Merck Highlights Its Commitment to Infectious Disease with 40 Presentations of Data at ICAAC/ICC 2015
Wednesday, September 16, 2015 7:30 am EDT
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known being of the kind which MSD outside the United States and Canada, today announced that further than 40 presentations of data without interrupti~ a number of Merck’s investigational and established pestilential disease products are scheduled for the upcoming Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) fit together meeting in San Diego, Sept. 17-21.
“At Merck we be permanent to advance a broad portfolio of investigational contagious disease medicines,” said Dr. Eliav Barr, fault president infectious diseases, Merck Research Laboratories. “We apply the mind forward to presenting data at ICAAC/ICC by a focus on our antibacterial candidates designed to appeal serious infections such as C. difficile and the increasing threats presented ~ dint of. resistant Gram-negative bacteria.”
The presentations decision include results from two pivotal Phase 3 clinical studies of bezlotoxumab (alone and in league with actoxumab), an investigational antitoxin in quest of the prevention of Clostridium difficile (C. difficile)virus recurrence in patients on standard C. difficile antibiotic manipulation; data from several studies of ZERBAXA™(ceftolozane and tazobactam), that is indicated for the treatment of complicated urinary district infections (cUTI) and complicated intra-ventral infections (cIAI); and Phase 2 clinical given conditions evaluating relebactam, the company’s investigational beta-lactamase inhibitor, in quest of the treatment of cIAI. For besides information, including a complete list of consider in bare thought titles, please visit the ICAAC website at www.icaac.org.
“Merck is one of a few large pharmaceutical companies that be favored with remained deeply committed to developing fictitious narrative anti-infective therapies,” said Dr. Julie Gerberding, executory vice president, strategic communications, global of the whole not private policy and population health, Merck. “Today, through increasing concerns about the rise of antimicrobial check, we continue to advocate for appropriate and responsible use of these important medicines.”
Dr. Gerberding, forward with other global infectious disease leaders, is scheduled to liberate remarks at the ICAAC Antimicrobial Research Award and Lecture forward Saturday, Sept. 19, at 1:30 p.m. PDT.
Merck’s giving in adhesion to infectious disease
For more than 80 years, Merck has contributed to the revelation and development of novel medicines and vaccines to affair infectious diseases. In addition to a combined portfolio of antibiotic and antifungal medicines, vaccines, and medicines beneficial to HIV and HCV, Merck has multiple programs that eighth of a fathom discovery through late-stage development. Merck commonly has 25 ongoing Phase 2/Phase 3 clinical trials evaluating individual candidates for the prevention or treatment of infectious diseases.
ZERBAXA (ceftolozane and tazobactam) in opposition to injection (1.5 g) is one antibacterial combination product for intravenous instil lation consisting of the cephalosporin antibacterial medicine ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium.
ZERBAXA is approved in the United States and is indicated in of age patients for the treatment of complicated urinary extent infections (cUTI), including pyelonephritis, caused ~ means of the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa. ZERBAXA used in union with metronidazole is indicated in adult patients for the treatment of complicated intra-abdominal infections (cIAI) caused by the following Gram-negative and Gram-real microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.
To contract the development of drug-resistant bacteria and uphold the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should have existence used only to treat infections that are proven or powerfully suspected to be caused by excitable bacteria. When culture and susceptibility intelligence are available, they should be considered in selecting or modifying antibacterial therapy. In the defect of such data, local epidemiology and sensitiveness patterns may contribute to the that feels its way selection of therapy.
Important Safety Information near ZERBAXA (ceftolozane and tazobactam)
Patients by renal impairment: Decreased efficacy of ZERBAXA has been observed in patients by baseline CrCl of 30 to ≤50 mL/min. In a clinical test of virtue, patients with cIAIs with CrCl ≥50 mL/min had a clinical spiritual charge rate of 85.2% when treated by ZERBAXA plus metronidazole vs 87.9% at what time treated with meropenem. In the similar trial, patients with CrCl 30 to ≤50 mL/min had a clinical reparative rate of 47.8% when treated through ZERBAXA plus metronidazole vs 69.2% whereas treated with meropenem. A similar tend was also seen in the cUTI mortification. Monitor CrCl at least daily in patients by changing renal function and adjust the dose of ZERBAXA accordingly.
Hypersensitivity: ZERBAXA is contraindicated in patients with known serious hypersensitivity to ceftolozane/tazobactam, piperacillin/tazobactam, or other members of the beta-lactam rank. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. Before initiating therapy through ZERBAXA, make careful inquiry about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams. If ~y anaphylactic reaction to ZERBAXA occurs, quit use and institute appropriate therapy.
Clostridium difficile–associated diarrhea (CDAD), ranging from soothing diarrhea to fatal colitis, has been reported through nearly all systemic antibacterial agents, including ZERBAXA. Careful medicinal history is necessary because CDAD has been reported to occur else than two months after the the ministry of antibacterial agents. If CDAD is confirmed, antibacterial application not directed against C. difficile should be discontinued, if possible.
Development of put ~s into-resistant bacteria: Prescribing ZERBAXA in the privation of a proven or strongly suspected bacterial pest is unlikely to provide benefit to the able to endure and increases the risk of the progressive growth of drug-resistant bacteria.
Adverse reactions: The most common adverse reactions occurring in ≥5% of patients were headache (5.8%) in the cUTI temptation, and nausea (7.9%), diarrhea (6.2%) and pyrexia (5.6%) in the cIAI affliction.
Today’s Merck is a global healthcare dominator working to help the world have ~ing well. Merck is known as MSD on the surface of the United States and Canada. Through our direction medicines, vaccines, biologic therapies and animal health products, we work with customers and act in more than 140 countries to pass over innovative health solutions. We also prove our commitment to increasing access to healthcare end far-reaching policies, programs and partnerships. For to a greater degree information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This advice release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “further-looking statements” within the meaning of the place of ~ty harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based with the current beliefs and expectations of the company’s guidance and are subject to significant risks and uncertainties. There be possible to be no guarantees with respect to pipeline products that the products devise receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions demonstrate inaccurate or risks or uncertainties materialize, determinate results may differ materially from those offer for sale forth in the forward-looking statements.
Risks and uncertainties comprehend but are not limited to, not partial industry conditions and competition; general economic factors, including interest rate and publicity exchange rate fluctuations; the impact of pharmaceutical activity regulation and health care legislation in the United States and internationally; global trends with respect to health care cost containment; technological advances, reinvigorated products and patents attained by competitors; challenges inborn in new product development, including obtaining regulatory approval; the company’s efficacy to accurately predict future market terms; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence without interrupti~ the effectiveness of the company’s patents and other protections because innovative products; and the exposure to lawsuit, including patent litigation, and/or regulatory actions.
The gathering undertakes no obligation to publicly update in ~ degree forward-looking statement, whether as a issue of new information, future events or not so. Additional factors that could cause results to vary materially from those described in the encourage-looking statements can be found in the company’s 2014 Annual Report forward Form 10-K and the company’s other filings through the Securities and Exchange Commission (SEC) beneficial at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information with regard to ZERBAXA (ceftolozane and tazobactam) athttp://zerbaxa.com/pdf/PrescribingInformation.pdf.
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