Philogen S.p.A. announced that its new GMP facility located in Rosia Siena, is now GMP certified. The certification was granted by the GMP MED office of the Agenzia Italiana del Farmaco (AIFA) following an inspection occurred in July 2023. AIFA confirmed that Philogen new facility complies with the requirements and guidelines of Good Manufacturing Practice outlined in the Directive 2003/94/EC issued by the European Parliament.

In the European Union, national competent authorities - AIFA in Italy - are responsible for inspecting manufacturing sites based within their own territories. Sites located in one European Member State also benefit from mutual recognition agreements (MRAs) that the European Commission has signed with the authorities of the United States, Switzerland, Canada, Israel, Australia, Japan and New Zealand concerning the conformity assessment of medicinal products. Philogen plant in Rosia was designed in accordance with the new Annex 1 of the Rules Governing Medicinal Products in the European Union for Good Manufacturing Practice of Medicinal Products for Human Use.

The site plans to produce therapeutic proteins in mammalian cells, with a focus on the company?s immunocytokines such as Nidlegy?, for both clinical trials and commercial purposes. The completion of the facility required an investment of over 15 million Euros. On 16 October 2023, Philogen had announced positive topline results from the Phase III trial of Nidlegy?

in patients with locally advanced fully resectable melanoma (NCT02938299). The Rosia facility will manufacture commercial supplies of Nidlegy? and has been structured to address a global distribution of the product.