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
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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
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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
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1 Material Change Report
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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 1, 2009
3. NEWS RELEASE
On June 1, 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 1, 2009, the Corporation announced that its partner, Keryx
Biopharmaceuticals (Nasdaq: KERX), presented positive Phase 2 data on
the clinical activity of perifosine (KRX-0401), an Akt-inhibitor
compound for cancer, as a treatment for advanced metastatic colon
cancer and advanced renal cell carcinoma.
5. FULL DESCRIPTION OF MATERIAL CHANGE
On June 1, 2009, the Corporation announced that its partner, Keryx
Biopharmaceuticals (Nasdaq: KERX), presented positive Phase 2 data on
the clinical activity of perifosine (KRX-0401), an Akt-inhibitor
compound for cancer, as a treatment for advanced metastatic colon
cancer and advanced renal cell carcinoma. Data was presented over the
weekend of May 30, 2009 at the American Society of Clinical Oncology
(ASCO) Annual Meeting, held at the Orange County Convention Center in
Orlando, Florida. The poster #4081 entitled, "Randomized Phase 2 study
of perifosine in combination with capecitabine versus capecitabine alone
in patients with second- or third-line metastatic colon cancer", showed
that perifosine combined with capecitabine, more than doubled time to
progression versus capecitabine plus placebo with a statistically
significant p-value (0.0006). In addition, perifosine plus capecitabine
more than doubled the Overall Response Rate and almost doubled the
Clinical Benefit Rate versus capecitabine plus placebo. The poster
#5034 entitled, "Phase 2 study of perifosine in metastatic renal cell
carcinoma (RCC) progressing after prior therapy (Rx) with a VEGF
receptor", demonstrated impressive single agent efficacy of perifosine
in patients who progressed after failing treatment either with a VEGF
receptor inhibitor or after treatment with both a VEGF receptor
inhibitor and an mTOR inhibitor.
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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 5, 2009.
SCHEDULE A
NEWS RELEASE
(JUNE 1, 2009)
AETERNA ZENTARIS PARTNER KERYX REPORTS POSITIVE PHASE 2 DATA FOR PERIFOSINE
(KRX-0401) IN COLON AND KIDNEY CANCER AT ASCO MEETING
DATA DEMONSTRATES PERIFOSINE'S ANTI-CANCER ACTIVITY AND EFFICACY BOTH AS A
SINGLE AGENT AND IN COMBINATION THERAPY
QUEBEC CITY, CANADA, JUNE 1, 2009 - AEterna Zentaris Inc. (TSX: AEZ; Nasdaq:
AEZS), a global biopharmaceutical company focused on endocrine therapy and
oncology, today announced that its partner, Keryx Biopharmaceuticals (Nasdaq:
KERX), presented positive Phase 2 data on the clinical activity of perifosine
(KRX-0401), an Akt-inhibitor compound for cancer, as a treatment for advanced
metastatic colon cancer and advanced renal cell carcinoma. Data was presented
over the weekend at the American Society of Clinical Oncology (ASCO) Annual
Meeting, currently being held at the Orange County Convention Center in
Orlando, Florida.
ADVANCED METASTATIC COLON CANCER
The poster #4081 entitled, "RANDOMIZED PHASE 2 STUDY OF PERIFOSINE IN
COMBINATION WITH CAPECITABINE VERSUS CAPECITABINE ALONE IN PATIENTS WITH SECOND-
OR THIRD-LINE METASTATIC COLON CANCER", showed that perifosine combined with
capecitabine, more than doubled time to progression versus capecitabine plus
placebo with a statistically significant p-value (0.0006). In addition,
perifosine plus capecitabine more than doubled the Overall Response Rate and
almost doubled the Clinical Benefit Rate versus capecitabine plus placebo.
ADVANCED METASTATIC RENAL CELL CANCER
The poster #5034 entitled, "PHASE 2 STUDY OF PERIFOSINE IN METASTATIC RENAL CELL
CARCINOMA (RCC) PROGRESSING AFTER PRIOR THERAPY (RX) WITH A VEGF RECEPTOR",
demonstrated impressive single agent efficacy of perifosine in patients who
progressed after failing treatment either with a VEGF receptor inhibitor or
after treatment with both a VEGF receptor inhibitor and an mTOR inhibitor.
"We are encouraged as well as excited about the recent data presented on
perifosine by our partner Keryx at ASCO", stated Juergen Engel, Ph.D., President
and CEO of AEterna Zentaris. "This data further shows perifosine's potential as
a novel anticancer compound both as a single agent and in combination therapy.
We now look forward to Keryx's future plan to develop perifosine in oncology."
Copies of the abstracts are currently available and can be viewed on-line
through the ASCO website: http://www.asco.org/.
ABOUT PERIFOSINE (KRX-0401)
Perifosine is the first orally active Akt inhibitor in multiple Phase 2 trials
in cancer. The compound modulates several key signal transduction pathways,
including Akt, MAPK, and JNK that have been shown to be critical for the
survival of cancer cells. Perifosine has demonstrated single agent anti-tumor
activity in Phase 1 and Phase 2 studies and is currently being studied as
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a single agent and in combination with several forms of anti-cancer
treatments for various forms of cancer. Perifosine is licensed to Keryx
Biopharmaceuticals in the United States, Canada and Mexico.
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, and 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 to do so 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
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 5, 2009 By: /s/ Dennis Turpin
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Dennis Turpin
Senior Vice President and
Chief Financial Officer