OREANDA-NEWS. Shire plc (LSE: SHP, NASDAQ: SHPG) and its subsidiary, Shire Development LLC, announced today that the United States District Court for Southern Florida has upheld its patent for LIALDA® (mesalamine) delayed release tablets for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.

The decision follows litigation by Shire against Watson Pharmaceuticals Inc., Watson Laboratories, Inc.-Florida, Watson Pharma, Inc. and Watson Laboratories, Inc. (collectively “Watson”, now “Actavis”) in connection with their Abbreviated New Drug Application (“ANDA”) for a generic version of LIALDA.

Judge Donald M. Middlebrooks issued a ruling holding that Actavis’ proposed ANDA formulation infringes US Patent No. 6,773,720 (“‘720 patent”), the Orange Book listed patent for LIALDA, which extends through June 8, 2020. Accordingly, Judge Middlebrooks entered an injunction prohibiting the FDA from approving the ANDA formulation until the expiration of the ’720 patent and an injunction against Actavis prohibiting them from making, using, selling or importing their proposed ANDA product until after the expiration of the ‘720 patent. This is the second patent infringement trial in which the proposed ANDA product from Actavis (formerly Watson) has been found to infringe the ‘720 patent.

“Shire is very pleased that the court has once again ruled in our favour, reaffirming the validity of the patent protecting LIALDA,” said James Harrington, Senior Vice President, Global Head of Intellectual Property, Shire. “This ruling supports the innovation and value we continue to bring to the patients who benefit from this important medicine that allows them to lead better lives.”

Shire’s LIALDA remains the only once-daily mesalamine product indicated for both the induction of remission of mild to moderate ulcerative colitis and the maintenance of remission of ulcerative colitis.

Indication

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
  • headache
  • 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.