The Medicines Company (NASDAQ:MDCO) today announced that
data from its portfolio of antimicrobial products and product
candidates will be featured in 16 presentations at IDWeek 2016, to
be held October 26-30, 2016, in New Orleans.
The Company will present data from the Phase 3 TANGO 1 clinical
trial of its investigational antibiotic, Carbavance®
(meropenem-vaborbactam), in the treatment of complicated urinary
tract infections (cUTIs) in the late breaker oral abstract session
on October 28, 2016. Data will also be presented from studies of
Orbactiv® (oritavancin) and Minocin® (minocycline) for Injection,
as well as other studies related to Carbavance.
“The scope and diversity of the research being presented at
IDWeek 2016 evidence The Medicines Company’s strong commitment to
its Infectious Disease Business and its leadership in discovering
and developing innovative, urgently-needed antimicrobial drugs for
patients with the most serious drug-resistant infections,” said
Mike McGuire, Senior Vice President and Co-Leader of The Medicines
Company’s Infectious Disease Business.
Michael Dudley, PharmD, FIDSA, Senior Vice President, Head of
R&D and Co-Leader of The Medicines Company’s Infectious
Diseases Business added, “The range and scientific rigor of our
work on multi-drug resistant bacterial infections is driving a
portfolio of novel agents from pre-clinical research to NDA
submission. We believe that Carbavance and our other research
projects will make a major contribution to patient care and
demonstrate The Medicines Company’s commitment to leadership in
treatment of antimicrobial drug-resistance.”
Tony Kingsley, President and Chief Operating Officer of The
Medicines Company, summarized, “With the Medicines Company’s
infectious disease franchise we are creating a fully-integrated
biopharma company with capabilities from discovery to
commercialization. We are tackling major antibacterial threats
which we also believe represent attractive global market
opportunities. There are few, if any, independent multi-product
firms fortunate enough to have a diversified and valuable portfolio
of assets and capabilities like ours. We are committed to growing
this focused, effective, and fully integrated infectious disease
business.”
IDWeek is the combined annual meeting of the Infectious Diseases
Society of America (IDSA), the Society for Healthcare Epidemiology
of America (SHEA), the HIV Medicine Association (HIVMA), and the
Pediatric Infectious Diseases Society (PIDS).
Details of presentations are provided below. The complete
program of titles and abstracts can be accessed on the IDWeek 2016
website at www.idweek.org.
Date
Time
Product Event Place
ThursdayOct. 27th
12:30 pmto2:00 pm
Orbactiv®
(oritavancin)
Session: HAI: MSSA, MRSA, and
other Gram-Positives
Prevalence of Main Gram-Positive Pathogens
Causing Bloodstream Infections in USA Medical Centers (2010-2015)
and Analysis of Oritavancin In Vitro Activity
Presentation author: R. .E. Mendes,JMI
Laboratories
PosterHall
(poster#303)
ThursdayOct. 27th
12:30 pmto2:00 pm
Session: HAI: Multi Drug ResistantGram
Negatives
Carbapenem Resistance in
Enterobacteriaceae Among Hospitalized Patients with Urinary Tract
Infection, Pneumonia and Sepsis Increases the Risk of Receiving
Inappropriate Empiric Treatment
Presentation author: MaryaZilberberg,
University ofMassachusetts and EviMedResearch Group
PosterHall
(poster#339)
FridayOct. 28th
12:30 pmto2:00 pm
Session: Clinical InfectiousDiseases:
Respiratory Infections
Impact of Inappropriate Empiric Treatment
of Enterobacteriaceae UTI, Pneumonia and Sepsis on Hospital
Outcomes
Presentation author: MaryaZilberberg,
University ofMassachusetts and EviMedResearch Group
PosterHall
(poster#1253)
SaturdayOct. 29th
10:30 pmto12:00 pm
Carbavance®
(meropenem-vaborbactam)
Session: Late Breaker Oral Abstracts
Meropenem-Vaborbactam (M-V) Compared with
Piperacillin-Tazobactam (P-T) in the Treatment of Adults with
Complicated Urinary Tract Infections (cUTI), including Acute
Pyelonephritis (AP) in a Phase 3 Randomized, Double-blind,
Double-dummy Trial (TANGO 1)
Presentation author: Jeff Loutit,
TheMedicines Company
Room:283-285
Oral latebreakerpresentation
12:30pm-2pm
Orbactiv®
(oritavancin)
Session: Antimicrobial
ResistanceMechanisms
Assessment of the Propensityof Oritavancin
to InduceSusceptibility Changes Among
Staphylococcus aureus NasalCarriage
Isolates in a Phase 2Study in Patients with AcuteBacterial Skin and
Skin StructureInfections
Presentation author: Francis Arhin,The
Medicines Company
PosterHall
(poster#2000)
12:30pm-2pm
Orbactiv®
(oritavancin)
Session: Antibiotic ResistantInfections:
Treatments
Assessment of Oritavancin Activityin
Combination with Beta-lactamsAgainst
Vancomycin-ResistantEnterococci
Presentation author: Francis Arhin,The
Medicines Company
PosterHall
(poster#2038)
12:30pm-2pm
Orbactiv®
(oritavancin)
Session: Antibiotic ResistantInfections:
Treatments
Efficacy of Oritavancin andComparator
Agents AgainstVancomycin-Resistant Enterococcus faecium in an In
Vivo Galleria mellonella Survival Model
Presentation author: Eric
Wenzler,University of Illinois
PosterHall
(poster#2026)
12:30pm-2pm
Orbactiv®
(oritavancin)
Session: AntimicrobialPharmacokinetics
andPharmacodynamics
Antibacterial Activity ofOritavancin and
DaptomycinAgainst Clinical Isolates ofVancomycin-Resistant
Enterococcus faecium in In
VitroPharmacokinetic/PharmacodynamicModels
Presentation author: Adam Belley,The
Medicines Company
PosterHall
(poster#1990)
SaturdayOct. 29th
12:30pm-2pm
Orbactiv®
(oritavancin)
Session: AntimicrobialPharmacokinetics
andPharmacodynamics
Lack of Effect of Oritavancin onWarfarin
Pharmacokinetics inHealthy Adult Subjects
Presentation author: S. Eralp Bellibas,The
Medicines Company
PosterHall
(poster#1954)
12:30pm-2pm
Orbactiv®
(oritavancin)
Session: Antibacterial Safety
Interference of Oritavancin onCoagulation
Tests as Assessed In vitro and in a Phase 1 Study ofNormal Healthy
Volunteers
Presentation author: Jeff Loutit,
TheMedicines Company
PosterHall
(poster#1807)
12:30pm-2pm
Minocin®
(minocycline)
for Injection
Session: Antimicrobial
ResistantInfections: Treatment
Estimating the Cost-Effectiveness
ofMinocycline for the Treatment ofMultidrug Resistant Acinetobacter
baumannii
Presentation author: Weihong Fan,
TheMedicines Company
PosterHall
(poster#2059)
12:30pm-2pm
Session: Antimicrobial
ResistantInfections: Treatment
Healthcare Outcomes and
ResourceUtilization Associated withColistin or Tigecycline use
inPatients with Multidrug ResistantAcinetobacter baumannii
Presentation author: Weihong Fan,
TheMedicines Company
PosterHall
(poster#2060)
12:30pm-2pm
Minocin®
(minocycline)| for Injection
Session: Antimicrobial
ResistantInfections: Treatment
Minocycline Activity is Enhancedby
Polymyxin B in TetBContaining Isolates of Acinetobacter baumannii,
Including ThoseResistant to Polymyxin B
Presentation author: Kirk Nelson,
TheMedicines Company
PosterHall
(poster#2041)
SaturdayOct. 29th
12:30pm-2pm
Minocin®
(minocycline)for Injection
Session: Antimicrobial
ResistantInfections: Treatment
TetB Testing and its AbsenceIdentifies
Minocycline (MINO)Susceptible Isolates of Acinetobacter baumannii
(ACB)
Presentation author: Michael Dudley,The
Medicines Company
PosterHall
(poster#2043)
12:30pm-2pm
Session: Antimicrobial
ResistantInfections: Treatment
The Impact of CarbapenemResistance on
Resource Utilizationin Enterobacteriaceae Infections
Presentation author: Kristin
Dascomb,Intermountain Healthcare
PosterHall
(poster#2022)
12:30pm-2pm
Carbavance®
(meropenem-vaborbactam)
Session: Antibacterial
SusceptibilitySurveillance
In Vitro Activity of Meropenem-Vaborbactam
Against Isolates ofKPC-producing EnterobacteriaceaeCollected
Worldwide in 2014-2015
Presentation author: M. Hackel, IHMA
PosterHall
(poster#1830)
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 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 full list of indications and designated susceptible
pathogens, please see the full US 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 US 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
Concomitant warfarin use: Co-administration of ORBACTIV® and
warfarin may result in higher exposure of warfarin, which may
increase the risk of bleeding. Use ORBACTIV® in patients on chronic
warfarin therapy only when the benefits can be expected to outweigh
the risk of bleeding.
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.
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 US prescribing
information.
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 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," 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 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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161017005243/en/
MediaRusso PartnersMatt Middleman,
M.D., 212-845-4272matt.middleman@russopartnersllc.comorInvestorsKrishna Gorti, M.D., 973-290-6122Vice
President, Investor Relationskrishna.gorti@themedco.com
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