QUEBEC CITY, Nov. 23, 2011 /PRNewswire/ - Aeterna Zentaris Inc.
(NASDAQ: AEZS) (TSX: AEZ) and Hikma Pharmaceuticals PLC (LSE: HIK)
(NASDAQ Dubai: HIK) announce today the signing of an exclusive
commercialization and licensing agreement for the registration and
marketing of perifosine, Aeterna Zentaris' lead anti-cancer compound,
for the MENA (Middle East and North Africa) region. Perifosine, a novel
oral 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 is entitled to
receive an upfront payment and additional payments upon achieving
certain pre-established milestones in the aggregate of $2 million.
Furthermore, Aeterna Zentaris will be supplying perifosine to Hikma
Pharmaceuticals on a cost-plus-basis and is entitled to receive
double-digit royalties on future net sales of perifosine in the MENA
region. Hikma Pharmaceuticals will be responsible for the registration
and commercialization of perifosine in the MENA territory.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris, stated,
"Hikma Pharmaceuticals has a proven track record in oncology and is a
leading drug company in the Middle East and North Africa region, which
is why we believe it is a perfect fit for the development and
commercialization of perifosine in that part of the world. Our
partnership network for perifosine now encompasses North America,
Japan, Korea and the MENA region, while we still retain all rights for
the rest of the world. We look forward to the Phase 3 results in
colorectal cancer during the first quarter of 2012, as we continue our
quest of bringing perifosine to the market worldwide for the benefit of
both patients and shareholders."
Mr. Mazen Darwazah, Vice Chairman of Hikma Pharmaceuticals, commented,
"Hikma is committed to improving the treatment of cancer in the MENA
region through the development of its oncology product portfolio. This
partnership gives Hikma access to a novel, oral anticancer treatment
with excellent potential and reinforces Hikma's commitment to
developing its product portfolio through strong partnerships. We look
forward to the Phase 3 results in colorectal cancer in 2012 and are
excited to work with Aeterna Zentaris to bring this critically needed
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
agent of its class. Perifosine, as monotherapy, is being explored in
other indications. The FDA has granted perifosine orphan-drug
designation in multiple myeloma and neuroblastoma, and Fast Track
designations in both multiple myeloma and refractory advanced
colorectal cancer. 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 multiple myeloma and
advanced colorectal cancer programs, with ongoing Phase 3 trials for
these indications expected to be sufficient for registration in Europe.
Perifosine rights have been licensed to Keryx Biopharmaceuticals, Inc.
(NASDAQ: KERX) for North America, to Yakult Honsha for Japan and to
Handok for Korea.
About Hikma Pharmaceuticals
Hikma Pharmaceuticals is a fast growing multinational group focused on
developing, manufacturing and marketing a broad range of both branded
and non branded generic and in-licensed products. Hikma's operations
are conducted through three businesses: "Branded", "Injectables" and
"Generics" based principally in the Middle East and North Africa (MENA)
region where it is a market leader, the United States and Europe. In
2010, Hikma achieved revenues of $731 million and profit attributable
to shareholders of $99 million. As of December 2010, Hikma had 5,396
employees. For more information, please visit www.hikma.com.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a late-stage oncology drug development company
currently investigating potential treatments for various cancers
including colorectal, multiple myeloma, endometrial, ovarian, prostate
and bladder cancer. The Company's 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 the Company with constant
and long-term access to state-of-the-art therapeutic options. For more
information please visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to
the safe harbor 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.