|[August 27, 2014]
The Medicines Company to Present New Data from its Infectious Disease Portfolio at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
PARSIPPANY, N.J. --(Business Wire)--
The Medicines Company (NASDAQ:MDCO) today announced that a series of
abstracts highlighting data from its Infectious Disease portfolio will
be presented at the 54th Interscience Conference on Antimicrobial Agents
and Chemotherapy (ICAAC), which takes place in Washington, DC from
September 5-9, 2014.
Data will be presented on ORBACTIVTM (oritavancin) for
injection, the first and only single-dose FDA approved antibiotic for
the treatment of adults with acute bacterial skin and skin structure
infections (ABSSSI) caused by susceptible isolates of designated
gram-positive pathogens. Data will also be presented on the
investigational intravenous antibiotic, CarbavanceTM
(meropenem/ RPX7009), a combination product consisting of the carbapenem
antibiotic meropenem, combined with RPX7009, the first of a novel class
of beta-lactamase inhibitors. A total of 19 presentations describing
clinical and nonclinical data spanning the two products will be
delivered during ICAAC.
"The Medicines Company is committed to developing solutions for
infections caused by pathogens that the US Centers for Disease Control
and Prevention (CDC) considers to be serious and urgent antimicrobial
resistance threats", said Dr. Michael Dudley, Senior Vice President and
Head of Health Science in the Infectious Disease Global Innovation
Group. "We are pleased to present these abstracts that show excellent
progress by our scientists and collaborators in developing innovative
new approaches to tackle critical problems in infectious diseases both
today and in the future."
Results from studies on ORBACTIV (Abstract L-1729) and Carbavance
(Abstract C-1193) will be featured in an ICAAC press briefing.
Additionally, two oral presentations highlighting the results from
studies with the novel beta-lactamase inhibitor RPX7009 will be given in
the session "New Insights into Beta-lactamase/Beta-lactamase Inhibitor
Combinations" on September 7th at 15:00 Eastern Standard Time.
Copies of abstracts and scheduled presentations are available on the
ICAAC 2014 website:
About the Medicines Company Infectious Disease Portfolio
The Medicines Company is positioned to address the complex problems
associated with multi-drug resistant infections. The research projects,
development programs, and marketed products span the spectrum of
infections caused by gram-positive bacteria including MRSA, and
gram-negative infections including Acinetobacter,
carbapenem-resistant Enterobacteriaceae and other multi-drug-resistant
pathogens. The product pipeline includes Carbavance, RPX-602 (new
formulation of MINOCIN® (minocycline) for injection, and a
pre-clinical developmental program of novel investigational agents.
ORBACTIV and MINOCIN are two antibiotics approved for use in the US. The
product portfolio has the potential to offer clinicians and patients a
suite of innovative new antibiotic approaches to tackle many of the most
vexing problems in infectious disease today.
About ORBACTIVTM (oritavancin)
ORBACTIVTM (oritavancin) for injection is indicated for the
treatment of adult patients with acute bacterial skin and skin structure
infections (ABSSSI) caused by susceptible isolates of the following
Gram-positive microorganisms: Staphylococcus aureus (including
methicillin-susceptible and methicillin-resistant 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).
ORBACTIV is the first and only single-dose antibiotic approved for
commercial use in the US. The EMA (News - Alert) accepted for review the Marketing
Authorization Application (MAA) for ORBACTIV in Q1 2014, for which the
Company is seeking approval for the treatment of complicated skin and
soft tissue infections (cSSTI). A decision from the European Commission
is expected during the first half of 2015.
IMPORTANT SAFETY INFORMATION
Use of intravenous unfractionated heparin sodium is contraindicated for
48 hours after ORBACTIV administration because the activated partial
thromboplastin time (aPTT) test results are expected to remain falsely
elevated for approximately 48 hours after ORBACTIV administration.
ORBACTIV is contraindicated in patients with known hypersensitivity to
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 48 hours, and may prolong PT and INR for up to 24
Hypersensitivity reactions have been reported with the use of
antibacterial agents incuding 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
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.
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 MINOCIN® IV (minocycline for injection)
MINOCIN® IV (minocycline for injection) is FDA-approved and indicated
for the treatment of infections due to susceptible strains of designated
microorganisms, including Acinetobacter spp. Acinetobacter
spp is considered by CDC to be a serious antimicrobial resistance
threat. While there are limited choices for treatment of patients with
infection due to multi-drug resistant isolates of Acinetobacter spp.,
minocycline retains in vitro activity against many of these isolates.
IMPORTANT SAFETY INFORMATION
MINOCIN is contraindicated in persons who have shown hypersensitivity to
any of the tetracyclines or to any of the components of the product
MINOCIN, LIKE OTHER TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL
HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. THE PATIENT SHOULD BE
APPRISED OF THE POTENTIAL HAZARD TO THE FETUS IF THE PATIENT BECOMES
PREGNANT WHILE TAKING THESE DRUGS OR USES A TETRACYCLINE DURING
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). TETRACYCLINE
DRUGS, THEREFORE SHOULD NOT BE USED DURING TOOTH DEVELOPMENT UNLESS
OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
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.
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.
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
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.
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 manifested by an exaggerated sunburn reaction has been
observed in some individuals taking tetracyclines. This has been
reported with minocycline.
Central nervous system side effects including lightheadedness, dizziness
or vertigo have been reported.
Clostridium difficile associated diarrhea (CDAD) has been reported with
use of nearly all antibacterial agents, including MINOCIN, and may range
in severity from mild diarrhea to fatal colitis. If CDAD is suspected or
confirmed, ongoing antibiotic use not directed against C. difficile may
need to be discontinued.
As with other antibiotic preparations, use of this drug may result in
overgrowth of nonsusceptible organisms, including fungi. If
superinfection occurs, the antibiotic should be discontinued and
appropriate therapy instituted.
Pseudotumor cerebri (benign intracranial hypertension) in adults has
been associated with the use of tetracyclines. The usual clinical
manifestations are headache and blurred vision. Bulging fontanels have
been associated with the use of tetracyclines in infants. While both of
these conditions and related symptoms usually resolve soon after
discontinuation of the tetracycline, the possibility for permanent
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 therapy when indicated.
Prescribing MINOCIN 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
For a complete list of adverse reactions that have been observed in
patients receiving tetracyclines, consult the full prescribing
information for MINOCIN.
Please see www.minociniv.com
for the full prescribing information.
About CarbavanceTM (meropenem/RPX7009)
Carbavance, an investigational agent not approved for commercial use in
any market, is a combination of meropenem and RPX7009 administered as a
fixed combination by IV infusion and is being developed to treat serious
gram-negative infections, such as cUTIs, including those infections
caused by bacteria resistant to currently available carbapenems.
Carbavance was designed to address gram-negative bacteria that produce
new beta-lactamase enzymes that have spread in the US 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 US and are
classified by the CDC to be an urgent antimicrobial resistance threat.
The FDA has designated Carbavance as a Qualified Infectious Disease
Product (QIDP). The QIDP designation provides Carbavance priority review
by the FDA, eligibility for the FDA's "fast track" status, and an
additional five years of any non-patent exclusivity upon approval of the
product for intravenous use in six indications. These include
complicated urinary tract and intra-abdominal infections,
hospital-acquired bacterial pneumonia/ventilator-associated bacterial
pneumonia, and febrile neutropenia. The QIDP designation was granted
pursuant to the Generating Antibiotic Incentives Now (GAIN) Act,
included in the FDA Safety and Innovation Act (FDASIA) that was signed
into law in 2012.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering
and contribute to the economics of healthcare by focusing on 3000
leading acute/intensive care hospitals worldwide. Its vision is to be a
leading provider of solutions in three areas: serious infectious disease
care, acute cardiovascular care and surgery and perioperative care. The
company operates in the Americas, Europe and the Middle East, and Asia
Pacific regions with global centers today in Parsippany, NJ, USA
and Zurich, Switzerland.
Statements contained in this press release about The Medicines
Company that are not purely historical, and all other statements 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 "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 the extent of the commercial success of the
Company's products, the Company's ability to develop its global
operations and penetrate foreign markets, whether the Company's products
will advance in the clinical trials process on a timely basis or at all,
whether the Company will make regulatory submissions for product
candidates on a timely basis, whether its regulatory submissions will
receive approvals from regulatory agencies on a timely basis or at all,
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 SEC (News - Alert) on August 4, 2014, which are incorporated herein by reference.
The Company specifically disclaims any obligation to update these
[ Back To TMCnet.com's Homepage ]