Moberg Derma Receives Regulatory Approval to Start Clinical Phase III trial for a Novel Treatment of Nail Fungus (Onychomycosis)

Stockholm, Sweden, June 27, 2007
The Swedish pharmaceutical company Moberg Derma AB today announced that it has received approval from the Swedish Medical Products Agency (MPA) to initiate a clinical multi-centre phase III trial for its novel nail fungus project K101. The trial will include up to 470 patients in Sweden and in at least one more country. Patient enrolment is planned to start in September 2007, and full data is expected by the end of 2008.

“We are very pleased with the rapid progress of the company” comments Peter Wolpert, CEO of Moberg Derma. “In fifteen months after the company was founded, our team has managed to conduct a phase II trial for K301 and to receive approval to start a Phase III trial for our second product candidate K101.”

K101 is a topical solution for the treatment of onychomycosis (nail fungus) applied once-daily on affected nails. In a pilot study including 58 nails with severe nail fungus, 31% of the nails were completely healed and an additional 56% were significantly improved after 6 months of treatment. Complete healing was defined as clinical and mycological healing.

Onychomycosis is caused by dermatophytes, common fungi responsible for several skin diseases in both humans and animals, and affects approximately 8% of the population. The hidden prevalence may be even higher since many patients do not seek treatment.

Moberg Derma is currently developing several pharmaceutical products based on the Kaprolac® principle. A Phase II study was recently completed for K301 – a topical treatment for Seborrheic Dermatitis of the scalp. The phase II results for K301 will be presented early Autumn 2007.

Contact:
Peter Wolpert, CEO
Telephone: +46 (70) 735 7135
Email: peter.wolpert@mobergderma.se
For more information, please visit our website www.mobergderma.se