Full Press Release Details
a2191692zex-99_1.txt
MATERIAL CHANGE REPORT
AETERNA ZENTARIS INC.
1. NAME AND ADDRESS OF COMPANY
AEterna Zentaris Inc. (the "CORPORATION")
1405 du Parc-Technologique Blvd.
Quebec, Quebec G1P 4P5
2. DATE OF MATERIAL CHANGE
On March 6, 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 March 6, 2009, the Corporation announced that it had signed a
development, commercialization and licensing agreement with sanofi-aventis
for the development, registration and marketing of cetrorelix in benign
prostatic hyperplasia (BPH) for the U.S. market.
5. FULL DESCRIPTION OF MATERIAL CHANGE
On March 6, 2009, the Corporation announced that it had signed a
development, commercialization and licensing agreement with sanofi-aventis
for the development, registration and marketing of cetrorelix in benign
prostatic hyperplasia (BPH) for the U.S. market.
Under the terms of the agreement, sanofi-aventis made an initial US$30
million upfront payment to the Corporation, which will also be entitled to
receive up to US$135 million in additional payments upon achieving certain
pre-established regulatory and commercial milestones. Furthermore, the
Corporation 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, the Corporation 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 the
Corporation will have free access to all data for other territories.
6. RELIANCE ON SUBSECTION 7.1(2) OF NATIONAL INSTRUMENT 51-102
7. OMITTED INFORMATION
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.
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
"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.
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
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