JERUSALEM--(BUSINESS WIRE)--Feb. 17, 2015--
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.
Source: Teva Pharmaceutical Industries
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C.
Mannix, 215-591-8912
United States
or
Tomer
Amitai, 972 (3) 926-7656
Israel
or
Ran Meir, 215-591-3033
United
States
or
PR:
Iris Beck Codner, 972 (3) 926-7687
Israel
or
Denise
Bradley, 215-591-8974
United States