EANS-News: Epigenomics AG and NextPharma Sign Global Manufacturing Deal for Colorectal Cancer Blood Test

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Company Information/Molecular diagnostics

Berlin, Germany and Surrey, United Kingdom, 6th October, 2010 (euro
adhoc) - The cancer molecular diagnostics company Epigenomics AG and
NextPharma Technologies, the leading European provider of product
development, contract manufacturing and cold chain and logistics
outsourcing services to the pharmaceutical and biotechnology
industries, today announced that the companies have signed a global
manufacturing contract for Epigenomics´ Epi proColon product. Epi
proColon, currently marketed in Europe, is the world´s first in-vitro
diagnostic test for the detection of colorectal cancer in a simple
blood draw.

Under the terms of the agreement between the companies, NextPharma
will manufacture Epigenomics´ CE-marked Epi proColon test kit for
European and other markets according to the ISO 13485 for medical
devices and will manufacture a cGMP-compliant version for the US
market that is currently under development. Epigenomics plans to
submit a marketing application to the US Food and Drug Administration
(FDA) for the Epi proColon test in 2011.

"In NextPharma we have found the ideal contract manufacturing partner
to satisfy the increasing demand for our Epi proColon test kit in
Europe," commented Dr. Uwe Staub, Senior Vice President Product
Development at Epigenomics. "With its high quality standards and
depth of experience in medical device manufacturing NextPharma is
also ideally positioned to manufacture our future US product."

NextPharma will manufacture the Epi proColon test kits at its US
facility based in San Diego, California. This operation serves small
to large corporations worldwide in the biotechnology, pharmaceutical,
diagnostic, and medical device industries. Its aseptic area has
multiple clean room suites offering Class 10,000 (Class 7 or Class C)
formulation rooms and Class 100 (Class 5 or Class A) filling hoods or
rooms. This facility is FDA licensed for pharmaceutical manufacturing
and medical devices and is ISO 13485 certified for medical device
manufacturing.

NextPharma´s medical device capabilities include in-vitro diagnostic
reagents and kit preparation, custom procedure pack preparation as
well as research analytical agents and research reagent kit
preparation. In addition NextPharma is capable of performing
prototype and pilot manufacturing of Class I/II Medical Devices.

"We are delighted to work alongside Epigenomics in manufacturing this
innovative diagnostic test for the early detection of colorectal
cancer for the global market" commented Bill Wedlake, Chief
Executive Officer, NextPharma Technologies. "This is a testament to
our skill, flexibility and speed in delivering this very important
product through a combination of our medical device team´s
significant experience combined with the utilization of our cutting
edge technologies at our San Diego site."

The Epi proColon colorectal cancer blood test is designed to be
convenient and patient friendly to overcome one of the biggest
hurdles in colorectal cancer detection: patients´ lack of acceptance
of currently available screening options. With the Epi proColon test,
patients simply provide a blood sample in the doctor´s office, which
can be part of a regular health check-up. The blood sample is then
shipped to a laboratory where it is tested for the presence of
methylated DNA of the Septin9 gene (mSEPT9). Detection of mSEPT9 in
blood plasma has been demonstrated to be a reliable indicator of the
presence of colorectal cancer in multiple case control studies with
CRC patients and colonoscopy-verified negative controls as well as
through a prospective population based study ("PRESEPT") of more than
7,900 subjects.

Current colorectal cancer screening methods - including fecal occult
blood tests (FOBT) and colonoscopy - are perceived to be inconvenient
and laborious and are infrequently used by individuals aged 50 and
older who should be screened at regular intervals. As a consequence,
the majority of cancers are detected at an advanced stage when the
chance of survival is greatly diminished. The blood-based Epi
proColon test may provide an opportunity for more people to
participate in early cancer detection schemes and as a result those
diagnosed with colon cancer may have a better prognosis.

About Epigenomics

Epigenomics is a molecular diagnostics company with a focus on the
development of novel products for cancer. Using DNA methylation
biomarkers, Epigenomics´ tests on the market and in development aim
at detecting cancer before symptoms occur and thereby potentially
reducing mortality from this disease.

Epigenomics´ product portfolio contains the CE-marked IVD test Epi
proColon, the world´s first regulatory cleared molecular diagnostic
test for the detection of colorectal cancer in blood that is based on
the biomarker Septin9, and further proprietary DNA methylation
biomarkers and IVD products at various stages of development and
commercialization for colorectal, lung and prostate cancer. For
development and global commercialization of IVD test products,
Epigenomics pursues a dual business strategy in which direct
commercialization of proprietary diagnostic test products is combined
with non-exclusive licensing to diagnostic industry players with
broad customer access. Strategic diagnostics industry partners
include Abbott Molecular, Sysmex Corporation,Quest Diagnostics
Incorporated, and ARUP Laboratories, Inc. for diagnostics test
products and services, and QIAGEN N.V. for sample preparation
solutions and research products. The company is headquartered in
Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc.,
in Seattle, WA, USA. For more information, please visit Epigenomics´
website at www.epigenomics.com.

About NextPharma

NextPharma Technologies, headquartered in the UK and founded in 2000,
is a world class outsourcing partner to the pharmaceutical and
biotechnology industry.

NextPharma offers a full range of services from early phase product
development, through clinical trial packaging (Phases I through III)
to high volume commercial manufacturing for New Chemical Entities
(NCEs)/New Biological Entities (NBEs) and generic products. The
company is a world leader in lyophilization, sterile fill finish and
pellet technologies and in specialist product manufacturing including
cytotoxics, hormones, penicillins, cephalosporins and controlled
drugs. Its sterile development and production offers a full range of
drug delivery technologies including pre-filled syringes, vials and
ampoules. Additionally NextPharma has significant expertise in
paediatric drug formulation, development and manufacture. NextPharma
offers `one-stop´ logistics solutions tailored to meet the needs of
the global pharmaceutical industry under the rigid standards of
cGSP/GDP regulations.

NextPharma operates globally with seven product development centers,
seven manufacturing plants and six temperature controlled storage and
distribution sites across Europe and North America, supplying
customers in North America, Europe and Japan.

NextPharma has 1,200 employees dedicated to serving over 200
customers worldwide and a customer base, which includes many of the
world´s leading pharmaceutical, specialty pharma and biotech
companies.

NextPharma has a proven track record in almost all pharmaceutical
technologies and product forms and in addition to the specialist
areas above have capabilities in solids, semi-solids, liquids, sprays
and dry dosage form technologies.

All of its sites are either FDA inspected, in the process of upgrade
for inspection or targeted for upgrade for inspection.

Epigenomics´ legal disclaimers. This communication expressly or
implicitly contains certain forward-looking statements concerning
Epigenomics AG and its business. Such statements involve certain
known and unknown risks, uncertainties and other factors which could
cause the actual results, financial condition, performance or
achievements of Epigenomics AG to be materially different from any
future results, performance or achievements expressed or implied by
such forward-looking statements. Epigenomics AG is providing this
communication as of this date and does not undertake to update any
forward-looking statements contained herein as a result of new
information, future events or otherwise.

The information contained in this communication does not constitute
nor imply an offer to sell or transfer any product, and no product
based on this technology is currently available for sale by
Epigenomics in the United States of America. The analytical and
clinical performance characteristics of any product based on this
technology which may be sold at some future time in the USA have not
been established.

Contact NextPharma Contact Epigenomics AG

Bill Wedlake Dr. Achim Plum
Chief Executive Officer Sen. VP Corporate Development
NextPharma Technologies Epigenomics AG
Holding Limited
Tel +44 (0) 1483 479 121 Tel +49 (0) 30 24345 368
www.nextpharma.com pr@epigenomics.com
www.epigenomics.com

end of announcement euro adhoc
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ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Epigenomics AG

Dr. Achim Plum

Sen. VP Corporate Development

Tel: +49 30 24345 368

achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technology All Share
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