Pharmaceutical

Actinium Pharmaceuticals, Inc. (NYSEMKT:ATNM) announced today that it has engaged a leading European-based regulatory affairs consulting firm to pursue orphan medicines designation by the European Medicines Agency (EMA) for Iomab-B.

Actinium Pharmaceuticals, Inc. (NYSEMKT:ATNM) announced today that it has engaged a leading European-based regulatory affairs consulting firm to pursue orphan medicines designation by the European Medicines Agency (EMA) for Iomab-B. The Company anticipates the following events to occur over the coming months and will provide updates on its EU orphan designation progress as key milestones occur.
According to the news:

In the immediate future, the Company along with its consultant expects to submit preliminary documentation along with the application form, questions and a presentation to the EMA. Following this, the parties are expected to participate in a pre-submission meeting with the EMA prior to entering the final submission to the EMA. These events are expected to occur over a period of a few weeks to months. The consultants anticipate that sometime in second half of this year, the Committee for Orphan Medicinal Products (COMP) will communicate with the Company to address validation issues. Once this interaction is complete, the formal regulatory procedure begins and the COMP will provide a summary report and potentially a list of items that would need to be addressed. The Company will then submit its responses to the COMP’s list of items to be addressed and after satisfying this request the COMP will issue an opinion on the orphan designation.

Kaushik J. Dave, Ph.D., Actinium’s Chief Executive Officer, CEO stated:

We are excited to begin the process of pursuing orphan designation in the EU for Iomab-B. Iomab-B is intended to address the niche patient population of relapsed and refractory Acute Myeloid Leukemia (AML) patients over the age of 55 and we are confident that it meets the criteria for orphan designation. We look forward to working with our regulatory consultants and the EMA over the next several months as we endeavor to obtain EU orphan designation for Iomab-B.

Click here to view the full press release. 

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