Aeterna Zentaris and Yakult Honsha Sign a Development, Commercialization and Licensing Agreement for Lead Oncology Compound, Perifosine, for the Japanese Market

March 9, 2011

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


Source: newswire

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