Shire Comments on USPTO Petitions Related to LIALDA and GATTEX

LEXINGTON, Massachusetts, April 6, 2015 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPG) acknowledges the two petitions filed with the U.S. Patent and Trademark Office (USPTO) on April 2nd by Hayman Capital Management regarding LIALDA® (mesalamine) and GATTEX® (teduglutide [rDNA origin]).

The patents listed in the FDA Orange Book for LIALDA and GATTEX protect the innovation and value Shire brings to patients who benefit from these important medicines. Shire will continue to defend vigorously its patents and pursue all legal options available to protect its products.

LIALDA remains the only once-daily mesalamine product indicated for both the induction of remission of mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. LIALDA is protected by the following FDA Orange Book listed patent: U.S. Patent No. 6,773,720, Mesalazine Controlled Release Pharmaceutical Compositions (the "'720 patent"), which expires in 2020.  This patent has already withstood a challenge on its validity in the Federal District Court for the Southern District of Florida.  There have not been any approvals of generic versions of LIALDA. 

GATTEX is approved in the United States to treat adults with short bowel syndrome (SBS) who are dependent on parenteral support.  GATTEX was awarded Orphan Drug Designation by the FDA in 2012 and has orphan drug exclusivity until December 2019.  GATTEX is also protected by FDA Orange Book patents which expire in 2015, 2022 and 2025.  The recently filed petition only challenges a subset of claims of the GATTEX patent expiring in 2022.  The remaining claims of that patent, and the claims of the other patents, were not challenged in the petition.

Information on LIALDA 

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.

Please see  Full Prescribing Information  for Lialda (mesalamine)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch, or call 1-800-FDA-1088.

Information on GATTEX 

GATTEX® (teduglutide [rDNA origin]) for injection is the first prescription medicine for the long-term treatment of adults with Short Bowel Syndrome (SBS) who are dependent on parenteral support

IMPORTANT SAFETY INFORMATION 

What is the most important information I should know about GATTEX? 

GATTEX may cause serious side effects, including: 

Making abnormal cells grow faster 

GATTEX can make abnormal cells that are already in your body grow faster. There is an increased risk that abnormal cells could become cancer. If you get cancer of the bowel (intestines), liver, gallbladder or pancreas while using GATTEX, your healthcare provider should stop GATTEX. If you get other types of cancers, you and your healthcare provider should discuss the risks and benefits of using GATTEX.

Polyps in the colon (large intestine) 

Polyps are growths on the inside of the colon. Your healthcare provider will have your colon checked for polyps within 6 months before starting GATTEX and have any polyps removed.

To keep using GATTEX, your healthcare provider should have your colon checked for new polyps at the end of 1 year of using GATTEX. If no polyp is found, your healthcare provider should check you for polyps as needed and at least every 5 years and have any new polyps removed. If cancer is found in a polyp, your healthcare provider should stop GATTEX.

Blockage of the bowel (intestines) 

A bowel blockage keeps food, fluids, and gas from moving through the bowels in the normal way. Tell your healthcare provider if you have any of these symptoms of a bowel blockage:

• trouble having a bowel movement or passing gas
• stomach area (abdomen) pain or swelling
• nausea
• vomiting
• swelling and blockage of your stoma opening, if you have a stoma

If blockage is found, your healthcare provider may temporarily stop GATTEX.

Swelling (inflammation) or blockage of your gallbladder or pancreas 

Your healthcare provider will do tests to check your gallbladder and pancreas within 6 months before starting GATTEX and at least every 6 months while you are using GATTEX. Tell your healthcare provider right away if you get stomach area (abdomen) pain and tenderness, chills, fever, change in your stools, nausea, vomiting, dark urine, or yellowing of your skin or the whites of eyes.

Fluid overload 

Your healthcare provider will check you for too much fluid in your body. Too much fluid in your body may lead to heart failure, especially if you have heart problems. Tell your healthcare provider if you get swelling in your feet and ankles, you gain weight very quickly (water weight), or you have trouble breathing.

The most common side effects of GATTEX include: 

• stomach area (abdomen) pain or swelling
• skin reaction where the injection was given
• nausea
• headache
• cold or flulike symptoms
• vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

What should I tell my healthcare provider before using GATTEX? 

Tell your healthcare provider if you: 

• Have cancer or a history of cancer
• Have or had polyps anywhere in your bowel (intestines) or rectum
• Have heart problems
• Have high blood pressure
• Have problems with your gallbladder, pancreas, kidneys
• Have any other medical condition
• Are pregnant or planning to become pregnant. It is not known if GATTEX will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while using GATTEX.
• Are breastfeeding or plan to breastfeed. It is not known if GATTEX passes into your breast milk. You and your healthcare provider should decide if you will use GATTEX or breastfeed. You should not do both.

Tell your healthcare providers about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Using GATTEX with certain other medicines may affect each other causing side effects. Your other healthcare providers may need to change the dose of any oral medicines you take while using GATTEX. Tell the healthcare provider who gives you GATTEX if you will be taking a new oral medicine.

Call your doctor for medical advice about side effects. To report suspected side effects, contact NPS Pharma at 1-855-5GATTEX (1-855-542-8839) or the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Please see GATTEX® (teduglutide [rDNA origin]) for injection

Full Prescribing Information: https://www.gattex.com/assets/pdf/PI_Med_Guide.pdf

and Medication Guide: https://www.gattex.com/assets/pdf/PI_Med_Guide.pdf#page=19

NOTES TO EDITORS

Shire enables people with life-altering conditions to lead better lives.

Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.

We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.

http://www.shire.com

THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included in this announcement that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:

• Shire’s products may not be a commercial success;
• product sales from ADDERALL XR and INTUNIV are subject to generic competition;
• the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for Shire's products may affect future revenues, financial condition and results of operations;
• Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of the Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of the Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
• the manufacture of Shire’s products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
• Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
• the actions of certain customers could affect Shire's ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire’s revenues, financial conditions or results of operations;
• investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
• adverse outcomes in legal matters and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
• Shire faces intense competition for highly qualified personnel from other companies and organizations. Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect Shire’s ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;
• failure to achieve Shire’s strategic objectives with respect to the acquisition of NPS Pharmaceuticals, Inc. may adversely affect Shire’s financial condition and results of operations;
  

and other risks and uncertainties detailed from time to time in Shire’s filings with the US Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.

For further information please contact:

Investor Relations
Sarah Elton-Farr
[email protected]
+44-1256-894157

Media
Stephanie Fagan
[email protected]
+1-781-482-0460

Gwen Fisher
[email protected]
+1-484-595-9836

SOURCE Shire plc