EANS-News: AGENNIX AG / 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 www.agennix.com.

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
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ots Originaltext: AGENNIX AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Barbara Mueller
Manager, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693
ir@agennix.com

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

Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Phone: +49 (0) 89 210 228 0
raimund.gabriel@mc-services.eu

Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.com

Branche: Pharmaceuticals
ISIN: DE000A1A6XX4
WKN: A1A6XX
Index: CDAX, Prime All Share, Technology All Share
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