Actinium Pharmaceuticals, a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, has announced that the company has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency (EMA).
Dr Roland Turck, Adviser to the Board of Directors of Actinium Pharmaceuticals, said: “SME status is an integral step in the company’s approach to the EU market and will serve the company well going forward. Based on our initial assessment of the EU market, we believe there is a compelling commercial opportunity for Iomab-B and I look forward to continuing to work with Actinium in the pursuit of orphan designation in the EU as well as progressing Actinium’s exciting radioimmunotherapy candidates.”
SME status was established by the EMA to promote innovation and development of new medicines. Companies granted SME status receive administrative and regulatory support including scientific advice, scientific services, pre-authorization inspection and post-authorization procedures. In addition, financial support is provided with fee reductions up to 100% in certain instances. Based on Actinium’s SME status, the company expects to receive fee reductions up to 90%.
“We are excited and grateful to have been granted this important SME status by the EMA,” said Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals. “The assistance and financial support we will receive as a result of this status will be beneficial as we drive towards bringing our Iomab-B and Actimab-A drug candidates to patients located in the EU.”