ZERBAXATM (ceftolozane and tazobactam) is approved in Canada for the treatment of complicated intra-abdominal and urinary tract infections caused by susceptible strains of bacteria

KIRKLAND, QC, Feb. 22, 2016 /CNW Telbec/ - Merck (NYSE: MRK), known as MSD outside Canada and the United States, announced today that ZERBAXA (ceftolozane and tazobactam) is now available in Canada. It is indicated for the treatment of complicated intra-abdominal or urinary tract infections, including pyelonephritis, caused by susceptible strains of bacteria.1 See 'About ZERBAXA' section below for full indication. 

Prevalence of antibiotics, and the serious and growing issue of drug resistance
Since the early twentieth century, antibiotics have been part of the fight against bacterial infections. Recent estimates from 2013 show that on average, Canadians spent $681 million on oral and parenteral antimicrobials and that over 22 million antibiotic prescriptions were dispensed by Canadian pharmacies.3, 4

The overall broad and increasing use of antibiotics has led to the accelerated development of bacterial drug resistance.2 Antibiotic resistant bacteria are difficult to control, and can potentially cause severe and life-threatening diseases. The Public Health Agency of Canada estimates that $1 billion in total medical care costs have been spent on dealing with antibiotic resistant infections.2

"The increasing prevalence of antibiotic-resistant bacteria in healthcare-associated infections represents a serious public health challenge. There are few antimicrobials capable of treating resistant Gram-negative infections which can have severe health complications if left untreated," explains Dr. Daniel Thirion, Clinical Professor at the Université de Montréal.

"Drug-resistant bacteria are a cause for concern due to their increasing prevalence in healthcare-associated infections. We are very excited to announce the launch of ZERBAXA to help treat patients with complicated infections including drug-resistant bacteria," said Bruce McDonald, Vice-President, Hospital/Specialty Care, Merck Canada Inc.

About ZERBAXA™ (ceftolozane/tazobactam) 
ZERBAXA is a new antibacterial combination product for intravenous infusion containing
ceftolozane (a novel cephalosporin) and tazobactam (a well-established beta-lactamase inhibitor). ZERBAXA is indicated for the treatment of patients 18 years of age or older with the following infections when caused by ZERBAXA-susceptible strains of the designated microorganisms:1

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 1

ZERBAXA has demonstrated efficacy against susceptible Gram-negative and Gram-positive bacteria in two Phase III studies of patients with cIAI and cUTI. 1

For further information on ZERBAXA, please consult the product monograph available at: http://www.merck.ca/assets/en/pdf/products/ZERBAXA-PM_E.pdf.

Merck's commitment to the treatment of infectious diseases
For more than 80 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of antibiotic and antifungal medicines, vaccines, and medicines for HIV and HCV, Merck has multiple programs that span discovery through late-stage development. As of October 2015, Merck has 25 ongoing Phase 2/Phase 3 clinical trials evaluating compounds addressing infectious disease.

About Merck
Today's Merck is a global healthcare leader working to help the world be well.  Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information about our operations in Canada, visit www.merck.ca and connect with us on YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2014 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

ZERBAXA™ is a trademark of Calixa Therapeutics, Inc. Used under license.

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References:

1. ZERBAXA™ Product Monograph. Merck Canada Inc. September 30, 2015.
2. Canadian antimicrobial resistance surveillance system – Report 2015. Public Health Agency of Canada. Available at http://healthycanadians.gc.ca/alt/pdf/publications/drugs-products-medicaments-produits/antibiotic-resistance-antibiotique/antimicrobial-surveillance-antimicrobioresistance-eng.pdf. Accessed on February 12, 2016.
3. Human antimicrobial use report – 2014. Public Health Agency of Canada. Available at http://healthycanadians.gc.ca/publications/drugs-products-medicaments-produits/human-antimicrobial-use-2014-utilisation-antimicrobiens-humains/index-eng.php. Accessed on February 12, 2016.
4. Antibiotic resistance: Facts and figures. Public Health Agency of Canada. Available at http://healthycanadians.gc.ca/alt/pdf/drugs-products-medicaments-produits/buying-using-achat-utilisation/antibiotic-resistance-antibiotique/material-materiel/info-parents-a-eng.pdf. Accessed on February 12, 2016.

SOURCE Merck Canada Inc.