AEterna Zentaris Announces Cetrorelix Development with Solvay Continues with Endometriosis as a Primary Indication
March 16 2005 - 7:01AM
PR Newswire (US)
AEterna Zentaris Announces Cetrorelix Development with Solvay
Continues with Endometriosis as a Primary Indication QUEBEC CITY,
March 16 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ;
NASDAQ: AEZS) today announced that the upcoming Phase III program
with cetrorelix, a luteinizing hormone-releasing hormone (LHRH)
antagonist, will be conducted in endometriosis as a primary
indication. This will be achieved through collaboration with Solvay
Pharmaceuticals, the Company's worldwide (ex- Japan) exclusive
development and marketing partner for cetrorelix. This decision was
made following the successful completion of a broad seven Phase II
trial program of cetrorelix in endometriosis, benign prostate
hyperplasia and uterine myoma. It also takes into account
recommendations from a thorough market research program showing
that endometriosis is still an area of high unmet medical needs. An
improved side effects profile, absence of hormonal castration,
convenience of dosing, suitability for long-term use as an
intermittent treatment and speed of onset of action are among key
attributes that could favorably position cetrorelix. "The striking
results we have seen with cetrorelix in Phase II trials,
particularly in endometriosis, deliver on the promise of LHRH
antagonists and are the culmination of our many years of research
and development efforts into LHRH and its antagonists domain
conducted along with Nobel Laureate Prof. Andrew Schally", said
Prof. Jurgen Engel, Executive Vice President Global R&D and
Chief Operating Officer at AEterna Zentaris. "We are excited to see
the strong commitment of Solvay towards cetrorelix, our lead
compound in endocrinology." In light of the decision, Dr. Werner
Cautreels, Solvay Pharmaceuticals' Chief Executive Officer,
confirmed: "We continue to strengthen our pipeline including a
strong Business Unit in Women Health which now includes cetrorelix
as a key asset. Given the exciting positive Phase II results
obtained with cetrorelix in endometriosis and the very favorable
profile of this compound, we are putting everything in place to
complete the full development of this novel therapeutic and to
expedite the registration of cetrorelix to maintain our leadership
position in the women's health market. Although we never comment on
the costs of individual projects that are ongoing, typical industry
figures for the costs from here going forward of one successful
full development program run into many tens of millions of
dollars." According to Gilles Gagnon, President and Chief Executive
Officer at AEterna Zentaris: "We are very excited about this
decision of Solvay Pharmaceuticals to invest heavily in our Company
by going ahead with cetrorelix in endometriosis as the upcoming
Phase III indication. At AEterna Zentaris, while we are working
towards the development of a fully-integrated company, we are now
in a position to propose a pipeline encompassing promising products
at all development stages to continue to deliver benefits to
patients and value to our shareholders." Endometriosis is the
growth of the endometrium, or the inside lining of the uterus,
outside of the uterus and is dependent upon the level of estrogens.
Endometriosis affects approximately 10% to 20% of women of child-
bearing age. The total market size is estimated to be around US$800
million. About Solvay Pharmaceuticals Solvay Pharmaceuticals is a
member of the Solvay group of pharmaceutical and chemical
companies. Operating globally with corporate offices in Europe, the
U.S. and Japan, and sales and marketing companies in more than 45
countries, Solvay Pharmaceuticals employs 8,000 people worldwide.
It has research and development activities concentrated onto
carefully selected clinical targets in the fields of women's and
men's health, mental health, gastroenterology, influenza prevention
and cardiology. The Solvay Group employs about 30,000 people in
three sectors of activity: pharmaceuticals, chemicals and plastics.
For further information on Solvay, please visit the website
http://www.solvay.com/ or http://www.solvaypharmaceuticals.com/ .
About AEterna Zentaris Inc. AEterna Zentaris Inc. is an oncology
and endocrine therapy focused biopharmaceutical company with proven
expertise in drug discovery, development and commercialization. The
Company's broad 20 product pipeline leverages five different
therapeutic approaches, including LHRH antagonists and signal
transduction inhibitors. The lead LHRH antagonist compound,
cetrorelix, is currently marketed for in vitro fertilization under
the brand name Cetrotide(R), and has successfully completed a broad
Phase II program in endometriosis and benign prostatic hyperplasia
(BPH). The lead signal transduction inhibitor compound, perifosine,
is an orally-active AKT inhibitor that is in several Phase II
trials for multiple cancers. AEterna Zentaris owns 61.1% of Atrium
Biotechnologies Inc., a leading developer, manufacturer and
marketer of value-added products for the cosmetics, pharmaceutical,
chemical and nutritional industries. News releases and additional
information about AEterna Zentaris are available on its Web site
http://www.aeternazentaris.com/ . Forward-Looking Statements 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, which 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 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 the 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. DATASOURCE: AETERNA
ZENTARIS INC. (FORMERLY/ANCIENNEMENT - LES LABORATOIRES AETERNA
CONTACT: Media Relations, Paul Burroughs, (418) 652-8525 ext. 406,
; Investor Relations, Ginette Vallieres, (418) 652-8525 ext. 265, ;
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of this organization's annual report, please go to
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