Merck’s Investigational Beta-lactamase Inhibitor Relebactam (MK-7655) Granted Qualified Infectious Disease Product (QIDP) &...
September 04 2014 - 9:00AM
Business Wire
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, announced today that the U.S. Food and Drug Administration
(FDA) has designated relebactam (previously known as MK-7655), the
company’s investigational beta-lactamase inhibitor, as a Qualified
Infectious Disease Product (QIDP) with designated Fast Track
status. The QIDP and Fast Track designations apply to intravenous
use of relebactam for the treatment of complicated urinary tract
infections, complicated intra-abdominal infections and
hospital-acquired bacterial pneumonia/ventilator-associated
bacterial pneumonia.
QIDP designation, provided under the Generating Antibiotic
Incentives Now (GAIN) Act, offers certain incentives for the
development of new antibiotics, including a five-year extension of
the data exclusivity provisions under the Hatch-Waxman Act and
priority review of the New Drug Application when filed. Fast Track
designation provides for enhanced communication with the FDA during
the drug development program.
“The lack of new medicines to fight drug-resistant infections is
a growing public health concern,” said Dr. Nicholas Kartsonis,
executive director, Infectious Disease, Merck Research
Laboratories. “We are pleased that the FDA has designated
relebactam as a QIDP with Fast Track status, and we look forward to
working with the FDA and other experts in infectious disease to
study this medicine with the goal of bringing it to people
suffering from potentially life-threatening resistant bacterial
infections as quickly as possible.”
Beta-lactamases are a family of enzymes produced by some
bacteria that can cause resistance to several widely used
beta-lactam antibiotics, including penicillins, cephalosporins and
carbapenems. By combining a beta-lactamase inhibitor with a
beta-lactam antibiotic, it may be possible to overcome the
resistance and extend the spectrum of activity of the antibiotic to
fight infections.
Relebactam is an investigational, class A and C, beta-lactamase
inhibitor that is being evaluated in combination with
imipenem/cilastatin in ongoing Phase 2 clinical trials for the
treatment of complicated urinary tract infections and complicated
intra-abdominal infections. In preclinical studies, relebactam
administered in combination with imipenem/cilastatin demonstrated
antibacterial activity against a broad range of Gram-negative and
beta-lactam-resistant pathogens. Merck plans to initiate Phase 3
studies with relebactam in combination with imipenem/cilastatin in
2015.
About Merck
Today's Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside of the United States
and Canada. Through our prescription medicines, vaccines, biologic
therapies, and consumer care 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, visit
www.merck.com and connect with us on Twitter, Facebook and
YouTube.
Forward-Looking Statement
This news release includes “forward-looking statements” within
the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of Merck’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; Merck’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 Merck patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Merck 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 Merck’s 2013 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).
Media:Caroline Lappetito, 267-305-7639orRobert Consalvo,
908-423-6595orInvestors:Joseph Romanelli, 908-423-5185orJustin
Holko, 908-423-5088
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