Teva Announces the Launch of a Generic Version of Delzicol® (mesalamine) Delayed-Release Capsules in the United States
May 10 2019 - 10:51AM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the launch of a generic version of Delzicol®1
(mesalamine) delayed-release capsules, 400 mg, in the U.S.
Mesalamine Delayed-Release Capsules are an aminosalicylate
indicated for the treatment of mildly to moderately active
ulcerative colitis in patients 5 years of age and older, and for
the maintenance of remission of ulcerative colitis in adults.
Teva EVP and Head of North America Commercial, Brendan O’Grady
said, “Ulcerative colitis is a chronic inflammatory bowel disease
and we’re proud to provide another treatment option for
patients.”
Mesalamine Delayed-Release Capsules further enhance Teva’s
already-comprehensive portfolio of medicines to treat
gastrointestinal disorders. With nearly 500 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 eight generic prescriptions dispensed
in the U.S. is filled with a Teva generic product.
Delzicol® delayed-release capsules have annual sales of
approximately $130 million in the U.S., according to IMS data as of
February 2019.
About Mesalamine Delayed-Release Capsules
Mesalamine Delayed-Release Capsules are indicated for the
treatment of mildly to moderately active ulcerative colitis in
patients 5 years of age and older and for the maintenance of
remission of ulcerative colitis in adults.
Important Safety Information
Mesalamine Delayed-Release Capsules are contraindicated in
patients with known or suspected hypersensitivity to salicylates or
aminosalicylates or to any of the ingredients of Mesalamine
Delayed-Release Capsules.
Renal impairment, including minimal change nephropathy, acute
and chronic interstitial nephritis, and renal failure, has been
reported in patients taking 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. Hypersensitivity
reactions have been reported in patients taking sulfasalazine. Some
patients may have a similar reaction to mesalamine or to other
compounds that contain or are converted to mesalamine. There have
been reports of hepatic failure in patients with preexisting liver
disease who have been administered mesalamine.
The most common adverse reactions (≥ 5%) in clinical trials were
eructation, abdominal pain, constipation, dizziness, rhinitis, back
pain, and rash in adults; and nasopharyngitis, headache, abdominal
pain, dizziness, sinusitis, rash, cough, and diarrhea in
pediatrics.
For more information, please see accompanying Full Prescribing
Information. A copy may be requested from Teva U.S. Medical
Information at 888-TEVA-USA (888-838-2872) or
druginfo@tevapharm.com, or Teva’s Public Relations or Investor
Relations contacts.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 35,000
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at 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 the generic version
of Delzicol®, 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 mesalamine, 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; the uncertainty of commercial
success of AJOVY® or AUSTEDO®; 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 substantial indebtedness, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, 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 our 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 selling 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, 2018, including the sections
thereof captioned "Risk Factors." 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.
1 Delzicol® is a registered trademark of Allergan
Pharmaceuticals International Limited.
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