Pherecydes Pharma (Paris:ALPHE) (FR0011651694 – ALPHE), a biotechnology company specializing in precision phage therapy to treat resistant and/or complicated bacterial infections, today announces that it has been granted AAC Early Access Program approval by the ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé, the French National Agency for the Safety of Medicines and health products) for its anti-Staphylococcus aureus (S. aureus) phages.
The new AAC system (formerly nominative authorization for early access – ATU), introduced in July 2021, allows certain categories of sick patients in France with no therapeutic solutions to benefit from drugs yet to be granted marketing approval.
Thus far, Pherecydes Pharma has treated more than 50 patients within the framework of compassionate treatment under the supervision of the ANSM, excluding AAC status, including 28 with its anti-S. aureus phages. These phages, administered via various routes (intra-articular, intravenous, bronchoalveolar nebulization, etc.), have demonstrated excellent tolerance with no reported side effects.
The AAC scheme allows Pherecydes Pharma to make its anti-S. aureus phages available to larger populations and thus generate the first revenue in the Company’s history.
The Company is intending to request AAC status also for its anti-Pseudomonas aeruginosa phages, and hopes to be granted approval by the end of 2022.
Didier Hoch, Chairman and CEO of Pherecydes Pharma, commented:
“The granting of AAC for our anti-S. aureus phages highlights the critical need for treatments for antibiotic-resistant infections, a real public health issue. This is a new hope for patients who currently have no therapeutic solutions. This approval represents a major value driver to support our development efforts, insofar as these treatments can henceforth generate revenue. We have clearly successfully reached a new and decisive milestone for the Company, and I am very grateful for the work accomplished by our team and I also thank all our partners and clinicians for their support. We intend to capitalize on this success to continue Pherecydes Pharma’s growth over the long term.”
Frédérique Vieville, Quality Director of Pherecydes Pharma, commented:
“We are proud to be one of the very first French companies to obtain an AAC, associated with a Temporary Use Protocol (TUP). Close collaboration with the ANSM over the last few months has enabled us to achieve this major validation for patients in therapeutic deadlock. The organisation is now in place to deliver our phages to all clinicians who request them.”