ORBACTIVTM (Oritavancin) Phase 3 Trial Results Published in New England Journal of Medicine

  ORBACTIVTM (Oritavancin) Phase 3 Trial Results Published in New England
  Journal of Medicine

SOLO I Trial studied single-dose ORBACTIV^TM (oritavancin) in the treatment of
  acute bacterial skin and skin structure infections caused by Gram-positive
    bacteria including methicillin-resistant Staphylococcus aureus (MRSA)

Business Wire

PARSIPPANY, N.J. -- June 5, 2014

TheMedicines Company(NASDAQ:MDCO) today announced the publication of
theresults from the SOLO I Phase 3 clinical trial of ORBACTIV^TM
(oritavancin), an investigational intravenous antibiotic treatment for Acute
Bacterial Skin and Skin Structure Infections (ABSSSI), in the New England
Journal of Medicine. The publication reported that a single 1200 mg
intravenous dose of ORBACTIV^TM was non-inferior to twice-daily intravenous
dosing of vancomycin given for 7 to 10 days in patients with ABSSSI caused or
suspected to be caused by Gram-positive bacteria including
methicillin-resistant Staphylococcus aureus (MRSA).

“A publication in the New England Journal of Medicine reflects the quality of
work of the SOLO investigators and the importance of new treatments for
ABSSSI,” said G. Ralph Corey, MD, lead author of the publication, Professor of
Medicine and Infectious Disease at Duke University and Principal Investigator
of the SOLO Trials. “We look forward to additional publications and
presentations of ORBACTIV^TM studies.”

An estimated 5.2 million patients in the US and Western Europe are admitted to
hospitals with ABSSSI annually. Patients often receive intravenous therapies
that require hospital admission and multiple-day dosing.

“We are committed to perform relevant and robust research and development of
new anti-infective products,” said Matthew Wikler, MD, Vice President,
Infectious Disease Care at The Medicines Company. “Our work with the SOLO
trials is the first in a series of major clinical trials that we are
undertaking in the quest to take on difficult-to-treat infections – sometimes
caused by so-called “superbugs” in patients in potentially life-threatening
situations requiring admission and care in the hospital. Our product portfolio
related research projects and development programs, and marketed products span
the spectrum of such infections caused by Gram-positive infections including
MRSA, and Gram-negative infections including Acinetobacter,
carbapenem-resistant Enterobacteriaceae and other dangerous
multi-drug-resistant pathogens.”

About the SOLO trials

ORBACTIV^TM (oritavancin) was evaluated in two large randomized,
well-controlled Phase 3 clinical trials (SOLO I and SOLO II). The combined
SOLO studies represent the largest patient population (1,987 patients in
intent-to -treat population) that evaluated an anti-infective for the
treatment of ABSSSI in controlled clinical trials, and have assessed one of
the largest subsets of patients with documented MRSA infection (405 patients).
ORBACTIV^TM was administered intravenously as a 1200 mg single dose in these
studies. In February 2014, the U.S. Food and Drug Administration(FDA)
accepted the filing of a new drug application (NDA) for ORBACTIV^TM with
priority review. TheMedicines Companyis seeking approval of ORBACTIV^TM for
the treatment of ABSSSI caused or suspected to be caused by susceptible
Gram-positive bacteria, including MRSA, administered as a single dose.
TheFDAaction date (PDUFA date) for ORBACTIV^TM isAugust 6, 2014.

About ORBACTIV^TM (oritavancin)

ORBACTIV^TM (oritavancin) is an investigational intravenous antibiotic not
approved for commercial use. TheMedicines Companyis seeking approval for
1200 mg single dose ORBACTIV^TM in the treatment of ABSSSI caused or suspected
to be caused by susceptible Gram-positive bacteria, including MRSA. In
clinical trials, the most frequently reported adverse events associated with
ORBACTIV^TM were nausea, headache, vomiting and diarrhea. Hypersensitivity
reactions have been reported with the use of antibacterial agents including
ORBACTIV^TM.

About TheMedicines Company

TheMedicines Company'spurpose 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 theAmericas,Europeand theMiddle East, andAsia Pacific regions with
global centers today inParsippany, NJ, USA andZurich, Switzerland.

Forward-Looking Statements

Statements contained in this press release about TheMedicines Companythat
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 underThe Private SecuritiesLitigation Reform Act of
1995. Without limiting the foregoing, the words "believes," "anticipates" and
"expects" 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 physicians,
patients and other key decision makers will accept clinical trial results 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
theSecurities and Exchange Commissionincluding, without limitation, the risk
factors detailed in the Company's Quarterly Report on Form 10-Q filed with
theSEConMay 12, 2014, which are incorporated herein by reference. The
Company specifically disclaims any obligation to update these forward-looking
statements.

Contact:

Investor Relations:
The Medicines Company
Neera Dahiya Ravindran, MD, +1 (973) 290 6044
Vice President, Investor Relations & Strategic Planning
neera.ravindran@themedco.com
or
Media Contact for this press release only:
Makovsky
Lee Davies, +1 (917) 679 6368
Senior Vice President
ldavies@makovsky.com
 
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