JERUSALEM--(BUSINESS WIRE)--Mar. 26, 2018--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of a generic version of Lialda®1
(mesalamine) delayed-release tablets, 1.2 g, in the U.S.
Mesalamine delayed-release tablets are indicated for the induction of
remission in adults with active, mild to moderate ulcerative colitis and
for the maintenance of remission of ulcerative colitis.
“The launch of mesalamine is a significant addition to Teva’s generic
portfolio,” said Brendan O’Grady, Executive Vice President and head of
North America Commercial at Teva. “With more than a million people in
the U.S. estimated to suffer from inflammatory bowel diseases, including
ulcerative colitis,2 this is an important and more affordable
generic treatment option for our customers.”
Mesalamine further enhances Teva’s already-comprehensive
anti-inflammatory portfolio. 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 seven generic prescriptions dispensed in the U.S. is
filled with a Teva generic product.
Mesalamine Delayed-Release Tablets, 1.2 g had annual sales of
approximately $1.11 billion in the U.S., according to IMS data as of
January 2018.
About Mesalamine Delayed-Release Tablets
Mesalamine delayed-release tablets are indicated for the induction of
remission in patients with active, mild to moderate ulcerative colitis
and for the maintenance of remission of ulcerative colitis.
Important Safety Information
Mesalamine delayed-release tablets are contraindicated in patients with
known hypersensitivity to salicylates or aminosalicylates or to any of
the ingredients of mesalamine delayed-release tablets.
Renal Impairment, including minimal change nephropathy, acute and
chronic interstitial nephritis, and, rarely, renal failure, has been
reported in patients given products that contain mesalamine or are
converted to mesalamine. Mesalamine has been associated with an acute
intolerance syndrome that may be difficult to distinguish from an
exacerbation of ulcerative colitis.
Some patients who have experienced a hypersensitivity reaction to
sulfasalazine may have a similar reaction to compounds that contain or
are converted to mesalamine. Mesalamine-induced cardiac hypersensitivity
reactions (myocarditis and pericarditis) have been reported with
mesalamine delayed-release tablets and other mesalamine medications.
There have been reports of hepatic failure in patients with pre-existing
liver disease who have been administered mesalamine.
Pyloric stenosis or other organic or functional obstruction in the upper
gastrointestinal tract may cause prolonged gastric retention of
mesalamine which would delay mesalamine release in the colon. The most
common adverse reactions (incidence greater than or equal to 2 %) in
clinical trials were ulcerative colitis, headache, flatulence, liver
function test abnormality, and abdominal pain.
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 the launch and potential benefits of Teva's generic version of
Lialda®, 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 mesalamine,
including due to a potential launch of an Authorized Generic version;
-
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 the potential benefits and success of our new
organizational structure and recent senior management changes; the
potential success and our ability to effectively execute a
restructuring plan; 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; 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 Lialda® is a registered trademark of Nogra
Pharma Limited., Ireland.
2 https://www.cdc.gov/ibd/ibd-epidemiology.htm
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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or
Israel
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or
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