The company has announced that the Decentralized Procedure has ended with a positive outcome and that MOB-015 is recommended for national approval in 13 European countries for the treatment of mild to moderate fungal infections of the nails in adults.
The Decentralized Procedure includes the following EU countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Hungary, Ireland, Italy, Netherlands, Norway, Spain and Sweden.
The first marketing authorizations for Moberg Pharma’s new onychomycosis treatment worldwide
The approval in the EU represents the first marketing authorizations for Moberg Pharma’s new onychomycosis treatment worldwide. The approval is supported by two Phase 3 trials where MOB-015 demonstrated superior levels of mycological cure (76% vs up to 42% for comparators), and a significantly better complete cure rate compared to vehicle, without any serious adverse reactions.
“We are incredible proud to bring a new efficacious treatment option with a favorable safety profile to people living with onychomycosis in Europe, an important part of our vision of making MOB-015 the leading nail fungus treatment worldwide,” says Anna Ljung, CEO of Moberg Pharma.
The first step – Scandinavia
Next steps include national implementation in each country and granting of marketing authorizations including OTC-approvals when applicable. National approvals are expected to follow during upcoming months and timelines may vary between countries.
The commercialization rollout will be a two-step process, planned to start in the company’s home market Scandinavia.
“This early Scandinavian launch enables us to gain valuable insights into consumer behaviour, collecting patient feedback and provide user data to support direct to OTC/OTC-switches in more countries. The launch in Scandinavia will take place in collaboration with our partner Allderma, managed by the commercial leaders which were responsible for the successful Nordic launch of Nalox, Moberg Pharma’s first-generation nail fungus product,” says Ljung.
The second step
Step 2 of the launch will be a pan-European rollout together with the company’s partner Bayer, following the results in the ongoing North American study.
“This as we believe it is likely that we will be able to strengthen the product claims further, including a shorter dosing regimen with the potential to deliver superior complete cure rates. The timing is also driven by our need to secure sufficient API for a pan-European launch. Over the recent months we have had many interactions with investigators in the ongoing North American trial, confirming the enthusiasm of the physicians for the treatment and the progress in the clinical study. Our partner Bayer is a world leader in OTC fungus treatments with the Canesten brand, and we are excited to work together on the pan-European launch. Our shared conviction is that it is in the best interest of MOB-015’s long term potential to include the new data expected from the North American trial into this launch,” the company states.
A rights issue of 100 million SEK
The Board of Directors of Moberg Pharma has also resolved to carry out a new issue of new ordinary shares and warrants with preferential rights for existing shareholders of approximately 100 million SEK before transaction costs.
The net proceeds will mainly be used for clinical and regulatory activities for MOB-015 and preparations ahead of launch.”
The net proceeds will mainly be used for clinical and regulatory activities for MOB-015 and preparations ahead of launch. The launch in two stages means that significant expected revenues are postponed and the Board of Directors of Moberg Pharma has therefore decided on the Rights Issue.
“Moberg Pharma is undergoing an exciting phase after MOB-015 is recommended for market approval in 13 European countries. The rights issue is a step in our continued development that ensures funding of clinical and regulatory activities for MOB-015 as well as preparations for launch. In connection with the financing, I want to thank our main shareholders, other existing shareholders and new investors for their trust in our business and continued growth journey,” states Anna Ljung.
Photo of Anna Ljung: Moberg Pharma