STOCKHOLM, June 15, 2026. Moberg Pharma AB (publ) announces that the first European countries have approved the rebranding of MOB-015 (Terclara®) to Karo Healthcare AB's brand. The approvals provide a defined timeline for launch preparations and marketing activities, with first deliveries planned around year-end. At the same time, launch preparations are also progressing in Israel, where the first patients are expected to gain access to the product during the third quarter of this year.
"After several years of development, it is highly rewarding to see market after market transition from regulatory processes into the launch phase. Israel marks an important milestone as the first market outside the Nordic region where patients will gain access to MOB-015, while we following the rebranding approvals now have a defined timeline to prepare for a broader rollout of the product," says Anna Ljung, CEO of Moberg Pharma.
Moberg Pharma's partner, Padagis, obtained marketing approval from the Israeli Ministry of Health in December 2025 and has since carried out pre-launch activities, including presentation of MOB-015 at the 3rd International Conference on Nail Disorders in Tel Aviv. Israel will be the first market where the drug MOB-015 (Terclara®) is launched outside the Nordic region. As in the Nordics, the product is being launched under Moberg Pharma's brand Terclara® in Israel. The first commercial deliveries are planned for the third quarter.
Within the framework of the collaboration with Karo Healthcare, local approvals of updated product information and packaging materials are now ongoing. Following these approvals, commercial production can commence while launch activities are intensified, including sell-in efforts with pharmacy chains and pharmaceutical wholesalers. Karo Healthcare is leveraging its established antifungal franchise, including the Lamisil® brand, and its broad European commercial platform with established distribution in all major pharmacy chains to support the rollout of MOB-015 across the region. Launch timing will subsequently depend primarily on local lead times, pharmacy chain launch windows and other market-specific conditions. The first commercial deliveries are planned around year-end, enabling start of consumer marketing activities ahead of the high season.
As previously communicated, as a result of local regulatory conditions, the Lamisil® brand will not be available in all markets covered by the collaboration between Moberg Pharma and Karo Healthcare, however the product will be launched using a similar visual identity and recognition factor in markets where other brands are used. In addition to Lamisil®, Pevaryl®, an antifungal brand within Karo Healthcare's portfolio with a strong local market position, will also be used. The companies' assessment is that the regulatory process for the approval of drug names is generally more complex in several Western European countries than in the other countries covered by the collaboration. Karo Healthcare and Moberg Pharma collaborate across 19 European markets as well as Australia, New Zealand, South Korea, Taiwan and China. The companies expect that the Lamisil® brand will be used across the majority of these markets.
About MOB-015/Terclara® and nail fungus
Nail fungus is a common infection affecting approximately 10% of the general population, with the majority of patients currently untreated. The global market potential is significant, with more than hundred million patients worldwide and a clear demand for improved products. Moberg Pharma estimates the annual worldwide peak sales potential for MOB-015/Terclara® to be in the range of USD 250-500 million.
MOB-015/Terclara®, developed by Moberg Pharma, represents the next generation of terbinafine treatment-a novel topical formulation. Oral treatments for nail fungus are associated with risks such as drug interactions and liver damage, which are avoided with topical treatment. Previous attempts at topical terbinafine treatment have failed due to the difficulty of delivering sufficient amounts of active substance through the nail. MOB-015 is the first topical treatment to achieve mycological cure rates comparable to oral therapy; mycological cure (fungal eradication) was achieved in 76% of patients in pivotal studies, and the product has received market approval in 14 countries.
About this information
The information was released for public distribution through the contact named below at 08.00 a.m. CET on June 15, 2026.
For additional information, please contact:
Anna Ljung, CEO, Phone: +46 8 522 307 01, e-mail: anna.ljung@mobergpharma.se
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 drug MOB-015 is a novel topical treatment for onychomycosis (nail fungus) with market approval in 14 countries. MOB-015 is sold in Sweden and Norway under the brand name Terclara® and is available at all pharmacy chains. Phase 3 clinical trials for MOB-015 involving more than 800 patients 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, APAC, Canada and China. Moberg Pharma is headquartered in Stockholm and the company's shares are listed under Small Cap on Nasdaq Stockholm (OMX: MOB).
