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Aeterna Zentaris Receives Orphan-Drug Designation from the FDA for AEZS-108 in Ovarian Cancer
Date:5/6/2010

QUEBEC CITY, May 6 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc. ( AEZS, TSX: AEZ), ("the Company") a late-stage drug development company specialized in oncology and endocrinology, today announced that it has received from the U.S. Food and Drug Administration (FDA), orphan-drug designation for AEZS-108, its doxorubicin targeted conjugate compound, for the treatment of ovarian cancer. AEZS-108 is currently in a Phase 2 trial in advanced ovarian and advanced endometrial cancer in Europe.

Juergen Engel, Ph. D., President and CEO of Aeterna Zentaris stated, "We are very pleased with AEZS-108 gaining orphan-drug designation for ovarian cancer from the FDA as it would provide it with extra market exclusivity protection. We look forward to reporting the final results from our ongoing European Phase 2 study in ovarian and endometrial cancer, later this year."

About Orphan-Drug Designation

Orphan-drug designation is granted by the FDA Office of Orphan Products Development 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 Ovarian Cancer

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SOURCE AETERNA ZENTARIS INC.
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5. AEterna Zentaris Reports First Patients Treated with Anti-Cancer Compound AEZS-108 in Phase 2 Trial in Ovarian and Endometrial Cancers
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