Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the launch of a generic equivalent of Epzicom®1 (abacavir
and lamivudine) tablets, 600 mg/300 mg, in the United States
(U.S.). Abacavir and lamivudine tablets are indicated in
combination with other antiretroviral agents for the treatment of
HIV-1 infection. When used in combination with other antiretroviral
medicines used to treat HIV-1 infection, abacavir and lamivudine
tablets may help to:
- Reduce the amount of HIV-1 in affected
patients’ blood (viral load), and
- Increase the number of CD4+ (T) cells
in affected patients’ blood to help fight off other
infections.
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells
in the blood may help improve affected patients’ immune systems,
and may reduce the risk of death or getting infections that can
happen when a patient’s immune system is weak (opportunistic
infections). Abacavir and lamivudine tablets are not a cure for HIV
or AIDS.
Teva continues its commitment to strengthening its generics
business with continued investment in newer, higher-quality generic
products. With nearly 600 generic medicines available, Teva has the
largest portfolio of FDA-approved generic products on the
market. The addition of this product to Teva’s HIV
antiretroviral portfolio allows Teva to continue to grow in this
therapeutic area.
To date, Teva has over 300 product registrations pending FDA
approval and holds the leading position in first-to-file
opportunities, with over 100 pending first-to-files in the U.S.
Currently, 1-in-6 generic prescriptions dispensed in the U.S. is
filled with a Teva generic product.
Epzicom® (abacavir and lamivudine) tablets had annual sales of
approximately $449 million in the U.S. according to IMS data as of
July 2016.
About Abacavir and Lamivudine
Tablets
Abacavir and lamivudine tablets, in combination with other
antiretroviral agents, are indicated for the treatment of human
immunodeficiency virus type 1 (HIV-1) infection.
Important Safety Information
Serious and sometimes fatal hypersensitivity reactions have
occurred with abacavir-containing products. Hypersensitivity to
abacavir is a multi-organ clinical syndrome. Patients who carry the
HLA-B*5701 allele are at a higher risk of experiencing a
hypersensitivity reaction to abacavir. Abacavir and lamivudine
tablets are contraindicated in patients with a prior
hypersensitivity reaction to abacavir and in HLA-B*5701-positive
patients. Lactic acidosis and severe hepatomegaly with steatosis,
including fatal cases, have been reported with the use of
nucleoside analogues. Severe acute exacerbations of hepatitis B
have been reported in patients who are co-infected with hepatitis B
virus (HBV) and human immunodeficiency virus (HIV-1) and have
discontinued lamivudine, a component of abacavir and lamivudine
tablets.
Abacavir and lamivudine tablets are contraindicated in patients
who have the HLA-B*5701 allele; patients with prior
hypersensitivity reaction to abacavir or lamivudine; and patients
with moderate or severe hepatic impairment.
Hepatic decompensation, some fatal, has occurred in HIV-1/HCV
co-infected patients receiving combination antiretroviral therapy
and interferon alfa with or without ribavirin. Discontinue abacavir
and lamivudine tablets as medically appropriate and consider dose
reduction or discontinuation of interferon alfa, ribavirin, or
both. Immune reconstitution syndrome and
redistribution/accumulation of body fat have been reported in
patients treated with combination antiretroviral therapy.
Abacavir and lamivudine tablets are not recommended with other
products containing abacavir or lamivudine or
emtricitabine-containing products. The underlying risk of coronary
heart disease should be considered when prescribing antiretroviral
therapies, including abacavir, and action taken to minimize all
modifiable risk factors. The most commonly reported adverse
reactions of at least moderate intensity (incidence greater than
5%) in an adult HIV-1 clinical trial were drug hypersensitivity,
insomnia, depression/depressed mood, headache/migraine,
fatigue/malaise, dizziness/vertigo, nausea, and diarrhea.
For more information, please see accompanying Full Prescribing
Information, including Boxed Warning.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients
every day. Headquartered in Israel, Teva is the world’s largest
generic medicines producer, leveraging its portfolio of more than
1,800 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 2015 amounted to $19.7
billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:
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 specialty
products, especially Copaxone® (which faces competition from
orally-administered alternatives and a generic version); our
ability to integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of
realizing such benefits); the fact that following the consummation
of the Actavis Generics acquisition, we are dependent to a much
larger extent than previously on our generic pharmaceutical
business; potential restrictions on our ability to engage in
additional transactions or incur additional indebtedness as a
result of the substantial amount of debt incurred to finance the
Actavis Generics acquisition; the fact that for a period of time
following the Actavis Generics acquisition, we will have
significantly less cash on hand than previously, which could
adversely affect our ability to grow; 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 investments in our
pipeline of specialty and other products; 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;
competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental
pricing pressures; 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 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, 2015 and in our other filings with
the U.S. Securities and Exchange Commission (the "SEC").
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 statements or other information, whether as a
result of new information, future events or otherwise.
1 Epzicom® is a registered trademark of GlaxoSmithKline.
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version on businesswire.com: http://www.businesswire.com/news/home/20160929006328/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, United States, 215-591-8912Ran Meir, United
States, 215-591-3033Tomer Amitai, Israel, 972 (3)
926-7656orPR Contacts:Iris Beck Codner, Israel, 972 (3)
926-7687Denise Bradley, United States, 215-591-8974Nancy
Leone, United States, 215-284-0213
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