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Epigenomics AG

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

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

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
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade

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