Biotec Pharmacon has during the past several months cooperated with and obtained scientific advise from the European Medicines Agency (EMEA) regarding the clinical development program for SBG for prevention and treatment of oral mucositis in patients that receive conventional cancer treatment (radiotherapy with or without concomitant chemotherapy) for head and neck cancer.
Biotec Pharmacon has completed one clinical phase II study within the oral mucositis indication, and a new study is currently under preparation. EMEA has now confirmed that the company may be in a position to file for marketing authorisation based on two positive, confirmatory phase III studies, of which the study that is now in preparation will qualify as one of these. Both studies may be conducted in parallel.
The scientific advice from EMEA is very positive for Biotec Pharmacon since it implies that time and costs associated with a marketing authorisation application for SBG within the oral mucositis indication may be reduced compared to earlier estimates.
Biotec Pharmacon maintains an optimistic objective to file for marketing authorisation in Europe during 2009.
The company already maintains orphan drug designation for SBG used for the treatment of oral mucositis in head and neck cancer patients treated with radiation therapy. The company may therefore achieve better protection against competitors once marketing authorisation has been obtained. A similar process is ongoing with FDA for the US market.
The Board of Directors has not yet decided whether the company shall complete the final phase of the clinical development program by its own. Value creation potential, competence and capacity as well as capital requirements will be important factors to consider in this respect.
Most patients that receive radiotherapy with or without chemotherapy for head and neck cancer develop oral mucositis which are large ulcers of the mucosa in the mouth and throat. Oral mucositis develops because the cancer treatment damages mucous immune cells. SBG from Biotec Pharmacon acts on immunce cells in the mouth and throat in such a way that patients develop less oral mucositis in addition to less severe lesions. In most cases patients can therefore continue their cancer treatment without interruptions as a function of less burden from oral mucositis.
Oral mucositis is a serious and painful illness that is estimated to affect approximately half a million people every year. There are only very few therapeutic alternatives available on the market today.
For further information, please contact:
CEO Lars Viksmoen, tel.: 40 62 08 70
CFO Finn Samuelsen, tel.: 95 14 87 51
