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JERUSALEM--(BUSINESS WIRE)--May 15, 2017--
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.
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,
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
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
1 Glumetza® is a registered trademark of Valeant
Pharmaceuticals Luxembourg SARL.2 http://www.diabetes.org/diabetes-basics/statistics/infographics.html
View source version on businesswire.com: http://www.businesswire.com/news/home/20170515006344/en/
Source: Teva Pharmaceutical Industries Ltd.
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