The specialist pharmaceutical company Moberg Pharma focuses on commercializing proprietary drugs against nail fungus based on proven substances. Nail fungus is a common disease that affects approximately one in ten people and which often goes untreated.
Medications for nail fungus can be divided into two categories. On the one hand, there is tablet treatment with terbinafine – a treatment that is effective but has side effects, especially the risk of liver damage and interactions with other medications. There are also various topical preparations, which have a good side effect profile but are less effective at killing the fungus.
Nail Fungus Killer MOB-015 more effective
Moberg Pharma has developed a topical preparation, MOB-015, based on a patented formulation technology and applied directly to the nail. The product enables high concentrations of terbinafine to be transported through the nail to kill the fungus, resulting in an effective treatment that is not associated with the same harmful side effects as tablet treatment.
According to the company, MOB-015 has a superior ability to kill the fungus compared to other topical nail fungus medications. Mycological cure (the patient is fungus-free) was achieved in 76 percent of patients in two phase III studies with 800 patients, which compares to the 30–54 percent reported for other topical medications.
Milestone payments of $120 million secured
Moberg Pharma wants to repeat the success of the company's first product with MOB-015 Kerasal Nail, which the company took to a market leading position in the US and through partners was also launched in more than 30 markets around the world. Kerasal Nail and Moberg Pharma's other products were divested in 2019 for SEK 1,4 billion, which resulted in a large extra dividend to shareholders.
The company retained the MOB-015 project, which is currently in the registration phase in Europe and where the company has already secured agreements for commercialization with leading pharmaceutical companies in the EU, Japan, Canada and South Korea, for a total value of USD 120 million in milestones, in addition to compensation for delivered products. However, the most important market for the company is by far the US, where the company has recently started a supplementary phase III study before the product can be brought to market.
Capital raising to take MOB-015 to market
To finance the continued development of MOB-015, Moberg Pharma is now conducting a fully guaranteed rights issue that could raise up to SEK 121 million before expenses. The subscription period runs from May 13, 2022 to May 27, 2022.
Moberg Pharma's CEO on the nail fungus killer
CEO of Moberg Pharma Anna Ljung has worked on the company since it was founded in 2006, for many years as CFO and now the last three years as CEO. BioStock contacted her to find out more about the company's plans to become a world leader in nail fungus treatment and the upcoming share issue.
You were involved in launching Kerasal Nail. How are you going to repeat the success and take MOB-015 to a world-leading position in the treatment of nail fungusp?
– As with Kerasal Nail, we want to combine direct sales in the US with strategic partnerships in a number of major regions. The most important markets for MOB-015 are expected to be the US, EU, Japan, Canada and China, all with granted patent protection until 2032. Results from phase 3 clinical studies with 800+ patients indicate that MOB-015 has the potential to become the future market leader in nail fungus.
– We have strong partners in place, including Bayer for Europe and Taisho for Japan. Over the years with Kerasal Nail, we have gathered valuable knowledge and networks, as we were involved in or responsible for marketing in a large number of markets including the USA.
– For the USA, we see good opportunities to build our own commercial platform with a focus on podiatrists with MOB-015 as the main product, and which will be supplemented with additional niche products in the future. By working with strong partners in other markets, we enable the best possible launch for our product even though Moberg Pharma is a small company. We expect MOB-015 to become the market leader because we combine world-leading ability to kill nail fungus with the commercial strength of our partners.
What is the market situation for drugs against nail fungus?
– Despite the fact that one in ten people have nail fungus, there is currently a lack of good treatment options. The most effective treatment is terbinafine in tablet form, which is associated with a risk of liver damage and interactions with other medications. Dermatologists around the world agree on the great need for better topical treatments without the risk of systemic side effects. 7 out of 10 doctors surveyed in the US avoid prescribing terbinafine tablets due to patients' concerns about side effects.
– MOB-015 is the first topical treatment to achieve mycological cure on par with terbinafine tablets. MOB-015 has the same active ingredient, terbinafine, but delivers it in a topical solution that delivers terbinafine through the nail. Compared to terbinafine in tablet form, treatment with MOB-015 results in a concentration of terbinafine that is a thousand times higher in the nail, 40 times higher in the nail bed, and a thousand times lower in plasma – ideal characteristics for an effective topical treatment without systemic exposure.
In the US, you are now conducting another phase 3 clinical study, why then?
– The purpose of the new study is to enable market approval in the US and strengthen the product's clinical evidence and marketing claims globally.
– For market approval in the US requires FDA normally two studies that demonstrate superiority (statistically better than the comparator) for the primary treatment objective. We have one of these studies in place in the already completed North American Phase III study and have now started recruiting patients in an additional Phase III study in North America. The study design is based on experience from the previous Phase III studies and Moberg Pharma is collaborating with the same CRO, the same principal investigator and high-performing clinics from the previously completed North American study. The new study includes a shorter treatment period followed by maintenance treatment, which is expected to strengthen the product's marketing claims globally.
What are the plans for the launch of MOB-015?
– In March of this year, we submitted the registration application for MOB-015 in Europe, with the goal of obtaining first market approval and launching MOB-015 in 2023.
– For Europe we have two commercial partners, the Consumer Health division within Bayer AG, a world leader in over-the-counter products for fungal treatment under the brand The canest and partly Allderma, for Scandinavia. Allderma's senior people were previously responsible for the launch of Moberg Pharma's first generation nail fungus product, Naloxone, in the Nordics. When Nalox was launched in Sweden, the product quickly became the market leader and grew the market by 400 percent. We look forward to repeating this successful collaboration and see a great advantage in being closely involved in the launch of MOB-015 in our home market, ahead of continued launches with our partners in other territories.
Moberg Pharma is now conducting a new share issue, can you tell us how you intend to use the issue proceeds?
– The net proceeds will be used for registration activities and clinical work for MOB-015 as well as preparations for launch in Europe in 2023.
Why are you raising capital right now?
– The guaranteed rights issue allows us to realize the full potential of MOB-015 and means that the new North American Phase III study is fully funded. With secured funding, the team can now focus fully on the registration process, the clinical study and preparations together with our partners for launch in 2023.
Finally, looking ahead, how do you see the company's development in the coming years?
– Our goal is to make MOB-015 the leading treatment option for nail fungus globally and to build a specialty pharmaceutical company with its own sales in the US and sales through partners in other markets.
– The submission of the registration application in Europe, as well as the start of the phase III study in North America, are two important milestones that have just been achieved and pave the way for launch in Europe, including our home market where we intend to launch already in 2023, and the USA, the largest and most important market for nail fungus. Both activities aim at the goal of registering a new drug to offer patients in many markets a significantly better treatment option for nail fungus.
– With a strong financial position and significant global growth opportunities for MOB-015, we see the potential to create significant shareholder value over time.
