Hemispherx Biopharma Receives Orphan Drug Designation for Ampligen in Treatment of Ebola Virus Disease

Hemispherx Biopharma, Inc. has announced that its European subsidiary, Hemispherx Biopharma Europe N.V./S.A., has received formal notification from the European Commission approving its Orphan Medicinal Product Application for Ampligen, an experimental therapeutic, to treat Ebola Virus Disease (EVD). This designation is an important achievement in the company's path towards commercial approval of Ampligen as a prophylactic and early onset therapeutic for Ebola and other lethal viral diseases. With this designation, Hemispherx Biopharma is now eligible for grants from European Union (EU) and Member State programs, as well as initiatives supporting research and development. Designated orphan medicines are assessed for marketing authorization centrally in the EU, resulting in a single opinion and a single decision from the European Commission, valid in all EU Member States.

Key Takeaways:

• Hemispherx Biopharma's Ampligen has received Orphan Medicinal Product Application approval from the European Commission for the treatment of Ebola Virus Disease (EVD).
• The orphan drug designation promotes the clinical development of drugs targeting rare life-threatening conditions, including tropical diseases primarily found in developing nations.
• With this designation, Hemispherx Biopharma is eligible for grants from European Union (EU) and Member State programs, as well as initiatives supporting research and development.
• The designated orphan medicine is assessed for marketing authorization centrally in the EU, resulting in a single opinion and a single decision from the European Commission.
• Designated orphan medicines receive benefits including ten years of complete protection from market competition with similar medicines.
• Ampligen has not yet completed clinical trials, and no assurances can be given that the EMA will approve it for treatment of EVD.

Statistics:

• 10 years: duration of complete protection from market competition with similar medicines for designated orphan medicines.
• 2 years: extension of protection from competition for medicines that comply with an agreed pediatric investigation plan.
• 100%: single opinion and single decision from the European Commission for designated orphan medicines assessed centrally.
• Single application: single application to the EMA for designated orphan medicines, resulting in a single opinion and single decision from the European Commission.

Sources:

• Hemispherx Biopharma
• European Commission (EU/3/15/1480-EMA/OD/310/14)
• European Medicines Agency (EMA)
• European Union (EU)
• Member State programs supporting research and development
• Contify.com (Source: Hemispherx Biopharma Copyright 2014)