How are drugs developed at Vifor Pharma?
The key compounds used to treat iron deficiency were developed in our Swiss R&D laboratories in St. Gallen, where they are also produced. This site continues to investigate novel options and compounds for the management of iron deficiency.
OM Pharma was already active in the field of infectious disease immunology when antibiotics were discovered, and has continued to broaden its expertise ever since in this complex and constantly evolving field. The result has been the development of medicines able to stimulate the body's defence mechanisms against infections.
Clinical development consists of four sequential phases performed by specialists around the world. Ongoing research is a combination of studies, designed and coordinated by Vifor Pharma (and partners) in addition to concepts developed by leading physicians in the relevant field:
Phase I evaluates in healthy volunteers how the human body absorbs, metabolises, and excretes the product and whether it has the desired effect. This phase lasts for about one year.
Phase II trials are conducted to find a dose with an optimal efficacy/safety profile in patients. Phase II can take one to two years.
Phase III trials involve various clinics and specialists around the world applying the product to large patient groups in the defined dosage. As regulatory authorities want proof of the safety of the product in long-term usage, at least one of the studies must involve a treatment period of one year. Due to the large number of patients, this phase can easily take up to three years. Only one out of ten candidates entering clinical development reaches this point. Furthermore, phase III trials can provide support for entering new therapeutic indications.
Phase IV of clinical development takes place when the product is on the market. The purpose of phase IV studies is to generate further scientific data that help the clinicians decide on optimal treatment options for their patients. Another important aspect of this phase is to publish the data in medical journals and present them at scientific congresses to educate physicians on the latest findings.