QUEBEC CITY, March 9 /PRNewswire/ - Aeterna Zentaris Inc.
(President & CEO: Juergen Engel,
(NASDAQ: AEZS) (TSX: AEZ) and Yakult Honsha Co., Ltd.
(President: Sumiya Hori,
Tokyo: 2267), today announced the
signing of an exclusive development, commercialization and
licensing agreement for the development, registration and marketing
of perifosine, Aeterna Zentaris' lead anti-cancer compound, for
Japan. Perifosine, a novel oral
PI3K/Akt inhibitor, is currently in two Phase 3 programs for the
treatment of colorectal cancer and multiple myeloma in the United States and Europe.
Under the terms of the agreement, Aeterna Zentaris will receive
an initial 6 million Euro
(US$ 8.3 M) upfront payment and will
be entitled to receive additional up to 44
million Euro (US$ 60.9 M)
payments upon achieving certain pre-established milestones
including clinical and regulatory events in Japan. Furthermore, Aeterna Zentaris will be
supplying perifosine to Yakult Honsha on a cost-plus-basis and be
entitled to receive double-digit royalties on future net sales of
perifosine in Japan. Yakult Honsha
will be responsible for the development, registration and
commercialization in Japan.
"We are delighted to have a partner such as Yakult Honsha who
has a proven track record in oncology and particularly in colon
cancer, one of the main indications being targeted with perifosine.
This partnership marks another important milestone in our quest to
bring perifosine to market worldwide which could provide cancer
patients with a novel treatment option. Furthermore, perifosine
could generate significant long-term revenue for Aeterna Zentaris
while building value for our shareholders," said Juergen Engel, Ph.D., President and CEO of
Aeterna Zentaris, and continued, "We have now out-licensed
perifosine rights to Keryx Biopharmaceuticals for North America, to Handok for Korea and to
Yakult Honsha for Japan, while
Aeterna Zentaris retains all rights for the rest of the world. In
order to ensure a worldwide timely development of perifosine,
Aeterna Zentaris and all its partners have agreed to free access to
all data."
Mr. Shigeyoshi Sakamoto, Head,
Pharmaceutical Division / Managing Director, Member of the Board of
Yakult Honsha, said, "We are delighted to have added perifosine to
our pipeline in oncology which we have positioned as our key
therapeutic domain. We look forward to pursuing development and
commercialization of perifosine in Japan, by appropriately and efficiently
utilizing the data of ongoing Phase 3 trials in the United States and Europe for patients with colorectal cancer and
multiple myeloma. This partnership will enable us to further
strengthen our initiative in the field of colorectal cancer and to
embark on new fields including multiple myeloma."
About Perifosine
Perifosine is a novel, oral anticancer treatment that inhibits
Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. The
product works by interfering with membranes of cancer cells thereby
inhibiting Akt signaling which then affects cell death, growth,
differentiation and survival. Perifosine, in combination with
chemotherapeutic agents, is currently being studied for the
treatment of colorectal cancer, multiple myeloma and other cancers,
and is the most advanced anticancer compound of its class in
late-stage development. Perifosine as monotherapy, is being
explored in other indications. The US Food & Drug
Administration ("FDA") has granted perifosine orphan-drug
designation in multiple myeloma and neuroblastoma, and Fast Track
designations in both refractory advanced colorectal cancer and
multiple myeloma. Additionally, an agreement was reached with the
FDA to conduct the Phase 3 trials in both of these indications
under a Special Protocol Assessment. Perifosine has also been
granted orphan medicinal product designation from the European
Medicines Agency ("EMA") in multiple myeloma. Furthermore,
perifosine has received positive Scientific Advice from the EMA for
both the advanced colorectal cancer and multiple myeloma programs,
with ongoing Phase 3 trials for these indications expected to be
sufficient for registration in Europe.
About Yakult Honsha Co., Ltd.
Yakult Honsha is a leading Japanese company focused on the
development and marketing of pharmaceuticals, foods, beverages, and
cosmetics. As for pharmaceutical business, Yakult Honsha has an
emerging presence in oncology. For more information on Yakult
Honsha,
visit: http://www.yakult.co.jp/english/index.html or view
the following company profile:
http://www.yakult.co.jp/english/pdf/profile2010-2011.pdf
About Aeterna Zentaris Inc.
Aeterna Zentaris is a late-stage oncology drug development
company currently investigating potential treatments for various
cancers including colorectal, ovarian, endometrial cancer and
multiple myeloma. Aeterna Zentaris' innovative approach of
"personalized medicine" means tailoring treatments to a patient's
specific condition and to unmet medical needs. Aeterna Zentaris'
deep pipeline is drawn from its proprietary discovery unit
providing Aeterna Zentaris with constant and long-term access to
state-of-the-art therapeutic options. 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 actual
results of Aeterna Zentaris and Yakult Honsha 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 ability of Aeterna Zentaris and
Yakult Honsha 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 Aeterna Zentaris' quarterly and annual filings with
the Canadian and U.S. securities commissions, and Yakult Honsha's
quarterly and annual filings with Tokyo Stock Exchange, for
additional information on risks and uncertainties relating to
forward-looking statements. Investors are cautioned not to rely on
these forward-looking statements. Aeterna Zentaris and Yakult
Honsha do not undertake to update these forward-looking statements,
and 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.