The Medicines Company to Present New Data from its Infectious Disease Portfolio at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
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 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 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.
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 formulation.
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.
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 sequelae exists.
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 drug-resistant bacteria.
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 on August 4, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
Neera Dahiya Ravindran, MD, +1-973-290-6044
Vice President, Investor Relations & Strategic Planning