– Eight posters presented on Friday and
Saturday highlight comprehensive results of TANGO-2, a
multi-center, randomized, open label clinical trial of VABOMERE vs.
“best available therapy” in subjects with known or suspected CRE
–
– VABOMERE was recently approved for the
treatment of adult patients with complicated urinary tract
infections, including polynephritis, caused by designated
susceptible enterobacteriacea –
The Medicines Company (NASDAQ:MDCO) today announced
that data from its portfolio of antimicrobial products will be
featured in presentations at IDWeek 2017 to be
held October 4-8, 2017 in San Diego. The Medicines Company’s
infectious disease research and product development is focused on
the most serious multi-drug resistant infections, including
carbapenem-resistant Enterobacteriaceae (CRE).
The Company will present data on VABOMERE™, its recently
FDA-approved fixed-dose meropenem-vaborbactam antibiotic
combination, from the TANGO-2, the multi-center, randomized,
open-label Phase III clinical trial of VABOMERE versus “best
available therapy” in patients with serious infections (complicated
urinary tract infections (cUTI), bacteremia, hospital-acquired or
ventilator-associated bacterial pneumonia, and complicated
intraabdominal infections) suspected or documented to be caused by
CRE.
Data from studies of the Company’s other marketed products
ORBACTIV® (oritavancin) and MINOCIN® (minocycline) for Injection
will also be presented.
“We are delighted to have the opportunity at IDWeek, the
premier gathering of the infectious disease community, to showcase
our industry leading portfolio of anti-infectives, including
presentation of key data for VABOMERE which was exquisitely
designed to address the growing problem of KPC-producing CRE,” said
Michael Dudley, PharmD, FIDSA, Senior Vice President, Head of
R&D and Co-Leader of The Medicines Company’s Infectious Disease
Business.
Tony Kingsley, President and Chief Operating Officer of The
Medicines Company, added, “We recognize the growing prevalence of
CRE in all settings of care in the U.S. We are pleased to be able
to discuss the findings from our TANGO-2 trial in multidrug
resistant infections where there is presently no standard of care
and outcomes are often poor.”
IDWeek is a forum for health professionals of varied
backgrounds to collaborate, cooperate, and learn from each other’s
expertise. With common issues and challenges cutting across our
four disciplines, IDWeek provides an opportunity to learn
from each other’s knowledge, experience and expertise, for the
improvement of patient care and public health. Details of The
Medicines Company’s presentations are provided below. The complete
program of titles, abstracts, and electronic versions of posters
can be accessed following their presentations on The Medicines
Company website at
http://www.themedicinescompany.com/investors/events or on the
IDWeek 2017 website at http://www.idweek.org. All times
listed below are in Pacific Daylight Time.
Date Time Product
Event Details Thursday October 5th 3:03
PM VABOMERE New Antibiotics: What's in the Pipeline
Overview of
Meropenem-Vaborbactam
Presentation author: M. Dudley
Symposium
Room 20ABCD
Friday October 6th 7:00 AM
to
8:15 AM
VABOMERE
Pipeline 2.0: New Antibiotics:
What's in the Pipeline
Panelists: M. Dudley, The Medicines
Company; S. Cammarata, Melinta Therapeutics; E. Ellis-Grosse,
Zavante Therapeutics; , R. Echols, ID3C; I. Friedland, Friedland
Strategic Consulting; P .McGovern, Paratek Pharmaceuticals; Steven
P. Gelone, Nabriva Therapeutics AG; David Huang, Motif BioSciences;
Amanda Paschke, Merck & Co., Inc.; P. Horn, Tetraphase
Pharmaceuticals
Panel Discussion and Q&A
Room
06DE
Friday October 6th
12:30 PM
to
2:00 PM
VABOMERE Session: Expanded Spectrum - New
Antimicrobial Susceptibility Testing
Activity of Meropenem-Vaborbactam
Against Enterobacteriaceae Isolates Carrying blaKPC
Collected Worldwide
Presentation authors: M. Castanheira, R.E.
Mendes, L.R. Duncan, L.N. Woosley, R.K. Flamm
Poster 1234
Hall CD
Saturday October 7th 12:30 PM
to
2:00 PM
VABOMERE Session: Clinical Study with New Antibiotics
and Antifungals
Meropenem-Vaborbactam vs.
Piperacillin-Tazobactam in TANGO I (a Phase 3 Randomized,
Double-blind Trial): Outcomes by Baseline MIC in Adults with
Complicated Urinary Tract Infections or Acute
Pyelonephritis
Presentation authors: T. Walsh, T.
Bhowmick, R. Darouiche, V. Zaitsev, E. Giamarellos-Bourboulis, A.
Shorr, E. Fedosiuk, T. File Jr., J. Loutit, O. Lomovskaya, M.
Dudley, D. Perlin
Poster 1866
Hall CD
Saturday October 7th 12:30 PM
to
2:00 PM
VABOMERE Session: Clinical Study with New Antibiotics
and Antifungals
Meropenem-Vaborbactam vs. Best
Available Therapy for Carbapenem-Resistant Enterobacteriaceae
Infections in TANGO II: Primary Outcomes by Site of
Infection
Presentation authors: R. Wunderink, E.
Giamarellos-Bourboulis, G. Rahav, A. Mathers, M. Bassetti, J.
Solomkin, E. Alexander, J. Loutit, S. Zhang, M. Dudley, K. Kaye
Poster 1867
Hall CD
Saturday October 7th 12:30 PM
to
2:00 PM
VABOMERE Session: Clinical Study with New Antibiotics
and Antifungals
Clinical Outcomes of Serious Infections
due to Carbapenem-Resistant Enterobacteriaceae (CRE) in TANGO II, a
Phase 3, Randomized, Multi-National, Open-Label Trial of
Meropenem-Vaborbactam (M-V) Versus Best Available Therapy
(BAT)
Presentation authors: K. Kaye, J. Vazquez,
A. Mathers, G. Daikos, E. Alexander, J. Loutit, S. Zhang, M.
Dudley, O. Cornely
Poster 1862
Hall CD
Saturday
October 7th
12:30 PM
to
2:00 PM
VABOMERE Session: Clinical Study with New Antibiotics
and Antifungals
Assessment of MIC Increases with
Meropenem-Vaborbactam and Ceftazidime-Avibactam in TANGOII (a Phase
3 Study of the Treatment of CRE Infections)
Presentation authors: O. Lomovskaya, M.
Castanheira, J. Vazquez, K. Kaye, K. Nelson, D. Sun, E. Alexander,
M. Dudley, M. Yin
Poster 1874
Hall CD
Saturday
October 7th
12:30 PM
to
2:00 PM
VABOMERE Session: Clinical Study with New Antibiotics
and Antifungals
Meropenem-Vaborbactam: Outcomes in
Subjects with Renal Impairment in Phase 3 Studies TANGO I and
II
Presentation authors: A. Mathers, W. Hope,
K. Kaye, J. Loutit, E. Alexander, M. Dudley, J. Vazquez
Poster 1879
Hall CD
Saturday
October 7th
12:30 PM
to
2:00 PM
VABOMERE Session: Clinical Study with New Antibiotics
and Antifungals
Meropenem-Vaborbactam Pharmacokinetics
in Subjects with Chronic Renal Impairment, Including
Hemodialysis
Presentation authors: C. Rubino, D.
Griffith, S. Bhavnani, J. Loutit, B. Lohse, M. Dudley, P.
Ambrose
Poster 1835
Hall CD
Saturday
October 7th
12:00 PM
to
2:30 PM
VABOMERE Session: Clinical Study with New Antibiotics
and Antifungals
Meropenem-Vaborbactam vs. Best
Available Therapy for Carbapenem-Resistant Enterobacteriaceae
Infections in TANGO II:Outcomes in Immunocompromised
Patients
Presentation authors: D. Paterson, E. J.
Kwak, T. Bhowmick, E. Alexander, J. Loutit, S. Zhang, M. Dudley, T.
Walsh
Poster 1868
Hall CD
Saturday
October 7th
12:00 PM
to
2:30 PM
VABOMERE Session: Clinical Study with New Antibiotics
and Antifungals
Meropenem-Vaborbactam
Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses
as Support for Dose Selection in Patients with Normal Renal
Function and Varying Degrees of Renal Impairment
Presentation authors: S. Bhavnani, M.
Trang, D. Griffith, O. Lomovskaya, J. Hammel, J. Loutit, M. Dudley,
P. Ambrose, C. Rubino
Poster 1852
Hall CD
Thursday October 5th 12:30 PM
to
2:00 PM
MINOCIN Session: Use of PK/PD to optimize existing
antibiotics and antifungal
Pharmacokinetics and Tissue
Distribution of Minocycline following Intravenous Administration in
Rabbits
Presentation authors: V. Petraitis, R.
Petraitiene, B. W. Maung, T. Nolan, D. Griffith, M. Dudley, T.
Walsh
Poster 804
Hall CD
Friday October 6th 12:30 PM
to
2:00 PM
ORBACTIV Session: Expanded Spectrum - New
Antimicrobial Susceptibility Testing
Analysis of Oritavancin Activity
against
Gram-Positive Clinical Isolates
Responsible for Bacterial Endocarditis in United States and
European Hospitals (2008-2016)
Presentation authors: M.A. Pfaller, H.S.
Sader, D. Shortridge, R.K. Flamm, R.E. Mendes
Poster 864
Hall CD
About VABOMERE™
VABOMERE™ (meropenem and vaborbactam) is indicated for the
treatment of patients 18 years of age and older with complicated
urinary tract infections (cUTI) including pyelonephritis caused by
the following susceptible microorganisms: Escherichia coli,
Klebsiella pneumoniae, and Enterobacter cloacae species
complex.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of VABOMERE and other antibacterial
drugs, VABOMERE should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible
bacteria.
IMPORTANT SAFETY INFORMATION
Contraindications
VABOMERE is contraindicated in patients with known
hypersensitivity to any components of VABOMERE (meropenem and
vaborbactam), or to other drugs in the same class or in patients
who have demonstrated anaphylactic reactions to beta-lactam
antibacterial drugs.
Warnings and Precautions
- Hypersensitivity reactions were
reported in patients treated with VABOMERE in the clinical trials.
Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions and serious skin reactions have been reported in patients
receiving therapy with beta-lactam antibacterial drugs. There have
been reports of individuals with a history of penicillin
hypersensitivity who have experienced severe hypersensitivity
reactions when treated with another beta-lactam antibacterial drug.
If an allergic reaction to VABOMERE occurs, discontinue the drug
immediately.
- Seizures and other adverse Central
Nervous System (CNS) experiences have been reported during
treatment with meropenem, which is a component of VABOMERE. Close
adherence to the recommended dosage regimens is urged, especially
in patients with known factors that predispose to convulsive
activity.
- Clostridium difficile-associated
diarrhea (CDAD) has been reported with use of nearly all
antibacterial agents, including VABOMERE, and may range in severity
from mild diarrhea to fatal colitis. Careful medical history is
necessary since CDAD has been reported to occur over two months
after the administration of antibacterial agents. If CDAD is
suspected or confirmed, ongoing antibacterial drug use not directed
against C. difficile may need to be discontinued.
- The concomitant use of VABOMERE and
valproic acid or divalproex sodium is generally not recommended.
Case reports in the literature have shown that co-administration of
carbapenems, including meropenem, to patients receiving valproic
acid or divalproex sodium results in a reduction in valproic acid
concentrations. The valproic acid concentrations may drop below the
therapeutic range as a result of this interaction, therefore
increasing the risk of breakthrough seizures. If administration of
VABOMERE is necessary, consider supplemental anticonvulsant
therapy.
- In patients with renal impairment,
thrombocytopenia has been observed in patients treated with
meropenem, but no clinical bleeding has been reported.
- Alert patients receiving VABOMERE on an
outpatient basis regarding adverse reactions such as seizures,
delirium, headaches and/or paresthesias that could interfere with
mental alertness and/or cause motor impairment.
- Prescribing VABOMERE in the absence of
a proven or strongly suspected bacterial infection is unlikely to
provide benefit to the patient and increases the risk of
drug-resistant bacteria.
- As with other antibacterial drugs,
prolonged use of VABOMERE may result in overgrowth of
nonsusceptible organisms.
Adverse Reactions The most frequently reported adverse
reactions occurring in ≥3% of patients treated with VABOMERE were
headache, phlebitis/infusion site reactions, and diarrhea.
About MINOCIN® (minocycline) for Injection
MINOCIN® (minocycline) for Injection is indicated for the
treatment of infections due to susceptible strains of designated
microorganisms, including Acinetobacter species bacteria. For
additional indications and designated susceptible pathogens, please
see the full prescribing information available at
www.MINOCINiv.com.
Important Safety Information Contraindications
MINOCIN® for Injection is contraindicated in persons who have
shown hypersensitivity to any of the tetracyclines or to any of the
components of the product formulation.
Warnings and Precautions Tooth Development
MINOCIN® for Injection, like other tetracycline-class
antibacterials, can cause fetal harm when administered to a
pregnant woman. If any tetracycline is used during pregnancy, or if
the patient becomes pregnant while taking these drugs, the patient
should be apprised of the potential hazard to the fetus. The use of
drugs of the tetracycline class during tooth development (last half
of pregnancy, infancy, and childhood to the age of 8 years) may
cause permanent discoloration of the teeth (yellow-gray-brown).
This adverse reaction is more common during long-term use of the
drugs but has been observed following repeated short-term courses.
Enamel hypoplasia has also been reported. Tetracycline drugs,
therefore, should not be used during tooth development unless other
drugs are not likely to be effective or are contraindicated.
Skeletal Development All tetracyclines form a stable calcium
complex in any bone-forming tissue. A decrease in the fibula growth
rate has been observed in premature human infants given oral
tetracycline in doses of 25 mg/kg every six hours. This reaction
was shown to be reversible when the drug was discontinued.
Results of animal studies indicate that tetracyclines cross the
placenta, are found in fetal tissues, and can have toxic effects on
the developing fetus (often related to retardation of skeletal
development). Evidence of embryotoxicity has been noted in animals
treated early in pregnancy.
Dermatologic Reaction Drug Rash with Eosinophilia and Systemic
Symptoms (DRESS) including fatal cases have been reported with
minocycline use. If this syndrome is recognized, the drug should be
discontinued immediately.
Anti-anabolic Action The anti-anabolic action of the
tetracyclines may cause an increase in BUN. While this is not a
problem in those with normal renal function, in patients with
significantly impaired function, higher serum levels of
tetracycline may lead to azotemia, hyperphosphatemia, and acidosis.
Under such conditions, monitoring of creatinine and BUN is
recommended, and the total daily dosage should not exceed 200 mg in
24 hours. If renal impairment exists, even usual oral or parenteral
doses may lead to systemic accumulation of the drug and possible
liver toxicity.
Photosensitivity Photosensitivity manifested by an exaggerated
sunburn reaction has been observed in some individuals taking
tetracyclines. This has been reported with minocycline.
Central Nervous System Effects Central nervous system side
effects including light-headedness, dizziness or vertigo have been
reported. Patients who experience these symptoms should be
cautioned about driving vehicles or using hazardous machinery while
on minocycline therapy. These symptoms may disappear during therapy
and usually disappear rapidly when the drug is discontinued.
Clostridium difficile Associated Diarrhea Clostridium difficile
associated diarrhea (CDAD) has been reported with use of nearly all
antibacterial agents, including MINOCIN® for Injection, and may
range in severity from mild diarrhea to fatal colitis. If CDAD is
suspected or confirmed, ongoing antibacterial use not directed
against C. difficile may need to be discontinued.
Intracranial Hypertension Intracranial hypertension (IH,
pseudotumor cerebri) has been associated with the use of
tetracyclines including MINOCIN® for Injection. Clinical
manifestations of IH include headache, blurred vision, diplopia,
and vision loss; papilledema can be found on fundoscopy. Women of
childbearing age who are overweight or have a history of IH are at
greater risk for developing tetracycline associated IH. Concomitant
use of isotretinoin and MINOCIN® for Injection should be avoided
because isotretinoin is also known to cause pseudotumor
cerebri.
Although IH typically resolves after discontinuation of
treatment, the possibility for permanent visual loss exists. If
visual disturbance occurs during treatment, prompt ophthalmologic
evaluation is warranted. Since intracranial pressure can remain
elevated for weeks after drug cessation patients should be
monitored until they stabilize.
As with other antibacterial preparations, use of this drug may
result in overgrowth of nonsusceptible organisms, including fungi.
If superinfection occurs, the antibacterial should be discontinued
and appropriate therapy instituted.
Hepatotoxicity has been reported with minocycline; therefore,
minocycline should be used with caution in patients with hepatic
dysfunction and in conjunction with other hepatotoxic drugs.
Incision and drainage or other surgical procedures should be
performed in conjunction with antibiotic antibacterial therapy when
indicated.
MINOCIN® for Injection contains magnesium sulfate heptahydrate.
Because magnesium is excreted primarily by the kidney, serum levels
of magnesium should be monitored in patients with renal
impairment.
Because MINOCIN® for Injection contains magnesium, close
monitoring is recommended in patients with heart block or
myocardial damage.
Prescribing MINOCIN® for Injection in the absence of a proven or
strongly suspected bacterial infection or a prophylactic indication
is unlikely to provide benefit to the patient and increases the
risk of the development of drug-resistant bacteria.
Adverse Reactions
For a complete list of adverse reactions that have been observed
in patients receiving tetracyclines, consult the full US
prescribing information for MINOCIN® for Injection.
Please see www.MINOCINiv.com for the full prescribing
information.
About ORBACTIV® (oritavancin) for Injection
ORBACTIV® (oritavancin) for Injection is indicated for the
treatment of adult patients with acute bacterial skin and skin
structure infections (ABSSSI) caused or suspected to be caused by
susceptible isolates of the following gram-positive microorganisms:
Staphylococcus aureus (including methicillin-susceptible [MSSA] and
methicillin–resistant [MRSA] isolates), Streptococcus pyogenes,
Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus
anginosus group (includes S. anginosus, S. intermedius, and S.
constellatus), and Enterococcus faecalis (vancomycin-susceptible
isolates only).
Important Safety Information
Contraindications
Use of intravenous unfractionated heparin sodium is
contraindicated for 120 hours (5 days) after ORBACTIV®
administration because the activated partial thromboplastin time
(aPTT) test results are expected to remain falsely elevated for
approximately 120 hours (5 days) after ORBACTIV®
administration.
ORBACTIV® is contraindicated in patients with known
hypersensitivity to ORBACTIV®.
Warnings and Precautions
Coagulation test interference: ORBACTIV® has been shown to
artificially prolong aPTT for up to 120 hours, and may prolong PT
and INR for up to 12 hours, ACT for up to 24 hours, and D-dimer for
up to 72 hours.
Hypersensitivity reactions have been reported with the use of
antibacterial agents including ORBACTIV®. Discontinue infusion if
signs of acute hypersensitivity occur. Monitor closely patients
with known hypersensitivity to glycopeptides.
Infusion-related reactions have been reported. Slow the rate or
interrupt infusion if infusion reaction develops.
Clostridium difficile-associated colitis: Evaluate patients if
diarrhea occurs.
Concomitant warfarin use: Patients should be monitored for
bleeding if concomitantly receiving ORBACTIV® and warfarin.
Osteomyelitis: Institute appropriate alternate antibacterial
therapy in patients with confirmed or suspected osteomyelitis.
Prescribing ORBACTIV® in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
Adverse Reactions
The most common adverse reactions (≥ 3%) in patients treated
with ORBACTIV® were headache, nausea, vomiting, limb and
subcutaneous abscesses, and diarrhea.
Please see www.ORBACTIV.com for the full prescribing
information.
About The Infectious Disease Business
The Medicines Company Infectious Disease Business (MDCO IDC) 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. MDCO IDC 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. MDCO IDC recently received approval for VABOMERE to
treat serious gram-negative infections, such as complicated urinary
tract infections, including those infections caused by bacteria
resistant to currently available carbapenems. MDCO IDC has a
leading pipeline of novel agents directed towards existing and
emerging multidrug-resistant bacteria.
In addition to the development and approval of VABOMERE, MDCO
IDC has, since 2014, successfully developed and launched two
antibiotics against serious infections: ORBACTIV® (oritavancin) for
the treatment of acute bacterial skin and skin-structure infections
in adults, caused by designated pathogens, including
methicillin-resistant Staphylococcus aureus, 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 spp., a pathogen classified by the CDC to be a
serious antimicrobial resistance threat. For more information on
these products, including their respective important safety
information and package inserts, please see www.ORBACTIV.com and
www.MINOCINiv.com.
About BARDA
In February 2014, The Medicines Company Infectious Disease
Business was awarded a cost-sharing contract by 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 VABOMERE.
In September 2016, The Medicines Company entered into a new
strategic partnership with BARDA that will provide the Company with
the potential for up to $132 million to support the development of
new antibiotics to fight drug-resistant, gram-negative infections
(HHSO100201600026C). 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 and The Medicines Company.
The initial $32 million award supports further development of
VABOMERE as well as advancement of the Company’s early stage
pipeline. Funding provided under any subsequent options exercised
by BARDA and The Medicines Company, will also support the
advancement of antibiotics in MDCO IDC’s portfolio of new
antibiotic drug candidates targeting drug 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
serious infectious disease care and cardiovascular care. The
Company is headquartered in Parsippany, New Jersey, with a global
innovation center in California.
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 clinical trials will
advance 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 on a timely basis, or at
all; whether the Company’s 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 Annual Report on Form 10-K filed with the
Securities and Exchange Commission on August 9, 2017, 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/20170928006296/en/
The Medicines CompanyMediaMeg Langan, (973) 290-6319Vice
Presidentmargaret.langan@themedco.comorInvestorsKrishna Gorti, M.D., (973)
290-6122Vice President, Investor
Relationskrishna.gorti@themedco.com
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