drugset / Press release

Philogen received combination pack approval for NidlegyTM

2020-06-24 · Philogen S.p.A. · original philogen.com ↗

Main Office: Loc. Bellaria, 35 - 53018 Sovicille (SI), Italy e-mail: [email protected] – web site: www.philogen.com _________________________________________________________________________________________________________________ _________________________________________________________________________________________________________________ PHILOGEN RECEIVED COMBINATION PACK APPROVAL FOR NIDLEGYTM Siena, Italy, June 24th, 2020 - Philogen S.p.A., a privately -owned biotechnology company, is pleased to announce that, on January 30th, 2020 EMA's CHMP expressed a favorable opinion to the request of a combination pack for the to -be-marketed pharmaceutical form of NidlegyTM, a combination of the active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF). Nidlegy TM is being developed as a neoadjuvant intr alesional treatment for resectable Stage III melanoma patients and in locally-advanced, not metastatic nonmelanoma skin cancers. NidlegyTM combination pack has now received confirmation of eligibility to the centralized procedure for submission of an appli cation for a Union Marketing Authorisation under Article 3(1) - Indent 1 - Biotech medicinal product of Regulation (EC) No 726/2004. “We are extremely pleased to record EMA's agreement to our strategy for marketing of NidlegyTM as a combination pack that w as considered by CHMP ‘indispensable for public health reasons'" commented Prof. Dario Neri, co -founder and President of the Scientific Advisory Board of Philogen. About the Philogen group Philogen is a Swiss-Italian clinical-stage company engaged in the discovery and development of novel pharmaceutical and biopharmaceutical products. Philogen’s strategy is to deliver bioactive agents, for example cytokines or drugs, to the site of disease using antibodies and other ligands that specifically and efficien tly target stromal antigens. This technology has generated a strong proprietary pipeline of clinical-stage products and preclinical compounds in an array of disease indications. Philogen is headquartered in Siena, Italy, and has research activities at its subsidiary company Philochem in Zürich, Switzerland. Philogen is independently owned, and has signed agreements with several major pharmaceutical companies. For more information please visit www.philogen.com and www.philochem.com. For more information please contact: Dr. Christian Lizak +41 (0) 43 544 88 00 [email protected]

The release as fetched from its publisher. philogen.com ↗