—Provides up to $132 million to support
development of the Company’s leading pipeline of antibiotics
targeting drug-resistant bacteria, including the ongoing
development of CARBAVANCE® (meropenem-vaborbactam)—
—First portfolio-based strategic partnership
between the Biomedical Advanced Research and Development Authority
(BARDA) and a U.S. headquartered company—
—Strategic partnership evidences the leadership
position of The Medicine’s Company’s Infectious Disease Business,
its proven track record of innovative research and development and
the strength of its growing commercial capabilities—
—Builds on the success of the Company’s
existing agreement with BARDA—
The Medicines Company (NASDAQ:MDCO) today announced that it has
entered into a new strategic partnership with 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), 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. It
is the first portfolio-based partnership between BARDA and a U.S.
headquartered private-sector company.
Under the terms of the OTA agreement, BARDA will provide $32
million in initial funding, and up to an additional $100 million
over approximately 5 years if all options to extend the partnership
are exercised by BARDA. The initial $32 million award will support
a Phase IIIb trial of the Company’s investigational
antibiotic, Carbavance® (meropenem-vaborbactam), 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. In 2014, the Company’s Infectious Disease
Business was also awarded a cost-sharing contract from BARDA, of
which $55.8 million in federal funds have been obligated to date to
support the development of Carbavance.
“The commitment of HHS and BARDA to establishing innovative
structures to support the development of novel antimicrobial drugs
demonstrates their leadership in combating the growing worldwide
public threat of antibiotic resistance. The size and scope of The
Medicines Company’s strategic relationship with BARDA reflects our
successful track record of innovative antibiotic discovery and
development, the strength of our commercialization capabilities and
the breadth of our leading pipeline of novel, antibacterial drug
candidates,” said Clive Meanwell, M.D., Ph.D., Chief Executive
Officer of The Medicines Company. “Our new portfolio-based
partnership with BARDA demonstrates our continuing commitment to
our Infectious Disease Business and will enable us to accelerate
the development of novel therapies to combat the rising threat of
antimicrobial drug-resistance, while expanding our integrated
discovery, development and commercialization platform. We view this
as a critical part of our mission to create transformational
solutions to address the most pressing healthcare needs facing
patients, physicians and providers.”
Michael Dudley, PharmD, Senior Vice President, Head of R&D
and Co-Leader of The Medicines Company’s Infectious Diseases
Business, added, “Multidrug-resistant bacterial infections are
widely-recognized as an urgent and growing threat to public health.
Existing support from BARDA has been integral to our rapid
advancement of Carbavance from our discovery labs through a
successful Phase III trial program, and has positioned us for an
NDA submission in early 2017. Our new partnership with BARDA will
allow us to advance the next generation of urgently-needed
antibiotics for the most serious drug-resistant infections,
particularly those for which there are limited or no effective
treatment options, and will provide flexibility to adjust our plans
according to the most promising candidates and evolving
drug-resistance priorities in the U.S. healthcare system.”
Antibiotic resistance, also known as antimicrobial
drug-resistance (AMR), is a rapidly-growing threat in the United
States and around the world. The U.S. Centers for Disease Control
(CDC) estimates that, in the United States alone, more than two
million infections and 23,000 deaths annually are caused by
bacteria resistant to at least first-line treatments, with an
estimated annual cost burden of $20 billion. Carbapenem-resistant
Enterobacteriaceae (CRE) infections are one of the deadliest, with
mortality rates reaching 40%. The CDC considers CRE as one of the
top three most urgent drug-resistant infectious disease threats and
the only one of the top three that causes systemic infections.
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 complicated urinary tract
infections, including those infections caused by bacteria resistant
to currently available carbapenems. Carbavance has been granted
Fast Track status by the U.S. Food and Drug Administration (FDA)
for the treatment of complicated urinary tract infections 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 carbapenem-resistant Enterobacteriaceae
(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 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®
(meropenem-vaborbactam) 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 business also has a leading pipeline of
novel agents that address 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," 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 BARDA, HHS and the Company will perform
as expected under the new OTA agreement; whether clinical trials
for our product candidates 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; whether the Company will
make regulatory submissions for its product candidates, including
Carbavance, on a timely basis or at all; whether its regulatory
submissions will receive approvals from regulatory agencies on a
timely basis, or at all; 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 August 5,
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/20160921005135/en/
MediaRusso PartnersMatt
Middleman, M.D., (212)
845-4272matt.middleman@russopartnersllc.comorInvestorsThe Medicines CompanyKrishna
Gorti, M.D., (973) 290-6122Vice President, Investor
Relationskrishna.gorti@themedco.com
Medicines (NASDAQ:MDCO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Medicines (NASDAQ:MDCO)
Historical Stock Chart
From Sep 2023 to Sep 2024