Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of a generic version of Uceris®1 (budesonide)
extended-release tablets, 9 mg, in the U.S.
Budesonide extended-release tablets are a glucocorticosteroid
indicated for the induction of remission in patients with active,
mild to moderate ulcerative colitis.
“The launch of generic budesonide extended-release tablets
signals an important addition to Teva’s portfolio,” said Brendan
O’Grady, EVP and head of North America Commercial. “We continue to
be focused on bringing affordable generic treatment options to our
customers, including those living with chronic, life-long
conditions like ulcerative colitis.”
With nearly 550 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 seven
generic prescriptions dispensed in the U.S. is filled with a Teva
generic product.
Uceris® had annual sales of approximately $196 million in the
U.S., according to IMS data as of May 2018.
About Budesonide Extended-Release Tablets
Budesonide extended-release tablets are indicated for the
induction of remission in patients with active, mild to moderate
ulcerative colitis.
Important Safety
InformationBudesonide extended-release tablets are
contraindicated in patients with hypersensitivity to budesonide or
any of the ingredients of budesonide extended-release tablets.
Anaphylactic reactions have occurred with other budesonide
formulations.
When glucocorticosteroids are used chronically, systemic effects
such as hypercorticism and adrenal suppression may occur.
Glucocorticosteroids can reduce the response of the
hypothalamus-pituitary-adrenal (HPA) axis to stress. Since
budesonide extended-release tablets are a glucocorticosteroid,
general warnings concerning glucocorticoids should be followed.
Care is needed in patients who are transferred from
glucocorticosteroid treatment with higher systemic effects to
glucocorticosteroids with lower systemic effects, such as
budesonide extended-release tablets, since symptoms attributed to
withdrawal of steroid therapy, including those of acute adrenal
suppression or benign intracranial hypertension, may develop.
Patients who are on drugs that suppress the immune system are
more susceptible to infection than healthy individuals. Chicken pox
and measles, for example, can have a more serious or even fatal
course in susceptible patients or patients on immunosuppressant
doses of glucocorticosteroids. In patients who have not had these
diseases, particular care should be taken to avoid exposure.
Glucocorticosteroids should be used with caution, if at all, in
patients with active or quiescent tuberculosis infection, untreated
fungal, bacterial, systemic viral or parasitic infections.
Reduced liver function affects the elimination of
glucocorticosteroids, and increased systemic availability of oral
budesonide has been demonstrated in patients with liver cirrhosis.
Caution should be taken in patients with hypertension, diabetes
mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or
with a family history of diabetes or glaucoma, or with any other
condition where glucocorticosteroids may have unwanted effects.
The most common adverse reactions (≥ 2%) in clinical trials were
headache, nausea, decreased blood cortisol, upper abdominal pain,
fatigue, flatulence, abdominal distension, acne, urinary tract
infection, arthralgia, and constipation.
For more information, please see accompanying Full Prescribing
Information.
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 2017 were $22.4 billion. For
more information, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding Teva's generic version of Uceris®, 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:
- The uncertainty of the commercial
success of our generic version of budesonide, including due to a
potential launch of an Authorized Generic version;
- our ability to successfully compete in
the marketplace, including: that we are substantially dependent on
our generic products; competition for our specialty products,
especially COPAXONE®, our leading medicine, which faces competition
from existing and potential additional generic versions and
orally-administered alternatives; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; 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 products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our substantially increased
indebtedness and significantly decreased cash on hand, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, and may result in
a further downgrade of our credit ratings; and our inability to
raise debt or borrow funds in amounts or on terms that are
favorable to us;
- our business and operations in general,
including: failure to effectively execute the restructuring plan
announced in December 2017; uncertainties related to, and failure
to achieve, the potential benefits and success of our new senior
management team and organizational structure; harm to our pipeline
of future products due to the ongoing review of our R&D
programs; our ability to develop and commercialize additional
pharmaceutical products; potential additional adverse consequences
following our resolution with the U.S. government of our FCPA
investigation; compliance with sanctions and other trade control
laws; 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;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; our ability to successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; and our prospects and opportunities for growth if we
sell assets;
- 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; governmental investigations
into sales and marketing practices; potential liability for patent
infringement; 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;
- other financial and economic risks,
including: our exposure to currency fluctuations and restrictions
as well as credit risks; potential impairments of our intangible
assets; potential significant increases in tax liabilities; and 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;
and other factors discussed in our Annual Report on Form 10-K
for the year ended December 31, 2017, including in the section
captioned “Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov and www.tevapharm.com. 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
put undue reliance on these forward-looking statements.
1 Uceris® is a registered trademark of Santarus, Inc. and
Valeant Pharmaceuticals International
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version on businesswire.com: https://www.businesswire.com/news/home/20180709005586/en/
Teva Pharmaceutical Industries Ltd.IR ContactsKevin C. Mannix,
215- 591-8912orRan Meir, 972 (3) 926-7516orPR ContactsUnited
StatesElizabeth DeLuca, 267-468-4329orIsraelYonatan Beker , 972
(54) 888 5898
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