RED LEAF MEDICAL FILES FOR APPROVAL OF UROMUNE™ IN CANADA

New Vaccine Significantly Decreases Urinary Tract Infections and Prevents Recurrence in Women

Mississauga, Canada (Mach 25, 2022) – Red Leaf Medical today announced that it has filed a new drug submission with Health Canada for approval of UROMUNE™, a sublingual vaccine for the prevention of recurrent urinary tract infections(rUTIs) in women.

The new drug submission is supported by results from a UROMUNE™ multicenter, prospective, randomized, double-blind, placebo-controlled trial. These results were recently published in the New England Journal of Medicine Evidence and showed that UROMUNE™ is effective at reducing the number of urinary tract infections in patients suffering from rUTIs.

“Uromune offers hope to women suffering from recurrent urinary tract infections who currently rely on multiple courses of antibiotics to treat their condition,” said Charles Ko, Managing Director, Red Leaf Medical Inc. “In addition to improving UTI management, Uromune has the potential to improve antibiotic stewardship and decrease the overall risk of antibiotic resistance.”

About UTIs

UTIs are one of the most common infections in Canada.[i] More than 50% of women experience a Urinary Tract Infection (UTI) in their lifetime[ii], with 20% to 40% of those suffering recurrences and requiring multiple short and long-term dosing of antibiotics.[iii]  Recurrent UTIs are defined as three or more UTIs during a 12-month period or 2 or more during a 6-month period.ii  UTIs are also the most common infection in older adults and the leading infection requiring antimicrobials in long term care.[iv]

The Cost of UTI’s and the Rise of Antimicrobial Resistance (AMR)

The Canadian Council of Academies (CCA) iii estimated that in 2018:

  • Approximately 23.9% of UTIs (1 in 4 patients) in Canada were resistant to antibiotics used to treat them
  • UTIs cost the Canadian health care system approximately 350 million dollars
  • Hospital cost per resistant UTI is approximately 20,000 dollars
  • UTIs were responsible for 6,700 deaths
  • UTIs were responsible for 3,000 years of lost employment
  • Antimicrobial resistance is likely to grow at an alarming rate – from 26% in 2018 to 40% in 2050 costing the healthcare system six to eight billion dollars a year.

Continued use of antibiotics for the treatment or prevention of UTIs not only contributes to the ill health of individual patients, but also to the alarming rise of antibiotic resistance. In Canada, this represents an exorbitant amount of antibiotics — a significant cost and burden to both society and patients. vii

About UROMUNE™

UROMUNE™ is a self-administered vaccine that works by stimulating the immune system, particularly the innate immune system of the bladder. The vaccine is a sublingual spray and the patient administers two sprays under the tongue once daily for three months. UROMUNE™ is composed of four whole cell inactivated bacteria, including equal amounts of UTI-causing pathogens: Escherichia coli; Klebsiella pneumoniae; Proteus vulgaris; and Enterococcus faecalis. UROMUNE™ was developed by Inmunotek, an innovative pharmaceutical company based in Spain. The product is exclusively licensed in Canada to Red Leaf Medical.

About Red Leaf Medical

Red Leaf Medical is a leading Canadian healthcare company specializing in urology and infectious disease. The Company provides innovative therapies and solutions in the areas of pelvic floor health, fertility and urinary tract infections. Red Leaf Medical is a trusted partner to patients and healthcare providers offering industry leading products and patient support programs. Founded in 2009, the company continues to expand its portfolio by launching important new products and services, such as CathetersPLUS™ and ConceptionPLUS™.  Learn more at redleafmedical.com.

[i] Council of Canadian Academies, 2019. When Antibiotics Fail. Ottawa (ON): The Expert Panel on the Potential Socio-Economic Impacts of Antimicrobial Resistance in Canada, Council of Canadian Academies.

[ii] Foxman B, Barlow R, D’Arcy H, et al. Self-reported incidence of urinary tract infection and associated costs. Ann Epidemiol 2000;10:509-15. https://doi.org/10.1016/S1047-2797(00)00072-7.

[iii] Epp A, Larochelle. ASOGC clinical guidelines for rUTI. J Obstet Gynaecol Can 2017;39:e422-31. https://doi.org/10.1016/j.jogc.2017.08.017

[iv] Nicolle, L. (2013). Urinary Tract Infection. In J. F. M. Nunez, J. S. Cameron & D. G. Oreopoulos (Eds.), The Aging Kidney in Health and Disease. London, United Kingdom: Spring Science+Business Media.