PARSIPPANY, N.J.--(BUSINESS WIRE)--Feb. 21, 2017--
The Medicines
Company (NASDAQ:MDCO) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for priority review the Company’s new
drug application (NDA) filing for Carbavance® (meropenem-vaborbactam)
for the treatment of complicated urinary tract infections (cUTIs). The
FDA does not currently plan to hold an advisory committee meeting to
discuss the application.
The NDA filing is based on results from the pivotal Phase III TANGO 1
clinical trial in patients with cUTIs. As previously announced, the
TANGO 1 trial met both FDA and European Medicines Agency (EMA)
pre-specified primary endpoints. Carbavance also demonstrated
statistical superiority over piperacillin-tazobactam with overall
success in 98.4% of patients. Supporting the NDA are interim data from
the ongoing TANGO 2 Phase III trial, which compares the safety,
tolerability and efficacy of Carbavance with best available therapy in
patients with selected serious infections due to confirmed or suspected
carbapenem-resistant Enterobacteriaceae (CRE). The TANGO 2 trial is
ongoing and the Company expects results to be available before the end
of the third quarter of 2017.
“The exceptionally rapid development of Carbavance demonstrates the
strong product discovery and development capabilities of The Medicines
Company’s Infectious Disease Business, and reflects our commitment to
making innovative antimicrobial products available to patients with the
most serious drug-resistant infections,” said Clive Meanwell, M.D.,
Ph.D., Chief Executive Officer of The Medicines Company. “We believe
that Carbavance could be a promising and highly-differentiated treatment
option for these patients and we look forward to continuing our dialogue
with the FDA during its review process.”
Tony Kingsley, President and Chief Operating Officer of The Medicines
Company added, “Reaching this point in the development of Carbavance
reflects the focus, commitment and expertise of our Infectious Disease
Business. Multiple studies support the potential for Carbavance to make
a meaningful difference in the treatment of serious infections. If
approved by the FDA, we will leverage our existing sales and
distribution infrastructure to launch Carbavance in the U.S. market.”
About Carbavance® (meropenem-vaborbactam)
Carbavance, an investigational agent not approved for commercial use in
any market, is a combination of the carbapenem, meropenem, and the novel
beta-lactamase inhibitor, vaborbactam (formerly known as RPX7009),
administered as a fixed combination by IV infusion. It is being
developed to treat serious gram-negative infections, such as cUTI,
including those infections caused by bacteria resistant to
currently-available carbapenems. Carbavance has been granted Fast Track
status by the FDA for the treatment of cUTI and has been designated by
the FDA as a Qualified Infectious Disease Product (QIDP), as authorized
under the GAIN Act.
Carbavance was designed to address gram-negative bacteria that produce
new beta-lactamase enzymes that have spread in the United States and
Europe, including strains producing the Klebsiella pneumoniae
carbapenemase (KPC) enzyme. KPC-producing bacteria are the predominant
form of CRE in the United States and are classified by the U.S. Centers
for Disease Control and Prevention (CDC) to be an urgent antimicrobial
resistance threat.
About BARDA
In February 2014, the Company’s Infectious Disease Business was awarded
a cost-sharing contract from the Biomedical Advanced Research and
Development Authority (BARDA), a division of the Office of the Assistant
Secretary for Preparedness and Response within the U.S. Department of
Health and Human Services (HHS), of which $55.8 million in federal funds
have been obligated to date to support the development of Carbavance.
In September 2016, The Medicines Company entered into a new strategic
partnership with BARDA that will provide the Company with up to $132
million to support the development of new antibiotics to fight
drug-resistant, gram-negative infections. The partnership was
established under HHS’s Other Transactional Authority (OTA) and is a
distinctive, flexible, portfolio-based approach to funding drug
development. The Medicines Company was awarded $32 million in initial
funding, and up to an additional $100 million (pending the availability
of funding) over approximately five years, if all options to extend the
partnership are exercised by BARDA. The initial $32 million award
support a Phase IIIb trial of the Carbavance, for the treatment of
gram-negative infections in hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia (HABP/VABP). The initial
award, as well as funding provided under any subsequent options
exercised by BARDA, will also support the advancement of additional
antibiotics in The Medicines Company’s leading portfolio of new
antibiotic drug candidates targeting drug resistant bacteria.
About The Infectious Disease Business
The Medicines Company’s Infectious Disease Business is committed to
bringing life-saving antimicrobial products to patients with the most
serious drug-resistant infections – infections caused by “super bugs”
which are no longer treatable with available antibiotics. The Infectious
Disease Business encompasses basic research and drug discovery focused
on bacterial mechanisms of drug resistance; drug development focused on
the most threatening bacterial diseases; and a distribution and
commercial infrastructure that serves the leading hospitals and
healthcare facilities in the United States. The business is currently
developing Carbavance to treat serious gram-negative infections, such as
complicated urinary tract infections, including those infections caused
by bacteria resistant to currently available carbapenems. A pivotal
Phase III clinical trial for Carbavance was successfully completed in
2016. Since 2014, our team has successfully developed and launched two
antibiotics against serious infections: Orbactiv® (oritavancin) for
treatment of acute bacterial skin and skin-structure infections in
adults, including those due to methicillin-resistant Staphylococcus
aureus (MRSA), and a new formulation of Minocin® (minocycline) for
Injection, which is among the few FDA-approved agents for the treatment
of infections due to Acinetobacter sp., a serious antimicrobial
resistance threat. For more information on these products, including
their respective prescribing information, please see www.orbactiv.com
and www.minociniv.com.
The Infectious Disease Business also has a leading pipeline of novel
agents directed towards existing and emerging multidrug-resistant
bacteria.
About The Medicines Company
The Medicines Company is a biopharmaceutical company driven by an
overriding purpose – to save lives, alleviate suffering and contribute
to the economics of healthcare. The Company’s mission is to create
transformational solutions to address the most pressing healthcare needs
facing patients, physicians and providers in three critical therapeutic
areas: serious infectious disease care, cardiovascular care and surgery
and perioperative care. The Company is headquartered in Parsippany, New
Jersey, with global innovation centers in California and Switzerland.
Forward Looking Statements
Statements contained in this press release that are not purely
historical may be deemed to be forward-looking statements for purposes
of the safe harbor provisions under The Private Securities Litigation
Reform Act of 1995. Without limiting the foregoing, the words
"believes," "anticipates," "expects," “potential,” and similar
expressions are intended to identify forward-looking statements. These
forward-looking statements involve known and unknown risks and
uncertainties that may cause the Company's actual results, levels of
activity, performance or achievements to be materially different from
those expressed or implied by these forward-looking statements.
Important factors that may cause or contribute to such differences
include: whether the Company will make regulatory submissions for
Carbavance on a timely basis, or at all; whether the Carbavance NDA and
other regulatory submissions will receive approvals from regulatory
agencies on a timely basis, or at all; whether clinical trials for
Carbavance will advance in the clinical process on a timely basis, or at
all, or succeed in achieving their specified endpoints; whether
physicians, patients and other key decision makers will accept clinical
trial results; and such other factors as are set forth in the risk
factors detailed from time to time in the Company's periodic reports and
registration statements filed with the Securities and Exchange
Commission, including, without limitation, the risk factors detailed in
the Company's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on October 27, 2016, which are incorporated
herein by reference. The Company specifically disclaims any obligation
to update these forward-looking statements.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170221005827/en/
Source: The Medicines Company
The Medicines Company
Media
Meg Langan, 973-290-6319
Vice
President
margaret.langan@themedco.com
or
Investors
Krishna
Gorti, M.D., 973-290-6122
Vice President, Investor Relations
krishna.gorti@themedco.com
