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EANS-News: Lonza and Agennix Sign Development and Manufacturing Deal for Production of Talactoferrin

Geschrieben am 12-04-2012

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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

Subtitle: • Contract covers the commercial production of
talactoferrin, an oral Dendritic Cell Mediated Immunotherapy (DCMI)
under investigation for the treatment of non-small cell lung cancer
(NSCLC)

• Lonza will manufacture talactoferrin at its microbial facility in
Kourim, Czech Republic

Basel (Switzerland), Planegg/Munich (Germany), Princeton, NJ and
Houston, TX, April 12, 2012 (euro adhoc) - Lonza and Agennix AG
(Frankfurt Stock Exchange: AGX) announced today an agreement for the
production of Agennix´s first-in-class oral Dendritic Cell Mediated
Immunotherapy (DCMI), talactoferrin, currently in Phase III testing
for the treatment of non-small cell lung cancer (NSCLC). Under the
agreement, Lonza will produce commercial material at its microbial
manufacturing facility in Kourim, Czech Republic. This agreement
initiates the process needed to be able to ultimately seek approval
for Lonza as a second manufacturer of talactoferrin after the initial
commercial launch.

"We are committed to supporting emerging therapeutics through
clinical trial milestones," said Dr. Stephan Kutzer, COO Lonza Custom
Manufacturing. "Our partnership with Agennix is an example of this
commitment and demonstrates Lonza´s ability to offer access to our
development and manufacturing expertise at an early stage of
production."

Rajesh Malik, M.D., Chief Medical Officer and Management Board member
of Agennix, said: "We are pleased to enter this agreement with Lonza,
which has extensive experience manufacturing biologics on a
commercial scale. In anticipation of positive Phase III data and a
potential product approval, it is important that we have more than
one manufacturer in place to ensure we can meet anticipated
commercial demand and that we have security of supply."

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.

About Lonza Lonza is one of the world's leading suppliers to the
pharmaceutical, healthcare and life science industries. Products and
services span its customers´ needs from research to final product
manufacture. It is the global leader in the production and support of
active pharmaceutical ingredients both chemically as well as
biotechnologically. Biopharmaceuticals are one of the key growth
drivers of the pharmaceutical and biotechnology industries. Lonza has
strong capabilities in large and small molecules, peptides, amino
acids and niche bioproducts which play an important role in the
development of novel medicines and healthcare products. Lonza is also
the world leader in microbial control providing innovative,
chemistry-based and related solutions to destroy or to selectively
inhibit the growth of harmful microorganisms. Its activities
encompass the areas of water treatment, personal care, health and
hygiene, industrial preservation, materials protection, and wood
treatment. In addition, Lonza is a leader in cell-based research,
endotoxin detection and cell therapy manufacturing. Furthermore, the
company is a leading provider of value chemical and biotech
ingredients to the nutrition and agro markets.

Lonza is headquartered in Basel, Switzerland and is listed on the SIX
Swiss Exchange and secondary listed on the Singapore Exchange
Securities Trading Limited ("SGX-ST"). Lonza is not subject to the
SGX-ST´s continuing listing requirements. Lonza is subject to the
listing rules of the SIX Swiss Exchange, which do not have specific
requirements equivalent to the listing rules of the SGX-ST in respect
of interested person transactions, acquisition and realizations, and
delisting. In 2011, the company had sales of CHF 2.69 billion.
Further information can be found at www.lonza.com.

Safe Harbor Statement for Agennix: 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:
Lonza Group Ltd
Head of Corporate Communications
Dominik Werner
Tel +41 61 316 8798
Fax +41 61 316 9798
dominik.werner@lonza.com

Lonza Group Ltd
Investor Relations
Dirk Oehlers
Tel +41 61 316 8540
Fax +41 61 316 9540
dirk.oehlers@lonza.com

Lonza Group Ltd
Media Relations
Melanie Disa
Tel +1 201 316 9413
Fax +1 201 696 3533
melanie.disa@lonza.com

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

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


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