Sagetis Biotech receives Orphan Designation from the European Medicines Agency for its novel product
Barcelona, November 28 2017 – Sagetis Biotech today announced that it has been granted Orphan Designation for SAG-101, its novel polymer-coated adenovirus for the treatment of pancreatic cancer.
Orphan Designation is granted by the European Commission to drugs that are intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating rare diseases where no satisfactory method of diagnosis, prevention or treatment of the condition concerned is authorized. If such a method exists, then the medicine must be of significant benefit to those affected by the condition. Rare diseases are those defined as having a prevalence of not more than five per 10,000 population in Europe. The Orphan Designation provides potential incentives for the sponsor from the EU to develop a medicine for a rare disease, such as protocol assistance, reduced fees, funding from the European Commission for clinical trials, and protection from competition once the medicine is placed on the market, including ten years of market exclusivity.
Eduard Diviu, CEO of Sagetis Biotech, commented: “We are delighted to announce the Orphan Drug designation for our lead candidate SAG-101. This further encourages us bring treat pancreatic cancer patients as soon as possible, a highly unmet need condition. For Sagetis, this represents a further step in the development of this unique class of virotherapy and may add to the successful financing of the company”.
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About Sagetis Biotech
Sagetis Biotech is devoted to developing an innovative gene delivery technology to overcome a fundamental engineering challenge in gene therapy: the development of safe and effective delivery vectors.
Privately funded and based in Barcelona, Sagetis Biotech is developing SAG-101: a polymer-coated adenovirus for the treatment of pancreatic cancer.