FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of March 2009
AETERNA ZENTARIS INC.
1405, boul. du Parc-Technologique
Quebec, Quebec
Canada, G1P 4P5
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F.
Form 20-F /X/ Form 40-F / /
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934
Yes / / No /X/
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-___
DOCUMENTS INDEX
DOCUMENTS DESCRIPTION
1. AEterna Zentaris and Sanofi-Aventis Sign a Development,
Commercialization and Licensing Agreement for Cetrorelix in
Benign Prostatic Hyperplasia
[AETERNA ZENTARIS LOGO]
AETERNA ZENTARIS INC. 1405 du Parc-Technologique Blvd.
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881
www.aezsinc.com
PRESS RELEASE
For immediate release
AETERNA ZENTARIS AND SANOFI-AVENTIS SIGN A DEVELOPMENT, COMMERCIALIZATION AND
LICENSING AGREEMENT FOR CETRORELIX IN BENIGN PROSTATIC HYPERPLASIA
ALL AMOUNTS ARE IN US DOLLARS
QUEBEC CITY, CANADA, MARCH 6, 2009 - AEterna Zentaris Inc. (NASDAQ: AEZS; TSX:
AEZ), a global biopharmaceutical company focused on endocrine therapy and
oncology, today announced the signing of a development, commercialization and
licensing agreement with sanofi-aventis (EURONEXT: SAN; NYSE: SNY) for the
development, registration and marketing of cetrorelix in benign prostatic
hyperplasia (BPH) for the U.S. market. Cetrorelix, a luteinizing
hormone-releasing hormone (LHRH) antagonist, is currently in a Phase 3 program
in BPH, a non-cancerous enlargement of the prostate, affecting more than 20
million men in the U.S. alone.
Under the terms of the agreement, sanofi-aventis will make an initial $30
million upfront payment to AEterna Zentaris which will also be entitled to
receive up to $135 million in additional payments upon achieving certain
pre-established regulatory and commercial milestones. Furthermore, AEterna
Zentaris will be entitled to receive escalating double-digit royalties on future
net sales of cetrorelix for BPH in the United States. Sanofi-aventis will be
responsible for the commercialization and booking of sales in the U.S.; however,
AEterna Zentaris has retained certain rights to co-promote cetrorelix for BPH in
the U.S. market. Finally, sanofi-aventis may perform future Phase 3b and Phase 4
clinical trials, while AEterna Zentaris will have free access to all data for
other territories.
"We are delighted to have a partner such as sanofi-aventis who has a proven
track record in urology. This partnership marks an important milestone in our
quest to bring cetrorelix to market which could provide millions of men with a
novel treatment for BPH. Furthermore, this compound could generate significant
long-term revenue for the Company while building value for our shareholders,"
said Juergen Engel, Ph.D., President and CEO of AEterna Zentaris.
ABOUT THE PHASE 3 PROGRAM WITH CETRORELIX IN BPH
Cetrorelix pamoate is currently in three Phase 3 trials involving more than
1,600 patients with symptomatic BPH in Canada, the United States and Europe.
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The first multi-center efficacy study for which patient recruitment was
completed in April 2008, is currently being conducted primarily in the United
States and Canada, with additional sites in Europe and involves 667 patients
under the supervision of lead investigator, Herbert Lepor, MD, Professor at NYU
School of Medicine, New York. Patients enter a 4-week run-in no-treatment
observation period to confirm severity and stability of voiding symptoms based
on the International Prostate Symptom Score (IPSS). Patients are then randomly
allocated to cetrorelix or placebo in a double-blind fashion. Patients are
administered cetrorelix by intra-muscular (IM) injection at Week 0, 2, 26 and 28
and are followed up to Week 52. Then, in an open-label extension, patients
receive cetrorelix by IM injection at Week 52, 54, 78 and 80 and are followed up
to Week 90.
The second multi-center Phase 3 efficacy study for which patient recruitment was
completed in October 2008, involves 420 patients, mainly in Europe. Patients in
this randomized placebo-controlled study with open-label extension conducted
under the supervision of lead investigator, Prof. Frans M.J. Debruyne, MD, of
the Andros Mannenkliniek, Arnhem, The Netherlands, receive cetrorelix according
to similar dosing regimens used in the first study.
The primary endpoint for both North American and European efficacy studies is
absolute change in IPSS between baseline and Week 52. Other efficacy endpoints
include additional measures of BPH symptom progression and the need for
BPH-related surgery. Safety endpoints include changes in sexual function. Other
important endpoints include plasma changes in levels of testosterone, and
assessment of other adverse events.
The third study in the Phase 3 program, a multi-center safety study, for which
patient recruitment was completed in December 2008, is an ongoing open-label,
single-armed study involving 529 patients in North America. The lead
investigator is Joel Kaufman, M.D., Associate Clinical Professor in Urology at
University of Colorado School of Medicine in Denver, Colorado and at Urology
Research Options in Aurora, Colorado.
First efficacy results are expected during the third quarter of 2009 with an NDA
filing targeted in 2010.
ABOUT CETRORELIX
Cetrorelix pamoate is an investigational agent that has shown in Phase 2 studies
to provide fast and long lasting relief of BPH symptoms and was well tolerated,
with a low incidence of sexual side effects. 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 Prof. Andrew Schally, currently of the U.S.
Veterans Administration in Miami.
Cetrorelix acetate 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 (now
Merck Serono) in the U.S., Europe and in several other countries, as well as in
Japan through Shionogi.
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ABOUT BENIGN PROSTATIC HYPERPLASIA
Benign prostatic hyperplasia (BPH) is one of the most common diseases of aging
men - affecting more than 20 million men in the United States - but its etiology
is far from being completely understood. Data from ongoing research suggest BPH
and lower urinary tract symptoms (LUTS) are more complex conditions than once
thought. While previous research on BPH etiology tended to focus on testosterone
and other hormones, more recent research suggests other factors - including
inflammation, various growth factors, and adrenoreceptors - actually may play a
greater role in the development of BPH and LUTS.
BPH is associated with LUTS, including: frequent urination, a sudden,
uncontrollable urge to urinate, waking at night to urinate (nocturia),
difficulty starting a urine stream (hesitancy and straining), decreased strength
of the urine stream (weak flow), feeling that the bladder is not completely
empty, an urge to urinate again soon after urinating and pain during urination
(dysuria). Currently available therapies may improve symptoms to some degree,
but often come with sexual and other side effects.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine
therapy and oncology, with proven expertise in drug discovery, development and
commercialization. News releases and additional information are available at
www.aezsinc.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. 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 except if we are requested by a
governmental authority or applicable law.
INVESTOR RELATIONS MEDIA RELATIONS
Ginette Vallieres Paul Burroughs
Investor Relations Coordinator Director of Communications
(418) 652-8525 ext. 265 (418) 652-8525 ext. 406
gvallieres@aezsinc.com pburroughs@aezsinc.com
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AETERNA ZENTARIS INC.
Date: March 6, 2009 By: /s/Dennis Turpin
-------------------- -------------------------------------------------
Dennis Turpin
Senior Vice President and Chief Financial Officer