Date: 2014-01-09
Type of information: Clinical research agreement
Compound: Bosulif® (bosutinib)
Company: Avillion (UK) Pfizer (USA - NY)
Therapeutic area: Cancer - Oncology - Rare diseases
Type agreement: clinical research development
Action mechanism: tyrosine kinase inhibitor. Bosulif® is intended for patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML who are resistant to or who cannot tolerate other therapies, including imatinib. Bosulif® works by blocking the abnormal tyrosine kinase (Bcr-Abl kinase) that promotes the development of abnormal and unhealthy granulocytes.
Disease: chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML)
Details: * On January 9, 2014, the Avillion Group, a co-developer of late-stage clinical assets, announced that it has entered into an exclusive collaborative development agreement with Pfizer Inc. to conduct a global Phase 3 clinical trial of Pfizer’s Bosulif® (bosutinib). The trial, which will be conducted across multiple sites in the United States, Asia and Europe, will evaluate Bosulif®, administered at a starting dose level of 400 mg daily, as a first-line treatment for patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). Under the terms of the agreement, Avillion will provide the funding for and will conduct the trial to generate the clinical data necessary to potentially support a registration dossier for marketing authorization of Bosulif® by regulatory authorities for an indication as first-line treatment of patients with chronic phase Ph+ CML. If approved for this indication, Avillion will be eligible to receive milestone payments from Pfizer upon regulatory approval of the drug. Pfizer will retain all rights to commercialize Bosulif® globally.
“Chronic myelogenous leukemia remains a difficult disease to treat despite recent advances,” said Garry Nicholson, president and general manager, Pfizer Oncology. “Today, the distinct tolerability profile of Bosulif® offers physicians an important therapeutic choice for their patients with Ph+ CML, as has already been shown in patients who are resistant or intolerant to prior therapy. Through our collaboration with Avillion, we plan to expand the development of Bosulif® by exploring its potential benefit as a first-line therapy for patients with CML.” Bosulif® is currently approved in the U.S. for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy and offers an important treatment option for these patients. In Europe, Bosulif® was granted conditional marketing authorization for the treatment of adult patients with Ph+ CML previously treated with one or more TKIs and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
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