EANS-News: AGENNIX AG /

--------------------------------------------------------------------------------
Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
--------------------------------------------------------------------------------

Research & Development

Heidelberg (euro adhoc) - Agennix AG Provides Update on
Development of Talactoferrin

Planegg/Munich (Germany), Princeton, NJ and Houston, TX, August 5, 2010 -

Agennix AG (Frankfurt Stock Exchange: AGX) today provided an
update on its development status and plans for oral talactoferrin.

Enrollment on track in Phase III FORTIS-M trial in non-small cell
lung cancer The Company reported that, as of July 31, 2010, 45% of
patients (327) in the FORTIS-M trial had been enrolled. The total
planned enrollment in the study is 720 patients. FORTIS-M is
evaluating talactoferrin plus best supportive care compared to
placebo plus best supportive care in patients with non-small cell
lung cancer, whose disease has progressed following two or more prior
treatment regimens. The trial remains on track with enrollment
expected to complete in the first half of 2011 and topline data
expected by the end of 2011, should all proceed as anticipated.

Phase III registration plan in severe sepsis The Company also
reported that it has held an End-of-Phase II meeting with the U.S.
Food & Drug Administration (FDA) to discuss future development
plans for talactoferrin in severe sepsis. The Company plans to
meet with European regulatory authorities within the next few
months to discuss its development plans in this indication. In
its discussions with the Company, the FDA strongly recommended that
Agennix conduct two adequate and well-controlled Phase III
studies to support a potential Biologic License Application (BLA)
submission.

Agennix plans to start an initial randomized, double-blind,
placebo-controlled Phase III trial evaluating oral talactoferrin in
adult patients with severe sepsis (sepsis plus one or more organ
dysfunctions) in early 2011. In order to maximize the chances of
success, the Company intends to base the design of this initial
Phase III trial closely on the randomized, double-blind,
placebo- controlled Phase II trial, the topline results of which
were announced in December 2009. In the Phase III trial, the
Company plans to accrue approximately 930 adult patients with
severe sepsis at 100-150 leading sites worldwide for the
treatment of sepsis. Similar to the Phase II trial, all
potentially eligible patients for the Phase III trial will be
centrally screened prior to enrollment to confirm that they
meet the eligibility criteria. Patients will be randomized to
receive oral talactoferrin or placebo. Patients in both arms will
also receive standard of care treatment for severe sepsis in an
intensive care unit (ICU) setting. The primary endpoint of the
Phase III trial will be 28-day all-cause mortality, with
secondary endpoints to include longer-term survival. The FDA has
confirmed that the proposed primary endpoint is acceptable and
indicated that secondary endpoints should include assessment of
mortality at 3, 6 and 12 months.

Rajesh Malik, M.D., Chief Medical Officer of Agennix, said, "We are
excited to advance the development of talactoferrin in severe
sepsis. This is a life- threatening condition that, with an
estimated mortality rate of 30% or higher, is urgently in need of
new, effective therapies. We look forward to initiating a Phase III
trial in early 2011 in this important indication."

Data update from Phase II trial in severe sepsis The Company also
reported that, as part of an independent final audit of the Phase
II trial with talactoferrin in severe sepsis prior to preparing
for publication of the results, it was determined that one
additional patient was affected by the previously disclosed drug
labeling and randomization error. The identified patient had
mistakenly been included in the placebo arm and should have been
included in the talactoferrin arm. Thus, there were 97 patients
in the talactoferrin arm and 93 patients in the placebo arm
(previously reported as 96 patients in the talactoferrin arm and
94 in the placebo arm). This change did not have a material
effect on the outcome of the trial. Baseline characteristics of
patients entering the study were mostly balanced between the
talactoferrin and placebo groups.

The final primary endpoint results are now as follows: 46% relative
reduction (13% absolute reduction) in 28-day all-cause mortality
from 26.9% in the placebo arm to 14.4% in the talactoferrin arm
(two-tailed p-value adjusted for cardiovascular dysfunction = 0.05,
odds ratio by logistic regression analysis = 0.48). These results
reflect a slightly larger improvement in mortality in the
talactoferrin arm when compared to the placebo arm than earlier
reported.[1] Talactoferrin continued to appear to show an effect over
the longer term, at three and six months. These results reflect a
slightly larger improvement in three- and six-month mortality in
the talactoferrin arm when compared to the placebo arm than
earlier reported. Three-month all-cause mortality was 29.7% in
the placebo arm compared to 17.9% in the talactoferrin arm, an
absolute reduction of 12% and relative reduction of 40% (adjusted
two-tailed p-value = 0.08, odds ratio = 0.54).[2] At six
months, there was a statistically significant reduction in
all-cause mortality from 35.6% in the placebo arm to 21.1% in the
talactoferrin arm, an absolute reduction of 15% and relative
reduction of 41% (adjusted two-tailed p-value = 0.04, odds ratio =
0.50).[3]

Talactoferrin continued to appear to show a substantial trend toward
a decrease in 28-day all-cause mortality in the upper two baseline
APACHE II score (an assessment of the severity of the condition)
quartiles, with a slight decrease in the second quartile and a
slight increase in patients in the lowest APACHE II quartile
(scores 0-19), i.e., the least sick patients. It should be noted,
however, that, for each of the lower two quartiles, the difference
was only one death between the arms. None of the differences was
statistically significant. In addition, there appears to have been
no effect on mortality in women in this trial, although it is
unclear whether this outcome would be seen in a larger Phase III
trial or whether it is merely a consequence of the relatively
small number of patients in this trial.

The above analyses were conducted on a modified intent-to-treat
basis (also referred to as intent-to-treat as treated),
meaning that patients were evaluated based on the treatment
they actually received (talactoferrin or placebo) during their
first week of treatment.

Talactoferrin was shown to be very well tolerated in the
study with no significant differences in adverse events between the
two treatment arms. Of those adverse events considered to be
possibly related to treatment, the most frequently reported
category in both treatment groups was gastrointestinal
disorders (5.5% of patients in the talactoferrin arm and 5.4% in
the placebo

arm). There were no serious adverse events considered to be related to
treatment with talactoferrin.

The Company expects the final results from the trial to be submitted for
publication in a peer-reviewed journal.

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. As a result of the promising results from Phase II studies,
two Phase III trials with talactoferrin in NSCLC have been
initiated. NSCLC is one of the most common types of cancer
worldwide and the most frequent cause of cancer death.
Agennix also plans to develop talactoferrin further for the
treatment of severe sepsis. 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 1
testing; the oral platinum-based compound satraplatin; 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. There can be no guarantee that the
Company will move talactoferrin forward in development for severe
sepsis in a timely manner, if at all, or that talactoferrin will
ultimately be approved for sale in any country. 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.
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.

----------------------- [1] Previously, the reported 28-day all-cause
mortality results were as follows: 26.6% in the placebo group
compared to 14.6% in the talactoferrin group, a 12% absolute and 45%
relative reduction (two-tailed adjusted p-value = 0.06, odds ratio =
0.49).

[2] Previously, the reported three-month all-cause mortality was
29.3% in the placebo arm compared to 18.1% in the talactoferrin arm
(adjusted two-tailed p- value = 0.09, odds ratio = 0.55).

[3] Previously, the reported six-month all-cause mortality was 35.2%
in the placebo arm versus 21.3% in the talactoferrin arm (adjusted
two-tailed p-value = 0.05, odds ratio = 0.51).

end of announcement euro adhoc
--------------------------------------------------------------------------------

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

Further inquiry note:

Agennix AG

Investor Relations & Corporate Communications

Phone: +49 (0)89 8565 2693

ir@agennix.com

In the U.S.: Laurie Doyle

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
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Düsseldorf / free trade
Hannover / free trade
München / free trade