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EANS-News: DSM and Agennix Sign New Contract for Commercial Manufacture of Talactoferrin

Geschrieben am 13-03-2012

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

Planegg/Munich (Germany), Princeton, NJ and Houston, TX, March 13,
2012 (euro adhoc) - DSM Pharmaceutical Products, the custom
manufacturing business of Royal DSM N.V. (NYSE, Euronext: DSM KON),
and Agennix AG (Frankfurt Stock Exchange: AGX), a biopharmaceutical
company focused on developing 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, announced that
they have signed a new contract under which DSM will manufacture the
oral Dendritic Cell Mediated Immunotherapy (DCMI) talactoferrin for
Agennix at commercial levels in anticipation of positive Phase III
clinical data and product approval. DSM is currently manufacturing
talactoferrin for use in ongoing clinical trials, including the
FORTIS-M trial in non-small cell lung cancer (NSCLC), and will
continue to supply talactoferrin for clinical trials as well as to
support a potential commercial launch.

Villaume Kal, Vice President of DSM BioSolutions, a business unit of
DSM Pharmaceutical Products serving the biopharmaceutical market,
stated, "This agreement recognizes intensive collaboration between
DSM and Agennix. DSM's process design for application in large scale
manufacturing largely contributed to this success, and we are
delighted to continue our support of Agennix."

Rajesh Malik, M.D., Chief Medical Officer and Management Board member
of Agennix, said: "We are pleased to continue our productive
relationship with DSM. Their long-term experience with talactoferrin
will be invaluable as we work with them in preparation for a
potential product approval and subsequent commercialization of
talactoferrin. It is important for Agennix to put in place now the
key elements of the talactoferrin supply chain, and expanding our
contract with DSM is an important part of this process."

The contract includes the manufacture of commercial supply of
talactoferrin, process development to continue to optimize the
manufacturing process, and the opportunity to significantly expand
production capacity as needed.

About talactoferrin Talactoferrin is a first-in-class oral Dendritic
Cell Mediated Immunotherapy (DCMI) currently being studied for the
treatment of NSCLC. In randomized, double-blind, placebo-controlled
Phase II studies in NSCLC, talactoferrin appeared to improve survival
across a broad range of patients, including the difficult-to-treat
refractory population, without many of the common toxicities seen
with other cancer therapies. Two Phase III trials with talactoferrin
in NSCLC are ongoing. The FORTIS-M trial, which completed enrollment
in March 2011, is evaluating talactoferrin in NSCLC patients whose
disease has progressed following two or more prior treatment
regimens. A second Phase III trial - FORTIS-C - is evaluating
talactoferrin in combination with the standard chemotherapy regimen,
carboplatin/paclitaxel, in first-line NSCLC patients. NSCLC is one of
the most common types of cancer worldwide and the most frequent cause
of cancer death.

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, a first-in
class oral Dendritic Cell Mediated Immunotherapy (DCMI).
Talactoferrin is currently in Phase III clinical trials in non-small
cell lung cancer. Other clinical development programs include
RGB-286638, a multi-targeted kinase inhibitor in Phase I testing for
cancer, 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. The achievement of
positive results in early stage clinical studies does not ensure that
later stage or large scale clinical studies will be successful. Even
if the results from our later stage trials with talactoferrin,
including the ongoing FORTIS-M trial in non-small cell lung cancer,
are considered positive, there can be no guarantee that they will be
sufficient to gain marketing approval in the United States or any
other country, and regulatory authorities may require additional
information, data and/or further pre-clinical or clinical studies to
support approval. In such event, there can be no guarantee that the
Company will have or be able to obtain the financial resources to
conduct any such additional studies or that such studies will yield
results sufficient for approval. 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™ is a trademark of the Agennix group.

Further inquiry note:
For Agennix:
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, Senior Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.com

For DSM:
Guy Tiene
Director
Marketing and Communications
DSM Pharmaceutical Products
Phone: +1 973 257 8160
guy.tiene@dsm.com

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

company: AGENNIX AG
Im Neuenheimer Feld 515
D-69120 Heidelberg
phone: +49 89 8565 2693
FAX: +49 89 8565 2610
mail: ir@agennix.com
WWW: http://www.agennix.com
sector: Pharmaceuticals
ISIN: DE000A1A6XX4
indexes: CDAX, Prime All Share, Technology All Share
stockmarkets: free trade: Hannover, Berlin, München, Hamburg, Düsseldorf,
regulated dealing/prime standard: Frankfurt
language: English


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