The Medicines Company Announces Participation at 2016 European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) to be held April 9-12 in Amsterdam

04 Apr 2016

The Medicines Company (NASDAQ:MDCO) today announced that investigators will present data for the Phase 3 investigational agent CARBAVANCE® (meropenem-vaborbactam) on activity against newly discovered BKC-1 and FR-1 serine lactamases at the 26th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), held April 9-12 in Amsterdam. Investigators will also present data for ORBACTIV® (oritavancin) activity tested against European staphylococcal clinical isolates, including those with reduced susceptibility to daptomycin, teicoplanin or vancomycin.

Researchers will also present data on a discovery program featuring a new series of novel broad-spectrum carbapenemase inhibitors (BCIs) that inhibit both serine and metallo carbapenemases in carbapenem-resistant Enterobacteriaceae (CRE). The novel beta-lactamase inhibitors are drugs that restore the in vitro potency of carbapenems and other beta-lactams against gram-negative bacteria.

A list of key presentations is included below. The complete program of titles and abstracts can be accessed on the ECCMID 2016 web site at ECCMID.org.

                     
   

Time

   

Product

   

Event

 

Place

MONDAY 11th

 

1:30pm -
2:30pm

   

ORBACTIV®
(oritavancin)

   

P1357: Oritavancin activity tested against European staphylococcal clinical isolates and resistant subsets including those with reduced susceptibility to daptomycin, teicoplanin or vancomycin (2010–2014)
Lead author: Rodrigo E. Mendes

Abstract

 

Poster Area

MONDAY 11th

 

1:30pm -
2:30pm

   

CARBAVANCE®
(meropenem-
vaborbactam)

   

P1289: Vaborbactam (RPX7009) plus meropenem is active against the newly discovered BKC-1 and FR-1 carbapenemases
Lead author: Olga Lomovskaya

Abstract

 

Poster Area

TUESDAY 12th

 

9:00am -
11:00am

   

CARBAVANCE®
(meropenem-
vaborbactam)

   

0529: Novel Broad-Spectrum Inhibitors of Serine and Metallo Carbapenemases
Lead author: Olga Lomovskaya
Abstract

 

Hall C

OS128

           

About CARBAVANCE® (meropenem-vaborbactam)

CARBAVANCE®, an investigational agent not approved for commercial use in any market, is a combination of meropenem and vaborbactam (formerly known as 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 US Centers for Disease Control and Prevention (CDC) to be an urgent antimicrobial resistance threat.

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 Medicines Company

The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 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.

Forward-Looking Statements

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 whether the physicians, patients and other key decision makers will accept clinical trial results, whether the Company can protect its intellectual property 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 Annual Report on Form 10-K filed with the SEC on February 29, 2016, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.


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Robert.Laverty@themedco.com
or
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Krishna Gorti, MD, +1 973-290-6122
Vice President, Investor Relations
Krishna.Gorti@themedco.com

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