AmpliPhi Biosciences granted Small and Medium Enterprise status by EMA

Europe to be a key market for the company's phage-based therapies to treat bacterial infections in patients with unmet medical needs.

SME designation was launched by the EMA to promote innovation and the development of new human therapeutics by early and mid-stage healthcare companies. SME status confers certain benefits on its member companies including financial support and incentives, including significantly reduced fees for regulatory procedures, including Scientific Advice, Marketing Authorizations and inspections, and increased incentives for orphan products. SME designation also offers access to administrative and regulatory support; scientific advice and protocol assistance, including guidance on clinical trial publication; and workshops and training sessions. Companies with SME status can apply for early application to the priority medicines (PRIME) scheme, which offers accelerated review times for drugs that truly address unmet medical needs.

“We expect Europe to be a key market for AmpliPhi and our phage-based therapies to treat bacterial infections in patients with unmet medical needs,” said M. Scott Salka, CEO of AmpliPhi. “We intend to take full advantage of the financial, scientific and regulatory benefits offered under the SME program and look forward to our future interactions with the EMA.”