STOCKHOLM, Sweden--(BUSINESS WIRE)--Dec. 22, 2005--The US Food and Drug Administration (FDA) in an End-of-Phase-II Meeting has recently approved Medivir’s proposal for configuring the pivotal clinical trials to allow drug registration of labial (oral) herpes project ME-609. A characteristic feature of the project is its low development risk, and it has the potential to offer patients, for the very first time, the opportunity to completely avoid the outbreak of a cold sore. The preparatory work for the phase III clinical trials has started and the trials are estimated to begin during the autumn of 2006. Discussions with the FDA have resulted in a cost-effective registration program, which means that the phase III costs during 2006 are limited to around SEK 40 m.
