The Medicines Company Announces Participation at IDWeek 2015 Meeting

01 Oct 2015

The Medicines Company today announced that it will make four presentations on its infectious disease programs at IDWeek between October 7 – 11 in San Diego, CA.

Company researchers will report on research investigating geographical differences in clinical outcomes for patients with carbapenem-resistant Enterobacteriaceae (CRE). The Centers for Disease Control (CDC) consider CRE to be one of the three most urgent antimicrobial resistant infectious disease threats. Two other posters will contribute data on dosing and nonclinical efficacy, and the in vitro activity of CARBAVANCE® (meropenem/RPX7009), an investigational agent that is currently in phase 3 clinical trials.

The fourth presentation will report data from a contemporary analysis of the in vitro activity of ORBACTIV® (oritavancin) for injection and competitive agents against Staphylococcus aureus (SA), including methicillin-resistant Staphylococcus aureus (MRSA), responsible for invasive community-associated and hospital-associated infections among patients with acute bacterial skin and skin structure infections (ABSSSI) in the US.

"These in vitro studies confirm the continued activity of ORBACTIV® and CARBAVANCE® against important resistant pathogens that afflict patients today,” said Michael Dudley, PharmD, FIDSA, Senior Vice President and Head, Health Science R&D, and Co-Leader of the Infectious Diseases Global Innovation Group at The Medicines Company. "We are committed to the ongoing evaluation of our approved products ORBACTIV® (oritavancin) and MINOCIN® (minocycline) for injection, as well as advancing our investigational agents in a variety of infections, and their impact on patient outcomes,” he added.

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 for all The Medicines Company activities at IDWeek are included in the listing below.

               
      Time     Product     Event     Place

FRIDAY 9TH

Poster Hall
     

12:30 pm

   

CARBAVANCE®
(meropenem/RP
X7009)

   

POSTER 773: Geographic Differences
in Patient Populations and Mortality
due to CRE Infections: Implications
for Clinical Trials of New Agents

     
Poster Hall
     

12:30 pm

   

CARBAVANCE®
(meropenem/RP
X7009)

   

POSTER 781: In Vitro Antibacterial
Activity of Meropenem/RPX7009, (a
Carbapenem/?-lactamase Inhibitor
Combination) against Contemporary
Enterobacteriaceae (ENT) Isolated
from Intra-abdominal (IAI) and
Urinary Tract Infections (UTI) in the
United States (USA)

     
Poster Hall
     

12:30 pm

   

CARBAVANCE®
(meropenem/RP
X7009)

   

POSTER 794: Rationale for Dose
Selection for Carbavance (CVC;
Meropenem/RPX7009) in Phase 3
Trials

     

SATURDAY 10TH

Poster Hall

12:30 pm

ORBACTIV®
(oritavancin)

POSTER 1843: Contemporary
Analysis of Oritavancin In Vitro
Activity against Staphylococcus
aureus Responsible for Invasive
Community- and Hospital-associated
Infections Among Patients in the USA
(2013-2014)

 

About ORBACTIV® (oritavancin) for injection

ORBACTIV® 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 48 hours after ORBACTIV® (oritavancin) 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 US prescribing information.

About MINOCIN® (minocycline) for Injection

MINOCIN® 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 prescribing information available at www.minociniv.com.

Important Safety Information

Contraindications

MINOCIN® (minocycline) 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

Tooth Development

MINOCIN® (minocycline), 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®, 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®. 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 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.

Precautions

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® (minocycline) 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® (minocycline) Injection contains magnesium, close monitoring is recommended in patients with heart block or myocardial damage.

Prescribing MINOCIN® 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 prescribing information for MINOCIN® (minocycline) for injection.

For U.S. Full Prescribing Information, click here.

About CARBAVANCE® (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 US Centers for Disease Control and Prevention (CDC) to be an urgent antimicrobial resistance threat.

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.

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," “hopes,” 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 our product candidates, including CARBAVANCE, will advance in the clinical trials process on a timely basis or at all, 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, the Company’s ability to successfully compete with potential competitors which may discover, develop or commercialize competing products more successfully than we do, 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 7, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.


Contacts

The Medicines Company
Media:
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Mobile +1 609-558-5570
Vice President, Communications
Robert.Laverty@themedco.com
or
Investor Relations:
Krisha Gorti, +1 973-290-6122
Investor.relations@themedco.com

Contact Us

The Medicines Company
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Tel 973 290 6000
Toll-free 800 388 1183
Global Medical Information

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Tel 973 290 6361
Fax 862 207 6361

Investors Relations

Krishna Gorti, MD
Tel 973 290 6122
krishna.gorti@themedco.com

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Michael Blash
Tel 973 290 6100
michael.blash@themedco.com