JERUSALEM--(BUSINESS WIRE)--Jul. 9, 2018--
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 Information
Budesonide
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 Statements
This
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20180709005586/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts
Kevin C.
Mannix, 215- 591-8912
or
Ran Meir, 972 (3) 926-7516
or
PR
Contacts
United States
Elizabeth DeLuca, 267-468-4329
or
Israel
Yonatan
Beker , 972 (54) 888 5898