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Shire to License Investigational Biologic for IBD from Pfizer
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Shire will license global rights to PF-00547659, an investigational biologic for moderate-to-severe inflammatory bowel disease, from Pfizer, according to a press release.
The fully human monoclonal antibody that targets mucosal addressin cell adhesion molecule 1 (MAdCam-1) has been evaluated in the phase 2 TURANDOT and OPERA trials, respectively involving adults with ulcerative colitis and Crohn’s disease. Primary and secondary endpoints were met in the TURANDOT trial, which included week 12 remission, response and mucosal healing. Adverse events “were consistent with the underlying disease,” and the researchers found no evidence of increased infection or progressive multifocal leukoencephalopathy, according to the press release.
The drug was also evaluated in the TOSCA safety study in adults with moderate-to-severe Crohn’s disease who failed previous treatments, and there was no change in cerebrospinal fluid lymphocyte counts after treatment at the highest dose.
Long-term treatment was assessed in OPERA II, and the long-term TURANDOT II study is ongoing.
Over 700 patients have been enrolled in the phase 1 and 2 trials to date, and Shire expects phase 3 trials to begin after consulting with global health authorities, according to the press release.
Closing of the transaction is subject to HSR antitrust approval, and the terms of the deal were not disclosed in the press release.