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Tuesday, 01/12/2016 4:18:57 AM

Tuesday, January 12, 2016 4:18:57 AM

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Shire to Present at 34th Annual J.P. Morgan Healthcare Conference
December 15, 2015

Enters 2016 with most robust clinical pipeline in its 30-year history, focused on rare diseases and specialty conditions
Over 25 clinical development programs planned for 2016 including over 10 in Phase 3
Lexington, Mass. – December 15, 2015 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that Flemming Ornskov, M.D., Chief Executive Officer, Shire, will present at the 34th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Tuesday, January 12, 2016 at 2:30 pm PT (5:30pm ET). Dr. Ornskov will provide an update on the business and the progress of Shire’s pipeline at the conference. A live audio webcast will be available on the Presentations and Webcasts section of Shire's Investor website at http://investors.shire.com/presentations-and-webcasts/year-2015.aspx. Subsequently, a replay of the webcast will be available on this same website for approximately 90 days.

“Shire enters 2016 with its most robust clinical pipeline in the Company’s 30-year history,” said Flemming Ornskov, M.D. “Our significant pipeline progress reflects our continued commitment to developing and delivering innovative, best-in-class programs in core therapeutic areas through our internal research and development efforts as well as our strategic acquisitions and partnerships. Our sharp focus on innovation is the driving force behind Shire’s ability to advance its mission of enabling people with life-altering conditions to lead better lives.”

“Shire’s expertise in developing therapies for rare, life-threatening genetic diseases and other specialty conditions is clearly evident from the advancement of our innovative pipeline, with over 25 programs in clinical development. In 2016, our pipeline will include more than 10 programs in Phase 3 trials and compounds already under regulatory review, such as lifitegrast (SHP-606) for Dry Eye Disease in adults,” said Philip J. Vickers, Ph.D., Head of Research & Development, Shire. “We continue to leverage a number of innovative platforms and technologies to advance our pipeline and are excited by the potential of these therapies for patients with severe unmet needs.”

Shire’s portfolio programs focus on five distinct areas: Complement Biology, Central Nervous System (CNS)/Neuromuscular diseases, Gastroenterology (GI)/Endocrine/Metabolic diseases, Ophthalmic diseases and Renal/Fibrotic diseases.

Shire’s planned Phase 3 programs for 2016 include:

SHP-465 for ADHD in adults
SHP-640 for Infectious Conjunctivitis (viral and bacterial)
SHP-620 (maribavir) for CMV infection in transplant recipients
SHP-621 for Eosinophilic Esophagitis
SHP-609 for Hunter Syndrome-intrathecal delivery (Phase 2/3)
SHP-555 in the United States for chronic constipation
SHP-616 (CINRYZE) for Antibody-Mediated Rejection (AMR) in kidney transplant recipients
SHP-616 (CINRYZE) for Acute Neuromyelitis Optica (Phase 2/3)
SHP-616 (CINRYZE) for subcutaneous delivery for Hereditary Angioedema (HAE) prophylaxis
SHP-616 (CINRYZE) for HAE prophylaxis in Japan
INTUNIV for ADHD in Japan
LDX for ADHD in Japan
GATTEX for Short Bowel Syndrome in Japan
FIRAZYR for Hereditary Angioedema (HAE) in Japan
Pending the approval by Dyax shareholders and the close of the proposed acquisition by Shire of Dyax Corp., Shire’s Phase 3 pipeline would also include DX-2930. A long-acting injectable monoclonal antibody for HAE prophylaxis, DX-2930 has the potential to lower rates of HAE attacks and significantly improve patient convenience based on clinical trial data reported to date. DX-2930 received Fast Track, Breakthrough Therapy and Orphan Drug designations by the FDA and Orphan Drug status in the EU. If approved for the prevention of angioedema attacks in patients with HAE, DX-2930 could expand HAE-treated patients and generate estimated annual worldwide sales of up to $2 billion with anticipated regulatory exclusivity beyond 2030.

The waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 as amended (HSR Act), which is applicable to the proposed acquisition of Dyax by Shire, was terminated by the United States Federal Trade Commission (FTC) on December 2, 2015. Termination of the HSR Act waiting period is one of the specified conditions required for the transaction to close. A Dyax shareholder meeting to vote on the proposed acquisition is scheduled for January 21, 2016.

Shire updates its pipeline on a quarterly basis. The current pipeline can be found in the Q3 2015 results presentation located at http://investors.shire.com/~/media/Files/S/Shire-IR/quarterly-reports/2015/q3-2015-presentation-23-october-2015.pdf.

FOR FURTHER INFORMATION PLEASE CONTACT:


Investor Relations
Matt Osborne mattosborne@shire.com + 1 781 482 9502
Sarah Elton-Farr seltonfarr@shire.com +44 1256 894157

Media
Jessica Cotrone jcotrone@shire.com +1 781 482 9538
Elizabeth Kalina ekalina@shire.com +1 781 482 2713


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.

www.shire.com

Things that are equal to the same thing are also equal to one another (Transitive property of equality). If equals are added to equals, then the wholes are equal. If equals are subtracted from equals, then the remainders are equal. Things that coincide wi

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