FDA Approves The Medicines Company's ORBACTIV™ (oritavancin) for Use in Acute Bacterial Skin and Skin Structure Infections

  FDA Approves The Medicines Company's ORBACTIV™ (oritavancin) for Use in
  Acute Bacterial Skin and Skin Structure Infections

  First and Only Single Dose Antibiotic for the Treatment of Skin Infections
           Caused by Susceptible Designated Gram-positive Bacteria

                   ORBACTIV™U.S. Launch Expected in 2H/2014

Business Wire

PARSIPPANY, N.J. -- August 6, 2014

The Medicines Company (NASDAQ:MDCO) today announced that the U.S. Food and
Drug Administration (FDA) has approved ORBACTIV™ (oritavancin) for injection
for the treatment of adults with acute bacterial skin and skin structure
infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria
including methicillin-resistant Staphylococcus aureus (MRSA). ORBACTIV is the
first and only antibiotic approved by FDA to treat ABSSSIs with a single,
once-only administration. Once fully infused over three hours, the ORBACTIV
treatment regimen is complete for patients with skin infections caused by
susceptible Gram-positive pathogens.

“Today’s FDA approval of ORBACTIV represents an important advance beyond the
current standard of care for bacterial skin and skin structure infections,”
said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The
Medicines Company. “This approval is also a significant milestone for The
Medicines Company as we continue to develop our infectious disease care
portfolio. We are committed to addressing the complex problems associated with
multi-drug resistant infections.”

ORBACTIV approval is based on the results of the SOLO I and SOLO II clinical
studies which were randomized, double-blind, multicenter trials that evaluated
a single 1200 mg IV dose of ORBACTIV for the treatment of ABSSSI in 1,987
patients, and assessed a large subset of patients with documented MRSA
infection (405 patients). These trials demonstrated non-inferiority for the
primary and secondary endpoints evaluating 1200 mg once-only IV ORBACTIV dose
infusion, versus 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg).

“ORBACTIV given as a single dose treatment is a welcome new development for
the treatment of skin infections,” said G. Ralph Corey, MD, Professor of
Medicine and Infectious Diseases at Duke University. “With a single dose
treatment regimen ORBACTIV may help reduce the dosing burden seen with
antibiotics given as multiple intravenous administrations to patients with
these infections.”

“The growing challenge of antibiotic resistance in the U.S. has had a
significant impact on the clinical management decisions in the emergency
department,” said Charles Pollack, MD, Chair, Department of Emergency
Medicine, Pennsylvania Hospital and Professor of Emergency Medicine at the
Perelman School of Medicine at the University of Pennsylvania. “A single,
once-only IV therapy such as ORBACTIV offers the option to administer a single
treatment in the outpatient setting for patients with skin infections caused
by Gram-positive bacteria likely due to MRSA.”

ORBACTIV was designated as a Qualified Infectious Disease Product (QIDP) under
the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP
designation qualifies ORBACTIV for certain incentives related to the
development of new antibiotics, including a five-year extension of any
non-patent exclusivity period awarded to the drug.

The European Medicines Agency has accepted for review the Marketing
Authorization Application (MAA) for ORBACTIV, for which the company is seeking
approval for the treatment of complicated skin and soft tissue infections
(cSSTI). A decision from the European Commission is expected during the first
half of 2015.

The FDA approval of ORBACTIV represents the first infectious disease treatment
in The Medicines Company’s product pipeline to address infections caused by
resistant strains of bacteria. The Medicines Company is developing solutions
that span the spectrum of infections caused by Gram-positive bacteria
including MRSA, and Gram-negative infections. The Medicines Company’s emerging
product pipeline has the potential to offer innovative new antibiotic
approaches to tackle many of the problems in infectious diseases today.

Conference Call

A conference call will be held with management tomorrow at 8:00 a.m. Eastern
Time to discuss the ORBACTIV approval. The conference call will be available
via phone and webcast. The webcast can be accessed at

Domestic Dial In: +1 (877) 359-9508

International Dial In: +1 (224) 357-2393

Passcode for both dial in numbers: 85925819

Replay is available from 11:00 a.m. Eastern Time following the conference call
through August 14, 2014. To hear a replay of the call dial +1 (855) 859-2056
(domestic) and +1 (404) 537-3406 (international). Passcode for both dial in
numbers is 85925819.

ORBACTIV: Indication and Important Safety Information



ORBACTIV™ (Oritavancin) for injection is indicated for the treatment of adult
patients with acute bacterial skin and skin structure infections (ABSSSI)
caused by susceptible isolates of the following Gram-positive microorganisms:

Staphylococcus aureus (including methicillin-susceptible and
methicillin–resistant 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


Use of intravenous unfractionated heparin sodium is contraindicated for 48
hours after ORBACTIV 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

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

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


About Skin and Skin Structure Infections

An estimated 5.2 million patients in the US and Western Europe are admitted to
hospitals with Acute bacterial skin and skin structure infections (ABSSSIs)
annually. Patients often receive intravenous therapies that require hospital
admission and multiple-day dosing. ABSSSI are deep tissue lesions (e.g.,
cellulitis, major cutaneous abscesses and wound infections) and can be
associated with significant comorbidities (e.g., diabetes). A variety of
pathogens may be identified in ABSSSI with two of the most common being
Staphylococcus aureus (methicillin susceptible Staphylococcus aureus and MRSA)
and Streptococcus pyogenes. Each year more than two million Americans develop
infections from antibiotic-resistant bacteria according to the U.S. Centers
for Disease Control and Prevention (CDC) “Antibiotic resistance threats in the
United States, 2013” report. One of the serious public health threats
identified by the CDC is methicillin-resistant Staphylococcus aureus (MRSA).
Based on CDC data, there are approximately 80,000 severe MRSA infections and
11,000 deaths from MRSA in the U.S. per year.

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"
"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 the extent of
the commercial success of the Company’s products, the Company's ability to
develop its global operations and penetrate foreign markets, whether the
Company's products will advance in the clinical trials process on a timely
basis or at all, whether the Company will make regulatory submissions for
product candidates on a timely basis, whether its regulatory submissions will
receive approvals from regulatory agencies on a timely basis or at all,
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 theSEConAugust 4, 2014,
which are incorporated herein by reference. The Company specifically disclaims
any obligation to update these forward-looking statements.


Investor Relations:
The Medicines Company
Neera Dahiya Ravindran, MD, +1 973-290-6044
Vice President, Investor Relations & Strategic Planning
Media (for this press release only):
Lee Davies, +1 917-679-6368
Senior Vice President
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