Teva Announces Launch of its Generic Version of Canasa® (mesalamine) Suppositories To Treat Adults with Active Ulcerative Proctitis (ulcerative rectal colitis), in the United States

By: Teva Pharmaceutical Industries Limited via Business Wire

April 23, 2021 at 11:09 AM EDT

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