BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

AEterna Zentaris (AEZS) and ErgoMed Sign Co-Development and Profit Sharing Agreement for AEZS-108 in Endometrial Cancer


4/10/2013 9:48:22 AM

All amounts are in US dollars

QUÉBEC CITY, April 10, 2013 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced the signing of a co-development and profit sharing agreement with Ergomed Clinical Research Ltd. ("Ergomed") for AEZS-108 in endometrial cancer. Ergomed was selected as the contract clinical development organization to conduct the multicenter, multinational, randomized Phase 3 trial with AEZS-108 in endometrial cancer.

Under the terms of the agreement, Ergomed will assume 30% (up to $10 million) of the clinical and regulatory costs for the Phase 3 trial with AEZS-108 in endometrial cancer, which are estimated at approximately $30 million over the course of the study. Ergomed will receive its return on investment based on an agreed single digit percentage of any net income received by Aeterna Zentaris for AEZS-108 in this indication, up to a specified maximum amount.

Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "We look forward to working with Ergomed which has a proven track record of delivering cost effective and efficient drug development services worldwide. This agreement is part of our non-dilutive strategy aimed at minimizing R&D costs while maximizing drug development efficiency. Our goal for AEZS-108 with this collaboration, is to provide a much needed new treatment option to women with late-stage endometrial cancer."

Miroslav Reljanovic, M.D., CEO of Ergomed said, "We are delighted to co-invest with Aeterna Zentaris in the development of AEZS-108 which has shown promising results in Phase 2 trials to date. This agreement is the fifth co-development deal we have signed to date, and demonstrates again the attractive alternative it offers to sophisticated drug developers, as they look to maximise investment returns. Ergomed is now established as one of the leading companies worldwide offering and completing deals under this innovative model."

The Study

This will be an open-label, randomized, multicenter Phase 3 trial conducted in North America, Europe, Israel and other countries under a Special Protocol Assessment, comparing AEZS-108 with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer. The trial will involve approximately 500 patients and the primary efficacy endpoint is improvement in median Overall Survival.

For more information on this trial, go to www.clinicaltrials.gov NCT 01767155.

About AEZS-108 (doxorubicin peptide conjugate)

AEZS-108 represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. AEZS-108 is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in more targeted treatment with less damage to healthy tissue. The product has successfully completed Phase 2 studies for the treatment of ovarian and endometrial cancer and the Company is currently planning a Phase 3 trial in endometrial cancer under a Special Protocol Assessment. AEZS-108 is also in Phase 2 trials in triple-negative breast cancer, prostate cancer and bladder cancer. AEZS-108 has been granted orphan drug designation by the FDA and orphan medicinal product designation from the European Medicines Agency for the treatment of ovarian cancer. Aeterna Zentaris owns the worldwide rights to AEZS-108.

About Endometrial Cancer

Endometrial cancer is the most common gynecologic malignancy and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. Approximately one in 30 women is diagnosed with endometrial cancer every year. According to the American Cancer Society, an estimated 49,560 new cases of endometrial cancer in the U.S., and 35,600 in Europe, are expected during 2013, with about 20% of recurring disease.

About Aeterna Zentaris

Aeterna Zentaris is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The Company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. For more information, visit www.aezsinc.com.

About Ergomed

Ergomed offers clinical development services for the biotechnology and pharmaceutical industry specializing in therapeutics for oncology, neurology and immunology. Ergomed also engages in shared risk ventures through co-development agreements. With its global infrastructure in Western and Eastern Europe, the Middle East and North America, Ergomed offers cost effective and efficient drug development. For further information, visit www.ergomed-cro.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that 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 risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, 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 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, unless required to do so by a governmental authority or by applicable law.

SOURCE AETERNA ZENTARIS INC.



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES