The specialist pharmaceutical company Moberg Pharma focuses on commercialization of proprietary drugs against nail fungus based on proven substances.
Nail fungus is a common disease that affects approximately one in ten people and often goes untreated. The need for an effective drug against nail fungus is therefore great.
Two categories of nail fungus treatments
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 which 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.
Patented formulation technology
Moberg Pharma has developed a topical preparation, MOB-015, which is based on a patented formulation technology and is applied directly to the nail. The product enables high concentrations of terbinafine to be transported through the nail to kill the fungus. 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, leading to an effective treatment that is not associated with the risk of the same harmful side effects as tablet treatment.
Moberg Pharma has been granted a patent in the most important markets in the USA, EU, Canada, Japan and China. The patent is protected until 2032.
MOB-015's ability to kill nail fungus
In December 2019, results from the first of two North American clinical trials in the MOB-015 Phase III program were presented, followed by results from the European study in June 2020. According to the studies, Moberg Pharma's product 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 the 800-patient studies, which compares to the 30–54 percent reported for other topical medications. Read more.
Advancing towards market launch in Europe in 2023
As the treatment goal has been achieved in both the first North American phase III study and the European phase III study, both studies have been able to be used as a basis for product registration in Europe.
In March 2022, Moberg Pharma submitted a registration application to the Swedish Medical Products Agency for MOB‐015, which allows for data exclusivity in Europe for up to 10 years after market approval. The goal is to obtain market approval and launch MOB‐015 in Europe in 2023.
Read more about the launch of MOB-015 in BioStock's interview with Moberg Pharma's CEO Anna Ljung here.
Additional North American Phase III study initiated
Simultaneously with the registration application in Europe, the second phase III study has been initiated in North America. Moberg Pharma submitted documentation on the new study to FDA in March this year and is in full swing with recruitment, which is planned to include a total of 350 patients in the US and Canada.
The purpose of the new study is to obtain market approval in the US and strengthen MOB-015's clinical evidence globally.
The study design is based on experiences from the previous phase III studies and Moberg Pharma is collaborating with the same CRO, the same principal investigator and clinicians from the previously conducted North American study.
The North American study will be fully funded thanks to the guaranteed rights issue the company is conducting in May 2022.
Read more about the study in BioStock's interview with CEO Anna Ljung here.
License agreements with strong partners (milestones up to 120 MUSD)
In addition to MOB-015 being in the registration phase in Europe, Moberg Pharma has already secured agreements for commercialization with leading pharmaceutical companies.
A total of five partnership agreements are in place for MOB‐015, with Cipher Pharmaceuticals for Canada, with Taisho in Japan, DongKoo in South Korea, with Allderma in Scandinavia and Bayer AG for Europe, world leader in over-the-counter products for fungal treatment under the brand The canest.
The agreements provide partners with exclusive rights to market and sell MOB‐015 in their respective markets, and Moberg Pharma is responsible for manufacturing and delivering the product. Under the agreements, Moberg Pharma may receive milestone payments of up to a total of USD 120 million upon successful development and commercialization, in addition to royalty payments and compensation for delivered products.
Proven commercial success model
Moberg Pharma's goal with MOB-015 is to repeat the success of the company's first product 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. With Kerasal Nail, the company achieved annual revenues of SEK 440 million with a 30 percent market share in the US and sales at more than 30 points of sale, including the major chains CVS, Walgreens and Walmart.
Kerasal Nail and Moberg Pharma's other commercial products were divested in 2019 for SEK 1,4 billion, resulting in a large extra dividend to shareholders. However, the company retained the MOB-015 project, which Moberg Pharma believes has significantly greater potential than Kerasal Nail.
The business model for MOB-015 includes direct sales with a focus on the US, distribution with partners and out-licensing in other markets.
Great market potential
Moberg Pharma believes that MOB-015 has a high demand as 100 million nail fungus patients in the EU and North America currently lack good treatment options.
According to LifeSci Physician Survey Most doctors (7/10) refrain from prescribing terbinafine tablets due to patients' fear of side effects. And 6/10 of the doctors surveyed prefer a product with MOB-015's target profile, over topical treatments. Read more.
The market potential for MOB-015 amounts to 250–500 million USD annually, according to the company's assessment.
Issuance brings Moberg Pharma's MOB-015 to market
To finance continued development and market launch of MOB-015, Moberg Pharma is now conducting a rights issue that could raise up to SEK 101,9 million after costs, which are expected to amount to approximately SEK 18,9 million. The rights issue is covered by approximately 14 percent of subscription commitments and approximately 86 percent of issue guarantees and is thus fully guaranteed. The company intends to use the net proceeds to:
- Fund clinical and regulatory work for MOB-015 as well as preparations for launch in Europe in 2023.
Read more about the issue in BioStock's interview with CEO Anna Ljung. here.
The offer in summary
| Terms & conditions | One existing share in the company entitles to one subscription right. Eight subscription rights entitle to subscribe for nine new ordinary shares. |
| Subscription period | May 13 – May 27, 2022 |
| Subscription price | SEK 2,30 per share |
| Issue volume | SEK 120,8 million |
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