Moberg Pharma announces multiple patent approvals for MOB-015
STOCKHOLM, May 18th, 2016. Moberg Pharma AB (OMX: MOB) provided an update on the intellectual property portfolio protecting MOB-015, the Company’s investigational topical treatment for onychomycosis (nail fungus). Patents have recently been granted and Notice of Allowances received in multiple territories worldwide. The patents granted are expected to be in effect until 2032.
“These patents are exceptionally important to Moberg since they secure IP rights for MOB-015 until at least 2032 in various markets worldwide where we plan to sell or license this product, once approved. They represent a strong addition to our portfolio which now includes 12 issued patents and 27 pending patent applications worldwide in four different patent families,” said Peter Wolpert, CEO of Moberg Pharma AB.
The patents granted include composition of matter claims for topical formulations of antifungal allylamines (including terbinafine), as well as methods of treatment claims for treating onychomycosis using these novel formulations, enabling enhanced penetration of antifungal allylamines into and through the nail.
Since February 2015, patents have been granted to Moberg in the U.S., Canada, Europe (EPO), Japan, Mexico, Singapore and South Africa. Notices of Allowances have been issued in Australia, Israel and Russia. Active applications are pending in several additional territories, including Brazil, China, Hong Kong, Indonesia, India and Korea.
Moberg is planning to initiate a Phase 3 program for MOB-015 in the second half of 2016. In a recent Phase 2 study, MOB-015 demonstrated delivery of high microgram levels of terbinafine into the nail, as well as 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 that the majority of the patients treated had severely affected nails – on average approximately 60% of the nail plate was affected by the infection. Plasma levels of terbinafine with MOB-015 were substantially lower than with oral administration, reducing the risk of liver toxicities observed with oral terbinafine.
About this information
Moberg Pharma discloses this information pursuant to the Swedish Securities Markets Act and/or the Financial Instruments Trading Act. The information was submitted for publication at 8:30 am (CET) on May 18th, 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 injury. 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.
For additional information contact:
Peter Wolpert, CEO, Telephone: +46 707 35 71 35, E-mail: email@example.com
Kjell Rensfeldt, VP R&D, Telephone: +46 707 12 4532, E-mail: firstname.lastname@example.org
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®, Domeboro®. Kerasal Nail®(Emtrix®or Nalox™ in certain markets) is a leading OTC treatment of nail disorders in the U.S., Canada and several EU markets and is currently being launched in 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).