Research & Development
Research is a significant aspect of Kedrion’s activities. Each stage of product development – from basic research to pre-clinical and clinical trials, to pharmacovigilance ongoing monitoring of product use and efficacy – contributes to the same objective: encouraging innovation so as to improve, one step at a time, how we serve patients worldwide.
Our commitment to this objective is very strong, especially in relation to extremely rare diseases for which there is still no treatment. Meeting this need is both a responsibility and a priority for us.
Kedrion is constantly seeking to create new products and improve existing ones – which requires careful and extensive clinical studies, including observational studies – as well as to increase efficiency and capacity of our manufacturing sites.
The solid and long-standing cooperation that, over the years, we have established with doctors, researchers, public and private entities, and national and international bodies, proves just how good for research the sharing of knowledge and skills actually is.
We like to imagine ourselves as a bridge: between state-of-the art projects and production activities, between the world of research and industry, between our company and local businesses and associations.
The history of Kedrion Biopharma is a testimony to our close relationship with the territory in which we operate and with local communities, with whom we have been cooperating for many years with a view to promoting research and innovation.
True to this vision, we have decided to expand and consolidate this commitment by initiating a real strategic path of “open innovation”. This path is aimed at promoting a continuous and active exchange of ideas, experience and expertise with doctors, researchers, universities, start-ups, public and private agencies, and patient organizations in order to gather and evaluate the most innovative ideas and projects proposed by our local partners, and promoting their implementation on an industrial scale.
Promoting innovation means improving the quality of patients’ lives.
There are many diseases and disorders that are life-threatening or chronically debilitating but which affect very few people. Some of these are referred to as “neglected” or “orphan diseases” because there is little economic incentive to research and develop treatment for them. Drugs that are found or developed to treat these disorders have come to be known as “orphan drugs”.
Kedrion commits to fighting against rare diseases and seeks to creating value in the field of orphan drugs.
Because our work at Kedrion is directed at providing relief from rare or extremely rare diseases, we take special interest in the development of orphan drugs.
Kedrion is developing, within this specific frame, plasma-derived Plasminogen eye drops for the treatment of Ligneous Conjunctivitis in subjects affected by Type 1 Plasminogen deficit, a not well-known very rare disease that could affect 1 person every 1.6 million. Kedrion’s efforts to help patients (we have a compassionate use/expanded access program in place since many years) has been acknowledged by the French Healthcare Authorities, which have authorized its use on individual basis through a program called A.T.U., and very recently by the Italian AIFA , which has authorized the use of Plasminogen drops and its reimbursement – according to the 648/96 law – by the National Public Health System for patients affected by Ligneous Conjunctivitis. These few patients will finally have access to the specific treatment that was until now missing.
In the framework of the Tuscany POR CReO FESR 2014-2020 program, the company has recently received two grants for the following projects:
- Development of a plasma-based Plasminogen concentrate in the form of eye drops for the treatment of Ligneous Conjunctivitis (CL); the grant will be used to improve the product purification process. For more information.
- R&D for the “Development of methods for the purification of Factor V from plasma, for the prophylaxis and treatment of hemorrhagic episodes in people with deficiencies,”; the grant will be used to accelerate and facilitate the development of the relevant product. For more information.
- Development of an intravenous 10% immunoglobulin formulation obtained by means of a chromatographic purification process. See here for further details. For more information.
Kedrion will consider granting “Early Access” to an Investigational Medicinal Product – i.e. to an investigational drug outside of a clinical trial and in compliance with applicable laws and regulations – to those patients affected by serious or life-threatening diseases or conditions for whom no approved effective therapies with specific indication are commercially available in the specific country, and participation in an on-going clinical trial is not an option.
Health Care Professionals (HCPs) treating patients who want to know more about this program can click on this link.