The Medicines Company Announces Participation at ICAAC/ICC 2015 Meeting

15 Sep 2015

The Medicines Company (NASDAQ:MDCO) today announced that 18 presentations on its infectious disease programs will be presented at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy and Infection (ICC) joint meeting in San Diego, CA, September 17 to 21.

Company researchers will also report on the discovery of a new series of compounds (termed Broad-spectrum Carbapenemase Inhibitors, or BCIs) that have been shown in vitro to inhibit carbapenem-hydrolyzing beta-lactamase enzymes (carbapenemases) of both families (serine and metallo types) that are responsible for resistance to beta-lactam antibiotics.

"Our discovery of a new series of beta-lactamase inhibitors represents a potentially important breakthrough in the treatment of drug-resistant infections, which remain a major public health problem affecting millions of people every year," said Michael Dudley, PharmD, Senior Vice President and Head, Health Science R&D, and Co-Leader of the Infectious Diseases Global Innovation Group. "We are committed to advancing this new series of compounds as quickly as possible along with Carbavance (meropenem/RPX7009), our Phase 3 investigational drug to treat antimicrobial resistance, and look forward to reporting on our progress with both these programs at ICAAC."

The Company will also discuss the results from a recent analysis of clinical outcomes in patients with infections due to carbapenem-resistant Enterobacteriaceae (CRE). CRE is considered to be an urgent antimicrobial resistance threat by the US Centers for Disease Control. “Clinicians face limited antibiotic choices in treating CRE, and the outcomes in these patients are very poor,” said Dudley. “The data from this retrospective analysis has provided important information to support our ongoing clinical studies of Carbavance (meropenem/RPX7009).”

In addition to the above, posters and an oral presentation focusing on the Company’s ORBACTIV® (oritavancin) for Injection and MINOCIN® (minocycline) for Injection, and the investigational agent Carbavance® (meropenem/RPX7009) will be presented.

Details for all activities are included in the grid below.

         
    Time     Product   Event   Place

FRIDAY 18TH

  12:00 pm     Carbavance  

POSTER C-152: Activity of
meropenem/RPX7009 (MER/RPX) and
Comparator Agents Tested Against
Contemporary Enterobacteriaceae (ENT)
Isolates Collected from Bloodstream
Infections (BSI) in USA Hospitals

  Exhibit Hall F
 

12:00 pm

   

Carbavance

 

POSTER B-078: Efficacy of Carbavance
(Meropenem-RPX7009) against
Carbapenem-resistant E. coli in a Murine
UTI Infection Model

 

Exhibit Hall F

  12:00 pm     Carbavance  

POSTER L-353: Designing Clinical Trials
for New Agents in CRE Infection: What is
“Best Available Therapy” in CRE and How
Well Does it Work?

  Exhibit Hall F
  12:00 pm    

Broad-spectrum
Carbapenemase
inhibitors

 

POSTER F-270: Discovery of a New
Series of Broad-spectrum
Carbapenemase Inhibitors (BCIs) with
Activity vs Serine and Metallo
Beta-lactamases

  Exhibit Hall F
  12:00 pm    

Broad-spectrum
Carbapenemase
inhibitors

 

POSTER F-264: Microbiological
Characterization of Novel
Broad-Spectrum Inhibitors of Serine and
Metallo Carbapenemases

  Exhibit Hall F
  12:00 pm    

Broad-spectrum
Carbapenemase
inhibitors

 

POSTER F-266: Biochemical
Characterization of the Broad-Spectrum
Carbapenemase Inhibitor (BCI) RPX7381

  Exhibit Hall F
    4:45 pm     Minocin  

SLIDE SESSION 044: Pharmacodynamics
of Minocycline Against Acinetobacter
baumannii in a Rat Pneumonia Model

  Meeting Room 31C
      <p class="bwcellpmargin">
        Upper Level
      </p>
    </td>
  </tr>
  <tr>
    <td class="bwpadl0 bwpadb1 bwnowrap bwpadr0 bwvertalignt bwalignl">
      <b>SATURDAY 19</b><sup><b>TH</b></sup>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      11:00 am
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Orbactiv
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        POSTER C-556: In Vitro Activity of<br>Oritavancin Against 
        Gram-positive<br>Pathogens Isolated in Canadian<br>Hospitals 
        from 2011 to 2014
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Exhibit Hall F
    </td>
  </tr>
  <tr>
    <td>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      11:00 am
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Orbactiv
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        POSTER C-567: Comparative in vitro<br>Activity of New Long-acting<br>Lipoglycopeptides 
        and Other Agents<br>against Enterococci, Including<br>Vancomycin-Resistant 
        Isolates
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Exhibit Hall F
    </td>
  </tr>
  <tr>
    <td>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      11:00 am
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Orbactiv
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        POSTER A-491: Comparison of the<br>Pharmacodynamics (PD) of the<br>Long-acting 
        Lipoglycopeptides<br>Oritavancin (ORI) and Dalbavancin (DAL)<br>against 
        Methicillin-resistant<br><i>Staphylococcus aureus</i> (MRSA) in 
        an In<br>Vitro Pharmacokinetic (PK)/PD model<br>(IVPM)
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Exhibit Hall F
    </td>
  </tr>
  <tr>
    <td>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      11:00 am
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Orbactiv
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        POSTER A-493: In Vitro Bactericidal<br>Activity of Oritavancin, 
        Dalbavancin and<br>Vancomycin against Non-dividing<br>Methicillin-Resistant 
        <i>Staphylococcus</i><br><i> aureus</i> (MRSA)
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Exhibit Hall F
    </td>
  </tr>
  <tr>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      11:00 am
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Orbactiv
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        POSTER C-560: Oritavancin In Vitro Activity<br>against a 
        Collection of<br>Molecularly-characterized Staphylococci<br>and 
        Enterococci Displaying Elevated<br>Linezolid MICs
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Exhibit Hall F
    </td>
  </tr>
  <tr>
    <td class="bwpadl0 bwpadb1 bwnowrap bwpadr0 bwvertalignt bwalignl">
      <b>SUNDAY 20</b><sup><b>th</b></sup>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      11:00 am
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Orbactiv
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        POSTER D-1173: Comparison of the In<br>Vitro Bactericidal 
        Activity of Seven Agents<br>Against MRSA
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Exhibit Hall F
    </td>
  </tr>
  <tr>
    <td>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      11:00 am
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Orbactiv
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        POSTER C-1054: Update of Oritavancin<br>and Comparator In Vitro 
        Activities Against<br>Gram-positive Clinical Isolates<br>Responsible 
        for Documented Skin and<br>Skin Structure Infections in the USA 
        (2014)
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Exhibit Hall F
    </td>
  </tr>
  <tr>
    <td>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      11:00 am
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Orbactiv
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwnowrap bwpadr0 bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        POSTER D-1143: Beta-lactams Enhance<br>Oritavancin (ORI) 
        Activity against<br>Methicillin-resistant <i>Staphylococcus</i><br><i> 
        aureus</i> (MRSA) with Reduced<br>susceptibility to Daptomycin 
        and<br>Vancomycin, and vancomycin-resistant<br>enterococci 
        (VRE)
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Exhibit Hall F
    </td>
  </tr>
  <tr>
    <td>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      11:00 am
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Minocin
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwnowrap bwpadr0 bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        POSTER D-1147: In Vitro Activity of<br>Minocycline against<br>Carbapenem-resistant 
        <i>Acinetobacter</i><br><i> baumannii</i> (CRAB)
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Exhibit Hall F
    </td>
  </tr>
  <tr>
    <td>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      11:00 am
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Minocin
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwnowrap bwpadr0 bwvertalignt bwalignl bwsinglebottom">
      <p class="bwcellpmargin">
        POSTER C-1009: Accumulation of Several<br>Chromosomal Mutations 
        Have Limited<br>Impact on the Sensitivity of <i>Acinetobacter</i><br><i> 
        baumannii</i> (ACB) to Minocycline (MINO)
      </p>
    </td>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td class="bwpadl0 bwvertalignt bwalignl bwsinglebottom">
      Exhibit Hall F
    </td>
  </tr>
  <tr>
    <td class="bwsinglebottom">
      &nbsp;
    </td>
    <td>
    </td>
    <td class="bwpadl0 bwpadb1 bwvertalignt bwalignl">
      11:00 am
    </td>
    <td>
    </td>
    <td>
    </td>
    <td class="bwpadl0 bwpadb1 bwvertalignt bwalignl">
      Minocin
    </td>
    <td>
    </td>
    <td class="bwpadl0 bwpadb1 bwnowrap bwpadr0 bwvertalignt bwalignl">
      <p class="bwcellpmargin">
        POSTER C-1024: In Vitro Activity of<br>Minocycline against <i>Acinetobacter</i><br><i> 
        baumannii</i>, <i>Stenotrophomonas</i><br><i> maltophilia</i> 
        and <i>Burkholderia cepacia</i><br>Isolated During 2013 from a 
        Global<br>Surveillance Program
      </p>
    </td>
    <td>
    </td>
    <td class="bwpadl0 bwpadb1 bwvertalignt bwalignl">
      Exhibit Hall F
    </td>
  </tr>
  <tr>
    <td>
    </td>
    <td>
    </td>
    <td>
    </td>
    <td>
    </td>
    <td>
    </td>
    <td>
    </td>
    <td>
    </td>
    <td>
    </td>
    <td>
    </td>
    <td>
      &nbsp;
    </td>
  </tr>
</tbody></table>
<p>
  <b>About ORBACTIV® (oritavancin)</b>
</p>
<p>
  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).
</p>
<p>
  <b>Important Safety Information</b>
</p>
<p>
  <b>Contraindications</b>
</p>
<p>
  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.
</p>
<p>
  ORBACTIV® is contraindicated in patients with known hypersensitivity to 
  ORBACTIV®.
</p>
<p>
  <b>Warnings and Precautions</b>
</p>
<p>
  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.
</p>
<p>
  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.
</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. Infusion-related reactions have been 
  reported. Slow the rate or interrupt infusion if infusion reaction 
  develops.
</p>
<p>
  Clostridium difficile-associated colitis: Evaluate patients if diarrhea 
  occurs.
</p>
<p>
  Osteomyelitis: 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=51180912&amp;newsitemid=20150915005960&amp;lan=en-US&amp;anchor=www.orbactiv.com&amp;index=1&amp;md5=ac98487176a98962fb1cd32b15b44c6a" rel="nofollow">www.orbactiv.com</a> 
  for the full US prescribing information.
</p>
<p>
  <b>About MINOCIN</b><sup><b>®</b></sup><b> (minocycline) for Injection</b>
</p>
<p>
  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 prescribing information available at <a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.minociniv.com&amp;esheet=51180912&amp;newsitemid=20150915005960&amp;lan=en-US&amp;anchor=www.minociniv.com&amp;index=2&amp;md5=60b9dade02ff7728aff4c7c67b006804" rel="nofollow">www.minociniv.com</a>.
</p>
<p>
  <b>Important Safety Information</b>
</p>
<p>
  <b>Contraindications</b>
</p>
<p>
  MINOCIN<sup>®</sup> (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.
</p>
<p>
  <b>Warnings</b>
</p>
<p>
  <span class="bwuline">Tooth Development</span>
</p>
<p>
  MINOCIN, 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>
  <span class="bwuline">Skeletal Development</span>
</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>
  <span class="bwuline">Dermatologic Reaction</span>
</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>
  <span class="bwuline">Anti-anabolic Action</span>
</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>
  <span class="bwuline">Photosensitivity</span>
</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>
  <span class="bwuline">Central Nervous System Effects</span>
</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>
  <span class="bwuline"><i>Clostridium difficile</i> Associated Diarrhea</span>
</p>
<p>
  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.
</p>
<p>
  <span class="bwuline">Intracranial Hypertension</span>
</p>
<p>
  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.
</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>
  <b>Precautions</b>
</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 (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.
</p>
<p>
  Because MINOCIN (minocycline) Injection contains magnesium, close 
  monitoring is recommended in patients with heart block or myocardial 
  damage.
</p>
<p>
  Prescribing MINOCIN® Injection in the absence of a proven or strongly
</p>
<p>
  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 prescribing 
  information for MINOCIN<sup>®</sup> (minocycline) for injection.
</p>
<p>
  For U.S. Full Prescribing Information, <a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.minociniv.com&amp;esheet=51180912&amp;newsitemid=20150915005960&amp;lan=en-US&amp;anchor=click+here&amp;index=3&amp;md5=afc12371516f694cbf8ff0ab3df76243" rel="nofollow">click 
  here</a>.
</p>
<p>
  <b>About CARBAVANCE</b><sup><b>®</b></sup>
</p>
<p>
  CARBAVANCE<sup>®</sup>, 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.
</p>
<p>
  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 <i>Klebsiella pneumoniae</i> 
  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.
</p>
<p>
  <b>About The&nbsp;Medicines Company</b>
</p>
<p>
  The&nbsp;Medicines Company's&nbsp;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&nbsp;Americas,&nbsp;Europe&nbsp;and the&nbsp;Middle East, and&nbsp;Asia 
  Pacific regions with global centers today in&nbsp;Parsippany, NJ, USA 
  and&nbsp;Zurich,&nbsp;Switzerland.
</p>
<p>
  <b>Forward-Looking Statements</b>
</p>
<p>
  Statements contained in this press release about The&nbsp;Medicines 
  Company&nbsp;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&nbsp;The Private 
  Securities&nbsp;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 the BCIs and 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.
</p>
<p>
</p>


Contacts

The Medicines Company
Media:
Bob Laverty, +1 973-290-6162
Mobile +1 609-558-5570
Vice President, Communications
Robert.Laverty@themedco.com
or
Investor Relations:
+1 973-290-6400
Investor.relations@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