Aeterna Zentaris to continue ongoing Phase 3 trial in
multiple myeloma
QUEBEC CITY, May 7, 2012
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the
"Company") today announced that it and Keryx Biopharmaceuticals,
Inc. ("Keryx") (NASDAQ: KERX) have agreed to terminate their
license agreement with respect to perifosine, as a result of which
Aeterna Zentaris has regained in full the North American rights to
its Akt inhibitor anticancer compound, perifosine, in all
indications. The Company also announced that it will continue the
ongoing Phase 3 trial in multiple myeloma with this compound.
Termination of the agreement was effective as of May 4, 2012.
Under the terms of the agreement to terminate, all intellectual
property and development data, including orphan drug designations
and Investigational New Drug ("INDs") applications on perifosine
generated by Keryx, have been transferred to Aeterna Zentaris. In
return, the Company has agreed to pay low single-digit royalties to
Keryx on future net sales of perifosine in North America (U.S., Canada and Mexico).
Juergen Engel, PhD, Aeterna
Zentaris President and CEO stated, "Our decision to continue the
Phase 3 trial in multiple myeloma is based first and foremost on
the existing solid preclinical and clinical data, and on the
support for this drug among key opinion leaders in this field.
Additionally, we believe that market opportunity, examples of other
drugs enjoying success after facing setbacks, as well as the
reasonable investment required to move forward with this study up
to the predefined interim analysis, also make this a sound decision
for the Company. Perifosine in multiple myeloma remains a key
component of our deep pipeline focused on providing novel, targeted
treatment options for cancer patients facing unmet medical
needs."
Paul Richardson, MD, Clinical
Director of the Jerome Lipper Multiple Myeloma Center at
Dana-Farber Cancer Institute commented, "On behalf of my colleagues
involved worldwide in the ongoing pivotal trial comparing
bortezomib and dexamethasone alone to the same combination with
perifosine in the treatment of relapsed, refractory multiple
myeloma, I am truly delighted with Aeterna Zentaris' decision to
continue this key Phase 3 study. We believe there is a strong
rationale for the use of perifosine as part of combination therapy
in multiple myeloma, both pre-clinically and clinically. The
promise of perifosine as an effective therapeutic agent given the
size, strength and maturity of the phase 2 results to date is very
considerable, and clearly warrants further study."
About the Phase 3 trial in multiple myeloma
The ongoing Phase 3 trial conducted under a Special Protocol
Assessment, is a randomized (1:1), double-blind trial comparing the
efficacy and safety of perifosine to placebo when combined with
bortezomib (Velcade®) and dexamethasone in approximately 400
patients with relapsed or relapsed/refractory multiple myeloma. The
primary endpoint is progression-free survival and secondary
endpoints include overall response-rate, overall survival and
safety. Two interim analyses have been pre-defined for the study.
Approximately 265 events (defined as disease progression or death)
will trigger the un-blinding of the data.
About Perifosine
Perifosine is a novel, oral anticancer treatment that inhibits
Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. It
has been granted orphan drug and orphan medicinal product
designations from both the FDA and EMA for multiple myeloma.
Perifosine has also received Fast Track designation from the FDA
and positive Scientific Advice from the EMA with results from the
Phase 3 trial in multiple myeloma expected to be sufficient for
registration in Europe, as well as
in North America. Perifosine is
also being explored in combination therapy and in monotherapy in
other cancer indications. Aeterna Zentaris holds rights to
perifosine for North America and
Europe, while rights have been
licensed to Yakult Honsha for Japan, to Handok for Korea, and to Hikma
Pharmaceuticals for the MENA (Middle
East and North Africa)
region.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug
development company currently investigating treatments for various
unmet medical needs. The Company's pipeline encompasses compounds
at all stages of development, from drug discovery through to
marketed products. For more information please visit
www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbour provisions of the U.S. Securities
Litigation Reform Act of 1995. Forward-looking statements involve
known and unknown risks and uncertainties that could cause the
Company's actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue
R&D projects, the successful and timely completion of clinical
studies, the risk that safety and efficacy data from any of our
Phase 3 trials may not coincide with the data analyses from
previously reported Phase 1 and/or Phase 2 clinical trials, the
ability of the Company to take advantage of business opportunities
in the pharmaceutical industry, uncertainties related to the
regulatory process and general changes in economic conditions.
Investors should consult the Company's quarterly and annual filings
with the Canadian and U.S. securities commissions for additional
information on risks and uncertainties relating to forward-looking
statements. Investors are cautioned not to rely on these
forward-looking statements. The Company does not undertake to
update these forward-looking statements. We disclaim any obligation
to update any such factors or to publicly announce the result of
any revisions to any of the forward-looking statements contained
herein to reflect future results, events or developments, unless
required to do so by a governmental authority or by applicable
law.
SOURCE AETERNA ZENTARIS INC.