The Medicines Company (NASDAQ:MDCO) announced the U.S. Court of
Appeals for the Federal Circuit Court has ruled against the Company
in its Angiomax® (bivalirudin) patent litigation with Hospira,
Inc.
In its ruling today, the Federal Circuit held that U.S. Patent
Nos. 7,582,727 (the ‘727 patent) and 7,598,343 (the ‘343 patent)
are invalid.
On March 31, 2014, the U.S. District Court of Delaware found
that all of the asserted claims of the ‘727 patent and the ‘343
patent covering Angiomax were valid but not infringed by Hospira’s
ANDA products. The Medicines Company appealed the District Court’s
claim construction and non-infringement rulings, while Hospira
appealed the validity rulings.
“We are evaluating today’s Court ruling and considering our next
steps,” said Clive Meanwell, MD, PhD, Chairman and Chief Executive
Officer, The Medicines Company. “We remain committed to
interventional cardiovascular medicine and will continue to support
bivalirudin. We are focused on the current launch of KENGREALTM,
our newly approved platelet inhibitor, which we anticipate will be
used by many of our existing customers in cardiac catheterization
laboratories. We also look forward to the release of important new
data on our PCSK9 RNAi compound at the European Society of
Cardiology meeting, August 31st to September 2nd. Meantime our
launch and launch preparations for IONSYS®, ORBACTIV® and a new
formulation of MINOCIN® for Injection are also underway.”
About ANGIOMAX® (bivalirudin)
Angiomax® is indicated in patients undergoing PCI with
provisional use of GPI and in patients with, or at risk of,
heparin-induced thrombocytopenia and thrombosis syndrome
(HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated
for use as an anticoagulant in patients with unstable angina
undergoing percutaneous transluminal coronary angioplasty (PTCA).
Angiomax is intended for use with aspirin. Angiomax is not approved
for use in patients with acute coronary syndromes (ACS) not
undergoing PCI or PTCA.
In clinical trials comparing Angiomax and heparin, the most
common adverse reaction for Angiomax was bleeding (28%). Other
common adverse reactions were headache, thrombocytopenia and fever.
An unexplained fall in blood pressure or hematocrit, or any
unexplained symptom, should lead to serious consideration of a
hemorrhagic event and cessation of Angiomax administration.
Angiomax should be used with caution in patients with disease
states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation,
including fatal outcomes, has been associated with the use of
Angiomax. Angiomax is contraindicated in patients with active major
bleeding or hypersensitivity to Angiomax or its components.
Please see full prescribing information for Angiomax, available
at http://www.angiomax.com.
About KENGREAL™ (cangrelor)
KENGREAL, a synthetic, small molecule, is indicated as an
adjunct to percutaneous coronary intervention (PCI) to reduce the
risk of periprocedural myocardial infarction (MI), repeat coronary
revascularization, and stent thrombosis (ST) in patients who have
not been treated with a P2Y12 platelet inhibitor and are not being
given a glycoprotein IIb/IIIa inhibitor.
Important Safety Information
KENGREAL is contraindicated in patients with significant active
bleeding.
KENGREAL is contraindicated in patients with known
hypersensitivity (e.g., anaphylaxis) to cangrelor or any component
of the product.
Drugs that inhibit platelet P2Y12 function, including KENGREAL,
increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events
of all severities were more common with KENGREAL than with
clopidogrel. Bleeding complications with KENGREAL™ were consistent
across a variety of clinically important subgroups. Once KENGREAL
is discontinued, there is no antiplatelet effect after an hour.
The most common adverse reaction is bleeding.
Please see full prescribing information for KENGREAL, available
at http://www.kengreal.com.
About IONSYS® (fentanyl iontophoretic transdermal system),
CII
IONSYS® contains the opioid fentanyl and is a compact,
needle-free, pre-programmed system that is indicated for the
short-term management of acute postoperative pain in adult patients
requiring opioid analgesia in the hospital. IONSYS is only for use
in patients who are alert enough and have adequate cognitive
ability to understand the directions for use. IONSYS is not for
home use and is intended for use only in patients in the hospital.
Discontinue treatment with IONSYS before patients leave the
hospital. IONSYS is for use after patients have been titrated to an
acceptable level of analgesia using alternate opioid
analgesics.
IONSYS will only be administered to patients in hospitals
enrolled in the IONSYS REMS program, the goal of which is to
decrease the risk of respiratory depression resulting from
accidental exposure to persons for whom it is not prescribed by
ensuring it is only dispensed to patients in certified hospitals
and informing health care providers of the serious risk of
respiratory depression resulting from accidental exposure to
fentanyl.
Important Safety Information
WARNING: HOSPITAL USE ONLY; LIFE-THREATENING RESPIRATORY
DEPRESSION; IONSYS REMS; ADDICTION, ABUSE, AND MISUSE; and
CYTOCHROME P450 3A4 INTERACTION
Life Threatening Respiratory
Depression
- Use of IONSYS may result in potentially
life-threatening respiratory depression and death as a result of
the active drug, fentanyl. Only the patient should activate IONSYS
dosing.
- Accidental exposure to an intact IONSYS
or to the hydrogel component, especially by children, through
contact with skin or contact with mucous membranes, can result in a
fatal overdose of fentanyl.
- Keep out of reach of children.
- IONSYS is for use only in patients in
the hospital. Discontinue treatment with IONSYS before patients
leave the hospital.
IONSYS Risk Evaluation and Mitigation
Strategy (REMS) Program
- Because of the of potentially
life-threatening respiratory depression resulting from accidental
exposure, IONSYS is available only through a restricted program
required by the Food and Drug Administration, called a Risk
Evaluation and Mitigation Strategy (REMS). Hospitals must enroll in
the program before they can dispense IONSYS. Further information is
available at www.ionsysrems.com, or by calling 1-877-488-6835.
Addiction, Abuse, and
Misuse
- IONSYS contains fentanyl, a Schedule II
controlled substance with abuse liability similar to other opioid
analgesics.
- IONSYS exposes users to risks of
addiction, abuse, and misuse, which can lead to overdose and death.
Assess each patient’s risk before prescribing, and monitor
regularly for development of these behaviors or conditions.
Cytochrome P450 3A4
Interaction
- The concomitant use of IONSYS with all
cytochrome P450 3A4 inhibitors may result in an increase in
fentanyl plasma concentrations, which could increase or prolong
adverse drug effects and may cause potentially fatal respiratory
depression. In addition, discontinuation of a concomitantly used
cytochrome P450 3A4 inducer may result in an increase in fentanyl
plasma concentration. Monitor patients receiving IONSYS and any
CYP3A4 inhibitor or inducer.
Contraindications
- Significant respiratory depression
- Acute or severe bronchial asthma
- Known or suspected paralytic ileus and
GI obstruction
- Hypersensitivity to fentanyl or
cetylpyridinium chloride (e.g., Cepacol®) or any component of
IONSYS
Warnings and Precautions
Interactions with CNS depressants: Concomitant use with alcohol
or other central nervous system (CNS) depressants (e.g., sedatives,
anxiolytics, hypnotics, neuroleptics, otheropioids) may cause
hypotension, profound sedation, respiratory depression, coma and
death. Monitor patients closely if co-administration is
required.
Risk of Injury During MRI Procedure: IONSYS contains metal parts
and must be removed and properly disposed of before an MRI
procedure.
Radiographic Imaging, Cardioversion, Defibrillation, Pacemakers:
IONSYS contains metal parts and must be removed and properly
disposed of before cardioversion or defibrillation to avoid damage
to IONSYS from the strong electromagnetic fields set up by these
procedures. IONSYS contains radio-opaque components and may
interfere with an X-ray image or CAT scan.
Topical Skin Reactions: Topical skin reactions may occur with
use of IONSYS and are typically limited to the site application
area. Reactions generally resolve without treatment. If a severe
skin reaction is observed, remove IONSYS and discontinue further
use.
Use in Elderly, Cachectic, and Debilitated Patients:
Life-threatening respiratory depression is more likely to occur in
elderly, cachectic, or debilitated patients. Monitor such patients
closely when IONSYS is used concomitantly with other drugs that
depress respiration.
Use in Patients with Chronic Pulmonary Disease: Monitor patients
with significant chronic obstructive pulmonary disease or cor
pulmonale, and patients having a substantially decreased
respiratory reserve, hypoxia, hypercapnia, or pre-existing
respiratory depression for respiratory depression, particularly
when initiating therapy with IONSYS. Consider the use of
alternative non-opioid analgesics in these patients if
possible.
Hypotensive Effect: IONSYS may cause severe hypotension
including orthostatic hypotension and syncope in ambulatory
patients. There is increased risk in patients whose ability to
maintain blood pressure has already been compromised by a reduced
blood volume, or concurrent administration of certain CNS
depressant drugs (e.g., phenothiazines or general anesthetics).
Monitor these patients after initiating IONSYS. In patients with
circulatory shock, IONSYS may cause vasodilation that can further
reduce cardiac output and blood pressure. Avoid the use of IONSYS
in patients with circulatory shock.
Patients with Head Injury or Increased Intracranial Pressure:
IONSYS is not suitable for use in patients who are not alert and
able to follow directions. Monitor for sedation and respiratory
depression. Avoid use of IONSYS in patients with impaired
consciousness or coma susceptible to intracranial effects of CO2
retention. IONSYS may reduce respiratory drive, and the resultant
CO2 retention can further increase intracranial pressure. Opioids
may obscure the clinical course of patients with head injury. Use
IONSYS with caution in patients with brain tumors.
Use in Patients with Gastrointestinal Conditions: IONSYS is
contraindicated in patients with gastrointestinal obstruction,
including paralytic ileus. Fentanyl may cause spasm of the
sphincter of Oddi. Monitor patients with biliary tract disease,
including acute pancreatitis for worsening symptoms. Opioids may
cause increases in serum amylase.
Use in Patients with Convulsive or Seizure Disorders: IONSYS may
aggravate convulsions in patients with convulsive disorders, and
may induce or aggravate seizures in some clinical settings. Monitor
patients with a history of seizure disorders for worsened seizure
control during IONSYS therapy.
Cardiac Disease: IONSYS may produce bradycardia in some
patients. Monitor patients with bradyarrhythmias closely for
changes in heart rate, particularly when initiating therapy with
IONSYS.
Hepatic Impairment: Insufficient data are available on the use
of IONSYS in patients with impaired hepatic function. Monitor for
signs of sedation and respiratory depression in patients with
hepatic impairment.
Renal Impairment: A clinical pharmacology study with intravenous
fentanyl in patients undergoing kidney transplantation has shown
that patients with high blood urea nitrogen level had low fentanyl
clearance. Monitor for signs of sedation and respiratory depression
in patients with renal impairment.
Adverse Reactions
Most common (frequency ≥ 2%) headache, hypotension, nausea,
vomiting, anemia, dizziness, application site reaction-erythema,
pruritus, and urinary retention.
Please see full prescribing information for IONSYS, available
at http://www.ionsys.com.
About ORBACTIV® (oritavancin)
ORBACTIV® (oritavancin) for injection
received FDA approval in the U.S. in August 2014.
ORBACTIV is the first and only FDA-approved single-dose IV
antibiotic 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 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
Contraindications
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 ORBACTIV.
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 occurs.
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 diarrhea.
Please see www.orbactiv.com for the full prescribing
information.
About MINOCIN® (minocycline) for Injection
Indication
MINOCIN® (minocycline) for Injection is indicated for the
treatment of infections due to susceptible strains of designated
microorganisms, including Acinetobacter species bacteria.
For additional full list of indications and designated susceptible
pathogens, please see the full prescribing information available
at www.minociniv.com.
IMPORTANT SAFETY INFORMATION
Contraindications
MINOCIN® (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.
Warnings
Tooth Development
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).
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.
Skeletal Development
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.
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.
Dermatologic Reaction
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.
Anti-anabolic Action
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.
Photosensitivity
Photosensitivity manifested by an exaggerated sunburn reaction
has been observed in some individuals taking tetracyclines. This
has been reported with minocycline.
Central Nervous System Effects
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.
Clostridium difficile Associated Diarrhea
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.
Intracranial Hypertension
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.
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.
PRECAUTIONS
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.
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.
Incision and drainage or other surgical procedures should be
performed in conjunction with antibiotic antibacterial therapy when
indicated.
MINOCIN (minocycline) Injection contains magnesium sulphate
heptahydrate. Because magnesium is excreted primarily by the
kidney, serum levels of magnesium should be monitored in patients
with renal impairment.
Because MINOCIN (minocycline) Injection contains magnesium,
close monitoring is recommended in patients with heart block or
myocardial damage.
Prescribing MINOCIN (minocycline) 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.
Adverse Reactions
For a complete list of adverse reactions that have been observed
in patients receiving tetracyclines, consult the full prescribing
information for MINOCIN® (minocycline) for injection available at
www.minociniv.com.
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.
Forward-Looking Statements
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,"
“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 physicians, patients and other key decision makers will
accept clinical trial results, the Company’s ability to
successfully compete with potential competitors which may discover,
develop or commercialize competing products more successfully than
we do, whether third parties on whom the Company relies to
manufacture and support the development and commercialization of
our products are able to fulfill their obligations or the Company
is able to establish or maintain such arrangements; 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 May 5, 2015,
which are incorporated herein by reference. The Company
specifically disclaims any obligation to update these
forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20150702005697/en/
The Medicines CompanyMedia:Bob Laverty, +1-973-290-6162Mobile
+1-609-558-5570Vice President,
CommunicationsRobert.Laverty@themedco.comorInvestor Relations:Neera
Dahiya Ravindran, MD, +1-973-290-6044Vice President, Investor
Relations & Strategic PlanningNeera.Ravindran@themedco.com
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