Negative opinion on the market authorisation application for intravenous iclaprim
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Arpida Ltd announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has reached a negative opinion on the market authorisation application (MAA) for intravenous iclaprim in complicated Skin and Soft Tissue Infections (cSSTI) in the European Union. Subsequently, Arpida decided to withdraw the MAA.
“We are obviously disappointed“, Dr Jürgen Raths, Arpida CEO commented, “but after the FDA decision of January this year, the CHMP recommendation does not come as a complete surprise. It confirms that a resumption of the iclaprim development programme would require large investments that are beyond our reach. As a consequence, we will no longer pursue the programme and continue the search for a partner for the compound. The proposed merger with Evolva is not impacted as iclaprim was never part of the transaction. At the planned Extraordinary General Meeting (EGM) we will ask our shareholders to support a new and promising perspective by merging Arpida and Evolva.“
In the coming weeks, all registered Arpida shareholders will receive an invitation to the EGM to be held on 26 November in Reinach (BL), Switzerland. The agenda will include several items related to the proposed merger with Evolva.
