Following Capital Market Commission?s letter dated 18.12.2007 with regards to the launch of the Fentanyl Transdermal System in the USA, Lavipharm notes the following:
As announced, a difference in opinion with the manufacturer has arisen regarding the reasons behind the deviations from the specifications observed in one of the three validation batches, during the validation process. Lavipharm, after thorough research and evaluation of all of the data received from the manufacturer and based also on studies performed by its independent advisors, has formed a position and has proposed a specific technical and procedural path forward, which would allow the completion of the validation process with the new batches as soon as possible.
Lavipharm?s objective, as announced, is to exhaust every possibility to find a common acceptable position with the manufacturer and it continues its discussions to this end, aiming towards a launch of the product in the market -according to Lavipharm?s estimation - in the next four-months. If, despite these efforts, no resolution is possible, Lavipharm will obviously turn to another manufacturer. In this case, the timeframe mentioned above will be revaluated and the Company will proceed with a new announcement informing the investor community regarding any future developments in line with existing legislation.