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