Keryx Biopharmaceuticals Inc fka KERX

[califax]

Perifosine ...

http://www.cnxmarketlink.com/en/releases/archive/March2010/24/c4373.html

AEterna Zentaris Reports Fourth Quarter and Full-Year 2009 Financial and Operating Results

All amounts are in U.S. dollars

QUEBEC CITY, March 24 /CNW Telbec/ - AEterna Zentaris Inc. (NASDAQ: AEZS,
TSX: AEZ) (the "Company"), a late-stage drug development company specialized
in oncology and endocrine therapy, today reported financial and operating
results as at and for the fourth quarter and the full year ended December 31,
2009.

<<
2009 Highlights

Perifosine

- Updated positive Phase 2 efficacy and safety data as well as new
survival data for perifosine in combination therapy for
relapsed/refractory multiple myeloma, were presented at the American
Society of Hematology's ("ASH") annual meeting. Results showed that the
overall response rate was 41% and median overall survival was reported
at 25 months for all evaluable patients. The combination therapy
maintained an acceptable safety profile and no unexpected adverse
events were reported.

- Positive Phase 2 data on perifosine in advanced metastatic colon cancer
and in advanced renal cell carcinoma were presented at the American
Society of Clinical Oncology's ("ASCO") annual meeting. The data
demonstrated perifosine's anti-cancer activity and efficacy both as a
single agent and in combination therapy. Data at ASCO and ASH meetings
were generated by the Company's North American partner, Keryx
Biopharmaceuticals ("Keryx").

- A Phase 3 registration trial with perifosine in relapsed/refractory
multiple myeloma was initiated under a Special Protocol Assessment
("SPA"). Perifosine was also granted Orphan Drug and Fast Track
designations by the Food and Drug Administration ("FDA") in this same
indication. The trial is being conducted by Keryx.

AEZS-108

- Positive Phase 2 preliminary results with AEZS-108 in platinum-
resistant and taxane-pretreated ovarian cancer were disclosed, which
showed that the study met its primary efficacy endpoint of 5 or more
responders in 41 evaluable patients.

- Positive Phase 2 preliminary results with AEZS-108 in advanced or
recurrent endometrial cancer were disclosed. The study met its pre-
defined primary efficacy endpoint of 5 or more responder patients. The
trial in endometrial and ovarian cancer was conducted in collaboration
with the German oncology study cooperative group, Arbeitsgemeinschaft
Gynackologisehe Onkologie ("AGO"). Data for both indications were
presented at the American Association for Cancer Research's ("AACR")
annual meeting.

AEZS-112

- Phase 1 results with AEZS-112 in advanced solid tumors or lymphoma were
disclosed, showing prolonged courses of stable disease, excellent
tolerability and potential for long-term use as a combination treatment
for cancer.

AEZS-130

- A Poster was presented at the Endocrine Society's ("ENDO") annual
meeting, on AEZS-130 (Solorel(TM)), reporting the first clinical data
relating to its use as a simple oral diagnostic test for adult Growth
Hormone Deficiency (GHD).

Cetrorelix

- A licensing agreement with sanofi-aventis U.S. ("sanofi-aventis") for
the development, registration and marketing of cetrorelix in benign
prostatic hyperplasia ("BPH") for the U.S. market was signed. The
agreement provided AEterna Zentaris with a $30 million gross upfront
payment.

- Results of two Phase 3 efficacy studies with cetrorelix in BPH which
did not achieve their primary endpoint were disclosed.

- The Company's licensing agreement with sanofi-aventis for cetrorelix in
BPH, subsequent to the aforementioned Phase 3 results, was terminated.

Corporate Developments

- The Company completed two registered direct offerings of common shares
and warrants to certain U.S. institutional investors, for combined
gross proceeds of $15.5 million.

Subsequent to Year-End

- A statistically significant benefit in survival from updated results of
a Phase 2 study of perifosine in advanced metastatic colon cancer was
reported by Keryx.

- A publication in the February 2010 issue of the Journal of Clinical
Cancer Research reported positive Phase 2 results for perifosine as a
single agent for the treatment of advanced Waldenstrom's
macroglobulinemia.

- The FDA granted a SPA for the Phase 3 trial of perifosine in
combination therapy for refractory metastatic colorectal cancer. The
trial is to be conducted by Keryx.

- The Committee for Orphan Medicinal Products of the European Medicines
Agency issued a positive opinion to AEterna Zentaris for orphan
medicinal product designation for perifosine in multiple myeloma.
>>

...