• Polyphor reports that its lead antibiotic product POL7080 received QIDP designation from the U.S. FDA for the treatment of Ventilator-Associated Bacterial Pneumonia caused by Pseudomonas aeruginosa.
• QIDP designation provides priority review and eligibility for the FDA fast-track status.
• QIDP also extends statutory exclusivity of POL7080 for five years if the product is ultimately approved by the FDA.
Allschwil, Switzerland, November 12, 2014 - Polyphor Ltd, a privately held pharmaceutical company specialized in the discovery and development of macrocycle drugs, announced today that the U.S. FDA designated POL7080 as a Qualified Infectious Disease Product (QIDP) for the treatment of Ventilator-Associated Bacterial Pneumonia (VABP) caused by Pseudomonas aeruginosa.
A QIDP designation, granted under the U.S. Generating Antibiotic Incentives Now (GAIN) Act, provides certain incentives for the development of new antibiotics including priority review, eligibility for fast-track status and a five-year extension of market exclusivity in the USA if the product is approved. Antimicrobial resistance represents a major threat to public health worldwide. Pseudomonas aeruginosa accounts for 10% of hospital-acquired infections in the USAi and is listed as one of the six most dangerous drug-resistant microbesii. Surveillance programs revealed that over 15% of Pseudomonas aeruginosa isolates were resistant to at least three classes of antibiotics and close to 5% were resistant to all five classesiii.
POL7080 belongs to a new class of antibiotics discovered by Polyphor. These antibiotics target Gram-negative bacteria via a novel mode of action. POL7080 has demonstrated clinical safety and tolerability in a Phase I clinical trial and is currently being tested in Phase II clinical trials in patients suffering from VABP or Bronchiectasis. POL7080 holds great promise for the treatment of serious and often life-threatening bacterial infections caused by multi-drug resistant (MDR) Pseudomonas aeruginosa.
In November 2013, Polyphor and Roche had joined efforts and Roche obtained the license rights to develop and commercialize POL7080 globally. Polyphor has retained the option to co-promote an inhaled formulation of POL7080 in Europe.
“Ventilator-Associated Pneumonia caused by Pseudomonas bacteria represents one of the most difficult to treat bacterial infections, particularly if such infections are caused by multi-drug resistant bacteria,” said Dr. Rangaraju Manickam, Senior Medical Project Leader, at Polyphor. “By expediting the FDA review process, the QIPD designation of POL7080 supports the ongoing development of this promising novel antibiotic and could ultimately bring a much-needed new treatment option to patients faster.”
For Further Information:
Michael Altorfer, Head Corporate Communications, Polyphor Ltd
Phone: +41 61 567 16 00
About antimicrobial resistance
Antimicrobial resistance represents a serious and growing threat to human and animal health worldwide. Resistance can also spread from animals to humans through the food chain or direct contact. According to the World Health Organization (WHO), “antibiotic resistance is becoming a public health emergency of yet unknown proportions.” Meanwhile, new forms of resistance continue to arise and spread, leaving clinicians with few options to treat such challenging infections. Despite the high unmet medical need only two new classes of antibiotics have been brought to the market in the last three decades.iv
About Pseudomonas aeruginosa
Pseudomonas is a bacterium commonly found in the environment which can give rise to serious and often life-threatening infections in various types of tissue. These infections usually occur in patients in the hospital and/or with weakened immune systems. A significant proportion of Gram-negative infections are caused by Pseudomonas aeruginosa.
Pseudomonas aeruginosa causes urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections. Any Pseudomonas infection represents a serious problem in immuno-suppressed patients with cancer, AIDS, and severe burns or in patients suffering from chronic infections such as Cystic Fibrosis. The case fatality rate in some of these patient groups is close to 50%.
Pseudomonas aeruginosa infections are generally treated with antibiotics. Unfortunately, in hospitalized patients, Pseudomonas infections, like those caused by many other hospital bacteria, are becoming more difficult to treat because of increasing antibiotic resistance.
About QIDP and the GAIN Act
The Qualified Infectious Disease Product (QIDP) designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, which was passed by the U.S. Congress in July 2012. The QIDP designation provides certain incentives to foster the development of new antibiotics, including priority review and eligibility for FDA’s fast track program, and five extra years of market exclusivity if the FDA approves the product in the USA.
Polyphor is a Swiss Pharma company focusing on the discovery and development of macrocycle drugs addressing high unmet medical needs. Macrocycles represent a new drug class complementary to the classical small molecules and large biopharmaceuticals. Polyphor leverages its unique and proprietary technologies to develop its own product portfolio and to pursue licensing and collaboration opportunities. The company’s lead drug candidates include POL6326, a CXCR4 antagonist, with ongoing and upcoming Phase II clinical trials for stem cell transplantation, tissue repair and combination treatments in oncology; POL7080, a highly specific antibiotic with a novel mode of action to treat Pseudomonas infections (Phase II, licensed to Roche); and POL6014, an inhaled inhibitor of neutrophil elastase for the treatment of Alpha-1 Antitrypsin Deficiency, Cystic Fibrosis, and other lung diseases (IND enabling studies). Polyphor is a privately held company with about 100 employees, headquartered in Allschwil, near Basel.
For additional information, please visit www.polyphor.com
iSource: US Center for Disease Control and Prevention
iiSource: Infectious Diseases Society of America
iiiSource: ECDC “Antimicrobial resistance surveillance in Europe” 2011 report
ivSource: Innovative Medicines Initiative, New IMI Projects to Revitalize Antibiotic Development, 11 February 2013