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The Medicines Company’s Infectious Disease Portfolio Featured in 16 Presentations at IDWeek 2016

Montag, 17.10.2016 13:35



PARSIPPANY, N.J. --(BUSINESS WIRE)--

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

Thursday
Oct. 27th

12:30 pm
to
2:00 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

 

Poster
Hall

(poster
#303)

Thursday
Oct. 27th

12:30 pm
to
2:00 pm

     

Session: HAI: Multi Drug Resistant
Gram 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: Marya
Zilberberg, University of
Massachusetts and EviMed
Research Group

 

Poster
Hall

(poster
#339)

Friday
Oct. 28th

12:30 pm
to
2:00 pm

     

Session: Clinical Infectious
Diseases: Respiratory Infections

 

Impact of Inappropriate Empiric
Treatment of Enterobacteriaceae
UTI, Pneumonia and Sepsis on
Hospital Outcomes

 

Presentation author: Marya
Zilberberg, University of
Massachusetts and EviMed
Research Group

 

Poster
Hall

(poster
#1253)

Saturday
Oct. 29th

10:30 pm
to
12:00 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, The
Medicines Company

 

Room:
283-285

Oral late
breaker
presentation

 

12:30pm
-2pm

 

Orbactiv®

(oritavancin)

 

Session: Antimicrobial Resistance
Mechanisms

 

Assessment of the Propensity
of Oritavancin to Induce
Susceptibility Changes Among

Staphylococcus aureus Nasal
Carriage Isolates in a Phase 2
Study in Patients with Acute
Bacterial Skin and Skin Structure
Infections

 

Presentation author: Francis Arhin,
The Medicines Company

 

Poster
Hall

(poster
#2000)

 

12:30pm
-2pm

 

Orbactiv®

(oritavancin)

 

Session: Antibiotic Resistant
Infections: Treatments

 

Assessment of Oritavancin Activity
in Combination with Beta-lactams
Against Vancomycin-Resistant
Enterococci

 

Presentation author: Francis Arhin,
The Medicines Company

 

Poster
Hall

(poster
#2038)

 

12:30pm
-2pm

 

Orbactiv®

(oritavancin)

 

Session: Antibiotic Resistant
Infections: Treatments

 

Efficacy of Oritavancin and
Comparator Agents Against
Vancomycin-Resistant Enterococcus
faecium in an In Vivo Galleria
mellonella Survival Model

 

Presentation author: Eric Wenzler,
University of Illinois

 

Poster
Hall

(poster
#2026)

 

12:30pm
-2pm

 

Orbactiv®

(oritavancin)

 

Session: Antimicrobial
Pharmacokinetics and
Pharmacodynamics

 

Antibacterial Activity of
Oritavancin and Daptomycin
Against Clinical Isolates of
Vancomycin-Resistant Enterococcus
faecium in In Vitro
Pharmacokinetic/Pharmacodynamic
Models

 

Presentation author: Adam Belley,
The Medicines Company

 

Poster
Hall

(poster
#1990)

Saturday
Oct. 29th

12:30pm
-2pm

 

Orbactiv®

(oritavancin)

 

Session: Antimicrobial
Pharmacokinetics and
Pharmacodynamics

 

Lack of Effect of Oritavancin on
Warfarin Pharmacokinetics in
Healthy Adult Subjects

 

Presentation author: S. Eralp Bellibas,
The Medicines Company

 

Poster
Hall

(poster
#1954)

 

12:30pm
-2pm

 

Orbactiv®

(oritavancin)

 

Session: Antibacterial Safety

 

Interference of Oritavancin on
Coagulation Tests as Assessed In
vitro and in a Phase 1 Study of
Normal Healthy Volunteers

 

Presentation author: Jeff Loutit, The
Medicines Company

 

Poster
Hall

(poster
#1807)

 

12:30pm
-2pm

 

Minocin®

(minocycline)

for Injection

 

Session: Antimicrobial Resistant
Infections: Treatment

 

Estimating the Cost-Effectiveness of
Minocycline for the Treatment of
Multidrug Resistant Acinetobacter
baumannii

 

Presentation author: Weihong Fan, The
Medicines Company

 

Poster
Hall

(poster
#2059)

 

12:30pm
-2pm

     

Session: Antimicrobial Resistant
Infections: Treatment

 

Healthcare Outcomes and Resource
Utilization Associated with
Colistin or Tigecycline use in
Patients with Multidrug Resistant
Acinetobacter baumannii

 

Presentation author: Weihong Fan, The
Medicines Company

 

Poster
Hall

(poster
#2060)

 

12:30pm
-2pm

 

Minocin®

(minocycline)
| for Injection

 

Session: Antimicrobial Resistant
Infections: Treatment

 

Minocycline Activity is Enhanced
by Polymyxin B in TetB
Containing Isolates of Acinetobacter
baumannii, Including Those
Resistant to Polymyxin B

 

Presentation author: Kirk Nelson, The
Medicines Company

 

Poster
Hall

(poster
#2041)

Saturday
Oct. 29th

12:30pm
-2pm

 

Minocin®

(minocycline)
for Injection

 

Session: Antimicrobial Resistant
Infections: Treatment

 

TetB Testing and its Absence
Identifies Minocycline (MINO)
Susceptible Isolates of Acinetobacter
baumannii (ACB)

 

Presentation author: Michael Dudley,
The Medicines Company

 

Poster
Hall

(poster
#2043)

 

12:30pm
-2pm

     

Session: Antimicrobial Resistant
Infections: Treatment

 

The Impact of Carbapenem
Resistance on Resource Utilization
in Enterobacteriaceae Infections

 

Presentation author: Kristin Dascomb,
Intermountain Healthcare

 

Poster
Hall

(poster
#2022)

 

12:30pm
-2pm

 

Carbavance®

(meropenem-
vaborbactam)

 

Session: Antibacterial Susceptibility
Surveillance

 

In Vitro Activity of Meropenem-
Vaborbactam Against Isolates of
KPC-producing Enterobacteriaceae
Collected Worldwide in 2014-
2015

 

Presentation author: M. Hackel, IHMA

 

Poster
Hall

(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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