The Medicines Company to Present Data at ECCMID 2017 on Infectious Disease Portfolio Including Investigational Antibiotic Meropenem-Vaborbactam

17 Apr 2017

The Medicines Company (NASDAQ:MDCO) today announced that data from its portfolio of antimicrobial products and late-stage product candidates will be featured in presentations at the 27th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2017) to be held April 22-25, 2017, in Vienna, Austria.

The Company will present data on its investigational antibiotic, meropenem-vaborbactam, from the pivotal TANGO 1 trial that compared it to piperacillin-tazobactam in the treatment of complicated urinary tract infections (cUTIs). Additional data on meropenem-vaborbactam’s in vitro activity against clinical isolates of carbapenem-resistant Enterobacteriaceae (CRE), and in experimental treatment models will also be presented as will data from studies of Orbactiv® (oritavancin) and Minocin® (minocycline) for Injection.

“The scope and diversity of the research being presented at ECCMID 2017 provides evidence of The Medicines Company’s strong commitment to advancing the discovery and development of innovative antimicrobial drugs for pathogens that The World Health Organization recently identified as a critical need,” said Michael Dudley, PharmD, FIDSA, Senior Vice President, Head of R&D and Co-Leader of The Medicines Company’s Infectious Disease Business.

Mike McGuire, Senior Vice President and Co-Leader of The Medicines Company’s Infectious Disease Business added, “We were delighted with the Food and Drug Administration (FDA) acceptance of our NDA for meropenem-vaborbactam. We believe that, if approved later in 2017, meropenem-vaborbactam will make a major contribution to patient care and demonstrate The Medicines Company’s continued commitment to leadership in treatment of antimicrobial drug-resistance.”

Tony Kingsley, President and Chief Operating Officer of The Medicines Company, summarized, “With The Medicines Company’s infectious disease franchise we have a fully-integrated biopharmaceutical company with capabilities from discovery to commercialization. We are tackling major antibacterial threats which we also believe represent attractive global market opportunities. We are committed to growing this focused, effective, and fully- integrated infectious disease business.”

ECCMID 2017, the 27th European Congress of Clinical Microbiology and Infectious Diseases, gathers the world’s leading experts in infectious disease management together to discuss the latest developments in infectious disease, infection control and clinical microbiology. Details of presentations are provided below. The complete program of titles, abstracts, and electronic versions of posters can be accessed on the ECCMID website at http://www.eccmid.org/. All times listed below are in European Central Time.

               

Date

Time

 

Product

 

Event

 

Details

Monday

April 24th

11:54 am
to
12:04 pm
  Meropenem-vaborbactam  

Session: New agents for bacterial infection in phase II and III clinical trials

 

Meropenem-vaborbactam (M-V) versus Piperacillin-tazobactam (P-T) in the Treatment of Adults with Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis (AP) in TANGO 1, a Phase 3 Randomized, Double-blind, Double-dummy trial

 

Presentation authors: V. Stus, O. Sagan, M. Bidair, J. Loutit, M. Dudley, A. Schorr

 

Oral Presentation

 

Presentation: #OS0604

 

View Abstract:
#1204

Monday April 24th

12:30 pm
to
1:30 pm
  Meropenem-vaborbactam  

Session: News on rebactam and vaborbactam

 

Meropenem-Vaborbactam Against Highly Carbapenem-resistant Enterobacteriaceae in an In Vitro Hollow Fiber Model using PK from Phase 1 and Phase 3 data in Patients

 

Presentation authors: D. Griffith, Z. Tarazi, M. Sabet, D. Rubio-Aparicio, T. Nolan, J. Parkinson, M. Dudley, O. Lomovskaya

 

Poster Session

 

Poster #P1288

 

View Abstract:
#6341

Monday April 24th 12:30 pm
to
1:30 pm
  Meropenem-vaborbactam  

Session: News on relebactam and vaborbactam

 

Clinical Outcomes in Adults with Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis (AP) in TANGO 1, a Phase 3 Randomized, Double-blind, Double-dummy Trial Comparing Meropenem-Vaborbactam (M-V) with Piperacillin-Tazobactam (P-T)

 

Presentation authors: J. Loutit, M. Didair, M. Zervos, O.Sagan, V. Zaitsev, M. Dudley, J.Vazquez

 

Poster Session

 

Poster: #P1289

 

View Abstract:
#886

Monday April 24th 12:30 pm
to
1:30 pm
  Meropenem-vaborbactam  

Session: News on relebactam and vaborbactam

 

Per Pathogen Outcomes of Meropenem-Vaborbactam (M-V) versus Piperacillin-Tazobactam (P-T) in the Treatment of Adults with Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis (AP), in TANGO 1, a Phase 3 Randomized, Double-blind, Double-dummy Trial

 

Presentation authors: T. Walsh, T. Bhowmick, R. Darouiche, A. Shorr, V. Zaitsev, D. Perlin, E. Giamarellos-Bourboulis, E. Fedosiuk, O. Lomovskaya, K. Fusaro, M. Dudley, J. Loutit, T. File

 

 

Poster Session

 

Poster: #P1290

 

View Abstract:
#887

Monday April 24th 12:30 pm
to
1:30 pm
  Meropenem-vaborbactam  

Session: News on relebactam and vaborbactam

 

Meropenem-Vaborbactam Activity Against Enterobacteriaceae Isolates Collected During 2014-2015 From European Countries

 

Presentation authors: M. Castanheira, L.R. Duncan, L.M. Deshpande, R.E. Mendes, R.K. Flamm

 

Poster Session

 

Poster: #P1286

 

View Abstract:
#2940

Monday April 24th 12:30 pm
to
1:30 pm
  Meropenem-vaborbactam  

Session: News on relebactam and vaborbactam

 

In Vitro Activity of Meropenem-Vaborbactam Against KPC-producing Enterobacteriaceae from Europe Collected in 2014-2015

 

Presentation authors: M. Hackel, R. Badal, D. Sahm

 

Poster Session

 

Poster: #P1287

 

View Abstract:
#1461

Tuesday
      <p class="bwcellpmargin">
        April 25th
      </p>
    </td>
    <td class="bwpadl0  bwvertalignt bwalignc bwsinglebottom">
      12:30 pm<br>to<br>1:30 pm
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0  bwvertalignt bwalignl bwsinglebottom">
      Meropenem-vaborbactam
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0  bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        <i>Session</i>: Bloodstream Infections: Epidemiology and Management
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        <i><b>Hospital resource use associated with treatment of 
        Enterobacteriaceae pneumonia, sepsis and UTI </b></i>
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        <i>Presentation authors</i>: M. Zilberberg, MPH, B. Nathanson,, K. 
        Sulham, W. Fan, MS, A. Shorr
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0  bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        Poster Session
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        Poster: #P1953
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        View Abstract:<br>#1585
      </p>
    </td>
  </tr>
  <tr>
    <td class="bwpadl0  bwvertalignt bwalignl bwsinglebottom">
      Saturday April 22nd
    </td>
    <td class="bwpadl0  bwvertalignt bwalignc bwsinglebottom">
      <p class="bwcellpmargin">
        8:45 am-<br>3:30 pm
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0  bwvertalignt bwalignl bwsinglebottom">
      Minocin<sup>®</sup>

      <p class="bwcellpmargin">
        (minocycline)
      </p>
      <p class="bwcellpmargin">
        for Injection
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0  bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        <i>Abstract: </i>Pharmacoepidemiology, improved prescribing and 
        antibiotic stewardship
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        <i><b>Coadministration of Minocycline with Colistin in Critically 
        Ill Patients is Associated with Reduced Incidence of Acute Renal 
        Failure</b></i>
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        <i>Presentation authors:</i> K. Sulham, T. Lodise, W. Fan, D. 
        Griffith, M. Dudley
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0  bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        Poster Session
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        Poster:<br>#EV0380
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        View Abstract:<br>#2850
      </p>
    </td>
  </tr>
  <tr>
    <td class="bwpadl0  bwvertalignt bwalignl bwsinglebottom">
      Saturday April 22nd
    </td>
    <td class="bwpadl0 bwnowrap bwpadr0 bwvertalignt bwalignc bwsinglebottom">
      <p class="bwcellpmargin">
        3:30 pm-<br>4:30 pm
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0  bwvertalignt bwalignl bwsinglebottom">
      Orbactiv<sup>®</sup>

      <p class="bwcellpmargin">
        (oritavancin)
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0  bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        <i>Session</i>: MRSA and MSSA Epidemiology and Resistance
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        <i><b>Updated Analysis of Oritavancin Activity against 
        Gram-positive Clinical Isolates Responsible for Documented Skin 
        and Skin Structure Infections in United States and European 
        Hospitals (2014-2016)</b></i>
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        <i>Presentation authors</i>: R.E. Mendes, H.S. Sader, M.D. Huband, 
        J.M. Streit, R.K. Flamm
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0  bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        Poster Session
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        Poster: #P0139
      </p>
      <p class="bwcellpmargin">
        &nbsp;
      </p>
      <p class="bwcellpmargin">
        View Abstract:<br>#6101
      </p>
    </td>
  </tr>
  <tr>
    <td>
    </td>
    <td>
    </td>
    <td>
      &nbsp;
    </td>
    <td>
    </td>
    <td>
      &nbsp;
    </td>
    <td>
    </td>
    <td>
      &nbsp;
    </td>
    <td>
    </td>
  </tr>
</tbody></table>
<p>
  <b>About Meropenem-Vaborbactam</b>
</p>
<p>
  Meropenem-vaborbactam, an investigational agent not approved for 
  commercial use in any market, is a combination of the carbapenem, 
  meropenem, and the novel beta-lactamase inhibitor, vaborbactam (formerly 
  known as RPX7009), administered as a fixed combination by IV&nbsp;infusion. 
  It is being developed to treat serious gram-negative infections, such as 
  complicated urinary tract infections, including those infections caused 
  by bacteria resistant to currently available carbapenems. 
  Meropenem-vaborbactam has been granted Fast Track status by the U.S. 
  Food and Drug Administration (FDA) for the treatment of complicated 
  urinary tract infections and has been designated by the FDA as a 
  Qualified Infectious Disease Product (QIDP), as authorized under the 
  GAIN Act.
</p>
<p>
  Meropenem-vaborbactam was designed to address gram-negative bacteria 
  that produce new beta-lactamase enzymes that have spread in the United 
  States and Europe, including strains producing the <i>Klebsiella 
  pneumoniae</i> carbapenemase (KPC) enzyme. KPC-producing bacteria are 
  the predominant form of carbapenem-resistant Enterobacteriaceae (CRE) in 
  the United States and are classified by the U.S. Centers for Disease 
  Control and Prevention (CDC) to be an urgent antimicrobial resistance 
  threat. A pivotal Phase III clinical trial for&nbsp;meropenem-vaborbactam&nbsp;in 
  cUTI was successfully completed in 2016, and our NDA was accepted for 
  filing by the FDA with a priority review classification in February 2017.
</p>
<p>
  <b>About MINOCIN® (minocycline) for Injection</b>
</p>
<p>
  In the United States, MINOCIN® (minocycline) for Injection is indicated 
  for the treatment of infections due to susceptible strains of designated 
  microorganisms, including <i>Acinetobacter</i> species bacteria. For 
  additional full list of indications and designated susceptible 
  pathogens, please see the full US prescribing information available at <a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.minociniv.com&amp;esheet=51541455&amp;newsitemid=20170417005349&amp;lan=en-US&amp;anchor=www.minociniv.com&amp;index=20&amp;md5=a2c0d7bb8290e048c9d18325754378c5" rel="nofollow">www.minociniv.com</a>. 
  Intravenous minocycline is an investigational agent in the EU.
</p>
<p>
  <b>Important Safety Information</b>
</p>
<p>
  <b>Contraindications</b>
</p>
<p>
  MINOCIN® 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.
</p>
<p>
  <b>Warnings and Precautions</b>
</p>
<p>
  <i>Tooth Development</i>
</p>
<p>
  MINOCIN® for Injection, 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).
</p>
<p>
  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.
</p>
<p>
  <i>Skeletal Development</i>
</p>
<p>
  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.
</p>
<p>
  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.
</p>
<p>
  <i>Dermatologic Reaction</i>
</p>
<p>
  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.
</p>
<p>
  <i>Anti-anabolic Action</i>
</p>
<p>
  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.
</p>
<p>
  <i>Photosensitivity</i>
</p>
<p>
  Photosensitivity manifested by an exaggerated sunburn reaction has been 
  observed in some individuals taking tetracyclines. This has been 
  reported with minocycline.
</p>
<p>
  <i>Central Nervous System Effects</i>
</p>
<p>
  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.
</p>
<p>
  <i>Clostridium difficile Associated Diarrhea</i>
</p>
<p>
  Clostridium difficile associated diarrhea (CDAD) has been reported with 
  use of nearly all antibacterial agents, including MINOCIN® for 
  Injection, 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.
</p>
<p>
  <i>Intracranial Hypertension</i>
</p>
<p>
  Intracranial hypertension (IH, pseudotumor cerebri) has been associated 
  with the use of tetracyclines including MINOCIN® for Injection. 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® for Injection should be avoided because 
  isotretinoin is also known to cause pseudotumor cerebri.
</p>
<p>
  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.
</p>
<p>
  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.
</p>
<p>
  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.
</p>
<p>
  Incision and drainage or other surgical procedures should be performed 
  in conjunction with antibiotic antibacterial therapy when indicated.
</p>
<p>
  MINOCIN® for 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.
</p>
<p>
  Because MINOCIN® for Injection contains magnesium, close monitoring is 
  recommended in patients with heart block or myocardial damage.
</p>
<p>
  Prescribing MINOCIN® for 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.
</p>
<p>
  <b>Adverse Reactions</b>
</p>
<p>
  For a complete list of adverse reactions that have been observed in 
  patients receiving tetracyclines, consult the full US prescribing 
  information for MINOCIN® for Injection.
</p>
<p>
  Please see <a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.minociniv.com%2F&amp;esheet=51541455&amp;newsitemid=20170417005349&amp;lan=en-US&amp;anchor=www.minociniv.com&amp;index=21&amp;md5=bf855b971fa6dc592233ad05f99eb45f" rel="nofollow">www.minociniv.com</a> 
  for the full US prescribing information.
</p>
<p>
  <b>About ORBACTIV® (oritavancin) for Injection</b>
</p>
<p>
  In the United States, 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). In March 2015, the European Commission granted marketing 
  authorization for ORBACTIV®, which is valid in the 31 countries of the 
  European Economic Area (EEA), plus Norway, Iceland and Liechtenstein.
</p>
<p>
  <b>Important Safety Information</b>
</p>
<p>
  <b>Contraindications</b>
</p>
<p>
  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.
</p>
<p>
  ORBACTIV® is contraindicated in patients with known hypersensitivity to 
  ORBACTIV®.
</p>
<p>
  <b>Warnings and Precautions</b>
</p>
<p>
  <i>Coagulation test interference:</i> 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.
</p>
<p>
  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.
</p>
<p>
  Infusion-related reactions have been reported. Slow the rate or 
  interrupt infusion if infusion reaction develops.
</p>
<p>
  <i>Clostridium difficile-associated colitis:</i> Evaluate patients if 
  diarrhea occurs.
</p>
<p>
  <i>Concomitant warfarin use:</i> Patients should be monitored for 
  bleeding if concomitantly receiving ORBACTIV® and warfarin.
</p>
<p>
  <i>Osteomyelitis:</i> Institute appropriate alternate antibacterial 
  therapy in patients with confirmed or suspected osteomyelitis.
</p>
<p>
  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.
</p>
<p>
  <b>Adverse Reactions</b>
</p>
<p>
  The most common adverse reactions (? 3%) in patients treated with 
  ORBACTIV® were headache, nausea, vomiting, limb and subcutaneous 
  abscesses, and diarrhea.
</p>
<p>
  Please see <a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.orbactiv.com&amp;esheet=51541455&amp;newsitemid=20170417005349&amp;lan=en-US&amp;anchor=www.orbactiv.com&amp;index=22&amp;md5=f91bcab320210699f2c02aa99446c0fd" rel="nofollow">www.orbactiv.com</a> 
  for the full US prescribing information.
</p>
<p>
  <b>About The Infectious Disease Business</b>
</p>
<p>
  The Medicines Company’s Infectious Disease Business (MDCO IDC) is 
  committed to bringing life-saving antimicrobial products to 
  patients&nbsp;with the most serious drug-resistant infections – infections 
  caused by “super bugs” which are no longer treatable with available 
  antibiotics. MDCO IDC encompasses basic research and drug discovery 
  focused on bacterial mechanisms of drug resistance; drug development 
  focused on the most threatening bacterial diseases; and a distribution 
  and commercial infrastructure that serves the leading hospitals and 
  healthcare facilities in the United States. MDCO IDC is currently 
  developing&nbsp;meropenem-vaborbactam&nbsp;to treat serious gram-negative 
  infections, such as complicated urinary tract infections, including 
  those infections caused by bacteria resistant to currently available 
  carbapenems. MDCO IDC has a leading pipeline of novel agents directed 
  towards existing and emerging multidrug-resistant bacteria. A pivotal 
  Phase III clinical trial for&nbsp;meropenem-vaborbactam&nbsp;was successfully 
  completed in 2016, and our NDA was accepted for filing by the FDA with a 
  priority review classification in February 2017.&nbsp;Since 2014, our team 
  has successfully developed and launched two antibiotics against serious 
  infections: Orbactiv<sup>®</sup>&nbsp;(oritavancin) for treatment of acute 
  bacterial skin and skin-structure infections in adults, including those 
  due to methicillin-resistant Staphylococcus aureus (MRSA), and a new 
  formulation of Minocin<sup>®</sup>&nbsp;(minocycline) for Injection, which is 
  among the few FDA-approved agents for the treatment of infections due to&nbsp;<i>Acinetobacter 
  sp.,&nbsp;</i>a serious antimicrobial resistance threat. For more 
  information on these products, including their respective prescribing 
  information, please see&nbsp;<a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.orbactiv.com%2F&amp;esheet=51541455&amp;newsitemid=20170417005349&amp;lan=en-US&amp;anchor=www.orbactiv.com&amp;index=23&amp;md5=888144170bf44bedbcdf079c7f151cdf" rel="nofollow">www.orbactiv.com</a> 
  and&nbsp;<a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.minociniv.com%2F&amp;esheet=51541455&amp;newsitemid=20170417005349&amp;lan=en-US&amp;anchor=www.minociniv.com&amp;index=24&amp;md5=c8d7f7275807b857ca9bdac980368c6d" rel="nofollow">www.minociniv.com</a>.
</p>
<p>
  <b>About The Medicines Company</b>
</p>
<p>
  The Medicines Company is a biopharmaceutical company driven by an 
  overriding purpose – to save lives, alleviate suffering and contribute 
  to the economics of healthcare. The Company’s mission is to create 
  transformational solutions to address the most pressing healthcare needs 
  facing patients, physicians and providers in three critical therapeutic 
  areas: serious infectious disease care, cardiovascular care and surgery 
  and perioperative care. The Company is headquartered in Parsippany, New 
  Jersey, with global innovation centers in California and Switzerland.
</p>
<p>
  <b>The Medicines Company Forward-Looking Statements</b>
</p>
<p>
  Statements contained in this press release 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," “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 clinical trials will advance on a timely basis, or at 
  all, or succeed in achieving their specified endpoints; whether 
  physicians, patients and other key decision makers will accept clinical 
  trial results; whether the Company will make regulatory submissions on a 
  timely basis, or at all; whether the Company’s regulatory submissions 
  will receive approvals from regulatory agencies on a timely basis, or at 
  all; 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 Securities and 
  Exchange Commission on March 1, 2017, which are incorporated herein by 
  reference. The Company specifically disclaims any obligation to update 
  these forward-looking statements.
</p>
<p>
</p>


Contacts

The Medicines Company
Media
Meg Langan, 973-290-6319
Vice President
margaret.langan@themedco.com
or
Investors
Krishna Gorti, M.D., 973-290-6122
Vice President, Investor Relations
krishna.gorti@themedco.com

Contact Us

The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054 USA
Tel 973 290 6000
Toll-free 800 388 1183
Global Medical Information

Human Resources
Verification of employment
Tel 973 290 6361
Fax 862 207 6361

Investors Relations

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

Media Inquiries

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