Full Press Release Details
MATERIAL CHANGE REPORT
1. Name and Address of Company
terna Zentaris Inc. (the Corporation )
1405 du Parc-Technologique Blvd.
Quebec City, Quebec G1P
2. Date of Material Change
2009, the Corporation issued a news release indicating the material change,
which was disseminated in Canada on the CanadaNewsWire service and in USA on
the PR Newswire. A copy of such news release is attached hereto as Schedule A.
4. Summary of Material Change
On December 7, 2009,
the Corporation reported Phase 3 results for its European efficacy trial Z-036
in benign prostatic hyperplasia (BPH), with cetrorelix pamoate.
5. Full Description of Material Change
On December 7, 2009,
the Corporation reported Phase 3 results for its European efficacy trial Z-036
in benign prostatic hyperplasia (BPH), with cetrorelix pamoate.
Study Z-036 did not reach its primary endpoint. There were no clear differences in overall efficacy, with all 3 groups (including placebo) showing an improvement in International Prostate Symptom Score (IPSS) of approximately 6 points that was maintained throughout the 52 weeks. There was observation of an improvement in uroflow, both maximum and mean, and in residual volume in all treatment groups. These favorable changes are reflected in an overall improvement in Quality of Life measures. Cetrorelix was well tolerated, there were no relevant differences to placebo with regard to both clinical adverse events or changes in laboratory parameters with the exception of the anticipated hormonal changes.
6. Reliance on subsection 7.1(2) of National Instrument 51-102
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.
terna Zentaris Announces Results from its European Phase 3 Study with Cetrorelix in Benign Prostatic Hyperplasia
Quebec City, Canada, December 7,
Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the Company ), a global
biopharmaceutical company focused on endocrine therapy and oncology, today
reported Phase 3 results for its European efficacy trial Z-036 in benign prostatic
hyperplasia (BPH), with cetrorelix pamoate.
Study Z-036 did not reach its primary endpoint.
There were no clear differences in overall efficacy, with all 3 groups
(including placebo) showing an improvement in International Prostate Symptom
Score (IPSS) of approximately 6 points that was maintained throughout the 52
weeks. There was observation of an improvement in uroflow, both maximum and
mean, and in residual volume in all treatment groups. These favorable changes
are reflected in an overall improvement in Quality of Life measures. Cetrorelix
was well tolerated, there were no relevant differences to placebo with regard
to both clinical adverse events or changes in laboratory parameters with the
exception of the anticipated hormonal changes.
Juergen Engel, Ph.D., terna Zentaris President and
CEO stated, We are obviously disappointed by the failure of study Z-036 to
reach its efficacy endpoint. Despite the disappointment, we would like to thank
the investigators and all those involved in this project for their dedicated
work. We will now focus our development efforts on our late-stage oncology
compounds perifosine, our oral PI3K/AKT inhibitor and AEZS-108, our targeted
doxorubicin conjugate, as well as our oral ghrelin agonist AEZS-130 in
The multi-center efficacy trial Z-036 was
conducted in 39 sites in 10 European countries, under the supervision of lead
investigator, Prof. Frans MJ Debruyne, M.D., Director of the Andros
Mannenkliniek in Arnhem, The Netherlands. Patients entered a 1- to 4-week screening
period to confirm severity and stability of voiding symptoms based on the IPSS.
Patients were then randomly allocated in a double-blind fashion to one of two
cetrorelix dose groups or placebo, in a 2:1:1 ratio. Patients were administered
cetrorelix by intra-muscular (IM) injection at Week 0, 2, 26 and 28 (for
treatment Arm A, those in Arm B received IM injection at week 0, 2 and placebo
injections both at Week 26 and 28). Patients in treatment Arm C received
placebo injections at Week 0, 2, 26 and 28. All patients were followed up to
Week 52. The study included 420 patients overall, 212, 106, and 102 patients
allocated to Arm A, B, and C, respectively.
The Company will host a conference call and webcast
to discuss these results later today, Monday, December 7, 2009 at 4:30 p.m., Eastern Time.
Participants may access the live webcast via the
Company s website at www.aezsinc.com in
the Investors section, or by telephone using the following numbers: (outside
Canada): 888-231-8191, (Canada): 514-807-9895 or 647-427-7450. A replay of the webcast will also
be available on the Company s website for a period of 30 days.
About the Phase 3 Program with
The Phase 3 trial program involving more than 1,600
patients with symptomatic BPH in Canada, the United States and Europe has been
completed. In addition to the efficacy trial Z-036, the program included a
placebo-controlled safety and efficacy trial Z-033, the single-armed safety
study Z-041, and the Thorough QT study Z-043. Results for all of these trials
were disclosed recently.
Cetrorelix pamoate is a
compound that was being investigated for the treatment of BPH. Cetrorelix is
part of terna Zentaris luteinizing hormone-releasing hormone (LHRH)
antagonist therapeutic approach.
About terna Zentaris Inc.
terna 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