Moberg Pharma hosts Key Opinion Leader event in New York City on December 14th
STOCKHOLM, December 13th, 2016. Moberg Pharma AB (publ) (OMX: MOB) hosts a Key Opinion Leader breakfast on “Advances in Treating Onychomycosis (Nail Fungus)”. The meeting will feature a keynote presentation by Dr Aditya K. Gupta, University of Toronto, who will provide an overview of current and novel approaches to treatment in onychomycosis. Members of the Moberg management team will provide an overview of the Company’s ongoing development work with MOB015.
The meeting will be held on December 14 2016, at 8:00-9:30am EST, at Lotte NY Palace Hotel, 455 Madison Ave, New York. Please see the full invitation at www.mobergpharma.se/kolinvite.
For those who are unable to attend in person, a live webcast and replay will be accessible at http://lifesci.rampard.com/20161214/reg.jsp
About this information
The information was submitted for publication, through the contact person set out above, at 9.30 a.m. (CET) on December 13th, 2016.
About MOB-015 and Onychomycosis
Approximately 10% of the general population suffer from onychomycosis and a majority of those afflicted go untreated. The prescription market is growing rapidly after the recent introduction of new topical treatments in North America and Japan. Moberg Pharma expects the U.S. market alone to exceed $2 billion by 2020 and estimates the peak sales potential for MOB-015 to be in the range of $250-$500 million.
MOB-015 is an internally developed topical formulation of terbinafine building on Moberg Pharma’s experience from its leading OTC product Kerasal Nail®. Oral terbinafine is 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 being evaluated over 52 weeks in two randomized, multicenter, controlled Phase 3 studies, conducted in North America and Europe. The primary endpoint in both studies is the proportion of patients achieving complete cure of their target nail. In total, approximately 700 patients are expected to be enrolled in the two studies. Enrolment started in September 2016.
For more information, please contact:
Peter Wolpert, CEO, telephone: +4670 - 735 71 35, e-mail: peter.wolpert@mobergpharma.se
Anna Ljung, CFO, telephone: +4670 - 766 60 30, e-mail: anna.ljung@mobergpharma.se
About Moberg Pharma, www.mobergpharma.com
Moberg Pharma AB (publ) is a rapidly growing Swedish pharmaceutical company with OTC sales operations in the U.S. and a distributor network in more than 40 countries. The company’s portfolio includes the OTC brands Kerasal®, Kerasal Nail®, Balmex®, NewSkin®, Domeboro®, Fiber Choice® and PediaCare® (under divestment). Kerasal Nail® (Emtrix® or Nalox™ in certain markets) is a leading OTC treatment of nail disorders in the U.S., Canada as well as in several markets in EU and Southeast Asia. The company is growing organically as well as through acquisitions. Internal development programs focuses on innovative drug delivery of proven compounds and include two clinical stage assets, MOB-015 (onychomycosis) and BUPI (pain management in oral mucositis). Moberg Pharma has offices in Stockholm and New Jersey and the Company’s shares are listed on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm (OMX:MOB).
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