LEXINGTON, Massachusetts,
June 14, 2016 /PRNewswire/ --
PF-00547659 is being
evaluated for inflammatory bowel disease
and has completed Phase 2 trials
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced it has agreed
to license global rights to all indications for PF-00547659 from
Pfizer Inc. (NYSE: PFE). PF-00547659 is an investigational biologic
being evaluated for the treatment of moderate-to-severe
inflammatory bowel disease (IBD). PF-00547659 has been evaluated in
more than 700 patients in 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 3.5 million people in the
United States, the European Union, and Japan.
"This licensing transaction fits with Shire's commitment to
advancing research and development in select specialty areas,
including areas of unmet patient need for gastrointestinal
conditions such as IBD," said Howard
Mayer, Head of Clinical Development, Shire. "We look forward
to continuing the development of PF-00547659, a biologic that
will benefit from our experience in IBD and across the
gastrointestinal space."
Terms of the deal were not disclosed.
PF-00547659 and Clinical Development
Program
PF-00547659 is a fully-human monoclonal antibody that is
designed to directly target a gastrointestinal (GI) endothelial
adhesion molecule known as mucosal addressin cell adhesion molecule
1 (MAdCAM-1), that binds to the α4β7 integrin on lymphocytes (white
blood cells).
PF-00547659 has completed Phase 2 clinical trials in UC and CD,
known as TURANDOT and OPERA, respectively. 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-00547659 showed an increased rate of remission,
response, and mucosal healing at week 12, compared to placebo. The
most commonly reported adverse events were consistent with the
underlying disease.
The safety study TOSCA evaluated PF-00547659 in adult patients
with moderate to severe 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-00547659, there was no change in CSF lymphocyte
cell count after treatment. Furthermore, in the completed Phase 2
clinical studies, there was no evidence of increased infection,
including in MAdCAM-expressing tissues (gastrointestinal tract,
nasal tissue, spleen, bladder, uterus and lung), and no progressive
multifocal leukoencephalopathy.
Additionally, long-term treatment with PF-00547659 has been
evaluated in the completed 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
100 countries across core therapeutic areas including 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.
http://www.shire.com
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and/or retain the highly skilled personnel needed to meet its
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- failure to achieve the strategic objectives with respect to
Shire's acquisition of NPS Pharmaceuticals Inc. or Dyax Corp.
("Dyax") may adversely affect the company's financial condition and
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efficiencies, cost savings, revenue enhancements, synergies or
other benefits at the time anticipated or at all; and
other risks and uncertainties detailed from time to time in
Shire's, Dyax's or Baxalta's filings with the Securities and
Exchange Commission, including those risks outlined in "ITEM 1A:
Risk Factors" in Shire's and Baxalta's Annual Reports on Form 10-K
for the year ended December 31,
2015.
All forward-looking statements attributable to us or any person
acting on our behalf are expressly qualified in their entirety by
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For further information please contact:
Investor Relations
Sarah Elton-Farr,
seltonfarr@shire.com, +44(0)1256-894157
Ian Karp, ikarp@shire.com,
+1-781-482-9018
Robert Coates, rcoates@shire.com,
+44(0)1256-894874
Media
Gwen Fisher, gfisher@shire.com,
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Clotilde Houze, chouze0@shire.com,
+1-781-266-3567
SOURCE Shire plc