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July 29, 2019 3:05 pm ET

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending ZERBAXA® 3g dose (ceftolozane and tazobactam) for an additional indication for the treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

The CHMP positive opinion will now be considered by the European Commission. If the European Commission affirms the CHMP opinion, it will grant an update to the centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. Supplemental marketing authorization applications for ZERBAXA for the treatment of nosocomial pneumonia, including VAP, are also under regulatory review in other countries, including Canada and Japan.

ZERBAXA is an antibacterial combination product for intravenous infusion consisting of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium.

“We are pleased with the CHMP’s positive opinion recommending approval of ZERBAXA for the treatment of HAP, including VAP, which marks an important step towards providing a new option for medical professionals treating critically ill patients in the hospital setting,” said Dr. Nicholas Kartsonis, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories. “This milestone reflects the valued contributions of all the health care professionals and patients involved in the pivotal ASPECT-NP trial.”

According to a recent publication, ventilated patients with hospital-acquired bacterial pneumonia (HABP) have a higher rate of mortality (39%) than those with ventilator-associated bacterial pneumonia (VABP) (27%). In addition,
Pseudomonas aeruginosa is the most common Gram-negative pathogen in HABP/VABP and is becoming increasingly difficult to treat.

The proposed additional indication for ZERBAXA is based on results of the pivotal Phase 3 ASPECT-NP trial that evaluated the efficacy and safety of ZERBAXA at a 3g dose for the treatment of adult patients with HAP, including VAP. The results of the ASPECT-NP trial were presented at the 29^th European Congress of Clinical Microbiology & Infectious Diseases, in Amsterdam, Netherlands, in April 2019.

ZERBAXA 1.5g (ceftolozane 1g and tazobactam 0.5g) was approved by the European Commission in 2015 for use as indicated in adult patients with complicated urinary tract infections (cUTI), acute pyelonephritis, and complicated intra-abdominal infections (cIAI).

Additional Important Safety Information about ZERBAXA (ceftolozane and tazobactam)

Patients with changing renal function: Dose adjustment is required for patients with creatinine clearance (CrCl) 50 mL/min or less. All doses of ZERBAXA are administered over 1 hour. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA accordingly.

Hypersensitivity: ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane/tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. Before initiating therapy with ZERBAXA, make careful inquiry about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams. If an anaphylactic reaction to ZERBAXA occurs, discontinue use and institute appropriate therapy.

Clostridium difficile-associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including ZERBAXA. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible.

Development of drug-resistant bacteria: Prescribing ZERBAXA (ceftolozane and tazobactam) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.

Adverse Reactions: The most common adverse reactions occurring in ≥5% of patients. in the HABP/VABP trial were increase in hepatic transaminases (11.9%), renal impairment/renal failure (8.9%) and diarrhea (6.4%).

Merck’s Commitment to Infectious Diseases

For more than 100 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 vaccines and antibacterial, antiviral and antifungal medicines, Merck has multiple programs that span discovery through late-stage development. To learn more about Merck’s infectious diseases pipeline, visit www.merck.com.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. 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 health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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 2018 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).

Please see Prescribing Information for ZERBAXA (ceftolozane and tazobactam) at
https://www.merck.com/product/usa/pi_circulars/z/zerbaxa/zerbaxa_pi.pdf

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