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The Medicines Company to Present New Data from its Infectious Disease Portfolio at the 54th Interscience Conference on Antimicrobial Agents and...

September 10, 2014



The Medicines Company to Present New Data from its Infectious Disease Portfolio at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy ICAAC

By a News Reporter-Staff News Editor at Biotech Week -- The Medicines Company (NASDAQ:MDCO) 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 (see also The Medicines Company).

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: http://www.icaac.org/ 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 MINOCINŽ (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 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 Contraindications 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 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 48 hours, and may prolong PT and INR for up to 24 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 prescribing information. About MINOCINŽ IV (minocycline for injection) MINOCINŽ 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 Contraindications MINOCIN is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation. Warnings 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 PREGNANCY. 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 pregnancy.

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. Precautions 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.

Keywords for this news article include: Antibacterial, Antibiotics, Antimicrobials, Bacterial Drug Resistance, Central Nervous System Diseases, Chemotherapy, Clostridium difficile, Diarrhea, Drugs, Gram-Positive Endospore-Forming Rods, Hydrocarbons, Hypersensitivity, Infectious Diseases, Microbial Drug Resistance, Minocycline, Naphthacenes, Obstetrics, Pregnancy, Tetracyclines, The Medicines Company, Therapy, Women's Health.

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Source: Biotech Week


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