EANS-News: Lonza and Agennix Sign Development and Manufacturing Deal for
Production of Talactoferrin
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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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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