Moberg Pharma announces issue of U.S. Patent related to MOB-015 for the treatment of Onychomycosis
STOCKHOLM, January 11, 2015 -- Moberg Pharma AB (OMX: MOB) today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8,952,070, relating to its topical treatment MOB-015 for onychomycosis. The patent is expected to be in effect until 2032. In September 2014, Moberg Pharma reported positive results from a Phase II study of MOB-015.
The new patent comprises composition of matter claims directed to a novel topical formulation of terbinafine, as well as claims directed to methods of treatment of onychomycosis using that novel formulation. The formulation enables enhanced penetration of terbinafine into and through the nail. Oral terbinafine is the gold standard for treatment of onychomycosis but is associated with a risk for severe side effects. Developing a topical terbinafine treatment without systemic side effects has been highly desirable but has previously proven to be challenging.
Moberg Pharma has demonstrated, ex vivo as well as in vivo, that MOB-015 delivers high microgram levels of terbinafine into the nail, as well as through the nail plate into the nail bed. A mycological cure rate of 54% and significant clear nail growth were observed in the 24 patients who completed the recent phase II study. The data is compelling, in light of the fact that the majority of the patients had severely affected nails; on average approximately 60% of the nail plate was affected by the infection. Moberg Pharma has estimated the peak sales potential of MOB-015 at $250-500 million.
“The approval of the U.S. patent for MOB-015 is a key milestone in our strategic goal to become the No. 1 player in products relating to nail fungus. We are moving forward in discussions with potential industrial as well as financial partners for the phase III program, with the aim of starting phase III in 2016,” said Peter Wolpert, CEO of Moberg Pharma AB.
About MOB-015 and Onychomycosis
Onychomycosis and related problems has been the main focus of Moberg Pharma since its inception in 2006. The company markets Kerasal Nail®, the leading product in the U.S. over-the-counter (OTC) fungal nail category, through its OTC sales team and through distributors in approximately 30 countries. MOB-015 is a proprietary topical formulation of terbinafine developed internally by Moberg Pharma and builds on the company’s experience from the OTC market.
Terbinafine is currently the world’s most widely used oral prescription treatment for onychomycosis and was a blockbuster before patent expiration. Topical administration of terbinafine eliminates concerns of oral treatment, including drug interactions or liver damage, but has previously not been successful due to insufficient delivery of the active substance through the nail. Moberg Pharma’s preclinical and clinical data confirm that MOB-015 delivers effective levels of terbinafine through the nail and into the nail bed.
Onychomycosis is a common nail infection caused predominantly by dermatophyte fungi, which typically occurs under the toenail, although fingernails may also be affected. Approximately 10% of the general population suffers from onychomycosis. In the U.S., MOB-015 targets the attractive prescription market, which, after recent launches of two new topical treatments, is expected to exceed $2 billion in the U.S. alone. The untapped potential is significant since the majority of patients are untreated.
About this information
Moberg Pharma is disclosing this information pursuant to the Swedish Securities Markets Act and/or the Financial Instruments Trading Act. The information was submitted for publication at 11:00 a.m. (CET) on February 11 2015.
For additional information contact:
Peter Wolpert, CEO, Telephone: +46 (0)70 - 735 71 35, E-mail: peter.wolpert@mobergpharma.se
Anna Ljung, CFO, Telephone: +46 (0)70 – 766 60 30, Email: anna.ljung@mobergpharma.se
About Moberg Pharma
Moberg Pharma AB (MOB.ST) is a rapidly growing Swedish pharmaceutical company with a direct sales and marketing organization in the U.S. and an extensive distribution network in more than 40 countries. The company’s OTC portfolio includes the brands Kerasal®, Jointflex®, Kerasal Nail®, Domeboro®, Vanquish® and Fergon®. Kerasal Nail® (Nalox™in certain markets outside the U.S.) is the leading product for the treatment of nail disorders in the U.S. and Nordic market. The strategy to expand the portfolio includes acquisitions and in-licensing, as well as internal development with a focus on innovative drug delivery of proven compounds. 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. For further information, please visit: www.mobergpharma.com.
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