Date: 2016-06-14
Type of information: Licensing agreement
Compound: PF-00547659
Company: Shire (UK - USA) Pfizer (USA - NY)
Therapeutic area: Inflammatory diseases - Gastrointestinal diseases
Type agreement: licensing
Action mechanism:
- monoclonal antibody. 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 alpha4beta7 integrin on lymphocytes (white blood cells).
Disease: moderate-to-severe inflammatory bowel disease (IBD) including ulcerative colitis and Crohn’s disease
Details:
- • On June 14, 2016, Shire announced it has agreed to license global rights to all indications for PF-00547659 from Pfizer). PF-00547659 is an investigational biologic being evaluated for the treatment of moderate-to-severe inflammatory bowel disease (IBD). PF-00547659 has completed Phase 2 clinical trials in ulcerative colitis and Crohn’s disease, known as TURANDOT and OPERA, respectively. TURANDOT met its primary and secondary end points; adult patients with moderate to severe active ulcerative colitis 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 Crohn’s disease 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 Crohn’s disease study, and is ongoing in the TURANDOT II ulcerative colitis study. Phase 3 trials are expected to begin after consultation with global health authorities.
Financial terms: Terms of the deal were not disclosed.
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