AEterna Zentaris Partner, Keryx Biopharmaceuticals, Receives Orphan-Drug Designation for Perifosine

AEterna Zentaris Partner, Keryx Biopharmaceuticals, Receives Orphan-Drug Designation for Perifosine (KRX-0401) for the Treatment of Multiple Myeloma

QUEBEC CITY, Sept. 16 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ:
AEZS, TSX: AEZ), ("the Company") a global biopharmaceutical company focused on
endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals,
Inc. (Nasdaq: KERX), its partner and licensee for perifosine in the North
American market, has received orphan-drug designation for this compound from
the U.S. Food and Drug Administration (FDA) for the treatment of multiple
myeloma. In August, Keryx announced that it had reached agreement with the FDA
regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial
with perifosine in relapsed/refractory multiple myeloma and that the study is
expected to start by year-end.
Juergen Engel, Ph. D., President and CEO of AEterna Zentaris stated, "We are
very pleased with perifosine gaining Orphan Drug Designation from the FDA as
it would provide extra market exclusivity protection for this compound. We now
look forward to the start of Keryx's Phase 3 trial in multiple myeloma by

About Orphan-Drug Designation

Orphan-drug designation is granted by the FDA Office of Orphan Drug Products
to novel drugs or biologics that treat a rare disease or condition affecting
fewer than 200,000 patients in the U.S. The designation provides the drug
developer with a seven-year period of U.S. marketing exclusivity if the drug
is the first of its type approved for the specified indication or if it
demonstrates superior safety, efficacy, or a major contribution to patient
care versus another drug of its type previously granted the designation for
the same indication. It also provides tax credits for clinical research costs,
the ability to apply for annual grant funding, clinical research trial design
assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About Multiple Myeloma

Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable
disease. Multiple myeloma is the second most-common hematologic cancer,
representing 1% of all cancer diagnoses and 2% of all cancer deaths. According
to the American Cancer Society, in 2009, there will be an estimated 20,580 new
cases of multiple myeloma and an estimated 10,500 deaths from multiple myeloma
in the United States. To date, several FDA approved therapies exist for the
treatment of multiple myeloma. Despite this progress, patients continue to
relapse, become refractory to prior treatments and eventually die from their
disease. Thus, new therapies are needed to treat these patients and extend
their survival.

About Perifosine

Perifosine is a novel oral anti-cancer agent that 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 both
safety and clinical efficacy in several tumor types, both as a single agent
and in combination with novel therapies. Perifosine. is currently in Phase 2
clinical development for multiple tumor types, with a Phase 3 in multiple
myeloma, under Special Protocol Assessment (SPA), pending commencement by

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

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