VANCOUVER, BC – October 03, 2018
The FDA designation provides five years of additional market exclusivity after approval for Ondine Biomedical Inc.’s nasal antimicrobial photodynamic disinfection system indicated to prevent post-surgical staphylococcal infections.
Ondine Biomedical Inc. and its wholly owned subsidiary, Champion ENT Products Inc., announced today that the US FDA has awarded Qualified Infectious Disease Product (QIDP) designation to the company’s lead photodisinfection product for the prevention of post-surgical staphylococcal infections. The QIDP designation was granted under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act, intended to encourage development of treatments for serious or life-threatening infections.
Ondine’s nasal photodisinfection system is a patented, first-in-class, light-activated antimicrobial therapy being developed to eradicate a broad spectrum of nasal pathogens without promoting antibiotic resistance, including the ‘superbug’ methicillin-resistant Staphylococcus aureus (MRSA).
“QIDP designation for Ondine’s nasal photodisinfection system marks an important milestone in our flagship development program,” stated Dr. Roger Andersen, MD, Vice President, Regulatory and Clinical Affairs. “With over 50,000 patients treated in Canada, we look forward to launching a robust US clinical development program with the goal of preventing post-surgical staphylococcal infections, and ultimately to bring this light-activated technology to patients across the world.”
About Post-Surgical Site Infections
Surgical site infections (SSI’s) account for 15% of all hospital acquired infections and contribute substantially to morbidity and mortality each year. Up to 5% of surgical patients will develop an SSI in hospital, often resulting from Staphylococcus aureus infection. In many cases this virulent pathogen exhibits multidrug resistance making it increasingly difficult to treat. The evolution of antimicrobial resistance stems from the widespread use of antibiotics as growth enhancers in animal feed, the inappropriate use in viral and non-susceptible infections, and the ease with which resistant microbes transfer between continents, cities, hospitals and patients. The relative risk of an SSI is up to 9 times greater in Staphylococcus carriers than in non-carriers. Furthermore, molecular epidemiology has demonstrated that the patient’s own nasal microflora are responsible for over 80% of post-operative infections. Existing approaches to eliminating nasal bacteria rely on expensive testing prior to surgery and/or prolonged antibiotic therapies. Compliance with these approaches is often poor, and the development of antibiotic resistance is a very real threat.
About the Generating Antibiotic Incentives Now (GAIN) Act
The GAIN Act of 2012 seeks to provide pharmaceutical and biotechnology companies with incentives to encourage the development of new approaches to the treatment, prevention, detection and diagnosis of antibiotic-resistant infections. Qualifying pathogens are defined by the GAIN Act to include multi-drug resistant Gram-negative bacteria, including Pseudomonas, Acinetobacter, Klebsiella, and Escherichia coli species; resistant Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus; multi-drug resistant tuberculosis; and Clostridium difficile. Awards under the GAIN Act extend the length of time an approved therapy is free from Hatch-Waxman competition and can also reduce review times during the approval process.
About Ondine Biomedical Inc.
Ondine Biomedical Inc. is dedicated to the development of non-antibiotic, anti-infective therapies for a broad-spectrum of bacterial, viral and fungal infections. Ondine’s antimicrobial program utilizes a platform technology called photodisinfection, a light-activated approach being developed to provide rapid antimicrobial efficacy and reduced risk of antibiotic resistance. Over 65 patents in 21 patent families have been granted or are pending covering various aspects of the technology. Ondine’s flagship nasal photodisinfection system has been deployed in Canada for several years, and other applications of the photodisinfection platform are under development, including SinuwaveTM, a photodisinfection product to treat chronic rhinosinusitis, and an endotracheal tube photodisinfection product designed to reduce the incidence of ventilator-associated pneumonia (VAP).
Forward Looking Statement
This press release contains certain forward-looking statements, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. The Company has made every reasonable effort to ensure the information and assumptions on which these statements are based are current, reasonable and complete. However, a variety of factors, many of which are beyond the Company’s control, affect the Company’s operations, performance, business strategy and results and there can be no assurances that the Company’s actual results will not differ materially from those indicated herein. Additional written and oral forward-looking statements may be made by the Company from time to time. The Private Securities Litigation Reform Act of 1995 provides a safe-harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.