Preclinical & Clinical
Italfarmaco is an important player in the Italian pharma industry landscape due to both, its products and its R&D activities.
The first molecule (imidazole salicylate) developed in its Research Center was a non-steroidal anti-inflammatory drug, marketed in 1984. Subsequently, a proteiniron complex was developed for the treatment of anemia resulting from iron deficiency, today marketed in over 20 countries worldwide. In 1988, the company began marketing choline alfoscerate, while also overseeing its international development for treating cerebral cognitive disorders, including both vascular and non-vascular Alzheimer’s disease. In the cardiovascular area it was a pioneer in the development of antithrombotic drugs, such as unfractionated and low molecular weight heparin, in the chronic treatment of ischemic heart disease. and in the prophylaxis and therapy of venous and arterial thrombosis.
Our present research is centered around neuromuscular disorders, fibrosis and cancer (including oncology supportive care) with a special focus on rare diseases. While our capabilities span three treatment modalities, small molecules, peptides and monoclonal antibodies from which we chose to best match the biology of the selected target, the distinctive feature of the ITF R&D group is its expertise in the field of zinc-dependent histone deacetylase (HDAC) inhibitors. Zn-dependent HDACs are a family of 11 related proteins that are involved in the post-translational modification of proteins and polyamines.
Several HDACs are involved in the control of gene expression and their inhibitors have the potential of repro- gramming cell fates by interfering with these processes. Our most advanced compound, Givinostat (a non-selective HDAC inhibitor), has recently been approved by the FDA for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older, and is also in an advanced stage of clinical development in Polycythemia Vera, a rare hematologic cancer. Our R&D group is working to identify exquisitely subtype-selective, second-generation inhibitors to specifically interfere with a defined subset of biological processes controlled by HDACs.
In addition to the development of new chemical entities, Italfarmaco’s R&D group also develops new formulations of established drugs to better respond to patient needs and generics/biosimilars of complex molecules. Examples developed up to market in Europe, USA and Rest of the World are the liquid formulations of antidepressants or hypnotic agents and of Riluzole for the treatment of Amiotrophic Lateral Sclerosis (ALS). Regarding the development of generics/biosimilar of complex molecules, Italfarmaco’s R&D group has developed a generic/biosimilar of enoxaparin which is currently marketed in Europe, USA and Rest of the World.
Our Focus
The goal of Italfarmaco’s research activity is to provide caregivers and patients with effective and safe drugs, to improve the health and to ensure a better quality of life of patients.
Our Focus
The goal of Italfarmaco’s research activity is to provide caregivers and patients with effective and safe drugs, to improve the health and to ensure a better quality of life of patients.
