Mississauga, Ontario (May 1, 2019) — Verity Pharmaceuticals announced today that, following a priority review, Health Canada has given a Notice of Compliance to their new antibiotic IVOZFO™ (fosfomycin for injection), for use in the Canadian healthcare community. IVOZFO has a chemical structure unrelated to other known intravenous antibiotics and is the first of its kind in Canada.¹

For years, Canadian physicians have prescribed oral fosfomycin for urinary tract infections. However, new IVOZFO (fosfomycin for injection) is formulated to treat hospital based, difficult to treat infections across five indications.

Proven

Intravenous fosfomycin has been available in Europe and Japan for more than 40 years. Its unique structure and novel mechanism of action distinguishes it from all other marketed classes of antimicrobial agents.^1‑2

Efficacy

IVOZFO is bactericidal and active against a wide range of both gram-positive and gram-negative drug-resistant organisms such as extended-spectrum β-lactamases (ESBLs), carbapenem-resistant enterobacteriaceae (CRE), Pseudomonas aeruginosa, and methicillin-resistant Staphylococcus aureus (MRSA).² As one of the smallest antibiotic molecules in clinical use, it confers broad tissue penetration. Its unique mechanism of action inhibits peptidoglycan synthesis in the cell membrane at an earlier stage than any other antibiotic. Fosfomycin has generally been found to be active in-vitro against clinical isolates of methicillin-resistant Staphylococci, vancomycin-resistant Enterococci, penicillin- and erythromycin-resistant Streptococci and multi-resistant Pseudomonas.^1‑6

Indications

IVOZFO (fosfomycin for injection) is indicated for the treatment of the following infections in adults and children, including neonates:

Complicated urinary tract infections

Nosocomial lower respiratory tract infections

Osteomyelitis

Bacterial meningitis

Bacteremia that occurs in association with, or is suspected to be associated with, any of the infections listed above¹

Safety

IVOZFO is well tolerated and is indicated for use in neonates and the elderly.^1-3 These qualities position IVOZFO as an effective therapeutic option for Canadian healthcare practitioners.

Anti-microbial resistance on the rise

It is estimated that by the year 2050 more people, as many as 10 million per year, will die from multi-drug resistant (MDR) infections, more than from diabetes and cancer combined. Antibiotic resistance leads to longer hospital stays, higher medical costs and increased mortality. Current treatment costs for hospital-based MDR infections in the U.S is now estimated at $2.39 billion annually. Responsible and appropriate use of antibiotics is one of the cornerstones of limiting the spread of resistance.^7‑10

“Whether in Canada or worldwide, hospitals are facing the growing presence of infections caused by antimicrobial-resistant, multidrug-resistant (MDR), and extensively-drug-resistant (XDR) pathogens.

The World Health Organization (WHO) lists new antimicrobials as one of the potential solutions to infections caused by resistant superbugs. But, treatment options for antimicrobial-resistant, MDR, and XDR organisms can be severely limited. Based on the new CANWARD study on antimicrobial-resistant pathogens in Canadian tertiary care hospitals, there is an urgent need for new antimicrobials in Canada. Long term, international experience with intravenous fosfomycin, and its inclusion on the WHO’s list of essential antibiotics for both adults and children, suggests that IVOZFO will be a valued agent for infectious disease experts to consider.”

– Dr. Neil Fleshner MD, MPH, FRCSC, Chief Medical Officer, Verity Pharmaceuticals.

IVOZFO – Meeting an unmet medical need in hard to treat infections

“Intravenous fosfomycin has the potential to be used in combination with β-lactams, carbapenems, fluoroquinolones, aminoglycosides, and glycopeptides/glycolipopeptides for the treatment of multi-drug resistant (MDR) MRSA, MDR methicillin-resistant S. epidermis (MRSE), MDR VRE, MDR Enterobacteriaceae, and MDR P. aeruginosa infections. Due to its exceptional tissue distribution, IVOZFO could be used not only for the most common infections such as bacteremia, urinary tract, skin and soft tissue, and respiratory infections but also for difficult to treat infections such as bone infections, meningitis, and invasive ocular infections. Finally, IVOZFO monotherapy would be a preferred option for treating cUTI due to resistant Enterobacteriaceae including MDR extended spectrum β-lactamase producing (ESBL) and MDR carbapenem resistant Enterobacteriaceae (CRE).” – Dr. George Zhanel, Professor-Department of Medical Microbiology and infectious Diseases, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba. Director-Canadian Antimicrobial Resistance Alliance (CARA, www.can-r.ca)

About Verity Pharmaceuticals

“Verity Pharma is a specialty pharmaceutical company focused on providing therapeutically relevant agents to the Canadian healthcare community. Our mandate is to ensure access to prescription products that have been withdrawn from the market, are in short supply, or have not yet been made available in Canada. IVOZFO is just one of several important products on track for launch by Verity Pharma in 2019.”

– Howard Glase, CEO and General Manager, Verity Pharmaceuticals

References:

1. IVOZFO™ Product Monograph. Verity Pharmaceuticals Inc. May 1, 2019.
2. Zhanel GG, Zhanel MA, Karlowsky JA. Intravenous Fosfomycin: An Assessment of Its Potential for Use in the Treatment of Systemic Infections in Canada. Canadian Journal of Infectious Diseases and Medical Microbiology; Volume 2018, Article ID 8912039.
3. Goberando M. Rev Esp Quimioter 2003;16(1):15-40.
4. Michalopoulos AS et al. Int J Infect Dis 2011;15(11):e732-739.
5. Popovic M et al. Eur J Clin Microbiol Infect Dis 2010;29(2):127-142.
6. Castañeda-Garcia A et al. Int J Infect Dis 2013;2:217-236.
7. WHO. Antimicrobial resistance: global report on surveillance 2014. https://www.who.int/publications/i/item/9789241564748.
8. WHO. Antibiotic resistance. https://www.who.int/en/news-room/fact-sheets/detail/antibiotic-resistance
9. Johnston KJ, et al. “The incremental cost of infections associated with multidrug‐resistant organisms in the inpatient hospital setting — A national estimate” Health Serv Res 2019; DOI: 10.1111/1475-6773.13135.
10. Eloit M, Graziano da Silva J, Chan M. Superbugs: Why we need action now. WHO website. https://apps.who.int/mediacentre/commentaries/superbugs-action-now/en/index.html