|[August 06, 2014]
FDA Approves The Medicines Company's ORBACTIV™ (oritavancin) for Use in Acute Bacterial Skin and Skin Structure Infections
PARSIPPANY, N.J. --(Business Wire)--
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
"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
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.
A conference call will be held with management tomorrowat 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 www.themedicinescompany.com.
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
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
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
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.
The most common adverse reactions (= 3%) in patients treated with
ORBACTIV were headache, nausea, vomiting, limb and subcutaneous
abscesses, and diarrhea.
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 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.
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" 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 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 (News - Alert) on August 4, 2014, which are incorporated herein by reference.
The Company specifically disclaims any obligation to update these
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