ADIENNE is an integrated biopharmaceutical group with its headquarter based in Lugano, Switzerland, and its Pharma & Biotech manufacturing facilities based in Caponago, Italy. With a proprietary portfolio of orphan-designated marketed medicinal product, clinical and preclinical product candidates focusing on critical conditions of high unmet medical needs.
ADIENNE aims to develop a range of product candidates for orphan diseases for which existing treatment options are limited, the patient population is small and the clinical needs for therapies is high.
ADIENNE is very pleased to announce that, on April 5th 2022, AIFA authorized the ADIENNE’s manufacturing site in Caponago (MB – Italy) for commercial aseptic productions of:
1) Large Volume Liquids
2) Lyophilized: Special Requirements Cytotoxic Products, Cytostatics.
3) Small Volume Liquids
This authorization will allow ADIENNE to start the manufacturing activities for commercial batched of its products in dual-chamber bags for its product TEPADINA 400mg and 200mg; it also opens new market horizons with the other products in our and CDMO pipe-lines.
MA extension for TEPADINA®
ADIENNE is very pleased to announce that on March 26th, 2021 the European Commission adopted an implementing decision concerning the granting of an extension of the marketing authorisation for TEPADINA®, which will be marketed also in a new strength as well as a new pharmaceutical form: 400mg in 400 ml bag, concentration 1 mg/ml, powder and solvent for solution for infusion. We are extremely proud to be the first company in the world obtaining a marketing authorisation for a cytotoxic product lyophilised directly in a ready-to-use bag – where both the underlying lyophilisation method and the bag are patented worldwide by us – thus marking an important step in the evolution of lyophilisation techniques.
The new ready-to-use system has been specifically designed to address all compliance issues associated with the reconstitution of cytotoxic drugs and meet the needs of pharmacists and nursing personnel for a safe and easy handling of the drug, avoiding the dangers posed by exposure to cytotoxic substances. Moreover, this innovative delivery system will soon enable cancer patients to be treated also outside care facilities and receive a safe and high quality healthcare at home.