Aeterna Zentaris Regains North American Rights for Perifosine from Keryx
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.
