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Philogen Received Combination Pack Approval for Nidlegy

Philogen S.p.A., a privately-owned biotechnology company, is pleased to announce that, on Jan. 30, 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). NidlegyTM is being developed as a neoadjuvant intralesional 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 application 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 the marketing of NidlegyTM as a combination pack that was considered by CHMP ‘indispensable for public health reasons,'” commented Prof. Dario Neri, co-founder and President of the Scientific Advisory Board of Philogen.

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 efficiently 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. 

Meeta Ramnani
Meeta Ramnani
Meeta develops credible content about various markets based on deep research, opinions from experts and inputs from industry leaders. As the managing editor at Smart Industry News, she assures that every piece of news and article adds to the knowledge of decision makers. An avid bike rider, Meeta, is a postgraduate from Indian Institute of Journalism and New Media (IIJNM) Bangalore, where her specialization was Business Journalism. She carries experience from mainstream print media including The Times Group and Sakal Media Group.