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.
+44 1256 894157
+1 781 482 0460
+1 484 595 9836
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.
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:
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.
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.
Do not take Lialda (mesalamine) if you are allergic to:
Tell your doctor if you:
The most common side effects reported in clinical studies of Lialda were:
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:
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.
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
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:
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.
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:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Tell your healthcare provider if you:
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 www.fda.gov/medwatch.
Click here for the PDF version of this press release.