Pfizer And Avillion Partner To Market BOSULIF
The Avillion Group announced it is venturing into a collaborative business agreement with Pfizer, with the intention of conducting a collaborative phase 3 clinical trial of BOSULIF. The trial will be centered upon a global setting including locations in the United States as well as Asia and Europe. The trial will commence with a starting dosage level of 400 mg a day, and will be administered as a first-line treatment for patients suffering from Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).
BOSULIF is sold as an oral treatment designated to be taken once a day. It is a TKI medication that prevents the Bcr-Abi kinase that encourages CML. The drug is currently approved in the United States as a treatment for adult patients with Ph+ CML who currently exhibit a form of resistance to previous therapy.
Until now, the drug has been used as a last line of defense. In Europe, the drug is approved and authorized as a treatment for adult patients, however it is only approved for patients who do not respond to previous TKI medications; specifically Imatinib, Nilotinib, and Dasatinib. According to the product label information, BOSULIF causes side effects including anemia and water retention, but is considered to be a safe treatment by the FDA.
This week the FDA approved Iclusig, another drug used to treat Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). The drug had been previously approved by the FDA for last line treatment and then disapproved because of serious health risks. Iclusig, unlike BOSULIF, will continue to be marketed and sold as a last line drug.
Gary Nicholson, President and GM of Pfizer Oncology stated “Chronic myelogenous leukemia remains a difficult disease to treat despite recent advances.” He went on to say “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.”
According to the venture terms, Avillion will take on the funding aspect of the clinical trial as well as conduct it in order to produce supporting clinical data. The clinical data will serve as a basis for both parties to seek a registration dossier for marketing authorization for the product, and be considered a viable first line of treatment for these patients.
If approved by regulatory authorities, Pfizer will continue to retain all rights to the BOSULIF product, including commercialization on a global level. However, Pfizer will agree to issue payment to Avillion in the form of milestones throughout the approval stages of the drug.
Source - http://avillionllp.pressvinepro.com/article/avillion-group-partners-with-pfizer-to-co-develop-bosulif-bosutinib-as-first-line-treatment-for-patients-with-chronic-myelogenous-leukemia-1279