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Cell Medica Achieves EU Orphan Drug Designation

Published: Tuesday, January 07, 2014
Last Updated: Tuesday, January 07, 2014
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Orphan drug designation in the European Union for Cytovir ADV.

Imperial Innovations Group plc has welcomed the announcement from portfolio company Cell Medica that its cell therapy Cytovir ADV has been awarded a positive opinion by the European Medicines Agency’s Committee for Orphan Medicinal Products.

The EU’s Orphan Medicinal Product Designation is designed to promote the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. The designation also provides eligibility for protocol assistance, possible exemptions or reductions in regulatory fees during development, and ten years of market exclusivity from product launch in the EU.

Cytovir ADV, a novel T cell immunotherapy, targets the treatment of adenovirus infections in patients following a bone marrow transplant. Adenovirus infections are a frequent cause of morbidity and mortality in patients, particularly children, who have received bone marrow transplants.

Cytovir ADV is being investigated as a novel method for transferring adenovirus immunity from the donor to the patient following the bone marrow transplant procedure. These patients are generally profoundly immuno-compromised for a period of six to nine months after the procedure and hence vulnerable to life-threatening infections. Cell Medica is developing a related product, Cytovir CMV, for cytomegalovirus infections in the same patient group.

Cytovir ADV is currently being investigated in the ASPIRE Phase I/II clinical trial under way at the Great Ormond Street Hospital (GOSH) in London.

Maina Bhaman, Director of Healthcare Investments at Innovations, said: “The EU orphan designation for Cytovir ADV, the first for a T cell therapy to treat infections, reflects Cell Medica’s continued leadership in developing cell-based immunotherapies. The orphan status can provide an important competitive advantage to support the company’s commercialization strategy going forward.”

Gregg Sando, Chief Executive Officer of Cell Medica, said: “Cytovir ADV represents a potential breakthrough for the treatment of life-threatening adenovirus infections in children following a bone marrow transplant and we are very excited about the continued progress for this cell therapy. Receiving orphan designation for Cytovir ADV in the European Union is a significant milestone for Cell Medica. The benefits include 10 years of market exclusivity from product launch in the EU as well as fee reductions.”

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