Avillion Group Partners with Pfizer to Co-develop BOSULIF® (bosutinib) as
First-Line Treatment for Patients with Chronic Myelogenous Leukemia
LONDON, Jan. 9, 2014
LONDON, Jan. 9, 2014 /PRNewswire/ -- The Avillion Group (Avillion), a
co-developer of late-stage clinical assets, announced today 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.
"We are delighted to announce Avillion's agreement with Pfizer, a global
leader in the biopharmaceutical industry, and we look forward to working with
them with the goal of advancing the development of BOSULIF and expanding its
availability to a broader range of CML patients," said Lewis Cameron, CEO of
Avillion. "Avillion offers pharmaceutical and biotech companies a compelling
option to partner late-stage drug development projects. We have an experienced
team focused on global drug development and regulatory approval, with the
capability to optimise contract research organization (CRO) management."
"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 an oral, once-daily, TKI which inhibits the Bcr-Abl kinase that
promotes CML; it is also an inhibitor of Src-family kinases. 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.
Forward-Looking Information and Cautionary Statement
This release contains forward-looking information about a potential additional
indication (the "Additional Indication") for BOSULIF, including its potential
benefits, that involves substantial risks and uncertainties. Such risks and
uncertainties include, among other things, the uncertainties inherent in
research and development; whether and when any drug applications may be filed
in any jurisdictions for the Additional Indication; whether and when any such
drug applications, if filed, may be approved by regulatory authorities, as
well as their decisions regarding labelling and other matters that could
affect the availability or commercial potential of the Additional Indication;
and competitive developments.
Lewis Cameron, CEO, Avillion LLP T: 0207 470 2458 E:
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SOURCE Avillion Group
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