Navigation Links
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 year-end."

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 year-end.

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

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 or developments except if we are required by a governmental authority or applicable law.

Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. AEterna Zentaris to Present at Upcoming Rodman Renshaw Annual Global Investment Conference
2. AEterna Zentaris Announces Results from Two Phase 3 Studies with Cetrorelix in Benign Prostatic Hyperplasia
3. AEterna Zentaris Reports Second Quarter 2009 Financial and Operating Results
4. AEterna Zentaris to Present at Upcoming Canaccord Adams 29th Annual Global Growth Conference
5. AEterna Zentaris to Announce Second Quarter 2009 Financial and Operating Results on August 11, 2009
6. AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma
7. AEterna Zentaris: New Data Published on its Ghrelin Antagonist Compound, AEZS-123 (JMV2959), Supports its Use in Alcohol Addiction
8. AEterna Zentaris Receives US$10 Million from Institutional Investors
9. AEterna Zentaris to Report Data from Safety Study of Phase 3 Program in Benign Prostatic Hyperplasia with Cetrorelix Ahead of Schedule
10. AEterna Zentaris Opens Extended Study for Cetrorelix in Benign Prostatic Hyperplasia
11. AEterna Zentaris Discloses Preliminary Phase 2 Trial Results for Perifosine in Combination with Radiotherapy for Non-Small Cell Lung Cancer
Post Your Comments:
(Date:11/25/2015)... CITY , Nov. 25, 2015 /PRNewswire/ - Aeterna ... affirms that its business and prospects remain fundamentally ... , Zoptrex™ (zoptarelin doxorubicin) recently received DSMB recommendation ... to completion following review of the final interim ... Phase 2 Primary Endpoint in men with heavily ...
(Date:11/25/2015)... SAN DIEGO , Nov. 25, 2015 ... that management will participate in a fireside chat discussion ... New York . The discussion is ... Time. .  A replay will ... Contact:  Media Contact:McDavid Stilwell  , Julie NormartVP, Corporate ...
(Date:11/25/2015)... ... November 25, 2015 , ... Jessica Richman and ... early in their initial angel funding process. Now, they are paying it forward ... make early stage investments in the microbiome space. In this, they join ...
(Date:11/24/2015)... ... 2015 , ... The United States Golf Association (USGA) today announced Dr. Bruce ... Presented annually since 1961, the USGA Green Section Award recognizes an individual’s distinguished service ... , Clarke, of Iselin, N.J., is an extension specialist of turfgrass pathology in the ...
Breaking Biology Technology:
(Date:11/26/2015)... 26, 2015 Research and Markets ( ... Fingerprint Sensors - Technology and Patent Infringement Risk Analysis" ... --> --> Fingerprint sensors using capacitive ... The fingerprint sensor vendor Idex forecasts an increase of ... mobile devices and of the fingerprint sensor market between ...
(Date:11/20/2015)... November 20, 2015 NXTD ) ... on the growing mobile commerce market and creator of ... Pereira , was recently interviewed on The RedChip ... on this weekend on Bloomberg Europe , Bloomberg ... --> NXTD ) ("NXT-ID" or the "Company"), ...
(Date:11/19/2015)...  Based on its in-depth analysis of the biometric ... the 2015 Global Frost & Sullivan Award for Product ... this award to the company that has developed the ... the market it serves. The award recognizes the extent ... customer base demands, the overall impact it has in ...
Breaking Biology News(10 mins):