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Shire to Present Data on Short Bowel Syndrome With Intestinal Failure at the ASPEN 2018 Nutrition Science & Practice Conference

Cambridge, Mass. – January 22, 2018 –  Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced today that data will be presented on GATTEX® / REVESTIVE®▼ (teduglutide [rDNA origin]) for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support (PS)1,2 at the ASPEN 2018 Nutrition Science & Practice (formerly Clinical Nutrition Week), in Las Vegas, Nev., January 22-25, 2018.

The data are post-hoc analyses from the pivotal STEPS study,3 examining potential factors affecting the relationship between GATTEX / REVESTIVE and the reduction of parenteral support (PS) volume. The poster presentations of these data are titled:

  • Post Hoc Analysis of the Relationship Between Plasma Citrulline and Parenteral Support Needs in Patients With Short Bowel Syndrome With Intestinal Failure Receiving Teduglutide4
  • Patients With Short Bowel Syndrome Stratified by Baseline Parenteral Support Volume: Post Hoc Analysis of the Clinical Effect of Teduglutide5
  • (Will also be featured in the Celebration of Research event at ASPEN 2018.)

“Shire is pleased to be able to add to the body of knowledge regarding the treatment of short bowel syndrome, a rare condition which can have a considerable impact on patients,” said Howard Mayer, Chief Medical Officer, Shire. “We remain committed to serving patients with rare diseases and we are proud to support a variety of activities to help people with SBS worldwide.”

In addition to the presentation of the data, Shire is a proud sponsor of the ASPEN meeting.

About Short Bowel Syndrome with Intestinal Failure
SBS is a rare and potentially life-threatening gastrointestinal condition.6 It is characterized by a clinically significant reduction in intestinal absorptive capacity,7,8 as a consequence of surgical resection of large portions of the intestine commonly due to congenital abnormalities, disease or trauma.7 If intestinal adaptation is inadequate, the absorptive capacity of the residual intestine becomes insufficient to meet the nutritional, fluid and electrolyte needs9,10,11; this leads to intestinal failure, which requires chronic dependence on PS to maintain adequate hydration, protein, electrolyte and micronutrient balances.7,11

About GATTEX / REVESTIVE
GATTEX / REVESTIVE contains the active substance teduglutide, a glucagon-like peptide-2 (GLP-2) analogue.1,2

In the United States, GATTEX (teduglutide [rDNA origin]) for injection is indicated for the treatment of adult patients with Short Bowel Syndrome who are dependent on Parenteral Support.1

In Europe, REVESTIVE is indicated for the treatment of patients aged one year and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.2 REVESTIVE received Market Authorization in Europe in 2012 for the treatment of adult patients with SBS, who should be stable following a period of intestinal adaptation after surgery. The European Commission extended the REVESTIVE license for treatment of SBS patients aged one year and above in July 2016.12

REVESTIVE (teduglutide for injection) is currently indicated in Canada for the treatment of adult patients with Short Bowel Syndrome who are dependent on Parenteral Support.13

US GATTEX Important Safety Information1

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. Polyps were found in patients taking GATTEX in clinical studies. 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. Bowel blockage was reported in patients taking GATTEX in clinical studies. 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
Swelling or blockage of the gallbladder or pancreas were reported in patients taking GATTEX in clinical studies. 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
Fluid overload and heart failure were reported in patients taking GATTEX in clinical studies. Too much fluid in your body may lead to heart failure, especially if you have heart problems. Your healthcare provider will check you for too much fluid in your body. 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. 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 additional safety information, please click here for the US Full Prescribing Information and discuss with your doctor.

International REVESTIVE Safety Information2

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system [found under section 4.8 of the SmPC].


Contraindications

Hypersensitivity to the active substance or to any of the excipients, or trace residues of tetracycline. Active or suspected malignancy. Patients with a history of malignancies in the gastrointestinal tract including the hepatobiliary system within the last five years.

Special warnings and precautions for use

Colo-rectal polyps
A colonoscopy with removal of polyps should be performed at the time of starting treatment with REVESTIVE. Once yearly follow‑up colonoscopies (or alternate imaging) are recommended during the first 2 years of REVESTIVE treatment. Subsequent colonoscopies are recommended at a minimum of five year intervals. An individual assessment whether increased frequency of surveillance is necessary should be performed based on the patient characteristics (e.g., age, underlying disease). If a polyp is found, adherence to current polyp follow‑up guidelines is recommended. In case of malignancy, REVESTIVE therapy must be discontinued.

Gastrointestinal neoplasia including hepatobiliary tract
In the rat carcinogenicity study, benign tumours were found in the small bowel and the extrahepatic bile ducts. These observations were not confirmed in clinical studies of more than one year duration. If a neoplasia is detected, it should be removed. In case of malignancy, REVESTIVE treatment must be discontinued.

Gallbladder and bile ducts
Cases of cholecystitis, cholangitis, and cholelithiasis have been reported in clinical studies. In case of gallbladder or bile duct‑related symptoms, the need for continued REVESTIVE treatment should be reassessed.

Pancreatic diseases
Pancreatic adverse events such as chronic and acute pancreatitis, pancreatic duct stenosis, pancreas infection and increased blood amylase and lipase have been reported in clinical studies. In case of pancreatic adverse events, the need for continued REVESTIVE treatment should be reassessed.

Monitoring of small bowel, gallbladder and bile ducts, and pancreas
SBS patients are to be kept under close surveillance according to clinical treatment guidelines. This usually includes the monitoring of small bowel function, gallbladder and bile ducts, and pancreas for signs and symptoms, and, if indicated, additional laboratory investigations and appropriate imaging techniques.

Intestinal obstruction
Cases of intestinal obstruction have been reported in clinical studies. In case of recurrent intestinal obstructions, the need for continued REVESTIVE treatment should be reassessed.

Fluid overload
Fluid overload has been observed in clinical trials. Fluid overload adverse events occurred most frequently during the first 4 weeks of therapy and decreased over time.

Due to increased fluid absorption, patients with cardiovascular disease, such as cardiac insufficiency and hypertension, should be monitored with regard to fluid overload, especially during initiation of therapy. Patients should be advised to contact their physician in case of sudden weight gain, swollen ankles and/or dyspnoea. In general, fluid overload can be prevented by appropriate and timely assessment of parenteral nutrition needs. This assessment should be conducted more frequently within the first months of treatment.

Congestive heart failure has been observed in clinical trials. In case of a significant deterioration of the cardiovascular disease, the need for continued treatment with REVESTIVE should be reassessed.

Management of fluids during treatment with REVESTIVE
In patients receiving REVESTIVE, parenteral support should be reduced carefully and should not be discontinued abruptly. The patient’s fluid status should be evaluated following parenteral support reduction and corresponding adjustment performed, as needed.

Concomitant medicinal products
Patients receiving oral concomitant medicinal products requiring titration or with a narrow therapeutic index should be monitored closely due to potential increased absorption.

Special clinical conditions
REVESTIVE has not been studied in patients with severe, clinically unstable concomitant diseases, (e.g., cardiovascular, respiratory, renal, infectious, endocrine, hepatic, or CNS), or in patients with malignancies within the last five years. Caution should be exercised when prescribing REVESTIVE.

Hepatic impairment
REVESTIVE has not been studied in patients with severe hepatic impairment. The data from use in subjects with moderate hepatic impairment do not suggest a need for restricted use.

Discontinuation of treatment
Due to the risk of dehydration, discontinuation of treatment with REVESTIVE should be managed carefully.

Paediatric population
See also general precautions for adults under this section.

Colo‑rectal polyps/Neoplasia
Prior to initiating treatment with REVESTIVE, faecal occult blood testing should be performed in all children and adolescents. Subsequent testing should be conducted annually while they are receiving REVESTIVE.

Prior to initiating treatment with REVESTIVE, children and adolescents 12 years of age and older should undergo a colonoscopy/sigmoidoscopy, unless one has been done within the past year. Children under 12 years of age should also have the procedure if they have unexplained blood in their stool. Colonoscopy is recommended for all children and adolescents after one year of treatment, and at least every 5 years thereafter of continuous treatment with REVESTIVE.

Excipients
REVESTIVE contains less than 1 mmol sodium (23 mg) per dose. This means that it is essentially ‘sodium‑free’. Caution is needed when administering REVESTIVE to persons with a known hypersensitivity to tetracycline.

Adverse reactions


Very common 
(frequency ≥1/10)

Respiratory tract infection, headache, abdominal pain and distension, vomiting, nausea, gastrointestinal stoma complication*, oedema peripheral, injection site reaction.

Common
(≥1/100 to <1/10)

Influenza, decreased appetite, anxiety, sleep disorder, paraesthesia, cardiac failure congestive, flushing, dyspnoea, cough, pancreatitis, intestinal obstruction, cholestasis and cholecystitis, dermatitis allergic, rash, arthalgia, renal colic, costovertebral angle tenderness, chest pain, night sweats, C-reactive protein increased.

Uncommon
(≥1/1,000 to <1/100)

Syncope.


*Gastrointestinal stoma complication (swelling of the stoma and associated complications) is considered to be rather a sign of efficacy than an adverse reaction.

Please consult the REVESTIVE Summary Product Characteristics (SmPC) before prescribing.

For EU Summary of Product Characteristics for REVESTIVE in adults please click HERE.

For further information please contact:

Investor Relations
Christoph Brackmannchristoph.brackmann@shire.com+41 795 432 359
Sun Kimsun.kim@shire.com+1 617 588 8175
Robert Coatesrcoates@shire.com+44 203 549 0874
Media
Linda Calandralinda.calandra@shire.com+1 917 697 7543
Katie Joycekjoyce@shire.com+1 781 482 2779

NOTES TO EDITORS

About Shire

Shire is the global leader in serving patients with rare diseases. We strive to develop best-in-class therapies across a core of rare disease areas including hematology, immunology, genetic diseases, neuroscience, and internal medicine with growing therapeutic areas in ophthalmics and oncology. Our diversified capabilities enable us to reach patients in more than 100 countries who are struggling to live their lives to the fullest.

We feel a strong sense of urgency to address unmet medical needs and work tirelessly to improve people’s lives with medicines that have a meaningful impact on patients and all who support them on their journey.

www.shire.com

Forward-Looking Statements

Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, projected revenues, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, 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, the following:

  • Shire’s products may not be a commercial success;
  • increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire’s 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 Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of 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, among other things, significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
  • certain of Shire’s therapies involve lengthy and complex processes, which may prevent Shire from timely responding to market forces and effectively managing its production capacity;
  • 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;
  • Shire’s products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
  • adverse outcomes in legal matters, tax audits 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 the Company’s revenues, financial condition or results of operations;
  • inability to successfully compete for highly qualified personnel from other companies and organizations;
  • failure to achieve the strategic objectives, including expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all with respect to Shire’s acquisitions, including NPS Pharmaceuticals Inc., Dyax Corp. or Baxalta Incorporated may adversely affect Shire’s financial condition and results of operations;
  • Shire’s growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
  • a slowdown of global economic growth, or economic instability of countries in which Shire does business, as well as changes in foreign currency exchange rates and interest rates, that adversely impact the availability and cost of credit and customer purchasing and payment patterns, including the collectability of customer accounts receivable;
  • failure of a marketed product to work effectively or if such a product is the cause of adverse side effects could result in damage to Shire’s reputation, the withdrawal of the product and legal action against Shire;
  • 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;
  • Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
  • Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which has increased its borrowing costs and may decrease its business flexibility;
  • Our ongoing strategic review of our Neuroscience franchise may distract management and employees and may not lead to improved operating performance or financial results; there can be no guarantee that, once completed, our strategic review will result in any additional strategic changes beyond those that have already been announced; and

a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM 1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.

All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.

References

  1. GATTEX U.S. Prescribing Information. United States Food and Drug Administration. Last updated July 2016. Available at: http://www.shirecontent.com/PI/PDFS/Gattex_USA_ENG.pdf Last accessed: January 2018
  2. REVESTIVE EMA Summary of Product Characteristics, Shire Pharmaceuticals Ireland Limited. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002345/WC500132926.pdf Last accessed: January 2018
  3. Jeppesen PB, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012;143:1473-1481.
  4. Jeppesen PB, et al. Post Hoc Analysis of the Relationship Between Plasma Citrulline and Parenteral Support Needs in Patients With Short Bowel Syndrome With Intestinal Failure Receiving Teduglutide. Poster W60. ASPEN 2018 Nutrition Science & Practice Conference, January 2018.
  5. Jeppesen PB, et al. Patients With Short Bowel Syndrome Stratified by Baseline Parenteral Support Volume: Post Hoc Analysis of the Clinical Effect of Teduglutide. Poster W61. ASPEN 2018 Nutrition Science & Practice Conference, January 2018.
  6. Kelly DG, et al. Short bowel syndrome: highlights of patient management, quality of life, and survival. JPEN J Enteral Parent Nutr 2014;38:427-437.
  7. Pironi L, et al. ESPEN endorsed recommendations. Definition and classification of intestinal failure in adults. Clin Nutr 2015;34(2):171-180.
  8. Jeppesen PB. Spectrum of Short Bowel Syndrome in Adults: Intestinal Insufficiency to Intestinal Failure. JPEN J Enteral Parent Nutr 2014;38(1 Suppl):8S-13S.
  9. Kaufman SS, et al. Management of pediatric intestinal failure. Minerva Pediatr 2015;67(4):321-40.
  10. Sulkowski JP, et al. Management of short bowel syndrome. Pathophysiology 2014;21(1):111-8.
  11. O’Keefe SJ, et al. Short bowel syndrome and intestinal failure: consensus definitions and overview. Clin Gastroenterol Hepatol 2006;4(1):6-10
  12. Shire Receives Extension of Market Authorization in Europe for REVESTIVE (Teduglutide) for the Treatment of Paediatric Patients with Short Bowel Syndrome (SBS). 7 July 2016. Available at: https://www.shire.com/-/media/shire/shireglobal/shirecom/pdffiles/newsroom/2016/pr-07-07-2016.pdf?la=en Last accessed: January 2018
  13. REVESTIVE Canada Product Monograph. Last updated: October 2017. Available at: http://www.shirecanada.com/-/media/shire/shireglobal/shirecanada/pdffiles/product%20information/revestive-pm-en.pdf Last accessed: January 2018

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