Teva Announces Launch of Generic Glumetza® in the United States
15 Mai 2017 - 7:20PM
Business Wire
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of generic Glumetza®1 (metformin hydrochloride
extended-release tablets), 500 mg and 1000 mg, in the U.S.
Metformin hydrochloride extended-release tablets are used with
diet and exercise to help control high blood sugar in adults with
type 2 diabetes mellitus. Metformin hydrochloride extended-release
tablets are not for people with type 1 diabetes or for people with
diabetic ketoacidosis.
More than 28 million people in the U.S. are living with type 2
diabetes2; a serious disease that can be managed through physical
activity, diet and appropriate use of medications to lower blood
sugar levels.
Teva is committed to strengthening its generics business through
continued investment in complex, high-quality products. With nearly
600 generic medicines available, Teva has the largest portfolio of
FDA-approved generic products on the market and holds the leading
position in first-to-file opportunities, with over 100 pending
first-to-files in the U.S. Currently, one in six generic
prescriptions dispensed in the U.S. is filled with a Teva
product.
Glumetza® had annual sales of approximately $1.03 billion in the
U.S. according to IMS data as of March 2017.
About Metformin Hydrochloride Extended-Release
Tablets
Metformin hydrochloride extended-release tablets are indicated
as an adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus. Important Limitations of Use:
Metformin hydrochloride extended-release tablets should not be used
in patients with type 1 diabetes or for the treatment of diabetic
ketoacidosis, as it would not be effective in these settings.
Important Safety Information
WARNING: LACTIC ACIDOSIS. Postmarketing cases of
metformin-associated lactic acidosis have resulted in death,
hypothermia, hypotension, and resistant bradyarrhythmias. The onset
of metforminassociated lactic acidosis is often subtle,
accompanied only by nonspecific symptoms such as malaise, myalgias,
respiratory distress, somnolence, and abdominal pain.
Metformin hydrochloride extended-release tablets are
contraindicated in patients with severe renal impairment, known
hypersensitivity to metformin hydrochloride, or acute or chronic
metabolic acidosis, including diabetic ketoacidosis.
Metformin may lower vitamin B12 levels. Hypoglycemia could occur
when caloric intake is deficient, when strenuous exercise is not
compensated by caloric supplementation, or during concomitant use
with other glucose-lowering agents or ethanol. Elderly,
debilitated, or malnourished patients, and those with adrenal or
pituitary insufficiency or alcohol intoxication are particularly
susceptible to hypoglycemic effects. There have been no clinical
studies establishing conclusive evidence of macrovascular risk
reduction with metformin hydrochloride extended-release tablets or
any other oral anti-diabetic drug.
In a controlled clinical trial, the adverse reactions reported
by greater than 5% of patients for the combined metformin
hydrochloride extended-release tablets group and greater than
placebo were hypoglycemia, diarrhea, and nausea.
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 approximately 200
million patients in 100 markets 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 the world-leading innovative treatment for
multiple sclerosis as well as late-stage development programs for
other disorders of the central nervous system, including movement
disorders, migraine, pain and neurodegenerative conditions, as well
as a broad portfolio of respiratory products. Teva is leveraging
its generics and specialty capabilities in order to seek new ways
of addressing unmet patient needs by combining drug development
with devices, services and technologies. Teva's net revenues in
2016 were $21.9 billion. For more information, visit
www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding the launch and potential benefits of Teva's generic
version of Glumetza®, which are based on management’s current
beliefs and expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- commercial success of Teva's generic
version of Glumetza®;
- our generics medicines business,
including: that we are substantially more dependent on this
business, with its significant attendant risks, following our
acquisition of Allergan plc’s worldwide generic pharmaceuticals
business (“Actavis Generics”); our ability to realize the
anticipated benefits of the acquisition (and any delay in realizing
those benefits) or difficulties in integrating Actavis Generics;
the increase in the number of competitors targeting generic
opportunities and seeking U.S. market exclusivity for generic
versions of significant products; price erosion relating to our
generic products, both from competing products and as a result of
increased governmental pricing pressures; and our ability to take
advantage of high-value biosimilar opportunities;
- our business and operations in general,
including: uncertainties relating to our recent senior management
changes; our ability to develop and commercialize additional
pharmaceutical products; manufacturing or quality control problems,
which may damage our reputation for quality production and require
costly remediation; interruptions in our supply chain; disruptions
of our or third party information technology systems or breaches of
our data security; the failure to recruit or retain key personnel,
including those who joined us as part of the Actavis Generics
acquisition; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; variations in
patent laws that may adversely affect our ability to manufacture
our products; adverse effects of political or economic instability,
major hostilities or terrorism on our significant worldwide
operations; and our ability to successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; and
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; product liability claims; increased government scrutiny
of our patent settlement agreements; failure to comply with
complex Medicare and Medicaid reporting and payment
obligations; and environmental risks.
and other factors discussed in our Annual Report on Form 20-F
for the year ended December 31, 2016 (“Annual Report”)
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 contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
rely on these forward-looking statements. You are advised to
consult any additional disclosures we make in our reports to
the SEC on Form 6-K, as well as the cautionary discussion of
risks and uncertainties under “Risk Factors” in our Annual Report.
These are factors that we believe could cause our actual results to
differ materially from expected results. Other factors besides
those listed could also materially and adversely affect us. This
discussion is provided as permitted by the Private Securities
Litigation Reform Act of 1995.
1 Glumetza® is a registered trademark of Valeant Pharmaceuticals
Luxembourg SARL.2
http://www.diabetes.org/diabetes-basics/statistics/infographics.html
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version on businesswire.com: http://www.businesswire.com/news/home/20170515006344/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7687orUnited
StatesDenise Bradley, 215-591-8974orNancy Leone,
215-284-0213
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