Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced the launch of its 1000 mg strength generic version of
Casana®1 (mesalamine) suppository medicine used to treat adults
with active ulcerative proctitis (ulcerative rectal colitis), in
the U.S.
Ulcerative colitis (UC) results in inflammation or swelling of
the rectum (the area between the colon and the anus). This
inflammation may cause symptoms like bleeding, stomach pain,
diarrhea, and urgency (a sudden urge to go to the bathroom).
Ulcerative proctitis is common in people who have inflammatory
bowel disease (IBD),2 and three times more common than Crohn
disease (CD).3
“Teva’s generic mesalamine suppository is an important treatment
option for the 1 million people in the U.S. affected with
ulcerative colitis,”4 said Christine Baeder, SVP, Chief Operating
Officer US Generics, Teva USA.
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
approximately 100 pending first-to-files in the U.S. Currently, 1
in 11 generic prescriptions dispensed in the U.S. is filled with a
Teva generic product.
Mesalamine suppositories have annual sales of more than $74
million in the U.S., according to IQVIA data as of February
2021.
About Mesalamine Suppositories
Mesalamine suppositories are a prescription medicine used to
treat adults with active ulcerative proctitis (ulcerative rectal
colitis).
It is not known if mesalamine suppositories are safe and
effective in children.
IMPORTANT SAFETY INFORMATION
Do not use mesalamine suppositories if you are:
• allergic to medicines that contain salicylates, including
aspirin.
• allergic to mesalamine or any of the ingredients in mesalamine
suppositories.
Ask your doctor if you are not sure if your medicine is included
above.
Before using mesalamine suppositories, tell your doctor if
you:
• have a history of allergic reaction to the medicine
sulfasalazine (Azulfidine).
• have kidney problems.
• have ever had inflammation of the sac around your heart
(pericarditis).
• have liver problems.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if
mesalamine suppositories can harm your unborn baby.
• are breastfeeding or plan to breastfeed. Mesalamine can pass
into your breast milk. Talk to your doctor about the best way to
feed your baby if you use mesalamine suppositories.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
herbal supplements.
Using mesalamine suppositories with certain other medicines may
affect each other. Using mesalamine suppositories with other
medicines can cause serious side effects.
Especially tell your doctor if you take nonsteroidal
anti-inflammatory drugs (NSAIDS), or medicines that contain
azathioprine or 6-mercaptopurine. Taking mesalamine with NSAIDS may
cause kidney problems. Taking mesalamine with azathioprine or
6-mercaptopurine may cause blood problems. You doctor may do
certain tests during treatment with mesalamine suppositories.
Know the medicines you take. Keep a list of them to show your
doctor and pharmacist when you get a new medicine.
What are the possible side effects of mesalamine
suppositories?
Mesalamine suppositories may cause serious side effects,
including:
• Kidney problems. Your doctor will do certain tests
before you start using mesalamine suppositories and during your
treatment with mesalamine suppositories.
• Acute Intolerance Syndrome or Other Allergic Reactions.
Some people who use mesalamine suppositories can have allergic type
reactions, including “Acute Intolerance Syndrome.” Other allergic
reactions can cause heart problems including an inflammation of the
sac around the heart (pericarditis), blood problems, and problems
with other organs in the body including the kidneys, liver and
lungs. These problems usually happen in people who have had an
allergic reaction to medicines containing sulfasalazine. Stop using
mesalamine suppositories and tell your doctor right away if you get
any of these symptoms: cramps, fever, stomach (abdominal) pain,
headache, bloody diarrhea, rash, chest pain shortness of breath,
decrease in the amount of urine, or fatigue.
• Liver problems. This can happen in people who have a
history of liver problems and have taken other medicines that
contain mesalamine. Tell your doctor right away if you get any of
these symptoms while using mesalamine suppositories: yellowing of
your eyes, flu-like symptoms, itchy skin, nausea or vomiting, or
feeling very tired.
The most common side effects of mesalamine suppositories
include dizziness, rectal pain, acne, fever, inflammation of
the large intestine (colitis), and rash.
These are not all of the possible side effects of mesalamine
suppositories.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at www.fda.gov/medwatch or
1-800-FDA-1088.
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), 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 3,500
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 of our 1000 mg strength generic version of
Casana® (mesalamine) suppository medicine in the United States,
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 commercial success of our 1000 mg strength generic version
of Casana® (mesalamine) suppository medicine;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; our ability to develop and commercialize additional
pharmaceutical products; 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: uncertainty
regarding the magnitude, duration, and geographic reach of the
COVID-19 pandemic and its impact on our business, financial
condition, operations, cash flows, and liquidity and on the economy
in general; our ability to successfully execute and maintain the
activities and efforts related to the measures we have taken or may
take in response to the COVID-19 pandemic and associated costs
therewith; effectiveness of our optimization efforts; our ability
to attract, hire and retain highly skilled personnel; manufacturing
or quality control problems; interruptions in our supply chain;
disruptions of information technology systems; breaches of our data
security; variations in intellectual property laws; challenges
associated with conducting business globally, including political
or economic instability, major hostilities or terrorism; costs and
delays resulting from the extensive pharmaceutical regulation to
which we are subject or delays in governmental processing time due
to travel and work restrictions caused by the COVID-19 pandemic;
the effects of reforms in healthcare regulation and reductions in
pharmaceutical pricing, reimbursement and coverage; significant
sales to a limited number of customers; 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:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; 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 this press release and in our
Annual Report on Form 10-K for the year ended December 31, 2020,
including in the sections captioned "Risk Factors” and “Forward
Looking Statements.” 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 CANASA and its design are trademarks of Aptalis Pharma Canada
ULC, an AbbVie company.
2 https://emedicine.medscape.com/article/179037-overview
3 https://emedicine.medscape.com/article/183084-overview#a6
4 https://emedicine.medscape.com/article/183084-overview#a6
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IR Contacts
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PR Contacts
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