District Court Issues Ruling in Hatch Waxman Case Regarding Shire’s LIALDA®
District Court Issues Ruling in Hatch Waxman Case Regarding Shire’s LIALDA®
Shire to consider appeal
Lexington, Mass., USA – September 16, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) was informed today that the United States District Court for the District of Delaware has ruled that Cadilla Healthcare Ltd./Zydus Pharmaceuticals (USA) Inc.’s (“Zydus”) proposed generic version of Lialda® (mesalamine) does not infringe U.S Patent No. 6,773,720 (“the ’720 patent”).
Despite this ruling, Shire believes that the proposed Zydus product infringes the ‘720 patent and will continue to vigorously defend its intellectual property rights. Shire has thirty days in which to file an appeal to the Court of Appeals to the Federal Circuit.
Notwithstanding the judge’s ruling in the trial, Zydus does not have a tentative or final approval of their abbreviated new drug application which is a prerequisite for Zydus’ commercial introduction of a generic product.
Lialda is a prescription medication approved for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.
Important Safety Information
Do not take Lialda (mesalamine) if you are allergic to salicylates, such as aspirin, or medications that contain aspirin; aminosalicylates; mesalamine; or any other ingredients in Lialda.
Tell your doctor if you:
- have or have had kidney problems. Kidney problems have been reported with medications that contain mesalamine, such as Lialda. Your doctor may check to see how your kidneys are working before starting Lialda and periodically while taking Lialda.
- have symptoms including cramping, stomach ache, bloody diarrhea, fever, headache, and rash. Medications that contain mesalamine, such as Lialda, have been associated with a condition that may be hard to tell apart from a UC flare. Call your doctor right away if you have any of these symptoms. He or she may tell you to stop taking Lialda.
- are allergic to sulfasalazine, as you may also be allergic to Lialda or medications that contain mesalamine.
- have or have had heart-related allergic reactions, such as inflammation of the heart muscle (myocarditis) or the lining of the heart (pericarditis). These reactions have been seen in patients taking Lialda or medications that contain mesalamine. Your chance of having these types of reactions may increase when taking Lialda.
- have or have had liver problems. Problems with liver function have been reported in patients who have or have had liver problems and were taking medications that contain mesalamine, such as Lialda.
- have a stomach blockage. It may take longer for Lialda to start working.
The most common side effects reported in clinical studies of Lialda were:
- ulcerative colitis
- passing gas
- abnormal liver function test results
- stomach ache
In clinical studies of Lialda, inflammation of the pancreas also occurred. If this happens to you, your doctor may tell you to stop taking Lialda.
Other side effects may occur.
Before starting Lialda, tell your doctor about all medications you are taking, including:
- non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen. Taking these medications with Lialda may increase your chance of kidney problems.
- azathioprine and 6-mercaptopurine. Taking these medications with Lialda may increase your chance of blood disorders.
Please see Full Prescribing Information for Lialda (mesalamine)
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088.
FOR FURTHER INFORMATION PLEASE CONTACT:
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NOTES TO EDITORS
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
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other risks and uncertainties detailed from time to time in Shire’s filings with the Securities and Exchange Commission, including those risks outlined in “ITEM 1A: Risk Factors” in Shire’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
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