Teva Announces the Launch of a Generic Version of Lialda® in the United States
March 26 2018 - 2:49PM
Business Wire
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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Teva Pharmaceutical Industries Ltd.IR ContactsUnited
StatesKevin C. Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926 7656orPR
ContactsUnited StatesElizabeth DeLuca,
267-468-4329Kaelan Hollon, 202-412-7076orIsraelYonatan
Beker, 972 (54) 888 5898
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