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16.03.2011 – 07:17


Agennix AG Announces Completion of Enrollment in Talactoferrin Phase III FORTIS-M Trial in Non-Small Cell Lung Cancer

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Company Information

Heidelberg (euro adhoc) - Planegg/Munich (Germany), Princeton, NJ and Houston, TX, March 16, 2011 -Agennix AG (Frankfurt Stock Exchange: AGX) today announced the completion of patient enrollment in the talactoferrin FORTIS-M Phase III registration trial. The FORTIS-M trial is a global randomized, double-blind trial evaluating talactoferrin plus best supportive care compared to placebo plus best supportive care in patients with non-small cell lung cancer (NSCLC) whose disease has progressed following two or more prior treatment regimens. The study enrolled 742 patients at over 160 sites globally.

"We are excited to have accomplished this important milestone in the development of talactoferrin by completing accrual in the FORTIS-M trial within the expected timeline," said Rajesh Malik, M.D., Chief Medical Officer. "There is a major need for effective and well-tolerated treatments for non-small cell lung cancer patients whose disease has already progressed after multiple therapies. I would like to thank the clinical investigators and study site personnel for their dedication, as well as the patients and their families who are participating in the trial."

The Company also provided an update on the anticipated availability of topline data from the FORTIS-M trial. Agennix now expects to see these data in the first half of 2012. This updated timeline is based on currently available information on the number of blinded death events in the study and is subject to further change. The Company will provide updates as appropriate when more information becomes available.

About non-small cell lung cancer Lung cancer is one of the most commonly diagnosed cancers worldwide and is the leading cause of cancer-related deaths around the globe. In the U.S., more people die of lung cancer than of colon, breast and prostate cancers combined. It is estimated that there were over 222,000 new cases of lung cancer in the U.S. in 2010 and over 157,000 deaths due to this disease. Recent statistics estimate that over 287,000 people in the European Union (EU) were diagnosed with lung cancer in 2008, and approximately 252,000 people in the EU died from this disease. According to the American Cancer Society, NSCLC accounts for approximately 85% of all newly diagnosed lung cancer in the U.S. The symptoms of lung cancer usually do not appear until the disease is already in an advanced stage. Thus, over 50% of NSCLC cases are already metastatic and not curable at the time of diagnosis. Despite recent advances in the treatment of this disease, NSCLC continues to be a major area of unmet medical need around the world.

About talactoferrin Talactoferrin is an oral biologic therapy with immunomodulatory and antibacterial properties, which is being studied for the treatment of cancer and severe sepsis. Talactoferrin has demonstrated activity in randomized, double-blind, placebo-controlled Phase II studies in non-small cell lung cancer (NSCLC), as well as in severe sepsis, a condition with significant mortality marked by severe inflammation in response to a serious infection. As a result of the promising results from Phase II studies, two Phase III trials with talactoferrin in NSCLC are ongoing. Agennix also plans to develop talactoferrin further for the treatment of severe sepsis and plans to initiate a Phase II/III trial in that indication. Talactoferrin has been shown to be very well tolerated in these patient populations.

About Agennix Agennix AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially improve the length and quality of life of critically ill patients in areas of major unmet medical need. The Company's most advanced program is talactoferrin, an oral therapy that has demonstrated activity in randomized, double-blind, placebo-controlled Phase II studies in non-small cell lung cancer, as well as in severe sepsis. Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer, and Agennix plans to develop this program further for the treatment of severe sepsis. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I testing, and a topical gel form of talactoferrin for diabetic foot ulcers. Agennix's registered seat is in Heidelberg, Germany. The Company has three sites of operation: Planegg/Munich, Germany; Princeton, New Jersey and Houston, Texas. For additional information, please visit the Agennix Web site at

This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. There can be no guarantee that the results of the FORTIS-M trial or other ongoing studies with talactoferrin will be obtained when expected, will be positive or will be adequate to support a marketing approval. Additionally, there can be no guarantee that talactoferrin will be approved for marketing in any country or at all. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.

Agennix(TM) is a trademark of the Agennix group.

end of announcement                               euro adhoc

Further inquiry note:

Barbara Mueller
Manager, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693

In the U.S.: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884

Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Phone: +49 (0) 89 210 228 0

Additional investor contact for Europe:
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Lauren Williams, Vice President
Phone: +44 207 936 9325

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