National approval for MOB-015 in Sweden
STOCKHOLM, August 4th, 2023, Moberg Pharma AB (OMX:MOB) hereby announces that MOB-015 has received national approval for the company’s home market, Sweden, for the treatment of mild to moderate fungal infections of the nails in adults. This is the second country to grant national approval for MOB-015, following the approval in Ireland announced July 31st, and Sweden is the first country where MOB-015 has been approved for over-the-counter (OTC) use.
Grant of market authorization in Sweden is significant as our commercialization rollout is planned to start in our home market. We will initiate the launch as quickly as possible and expect to initiate launch preparations in Sweden before the end of the year.
National approvals follow the completion of the decentralized procedure with a positive outcome, where MOB-015 was recommended for national approval in 13 European countries, see press release from June 28th, 2023. The following countries are included: Austria, Belgium, Czech Republic, Denmark, Finland, France, Hungary, Ireland, Italy, Netherlands, Norway, Spain and Sweden. Currently, national implementation in each country and granting of marketing authorizations including OTC-approvals when applicable, is ongoing. National approvals are expected to occur in the coming months and timelines may vary between countries. Further national approvals will be reported in quarterly reports and will not be announced separately in press releases.
For additional information, please contact:
Anna Ljung, CEO, telephone: +46 707 66 60 30, E-mail: anna.ljung@mobergpharma.se
About this information
The information was submitted for publication, through the agency of the contact person set out above, on August 4th, 2023, at 8.00 am CEST.
About MOB-015 and Onychomycosis
Approximately 5-10% of the general population suffer from onychomycosis and a majority of those afflicted go untreated. The global market opportunity is significant with more than hundred million patients worldwide and a clear demand for better products. Moberg Pharma estimates the annual worldwide peak sales potential for MOB-015 to be in the range of USD 250-500 million.
MOB-015 is an in-house developed topical formulation of terbinafine, enabling effective concentrations of terbinafine to the nail and nail bed while avoiding the risk of systemic exposure seen with oral terbinafine use. Oral terbinafine is currently the gold standard for treating onychomycosis but associated with safety issues, including drug interactions and liver damage. MOB-015 has recently been granted its first marketing authorization, and 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.
About Moberg Pharma, www.mobergpharma.com
Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The Company’s asset, MOB-015, is a novel topical treatment for onychomycosis, for which the first market approval has recently been obtained. Data from phase 3 clinical trials in more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in various regions including Europe and Canada. Moberg Pharma is headquartered in Stockholm and the Company’s shares are listed on the Small Cap list of the Nasdaq Stockholm (OMX: MOB).