Biotec Pharmacon announced on June 11th 2007 that the European Medicines Agency (“EMEA”) had confirmed that the company may be in a position to file for marketing authorization based on two positive confirmatory phase III clinical studies within each of the diabetic ulcer and oral mucositis therapeutic indications.
The Board of Directors in Biotec Pharmacon has today resolved that the Company will initiate the needed phase III studies on its own. This is an exception to the current business model (which is to seek partnership following phase II). However it does not exclude bringing partners onboard during the phase III program.
The Board’s decision is based on the above mentioned positive feedback from EMEA. Now that the Company sees that the confirmatory studies require fewer resources and involve less risk than previously expected, the Board believes that it is in the best interest of the shareholders to fund and initiate phase III studies on its own.
Biotec Pharmacon ASA has retained SEB Enskilda ASA and Pareto Securities ASA to advise on and effect an equity issue directed towards professional Norwegian and international investors after the close of Oslo Stock Exchange today. The equity issue will be carried out through a book-building process.
