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 email@example.com, or Teva’s Public Relations or Investor Relations contacts.
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:
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.
Kevin C. Mannix
972 (54) 888 5898