AmpliPhi Biosciences Corporation (NYSEMKT: APHB), a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics, today announced that it has been granted Small and Medium Enterprise (SME) designation by the European Medicines Agency (EMA).
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.”
For more information, visit www.ampliphibio.com.
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation (NYSEMKT: APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. AmpliPhi's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi has reported topline results from two Phase 1 clinical trials of AB-SA01, one for the treatment of Staphylococcus aureus in chronic rhinosinusitis patients and one to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi expects to report final data from each trial by the end of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa and Clostridium difficile in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies.
Bacteriophage are naturally-occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, producing hundreds of offspring viruses in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms, which are a major line of defense for bacteria and help them resist antibiotics. Bacteriophage can effectively penetrate biofilms to produce strong local therapeutic effects without destroying bacteria important to normal human health.
Forward Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements about the expected timing of reporting data from AmpliPhi’s two AB-SA01 trials, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, the potential markets for AmpliPhi’s phage-based therapies, the potential benefits of phage therapy, and AmpliPhi’s development of bacteriophage-based therapies. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon AmpliPhi’s current expectations and involve a number of risks and uncertainties, including the risks and uncertainties described in AmpliPhi’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, as filed with the Securities and Exchange Commission. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
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Last updated on: 01/11/2016
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