Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), a leading
global pharmaceutical company, today announced the launch of the
generic equivalent of Lovenox® (enoxaparin sodium injection)
in seven dosage strengths in the United States. Enoxaparin Sodium
Injection, USP is used for prophylaxis of deep vein thrombosis
(DVT) in patients undergoing abdominal surgery, hip or knee
replacement surgery, or in medical patients with severely
restricted mobility during acute illness; and also for the
treatment of acute DVT. Lovenox® had annual sales of
approximately $1.8 billion in the United States, according to IMS
data as of November 2014. Under a licensing agreement, Teva has
partnered with Chemi SPA to leverage their internal research based
technology in the development and manufacture of Enoxaparin Sodium
Injection, USP.
Teva has also recently launched the generic equivalent to
Zyvox® (linezolid) Injection which is used for the treatment
of infections caused by Gram-positive bacteria.
Zyvox® Injection had annual sales of approximately $464
million in the United States, according to IMS data as of October
2014.
“Teva is committed and focused on building a stronger generic
injectable business globally,” said Siggi Olafsson, President and
CEO of Teva Global Generic Medicines. “With the launch of
Enoxaparin Sodium Injection, USP and Linezolid Injection,
accompanied by the reintroduction of three generic injectable
products, we are leveraging the strength of our internal and
external resources to deliver the right portfolio as part of our
growth strategy. As the number one generics company in the world,
we can quickly bring a range of high-quality, cost-effective
generic injectable treatments to patients within the doctor’s
office, hospital, or clinic.”
Teva continues to invigorate the injectable business in the
United States with a selective reintroduction of older generic
injectable products as well as continued investment in newer,
higher-value generic injectable products. Additionally, Teva has
progressed in building its Research and Development capabilities in
complex, generic injectables including drug-device combinations,
complex drug delivery, and complex molecules. This month, Teva has
launched Nafcillin for Injection, USP and is reintroducing into the
market Leucovorin Calcium for Injection (100 mg/vial),
Methylprednisolone Acetate Injectable Suspension, USP (40 mg/mL),
and Ondansetron Injection, USP (2 mg/mL).
As of January 22, 2015, Teva had 120 product registrations
pending FDA approval, including 29 tentative approvals.
Collectively, these 120 products had U.S. sales in 2014 exceeding
$86 billion. Of these applications, 87 were “Paragraph IV”
applications challenging patents of branded products; 42 of these
pending ANDAs are potential first-to-file opportunities.
About Enoxaparin Sodium Injection, USP
Enoxaparin Sodium Injection USP, is indicated for:
- Prophylaxis of deep vein thrombosis
(DVT), which may lead to pulmonary embolism (PE) in patients
undergoing abdominal surgery who are at risk for thromboembolic
complications; undergoing hip replacement surgery, during and
following hospitalization; undergoing knee replacement surgery; or
who are at risk for thromboembolic complications due to severely
restricted mobility during acute illness.
- Inpatient treatment of acute DVT with
or without PE, when administered in conjunction with warfarin
sodium.
- Outpatient treatment of acute DVT
without PE, when administered in conjunction with warfarin
sodium.
- Prophylaxis of ischemic complications
of unstable angina and non-Q-wave myocardial infarction, when
concurrently administered with aspirin.
- Treatment of acute ST-segment elevation
myocardial infarction (STEMI) managed medically or with subsequent
percutaneous coronary intervention.
Important Safety Information
Epidural or spinal hematomas may occur in patients who are
anticoagulated with low molecular weight heparins (LMWH) or
heparinoids and are receiving neuraxial anesthesia or undergoing
spinal puncture, resulting in long-term or permanent paralysis.
Enoxaparin Sodium Injection, USP is contraindicated in patients
with active major bleeding; thrombocytopenia with a positive in
vitro test for anti-platelet antibody in the presence of enoxaparin
sodium; or known hypersensitivity to enoxaparin sodium, heparin, or
pork products. Serious adverse reactions reported with enoxaparin
sodium injection include increased risk of hemorrhage and
thrombocytopenia. Enoxaparin Sodium Injection, USP should be used
with extreme caution in conditions with increased risk of
hemorrhage, or in patients treated concomitantly with platelet
inhibitors. Major hemorrhages including retroperitoneal and
intracranial bleeding have been reported with enoxaparin sodium
injection. Some of these cases have been fatal. Bleeding can occur
at any site during therapy with Enoxaparin Sodium Injection,
USP.
Enoxaparin Sodium Injection, USP should be used with care in
patients with a bleeding diathesis, uncontrolled arterial
hypertension or a history of recent gastrointestinal ulceration,
diabetic retinopathy, renal dysfunction and hemorrhage.
In clinical trials, the most common adverse reactions (> 1%
in patients treated with enoxaparin sodium injection) were
bleeding, anemia, thrombocytopenia, elevation of serum
aminotransferase, diarrhea, and nausea. Mild local irritation,
pain, hematoma, ecchymosis, and erythema may follow subcutaneous
injection.
Please see accompanying Full Prescribing Information, including
Boxed Warning.
About Linezolid Injection
Linezolid Injection is indicated for the treatment of the
following infections caused by susceptible Gram-positive bacteria:
Nosocomial pneumonia; Community-acquired pneumonia; Complicated
skin and skin structure infections, including diabetic foot
infections, without concomitant osteomyelitis; Uncomplicated skin
and skin structure infections; and Vancomycin-resistant
Enterococcus faecium infections. Linezolid Injection is not
indicated for the treatment of Gram-negative infections.
Gram-negative therapy should be initiated immediately if a
concomitant Gram-negative pathogen is documented or suspected.
Important Safety Information
Linezolid Injection is contraindicated in patients with a known
hypersensitivity to linezolid or any of the other product
components and in patients taking any monoamine oxidase inhibitor
(MAOI) or within two weeks of taking an MAOI.
Myelosuppression has been reported in patients receiving
linezolid. Complete blood counts should be monitored weekly. Other
serious adverse reactions reported with linezolid include
peripheral and optic neuropathy; serotonin syndrome, including
fatal cases associated with co-administration of linezolid and
serotonergic agents; Clostridium difficile associated diarrhea;
lactic acidosis; convulsions; hypoglycemia; and development of
drug-resistant bacteria.
Unless patients are monitored for potential increases in blood
pressure, linezolid should not be administered to patients with
uncontrolled hypertension, pheochromocytoma, thyrotoxicosis and/or
patients taking sympathomimetic, vasopressive, or dopaminergic
agents.
In clinical trials, the most common adverse reactions (>5% of
adult and/or pediatric patients treated with linezolid) were
diarrhea, vomiting, headache, nausea, and anemia.
Please see accompanying Full Prescribing Information.
About Chemi SPA
Chemi SPA is an Italian fine chemical and pharmaceutical
company, belonging to Italfarmaco Group and specialized in the
development and full characterization of complex molecules, with
full manufacturing capabilities from API Synthesis to finished
dosage formulation of injectable drugs. Chemi SPA has a prominent
experience in the development of LMWHs and polysaccharidic
derivatives, peptides, oncological products; a multiple
technology-enabled innovative products in its pipeline and several
FDFs for which MAs have been granted worldwide. Chemi, taking
advantage of its Mother Company Italfarmaco’s huge facility of
pre-filled syringes, has developed, optimized and produced
Enoxaparin Sodium API and prefilled syringes, supporting Teva in
the achievement of the MA for Enoxaparin generic in US in June
2014.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,000
molecules to produce a wide range of generic products in nearly
every therapeutic area. In specialty medicines, Teva has a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
Cautionary Notice Regarding Forward-Looking
Statements
This release contains forward-looking statements, which are
based on management’s current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could
cause our future results, performance or achievements to differ
significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include
risks relating to: our ability to develop and commercialize
additional pharmaceutical products; competition for our innovative
products, especially Copaxone® (including competition from
orally-administered alternatives, as well as from potential
purported generic equivalents) and our ability to migrate users to
our new 40 mg/mL version; the possibility of material fines,
penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters;
our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent
and during the timeframe intended by our cost reduction program;
our ability to identify and successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; the extent to which any manufacturing
or quality control problems damage our reputation for quality
production and require costly remediation; increased government
scrutiny in both the U.S. and Europe of our patent settlement
agreements; our exposure to currency fluctuations and restrictions
as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into sales and marketing practices, particularly for our specialty
pharmaceutical products; adverse effects of political or economic
instability, major hostilities or acts of terrorism on our
significant worldwide operations; interruptions in our supply chain
or problems with internal or third-party information technology
systems that adversely affect our complex manufacturing processes;
significant disruptions of our information technology systems or
breaches of our data security; competition for our generic
products, both from other pharmaceutical companies and as a result
of increased governmental pricing pressures; competition for our
specialty pharmaceutical businesses from companies with greater
resources and capabilities; the impact of continuing consolidation
of our distributors and customers; decreased opportunities to
obtain U.S. market exclusivity for significant new generic
products; potential liability in the U.S., Europe and other markets
for sales of generic products prior to a final resolution of
outstanding patent litigation; our potential exposure to product
liability claims that are not covered by insurance; any failure to
recruit or retain key personnel, or to attract additional executive
and managerial talent; any failures to comply with complex Medicare
and Medicaid reporting and payment obligations; significant
impairment charges relating to intangible assets, goodwill and
property, plant and equipment; the effects of increased leverage
and our resulting reliance on access to the capital markets;
potentially significant increases in tax liabilities; the effect on
our overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business; variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner;
environmental risks; and other factors that are discussed in our
Annual Report on Form 20-F for the year ended December 31, 2014 and
in our other filings with the U.S. Securities and Exchange
Commission. Forward-looking statements speak only as of the date on
which they are made and we assume no obligation to update or revise
any forward-looking statement, whether as a result of new
information, future events or otherwise.
Teva Pharmaceutical Industries Ltd.IR:Kevin C.
Mannix, 215-591-8912United StatesorTomer Amitai, 972 (3)
926-7656IsraelorRan Meir, 215-591-3033United
StatesorPR:Iris Beck Codner, 972 (3)
926-7687IsraelorDenise Bradley, 215-591-8974United
States
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