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 June 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 Material Change Report
FORM 51-102F3
MATERIAL CHANGE REPORT
AETERNA ZENTARIS INC.
1. NAME AND ADDRESS OF COMPANY
AEterna Zentaris Inc. (the "CORPORATION")
1405 du Parc-Technologique Blvd.
Quebec City, Quebec G1P 4P5
2. DATE OF MATERIAL CHANGE
June 15, 2009
3. NEWS RELEASE
On June 15, 2009, the Corporation issued a news release indicating the
material change, which was disseminated in Canada on the CanadaNewsWire
service. A copy of such news release is attached hereto as SCHEDULE A.
4. SUMMARY OF MATERIAL CHANGE
On June 15, 2009, the Corporation announced that patient follow-up in the
open-label safety study (study 041) of its Phase 3 program in benign
prostatic hyperplasia (BPH) with its lead endocrinology compound,
cetrorelix pamoate, is scheduled to be completed at the end of this week.
Therefore, data analysis and reporting will be brought forward from the
scheduled fourth quarter into the third quarter of 2009, and will follow
the disclosure of results from the first double-blind placebo controlled
efficacy study (study 033).
5. FULL DESCRIPTION OF MATERIAL CHANGE
On June 15, 2009, the Corporation announced that patient follow-up in the
open-label safety study (study 041) of its Phase 3 program in benign
prostatic hyperplasia (BPH) with its lead endocrinology compound,
cetrorelix pamoate, is scheduled to be completed at the end of this week.
Therefore, data analysis and reporting will be brought forward from the
scheduled fourth quarter into the third quarter of 2009, and will follow
the disclosure of results from the first double-blind placebo controlled
efficacy study (study 033).
The safety study (041) titled, "Cetrorelix pamoate in patients with
symptomatic BPH: an open-labeled safety and efficacy assessment study",
will assess an intermittent dosage regimen of cetrorelix pamoate as a
potential safe and tolerable treatment providing prolonged improvement in
BPH-related signs and symptoms. Patients receive cetrorelix pamoate by
intra-muscular (IM) injection at Weeks 0 and 2, and are followed up to Week
26. The main endpoint is the incidence of possibly drug-related adverse
events.
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6. RELIANCE ON SUBSECTION 7.1(2) OF NATIONAL INSTRUMENT 51-102
Not applicable.
7. OMITTED INFORMATION
Not applicable.
8. EXECUTIVE OFFICER
Further information regarding the matters described in this report may be
obtained from Dennis Turpin, Senior Vice President and Chief Financial
Officer. Mr. Turpin is knowledgeable about the details of the material
change and may be contacted at (418) 652-8525.
9. DATE OF REPORT
June 23, 2009.
SCHEDULE A
NEWS RELEASE
(June 15, 2009)
AETERNA ZENTARIS TO REPORT DATA FROM SAFETY STUDY OF PHASE 3 PROGRAM IN BENIGN
PROSTATIC HYPERPLASIA WITH CETRORELIX AHEAD OF SCHEDULE
QUEBEC CITY, CANADA, JUNE 15, 2009 - AEterna Zentaris Inc. (NASDAQ: AEZS; TSX:
AEZ), a global biopharmaceutical company focused on endocrine therapy and
oncology, today reported that patient follow-up in the open-label safety study
(study 041) of its Phase 3 program in benign prostatic hyperplasia (BPH) with
its lead endocrinology compound, cetrorelix pamoate, is scheduled to be
completed at the end of this week. Therefore, data analysis and reporting will
be brought forward from the scheduled fourth quarter into the third quarter of
2009, and will follow the disclosure of results from the first double-blind
placebo controlled efficacy study (study 033). BPH is a benign enlargement of
the prostate, affecting more than 20 million men in the U.S. alone.
"We are very pleased to have reached this stage of the Phase 3 development of
cetrorelix in BPH and look forward to the data emerging in the next quarter. We
are also pleased that the ongoing reviews of safety data from our Data and
Safety Monitoring Committee have not shown any need for protocol or study
procedure amendments to the studies," said Paul Blake M.D., Senior Vice
President and Chief Medical Officer of AEterna Zentaris.
The safety study (041) titled, "CETRORELIX PAMOATE IN PATIENTS WITH SYMPTOMATIC
BPH: AN OPEN-LABELED SAFETY AND EFFICACY ASSESSMENT STUDY", will assess an
intermittent dosage regimen of cetrorelix pamoate as a potential safe and
tolerable treatment providing prolonged improvement in BPH-related signs and
symptoms. Patients receive cetrorelix pamoate by intra-muscular (IM) injection
at Weeks 0 and 2, and are followed up to Week 26. The main endpoint is the
incidence of possibly drug-related adverse events. More information on this
trial may be obtained at www.clinicaltrials.gov under the reference number
NCT00670306.
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.
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.
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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 528 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.
Recently, AEterna Zentaris also announced that patients completing two years of
therapy with cetrorelix in the first efficacy study (study 033), will be
eligible to continue with the cetrorelix treatment, according to treatment
regimen of the ongoing Phase 3 study, until the end of 2011. Patients entering
this extension study sponsored by the Company's partner sanofi-aventis, will be
followed-up for safety, International Prostate Symptom Score (IPSS) and quality
of life during the extended treatment, providing follow-up data on cetrorelix
for up to 5 years.
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.
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.
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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
Ginette Vallieres
Investor Relations Coordinator
(418) 652-8525 ext. 265
gvallieres@aezsinc.com
MEDIA RELATIONS
Paul Burroughs
Director of Communications
(418) 652-8525 ext. 406
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: June 23, 2009 By: /s/Dennis Turpin
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Dennis Turpin
Senior Vice President and Chief Financial Officer