In response to the question raised by the Capital Market Commission regarding the developments concerning its fentanyl transdermal system in the USA, Lavipharm S.A. notes the following:
As previously announced, Lavipharm's subsidiary company in the USA has initiated legal proceedings against the manufacturer, alleging that the defendants have breached their agreement with Lavipharm in several respects, thus preventing Lavipharm's product from reaching the market. The action is still pending against the defendants in the Superior Court of New Jersey and the time allowed for the defendants to respond to Lavipharm's complaint has not yet passed.
Lavipharm, as already mentioned in a previous announcement, is evaluating all of its alternatives, including selecting an alternative manufacturer of the product. The Company has identified other qualified manufacturers for the purpose of transferring the manufacturing responsibilities, which the Company deems preferable than upgrading its own facilities in the USA. In that context, the Company is in the process of discussing the potential financial terms and manufacturing timetable for the transfer of the manufacturing process to a new party. In any event, it is estimated that the process necessary to shift production to a new facility will require a timeline of at least 15 months. The Company will proceed with a new announcement informing the investor community regarding any future developments in line with existing regulations.