Application submitted to include an additional terbinafine supplier
Application submitted to include an additional terbinafine supplier
STOCKHOLM, April 8th, 2024, Moberg Pharma AB (OMX:MOB) has submitted an application to include the proposed terbinafine supplier in the company's registration dossier for its nail fungus drug MOB-015. Approval is expected before the end of the year.
Together with its intended terbinafine supplier, Moberg Pharma has submitted an application to add the manufacturer for MOB-015. In addition, Moberg Pharma is actively working to secure an additional terbinafine supplier and thus has two parallel tracks to ensure a stable long-term supply of terbinafine.
"The submission of the application to include an additional supplier is important to secure the supply of terbinafine ahead of the planned pan-European roll-out of MOB-015. MOB-015 is already available to Swedish patients and we look forward to reaching patients in more countries in the future, since there is significant need for a topical treatment that truly cures the nail infection", says Anna Ljung, CEO of Moberg Pharma AB.
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 April 8th, 2024, at 8.00 am CEST.
About MOB-015 and Onychomycosis
Approximately 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 is recommended for national approval in 13 European countries and is launched in Sweden under the brand name Terclara®. 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.
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 market approvals in several EU-countries 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).
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Moberg Pharma, Gustavslundsvägen 42, BROMMA, 16751 SVERIGE
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