Moberg Pharma expects to announce phase II data for BUPI in January

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STOCKHOLM, December 22, 2015. Moberg Pharma AB (OMX: MOB) today announced that topline data from the clinical phase II-study for BUPI is expected to be announced in January

The BUPI lozenge is investigated in a clinical phase II study with the aim of demonstrating an added benefit to standard pain treatment. Earlier this year, the inclusion period was extended after an amendment of the inclusion criteria which introduced a threshold pain level for patients to be included in the study.

“In total, 32 patients meeting the amended inclusion criteria have now completed the study. We expect to announce topline data in January”, said Kjell Rensfeldt, VP R&D of Moberg Pharma AB.

About Oral Mucositis and BUPI
Oral mucositis (“OM)” is a painful inflammation and ulceration of the mucous membranes lining the mouth. OM is a common and often debilitating complication of cancer treatment which affects 80% of patients with head and neck cancer receiving radiotherapy, almost all patients undergoing bone marrow transplantation, and a wide range of patients receiving chemotherapy. OM makes the patient less likely to comply with their cancer treatment, increases mortality and morbidity and contributes to rising health care costs. In the U.S., every year approximately 400 000 patients suffer from OM during cancer therapy. 

The BUPI technology encompasses novel lozenge formulations of bupivacaine, a local anesthetic with a well-established long acting effect, currently available on the market for other indications as an injectable. A BUPI lozenge is currently investigated in an ongoing clinical phase II study.

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 December 22, 2015.

For additional information contact:                     
Peter Wolpert, CEO, Telephone: +46 (0)70 - 735 7135, E-mail: peter.wolpert@mobergpharma.se  
Kjell Rensfeldt, VP R&D, Telephone: +46 (0)70 - 712 45 32, E-mail: kjell.rensfeldt@mobergpharma.se

About Moberg Pharma
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®, Jointflex®, Vanquish®, and Fergon®. 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 phase II assets, MOB-015 (onychomycosis) and BUPI (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). For further information, please visit: www.mobergpharma.com.

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Quotes

In total, 32 patients meeting the amended inclusion criteria have now completed the study. We expect to announce topline data in January
Kjell Rensfeldt, VP R&D of Moberg Pharma AB