Lexington, Massachusetts, US – June 14, 2016 – 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.
June 14, 2016