The Medicines Company Announces Participation at ASM MICROBE 2016 to be held June 16 – 20 in Boston

  • Total of 11 presentations highlighting company’s infectious disease program targeted at the most urgent needs in combating resistant organisms
  • Includes data on clinical experience with ORBACTIV® (oritavancin) in outpatient infusion center compared to standard-of-care
  • In vitro data on meropenem-vaborbactam (formerly known as RPX7009) against clinical isolates of Enterobacteriaceae to be presented

PARSIPPANY, N.J.--()--The Medicines Company (NASDAQ:MDCO) today announced that 11 presentations on its infectious disease programs will be presented at the first annual ASM Microbe 2016 to be held June 16-20 in Boston, MA. The company’s infectious disease R&D program is targeted at the most deadly and insidious bacterial threats threatening global health.

Investigators will present data on ORBACTIV® (oritavancin) in the single-dose treatment of acute bacterial skin and skin-structure infections (ABSSSIs), including results from an outpatient infusion center. Researchers will also present in vitro activity of ORBACTIV against frequently isolated gram-positive bacteria and clinical isolates, including those with reduced or non-susceptibility to daptomycin and linezolid.

“We are seeing increasing adoption and use of a single, once-only dose of ORBACTIV in the management of ABSSSIs in real-world settings outside the hospital,” said Mike McGuire, Senior Vice President and Co-Leader of the Infectious Diseases Global Innovation Group, The Medicines Company. “Studies supporting this experience are important for validation of the value of this approach for patients and clinicians.”

Company researchers will present in vitro data for the Phase 3 investigational agent CARBAVANCE® (meropenem-vaborbactam) on activity against Enterobacteriaceae isolates recently collected in US hospitals, including carbapenem-resistant Enterobacteriaceae (CRE), which has been identified as an urgent microbial threat by the Centers for Disease Control (CDC). Researchers will also present data on vaborbactam inhibitory activity against a mutation of the KPC gene that affects the activity of some beta-lactamase inhibitors.

In addition, researchers from Monash University and The Medicines Company will present data on the discovery of a novel series of polymyxins from a NIAID-funded research collaboration.

“As we have heard once again in recent weeks, this time from the AMR final report by Lord O'Neill's UK-based group, there is a global need to accelerate the discovery and development of new agents to treat drug-resistant bacteria,” said Michael Dudley, PharmD, Senior Vice President and Head, Health Science R&D, and Co-Leader of the Infectious Diseases Global Innovation Group, The Medicines Company. “The so-called superbugs are major threats globally, and we must find ways to continually to stay one step ahead of these organisms. Our development program is moving quickly and efficiently, and we believe our products and pipeline of ongoing discovery and development programs are among the few but best in industry, and are well-positioned to meet this need.”

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

 

 

     
 

Time

Product

Event

Place

FRIDAY

12:30pm -

ORBACTIV® Session 060: BCEC

17th

2:30pm

(oritavancin)

Effectiveness of Oritavancin to Treat Acute Bacterial Skin and Skin Structure

Hall A

Infections in a Physician Owned Infusion Center

(poster)

Lead author: P.J. Anastasio, Emerald Coast Infusion Center

#416

 

 

12:30pm -

ORBACTIV® Session 060: BCEC

2:30pm

(oritavancin) In Vitro Activity of Oritavancin against Hall A
Gram-Positive Pathogens Isolated in Canadian (poster)
Hospitals from 2011 to 2015 #417

 

Lead author: J. Karlowsky, University of Manitoba

 

 

12:30pm -

ORBACTIV(®) Session 060: BCEC

2:30pm

(oritavancin) Oritavancin activity against Enterococcus Hall A
faecalis in vitro and in a murine thigh (poster)

 

 

infection model #418

 

Lead author: M. Sabet, The Medicines Company
 

12:30pm -

ORBACTIV(®)

Session 060:

BCEC

2:30pm

(oritavancin)

Assessment of Antibacterial Activity of

Hall A

Oritavancin, Dalbavancin and Vancomycin

(poster)

against Non-Dividing Methicillin-Resistant

#419

Staphylococcus aureus Using Fluorescence

 

Microscopy

 

Lead author: A. Belley, The Medicines Company

         

SATURDAY

12:45pm -

ORBACTIV(®) Session 173: BCEC

18th

2:45pm

(oritavancin) Oritavancin longitudinal in vitro activity Hall A
against gram-positive organisms from USA (poster)

 

medical centers: Results from the SENTRY

#345

 

Antimicrobial Surveillance Program for 2010 – 2014

 

Lead author: R.E. Mendes, JMI Laboratories
 

12:45pm -

Novel Session 179: BCEC

2:45pm

polymyxins

Developing Safer Polymyxins:

Hall A

Structure-activity (SAR) and Structure-toxicity (STR)

(poster)

Relationships of Modifications to Positions 6 and 7

#434

 

Lead author: K.D. Roberts, Monash University

 

and The Medicines Company
 

12:45pm -

Novel Session 184: BCEC

2:45pm

polymyxins In Vitro Activity of FADDI-287, a Hall A
Representative of a Novel Series of (poster)

Polymyxins (PM) with Reduced Nephrotoxic Potential

#495

 

 

Lead author: D. Rubio-Aparicio, The Medicines Company

 

 

12:45pm -

Novel Session 184: BCEC

2:45pm

polymyxins Pharmacology of the novel polymyxin FADDI-287 Hall A

 

in Preclinical Models (poster)

 

Lead author: M. Sabet, The Medicines Company #499
         

SUNDAY

12:30pm -

CARBAVANCE® Session 305: BCEC

19th

2:30pm

(meropenem-vaborbactam)

Meropenem/vaborbactam (MER/VAB) tested Hall A

 

 

against contemporary Enterobacteriaceae (poster)

 

(ENT) isolates from USA hospitals #452

 

Lead author: M. Castanheira, JMI Laboratories
         

MONDAY

8:15am -

CARBAVANCE® Session 373: BCEC

20th

10:45am

(meropenem-vaborbactam)

Inhibition of KPC-2 by Vaborbactam

Room 257A

 

 

(VAB; Formerly Rpx7009) Does Not Involve Ser130 (S130)

(oral session)

That Is Important for Its Inhibition by Avibactam (AVI)

Lead author: R. Tsivkovski, The Medicines Company

 

12:30pm -

ORBACTIV(®) Session 394: BCEC

2:30pm

(oritavancin) Oritavancin Susceptibility Testing among Hall A
Vancomycin Resistant Enterococcus faecium (poster)
Blood Isolates #015

 

Lead author: A. Paskovaty, Memorial Sloan

 

Kettering Cancer Center
         
 

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 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 Quarterly Report on Form 10-Q filed with the SEC on May 9, 2016, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

Contacts

Media:
Bob Laverty, +1 973-290-6162
Mobile: +1 609-558-5570
Vice President, Communications
Robert.Laverty@themedco.com
or
Investor Relations:
Krishna Gorti, MD, +1 973-290-6122
Vice President, Investor Relations
Krishna.Gorti@themedco.com

$Cashtags

Contacts

Media:
Bob Laverty, +1 973-290-6162
Mobile: +1 609-558-5570
Vice President, Communications
Robert.Laverty@themedco.com
or
Investor Relations:
Krishna Gorti, MD, +1 973-290-6122
Vice President, Investor Relations
Krishna.Gorti@themedco.com