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Shire to License PF- 0. Pfizer, Adding to Established and Leading Gastrointestinal Portfolio.

LEXINGTON, Massachusetts, June 1. PRNewswire/ - -PF- 0. Phase 2 trials  Shire plc (LSE: SHP, NASDAQ: SHPG) today announced it has agreed to license global rights to all indications for PF- 0. Pfizer Inc. PF- 0. IBD). PF- 0. 05. 47. Phase 1 and 2 trials, and Phase 3 trials are expected to begin after consultation with global health authorities.

Closing of the transaction is subject to HSR approval. IBD includes ulcerative colitis (UC) and Crohn's disease (CD), which are serious, chronic diseases characterized by inflammation of the intestine; symptoms include abdominal pain, severe diarrhea, rectal bleeding, fatigue, and weight loss, and can be debilitating. Treatment of IBD focuses on reducing inflammation and associated symptoms through diet and lifestyle changes, pharmacologic therapy, other treatments, or surgery.

The prevalence of IBD is estimated to be more than 3. United States, the European Union, and Japan. TURANDOT met its primary and secondary end points; adult patients with moderate to severe active UC who failed at least one previous treatment who were treated with PF- 0. The most commonly reported adverse events were consistent with the underlying disease. The safety study TOSCA evaluated PF- 0. CD with prior treatment with both anti- TNF and immunosuppressants (azathioprine, 6- MP or methotrexate).

In patients who received a full induction course of the highest clinical dose of PF- 0. CSF lymphocyte cell count after treatment.

Furthermore, in the completed Phase 2 clinical studies, there was no evidence of increased infection, including in MAd. CAM- expressing tissues (gastrointestinal tract, nasal tissue, spleen, bladder, uterus and lung), and no progressive multifocal leukoencephalopathy. Additionally, long- term treatment with PF- 0. OPERA II CD study, and is ongoing in the TURANDOT II UC study.

More. About Inflammatory Bowel Disease (IBD) IBD includes UC and Crohn's disease. Both conditions often onset during young adulthood and have a relapsing- remitting course, where patients go through quiet periods (remission) and active periods with symptoms (flares). Specific symptoms of IBD vary from patient to patient, and can range from mild- to- moderate and moderate- to- severe. Different treatment options exist for IBD and may include diet and lifestyle changes, pharmacologic therapy, other treatments, or surgery. NOTES TO EDITORS Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best- in- class products available in more than 1.

Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high- need conditions, and who lack effective therapies to live their lives to the fullest. Forward- Looking Statements Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, 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: disruption from the acquisition and integration of Baxalta Incorporated (.

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 republish revised forward- looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

For further information please contact: Investor Relations        Sarah Elton- Farr, seltonfarr@shire. Ian Karp, ikarp@shire. Robert Coates, rcoates@shire. Media        Gwen Fisher, gfisher@shire. Clotilde Houze, chouze. SOURCE Shire plc.