This is the first AAC for a treatment in patients who have failed antibiotic therapy, particularly expected in the context of the fight against antibiotic resistance.
Regulatory News:
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."
About Pherecydes Pharma
Founded in 2006, Pherecydes Pharma is a biotechnology company that develops treatments against resistant bacterial infections, responsible for many serious infections. The Company has developed an innovative approach, precision phage therapy, based on the use of phages, natural bacteria-killing viruses. Pherecydes Pharma is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which alone account for more than two thirds of hospital-acquired resistant infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. The concept of precision phage therapy has been successfully applied in several dozen patients in the context of compassionate use, under the supervision of the French National Agency for the Safety of Medicines (ANSM). Headquartered in Nantes, Pherecydes Pharma has a team of around twenty experts from the pharmaceutical industry, biotechnology sector and academic research.
For more information, www.pherecydes-pharma.com
Disclaimer
This press release contains non-factual elements, including, but not limited to, certain statements regarding future results and other future events. These statements are based on the current vision and assumptions of the management of the Company. They incorporate known and unknown risks and uncertainties that could result in significant differences in results, profitability and expected events. In addition, Pherecydes Pharma, its shareholders and its affiliates, directors, officers, counsels and employees have not verified the accuracy of, and make no representations or warranties about, statistical information or forecast information contained within this news release and that originates or is derived from third party sources or industry publications; these statistical data and forecast information are only used in this press release for information purposes. Finally, this press release may be drafted in French and in English. In the event of differences between the two texts, the French version will prevail.
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Contacts:
Pherecydes Pharma
Thibaut du Fayet
Deputy CEO
investors@pherecydes-pharma.com
NewCap
Dusan Oresansky Olivier Bricaud
Investor Relations
pherecydes@newcap.eu
T.: +33 1 44 71 94 92
NewCap
Arthur Rouillé
Media Relations
pherecydes@newcap.eu
T.: +33 1 44 71 00 15
