Abiogen Pharma S.p.A.
Abiogen Pharma S.p.A (Abiogen) is a Tuscany-based pharmaceutical company that operates through three integrated units to market its own products and those in license, as well as develop and produce its own and external products.
Through the spin off, Galileo Research, Abiogen also functions as a research center.
Abiogen’s mission is to enhance its own know-how by specializing and partnering with other companies in the sector, in order to develop, manufacture and market targeting medical solutions in Primary Care and rare diseases worldwide. The company relies on high levels of competence and quality production to achieve excellence in pursuit of the widely available and marketable therapeutic solutions.
Products & Services
Abiogen provides products and services such as CMO, CDMO, Product development and pre-clinical research-services focused on four areas.
- Product out-licensing
- Contract Manufacturing
- Pharmaceutical Development services
- Clinical Supply
Product areas include:
- Hypovitaminosis D: Abiogen Pharma has contributed in a substantial way to provide the medical class with adequate instruments for the prevention and treatment of hypovitaminosis D, a particularly widespread condition among the elderly and in young people, affected by age, skin pigmentation and exposure to sun. In children, a deficiency of vitamin D can lead to rickets, a pathology typical of childhood, characterized by a reduced mineralization of the bones, causing disability and contributing to the pathogenesis of osteoporosis.
- Bone metabolism: Abiogen Pharma is a leader in this market thanks to the marketing of drugs, conceived and developed in its Research Centre and now used worldwide. Abiogen Pharma developed therapies destined both to the treatment of more well- known pathologies such as osteoporosis, bone metastases and osteolysis deriving from multiple myeloma, and to the treatment of rare pathologies such as the Paget syndrome, osteogenesis imperfecta and algodystrophy, also known as Complex Regional Pain Syndrome (CPRS). Recently Abiogen Pharma has integrated its pipeline with Calciobase, the only calcium citrate supplement in the market: the special formulation of calcium citrate has been designed to encourage adherence to supplementation, often abandoned, especially by the elderly, for the notes problems caused by the digestibility of calcium.
- Pain & viscosupplementation: Abiogen Pharma is present in the therapeutic area of Pain Relief with a complete and complementary line of products for the management of inflammatory-related and non-inflammatory/neuropathic pain. Abiogen is also active in the field of viscosupplementation with a medical device class III.
- Dermatology: Abiogen Pharma has always been present in the dermatological area aiding the specialist and the general practitioner by offering therapeutic solutions for the improvement of various skin pathologies. In psoriasis, Abiogen Pharma has acquired high visibility with a drug for topical use contributing to its clinical development.
- Respiratory disease: From its beginnings, Abiogen Pharma has operated in the Respiratory Area in close collaboration with general practitioners and specialists alike including nose and throat specialists, lung specialists and pediatricians offering solutions for the management of respiratory infections.
- Diabetology: Abiogen Pharma provides diabetology specialists with consolidated oral therapies for the treatment of type 2 diabetes, widely favored for their excellent safety/effectiveness profile combined with a very competitive therapy cost.
Abiogen Pharma has inherited the results of many years of R&D activities since the late 70’s in the field of osteoarticular metabolism, leading to expertise in Bisphosphonate and the discovery of effective drugs for the treatment of bone pathologies.
Today, three bisphosphonates are marketed by Abiogen Pharma, including an amino-bisphosphonate used in metabolic osteopathy, the first drug to have obtained the Italian Health Authorities designation for a “rare disease” such as Osteogenesis Imperfecta, with clinical studies progressing for its support in new therapeutic indications.
In the osteoarticular field, studies are also underway for new products with a strong chondro- protective action to be used in osteoarthritis. Intra-articular new combined formulations are in advanced clinical stage.
Structure and history
Abiogen celebrated its Centenary Year in 2017, tracing its origins to early 20th century Pisa, where Commendatore Alfredo Gentili founded Istituto Galenico, which later became Istituto Gentili S.p.A.
The purchase of Istituto Gentili S.p.A. by the American multinational Company Merck Sharp & Dohme in 1997, opened a path for the creation of Abiogen Pharma, which maintained most of the product list, staff and site of Istituto Gentili.
Abiogen was launched onto the Italian and international market with the inherited skills and professionalism acquired in over 90 years of activity in the field.
Abiogen Pharma has underlined its commitment to R&D with the creation of the Alfredo Gentili Research Centre based in the 13th century historic St. Peter’s Church in Malaventre, subject of an ambitious restoration project undertaken in collaboration with the Superintendent for Monuments in Pisa. The study center is committed to promote exchange and spreading of knowledge between the academic and business world, exploiting the knowhow gained in the pharmacological and clinical fields with initiatives that feature the site as a permanent point for national and international meetings and training.
Quality and Regulatory
Abiogen processes and facilities comply with EU Good Manufacturing Practices (UE GMP); EU Directive 2001/83/EC and following amendments as well as national laws such as Italian Decree 219/2006 and following amendments.
The company holds manufacturing license and GMP certificates issued by the Italian Medicines Agency (AIFA), Korean Food and Drug Administration (KFDA) and Ministry of Industry and Trade of the Russian Fedaration as well as ISO 9001:2015 and OHSAS 18001:2007 certification, along with Certificate of compliance to FARMINDUSTRIA reference documentation for procedures related to Scientific Information Activities; Ministry of Health Authorization for use and commerce of narcotic substances.
To learn more about Abiogen Pharma services and capabilities and how they can assist your business, please contact the supplier.
- CRO, CMO, CRAMS & CDMO
- Clinical Trials & Studies
- Drug Delivery
- Drug Discovery
- Formulation & Ingredients
- Laboratory Equipment & Services
- Manufacturing & Production
- Pre-Clinical Research
- Regulatory Affairs & Compliance