciclopirox, the most widely used topical drug for nail fungus, but not against vehicle.
What feedback have you received so far from the doctors participating in the new study?
– Over the past few months, we have had many interactions with physicians in the ongoing North American study, which confirms the physicians' enthusiasm for the treatment and the progress in the clinical study.
What does the timeline for the study look like?
– Moberg Pharma submitted documentation about the study to the FDA in March 2022 and the first patient was included in May 2022. In total, more than 30 clinics in the US and Canada are accepting nail fungus patients. The study is planned to include 350 patients and we expect to complete the recruitment of patients during the year.
– Since patients are evaluated for 52 weeks and it then takes some time to culture fungal samples from the last patient's last visit, we expect to be able to present topline results 15 months after the last patient is recruited, i.e. during the first quarter of 2025.
Given that you are getting positive results from the study, how do you view a launch in the US?
– During the years of OTC operations, Moberg Pharma has gathered valuable knowledge and relevant experience ahead of commercialization through Nalox/Kerasal Nail, where we have been involved in or responsible for marketing in a large number of markets including the USA.
– In the US, the focus this time is on the significantly larger prescription market for nail fungus preparations. We see good opportunities to build our own commercial platform in the US with a focus on podiatrists with MOB-015 as the main product, and which will be supplemented with additional niche products in the future.
– We also intend to collaborate with an American partner with an established sales force focused on dermatologists. However, Europe, where we have an approved product, will come first in terms of time. After the North American study is completed, a similar approval process will follow that we have carried out in Europe, which will take at least another year. The approval we received in the EU may also open up new partner agreements and opportunities to take the product to market in other regions outside Europe, using the European documentation as a basis.
With MOB-015 you will be competing with your previous products, among other things. How do you see the market potential?
– Despite the fact that one in ten people suffer from nail fungus, there are currently no good treatment options. The most effective treatment is terbinafine tablets, which is associated with the risk of liver damage and interactions with other medications.
– In phase III, MOB-015 showed a 76 percent mycological cure, i.e. killed the fungi. This is significantly higher than reported for other topical treatments, where 30 – 54 percent have been seen. It is also on par with terbinafine tablets, but with 1000x lower drug concentration in plasma.
– The global market potential is very large with more than one hundred million patients and a clear need for better products. We assess that MOB-015 has the potential to become the future market leader in nail fungus with an annual sales potential of 250 – 500 MUSD.
