Lavipharm S.A., following questions raised by the Capital Market Committee on its announcement of November 30, 2007 and in the context of providing explicit and accurate information to the investment community, clarifies the following:
During the validation process of the fentanyl trandermal system in the USA, deviations from the specifications were observed by the contract manufacturer in one of the three validation batches. This required an investigation on the causes of these deviations.
The initial position of the Company, which was further supported by reports and analyses from its expert consultants during this period, is that the deviations are related to errors during the analytical process. At this point, there is a difference in opinion with the manufacturer, which has resulted in the inability to complete the validation process and, consequently, in the postponement of the launch of Lavipharm's fentanyl transdermal system in the US market.
As mentioned in the announcement of September 14, 2007, concurrently with the ongoing investigation regarding the deviations and in order to expedite the launch of the product, the Company was prepared to proceed with the completion of the production of three new batches, which were scheduled for commercial use. Following the aforementioned developments, these commercial batches can not be validated, as long as a mutually acceptable justification of the causes of the deviating measurements is still pending.
Lavipharm S.A. continues to seek agreement with the manufacturer, while at the same time is examining all possible production and analytical alternatives, with the aim to launch the product in the US market as soon as possible. The Company will immediately inform the investor community regarding any future developments.