AEterna Zentaris Receives Green Light from FDA to Move Forward into Phase 3 Program with Cetrorelix in BPH
June 21 2006 - 8:00AM
PR Newswire (US)
Company plans to submit IND over the next few months QUEBEC CITY,
June 21 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ;
Nasdaq: AEZS) today announced that during a recent end of Phase 2
meeting, the U.S. Food & Drug Administration (FDA) reviewed the
safety and efficacy data from an extensive Phase 2 program with
cetrorelix, its lead luteinizing hormone-releasing hormone (LHRH)
antagonist product candidate, for the treatment of benign prostatic
hyperplasia (BPH). Accordingly, the Company plans to submit an
Investigational New Drug (IND) application to the FDA within the
next few months for the initiation of a Phase 3 program for
cetrorelix in BPH. "We are very excited and encouraged with the
outcome of our recent meeting with the FDA, which, we believe, will
allow us to further pursue the development of cetrorelix in BPH
with a Phase 3 program," commented Dr. Jurgen Engel, Executive Vice
President, Global R&D and Chief Operating Officer at AEterna
Zentaris. "Cetrorelix has shown promising and compelling results in
our extensive Phase 2 program, and we now look forward to bringing
it to its final development stage." Gilles Gagnon, President &
Chief Executive Officer at AEterna Zentaris, stated, "We continue
to commit our resources as we aggressively advance our promising
product candidates through our pipeline and pursue our strategy of
becoming a late-stage biopharmaceutical company before year-end.
Our successful meeting with the FDA regarding cetrorelix marks a
major milestone for the Company and is further proof of the
significant potential of our LHRH antagonist therapeutic approach.
Our LHRH-antagonist platform remains a priority. We look forward to
announcing the acceptance of our Investigational New Drug
application from the FDA over the next few months for our Phase 3
program with cetrorelix, as well as plan to disclose Phase 2
results for our other promising LHRH-antagonist product candidate,
ozarelix in prostate cancer, over the next few weeks," concluded
Mr. Gagnon. About Benign Prostatic Hyperplasia (BPH) Benign
prostatic hyperplasia (BPH) is characterized by an abnormal benign
growth of the prostatic tissues caused by testosterone. Symptoms
linked to BPH include pain while urinating and frequent urges to
urinate during the night and sometimes, kidney problems. In some
cases, if left untreated, BPH may develop into prostate cancer. BPH
affects more than 50% of men 60 years and over, with approximately
56 million cases in the U.S., Europe and Japan. In 2004, BPH
treatment represented a market size of US$2.6 billion. Contrary to
most of the present treatments for BPH, cetrorelix is not
associated with side effects such as erectile dysfunction, loss of
libido and chemical castration. According to Decision Resource,
cetrorelix is currently the most advanced LHRH- antagonist in
development for the treatment of benign prostatic hyperplasia.
About Cetrorelix Cetrorelix is part of AEterna Zentaris'
Luteinizing Hormone Releasing Hormone (LHRH) antagonist therapeutic
approach. This peptide-based active substance was developed by the
Company in cooperation with Nobel-prize winner Professor Andrew
Schally of the U.S. Veterans Administration in Miami. Cetrorelix is
marketed under the brand name Cetrotide(R), the first LHRH-
antagonist approved for therapeutic use as part of in vitro
fertilization programs (controlled ovulation stimulation/assisted
reproductive technologies) in Europe, the USA and Japan. It was
launched on the market through Serono S.A. in the USA, Europe and
in several other countries. Cetrorelix is currently in a pivotal
clinical program for endometriosis sponsored by our partner,
Solvay. In addition to the planned Phase 3 program in BPH,
cetrorelix is in a Phase 2 trial program in Japan, sponsored by our
partners, Shionogi and Nippon Kayaku. About Cetrorelix Successful
Phase 2 Program Cetrorelix has shown to adequately suppress the
formation of the male sex hormone testosterone, which plays a
principal role in cell growth of the prostate. Since cell growth is
stopped, surgical removal of the prostate might be avoided. All
studies performed so far with cetrorelix in patients with
symptomatic BPH, revealed an improvement in symptoms as assessed
primarily by the I-PSS (International Prostate Symptom Score), an
increase in urinary peak flow rate as well as a reduction in
prostate volume. Studies have also shown the excellent safety and
tolerability profile of cetrorelix. Cetrorelix has successfully
completed a broad 7-Phase 2 program in BPH, endometriosis, and
uterine myoma. This extensive clinical program involved 735
patients and yielded significant and medically important results.
Rapid and durable responses were observed without chemical
castration and cetrorelix proved to have an excellent safety and
tolerability profile. Overall, cetrorelix has shown to have a fast
onset of action allowing for a shorter treatment period, which
could translate into an intermittent/chronic therapy. Such long
treatment-free intervals are actually supported by the results
derived from multiple Phase 2 placebo-controlled studies. About
AEterna Zentaris Inc. AEterna Zentaris Inc. is a growing global
biopharmaceutical company engaged in the discovery, development and
marketing of therapies for cancer and endocrine disorders. AEterna
Zentaris also owns 48.29% of the equity of Atrium Biotechnologies
Inc. (TSX: ATB) and 64.7% of its voting rights. Atrium is a
developer, manufacturer and marketer of science-based products for
the cosmetics, pharmaceutical, chemical and nutritional industries.
News releases and additional information are available at
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. 280,
; Investor Relations: Jenene Thomas, (418) 655-6140, ; To request a
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