Shire Comments on USPTO Petitions Related to LIALDA and GATTEX

Lexington, Massachusetts (ots/PRNewswire) -

Shire plc acknowledges the two petitions filed with the U.S.
Patent and Trademark Office (USPTO) on April 2nd by Hayman Capital
Management regarding LIALDA(R) (mesalamine) and GATTEX(R)
(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.

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.

Information on LIALDA

Lialda(R) 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
[http://pi.shirecontent.com/?product=LIALDA&country=USA&language=ENG
] 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(R) (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 .

For further information please contact:

Investor Relations
Sarah Elton-Farr
seltonfarr@shire.com
+44-1256-894157

Media
Stephanie Fagan
sfagan@shire.com
+1-781-482-0460

Gwen Fisher
gfisher@shire.com
+1-484-595-9836

ots Originaltext: Shire Pharmaceuticals Group Plc
Im Internet recherchierbar: http://www.presseportal.de