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21-Oct-2019

Moberg Pharma and DongKoo sign agreement for MOB-015 in the Republic of Korea

STOCKHOLM, October 21st, 2019, Moberg Pharma AB (OMX: MOB) has signed a distribution agreement with DongKoo Bio & Pharma Co., Ltd for MOB-015 in the Republic of Korea. Under the agreement DongKoo is granted exclusive rights to market and sell MOB-015 in the Republic of Korea. Moberg Pharma assumes production and supply responsibility.

DongKoo will conduct registration activities in the Republic of Korea, and will be marketing, distributing and selling MOB-015 in the Republic of Korea upon completion of registration.

This is the fourth commercial agreement for MOB-015, this time with the market leader in dermatology in Korea with excellent coverage of the dermatology clinics. We look forward to work with DongKoo and making MOB-015 available in Korea, contributing to our vision of making MOB-015 the leading nail fungus treatment worldwide”, says Anna Ljung, CEO of Moberg Pharma.

According to Moberg Pharma’s market intelligence, the Korean market for topical drugs for onychomycosis amounts to $40 million (rolling 12m ending June 2019).                 

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 internally developed topical formulation of terbinafine based on Moberg Pharma’s experience from previously having developed and commercialized a leading OTC product for onychomycosis. Oral terbinafine is currently the gold standard for treating onychomycosis but associated with safety issues, including drug interactions and liver damage. For many years, developing a topical terbinafine treatment without the safety issues of oral terbinafine has been highly desirable, but unsuccessful due to insufficient delivery of the active substance through the nail.

In a previous phase 2 study, MOB-015 demonstrated delivery of high microgram levels of terbinafine into the nail and through the nail plate into the nail bed. Mycological cure of 54% and significant clear nail growth was observed in patients who completed the phase 2 study. The results are remarkable, particularly when taking into account the severity of the nails included in the study – on average approximately 60% of the nail plate was affected by the infection. Plasma levels of terbinafine with MOB-015 were substantially lower than after oral administration, reducing the risk of liver toxicities observed with oral terbinafine.

MOB-015 is currently being evaluated over 52 weeks in two randomized, multicenter, controlled Phase 3 studies, including in total more than 800 patients in North America and Europe. The primary endpoint in both studies is the proportion of patients achieving complete cure of their target nail. Topline results from the North American study are expected in December 2019, followed by results in Europe expected in the second quarter of 2020.

For additional information, please contact:
Anna Ljung, CEO, telephone: +46 707 66 60 30, E-mail: anna.ljung@mobergpharma.se
Peter Wolpert, Executive Chairman, phone: US: +1 908 432 2203, e-mail: peter.wolpert@mobergpharma.se

About this information
This information is information that Moberg Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 7.00 a.m. CET on October 21st, 2019.

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 main asset, MOB-015, is a novel topical treatment for onychomycosis, for which phase 3 data in more than 800 patients is expected in late 2019 in North America and the first half of 2020 in Europe. The pipeline also includes the late-stage asset BUPI for pain relief in oral mucositis. Clinical data generated for both assets indicate they have the potential to become market leaders in their respective niches. Moberg Pharma is headquartered in Stockholm and the company’s shares are listed on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm (OMX: MOB).

About DongKoo, http://www.dongkoo.com/eng
Dongkoo Bio&Pharma is a leading pharmaceutical company with 3 main business fields, medicine, medical device and cosmeceuticals in Korea. As a No.1 pharmaceutical company in dermatology prescription market in Korea, DongKoo has a broad portfolio of dermatology products that serve unmet medical needs. DongKoo is focusing on science-based solutions to enhance the quality of life and moreover is making constant efforts to strengthen synergic effects between pharmaceutical business model and bio-technology, acquiring the bio-engineered company that has peptide library technology and stem cell technology.

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Last Updated: 21-Oct-2019