Prepares to Bring Vaccines to Canada to Prevent Recurrent UTIs and RTIs

MISSISSAUGA, Canada (March 2021) Red Leaf Medical Inc. announced the signing of an expanded exclusive licensing agreement with Inmunotek, a leading pharmaceutical company specializing in allergy and immunology, to bring innovative vaccines to the Canadian market. The Agreement includes BACTEK™, a novel sublingual vaccine for the prevention of recurrent respiratory tract infections (RTIs), and UROMUNE™, a novel sublingual vaccine for the prevention of recurrent Urinary Tract Infections (UTIs).

Patients suffering from repeated UTIs and RTIs – some of the most common infections – often rely on continuous and prolonged courses of antibiotics to prevent recurrence. In Canada, this represents an exorbitant amount of antibiotics, significant cost and burden to both society and patients. [i]

Approximately 50-60% of women experience a UTI in their lifetime with >25% developing recurrent UTIs requiring long-term dosing of antibiotics.[ii] In When Antibiotics Fail, a research report sponsored by the Public Health Agency of Canada, it was estimated that 23.9% of UTIs were resistant to drugs used to treat them costing the health care system $350 million dollars annually and resulting in 6,700 deaths per year from UTIs.[iii] With the alarming rise of antibiotic resistance worldwide, and with the World Health Organization initiating a Global Action Plan to combat antibiotic resistance, there is an urgent need to find viable alternatives.

BACTEK™ is currently in phase III development with several other clinical trials demonstrating success. The phase III randomized control trial of UROMUNE™ has been completed and the results will be presented at major urology congresses in 2021. Red Leaf Medical intends to file a new drug submission to Health Canada for UROMUNE™ later this year.

“Red Leaf Medical’s proven track record of successfully launching new products and growing established brands will help UROMUNE™ and BACTEK™ gain a strong foothold in Canada,” said Charles Ko, Chief Executive Officer, Red Leaf Medical. “We are pleased with the opportunity to help patients and healthcare professionals manage these serious infections and to offer solutions that will mitigate the critical issue of antimicrobial resistance.”

“We are excited to expand our partnership in Canada with Red Leaf Medical,” said Jose Luis Subiza, Chief Executive Officer, Inmunotek. “Red Leaf Medical has played a pivotal role in facilitating UROMUNE’s first North American clinical study and has established important relationships with key stakeholders to set up UROMUNE™ for success in Canada and beyond. “

About Inmunotek

Inmunotek is an innovative pharmaceutical company that researches, develops, manufactures and markets products for the diagnosis and treatment of diseases in the field of allergy and immunology. The Company is based in Madrid, Spain.

Inmunotek was listed on the 2017 FT 1000 – Financial Times listing of Europe’s fastest growing companies.

About Red Leaf Medical Inc.

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 services 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]Wagenlehner F, Wullt B, Ballarini S, et al. Social and economic burden of recurrent urinary tract infections and quality of life: A patient web-based study (GESPRIT). Expert Rev Pharmacoecon Outcomes Res 2018;18:107-17. https://doi.org/10.1080/14737167.2017.1359543

[ii]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

[iii]When antibiotics fail: The Expert Panel on the potential socio-economic impacts of antimicrobial resistance in Canada 2019. Available at: https://cca-reports.ca/reports/the-potential-socio-economic-impacts-ofantimicrobial-resistance-in-canada/